A Safety Study For Prevenar 13 Among Chinese Children

Fever Clinical Trial

Official title:

AN OBSERVATIONAL SAFETY STUDY FOR PREVENAR 13 AMONG CHINESE CHILDREN

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03656939
• Other study ID #: B1851193
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: July 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational study based on a population-based EHR database.

Description:

This observational study based on a population-based EHR database in Yinzhou district of Ningbo city in China is to estimate incidence rates of seizures (including febrile seizures), urticaria and angioedema, apnea, and fever among Chinese children after receiving Prevenar 13. In addition, a validation study including validation of International classification of diseases, tenth revision (ICD-10) codes or ICD-10 code based algorithm for identifying all safety outcomes of interest and a prospective cohort study in a sub-population of the main study will be conducted in order to offset the potential biased results from the main study because of potential misclassification of the safety outcomes of interest due to miscoding and/or undercoding of ICD-10 codes used to identify these safety outcomes in the EHR database.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21240
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 24 Months

Eligibility

Inclusion Criteria:

To be eligible for the main study, children in Yinzhou population-based EHR database must be aged 1 to 24 months and receive at least one dose of 13vPnC between May 1st, 2017 and July 24th, 2020 where the first dose is received before or on July 24th, 2020 since a 7-day post-vaccination follow-up for each dose in each child receiving 13vPnC is needed. For the prospective cohort in a sub-population of the main study, eligible children for the main study must receive the first dose of 13vPnC between August 1st, 2018 and July 24th, 2020 and an informed consent must be obtained from parents/legal guardians. Exclusion Criteria: There are no exclusion criteria for this study.

Related Conditions & MeSH terms

• Angioedema
• Apnea
• Fever
• Seizures
• Urticaria
• Urticaria and Angioedema

Locations

Country	Name	City	State
China	School of Public Health at Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 1	Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 3 days after Dose 1
Primary	Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 1	Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	4 to 7 days after Dose 1
Primary	Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 1	Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 7 days after Dose 1
Primary	Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 1	Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 3 days after Dose 1
Primary	Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 1	Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	4 to 7 days after Dose 1
Primary	Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 1	Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 7 days after Dose 1
Primary	Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	0 to 3 days after Dose 1
Primary	Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	4 to 7 days after Dose 1
Primary	Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	0 to 7 days after Dose 1
Primary	Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 1	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.	0 to 3 days after Dose 1
Primary	Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 1	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.	4 to 7 days after Dose 1
Primary	Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 1	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.	0 to 7 days after Dose 1
Primary	Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 1	Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 3 days after Dose 1
Primary	Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 1	Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	4 to 7 days after Dose 1
Primary	Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 1	Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 7 days after Dose 1
Primary	Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 2	Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 3 days after Dose 2
Primary	Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 2	Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	4 to 7 days after Dose 2
Primary	Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 2	Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 7 days after Dose 2
Primary	Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 2	Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 3 days after Dose 2
Primary	Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 2	Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	4 to 7 days after Dose 2
Primary	Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 2	Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 7 days after Dose 2
Primary	Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	0 to 3 days after Dose 2
Primary	Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	4 to 7 days after Dose 2
Primary	Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	0 to 7 days after Dose 2
Primary	Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 2	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.	0 to 3 days after Dose 2
Primary	Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 2	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.	4 to 7 days after Dose 2
Primary	Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 2	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.	0 to 7 days after Dose 2
Primary	Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 2	Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 3 days after Dose 2
Primary	Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 2	Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	4 to 7 days after Dose 2
Primary	Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 2	Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 7 days after Dose 2
Primary	Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 3	Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 3 days after Dose 3
Primary	Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 3	Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	4 to 7 days after Dose 3
Primary	Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 3	Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 7 days after Dose 3
Primary	Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 3	Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 3 days after Dose 3
Primary	Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 3	Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	4 to 7 days after Dose 3
Primary	Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 3	Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 7 days after Dose 3
Primary	Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	0 to 3 days after Dose 3
Primary	Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	4 to 7 days after Dose 3
Primary	Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	0 to 7 days after Dose 3
Primary	Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 3	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.	0 to 3 days after Dose 3
Primary	Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 3	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.	4 to 7 days after Dose 3
Primary	Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 3	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.	0 to 7 days after Dose 3
Primary	Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 3	Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 3 days after Dose 3
Primary	Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 3	Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	4 to 7 days after Dose 3
Primary	Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 3	Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 7 days after Dose 3
Primary	Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 4	Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 3 days after Dose 4
Primary	Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 4	Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	4 to 7 days after Dose 4
Primary	Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 4	Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 7 days after Dose 4
Primary	Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 4	Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 3 days after Dose 4
Primary	Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 4	Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	4 to 7 days after Dose 4
Primary	Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 4	Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 7 days after Dose 4
Primary	Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	0 to 3 days after Dose 4
Primary	Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	4 to 7 days after Dose 4
Primary	Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	0 to 7 days after Dose 4
Primary	Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 4	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.	0 to 3 days after Dose 4
Primary	Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 4	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.	4 to 7 days after Dose 4
Primary	Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 4	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.	0 to 7 days after Dose 4
Primary	Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 4	Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 3 days after Dose 4
Primary	Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 4	Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	4 to 7 days after Dose 4
Primary	Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 4	Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 7 days after Dose 4
Primary	Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After All Doses	Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 3 Days after all Doses
Primary	Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After All Doses	Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	4 to 7 Days after all Doses
Primary	Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After All Doses	Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 7 Days after all Doses
Primary	Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After All Doses	Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 3 Days after all Doses
Primary	Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After All Doses	Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	4 to 7 Days after all Doses
Primary	Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After All Doses	Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 7 Days after all Doses
Primary	Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After All Doses	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	0 to 3 days after all Doses
Primary	Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After All Doses	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	4 to 7 days after all Doses
Primary	Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After All Doses	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	0 to 7 days after all Doses
Primary	Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After All Doses	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.	0 to 3 days after all doses
Primary	Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After All Doses	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.	4 to 7 days after all doses
Primary	Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After All Doses	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.	0 to 7 days after all doses
Primary	Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After All Doses	Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 3 days after all doses
Primary	Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After All Doses	Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	4 to 7 days after all doses
Primary	Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After All Doses	Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.	0 to 7 days after all doses
Primary	Incidence Rate (IR) (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 1	IR was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 3 days after Dose 1
Primary	Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 1	Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.	4 to 7 days after Dose 1
Primary	Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 1	Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 7 days after Dose 1
Primary	Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 1	Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 3 days after Dose 1
Primary	Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 1	Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.	4 to 7 days after Dose 1
Primary	Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 1	Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 7 days after Dose 1
Primary	Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	0 to 3 days after Dose 1
Primary	Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	4 to 7 days after Dose 1
Primary	Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	0 to 7 days after Dose 1
Primary	Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 1	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.	0 to 3 days after Dose 1
Primary	Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 1	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.	4 to 7 days after Dose 1
Primary	Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 1	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.	0 to 7 days after Dose 1
Primary	Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 1	Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 3 days after Dose 1
Primary	Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 1	Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.	4 to 7 days after Dose 1
Primary	Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 1	Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 7 days after Dose 1
Primary	Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 2	Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 3 days after Dose 2
Primary	Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 2	Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.	4 to 7 days after Dose 2
Primary	Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 2	Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 7 days after Dose 2
Primary	Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 2	Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 3 days after Dose 2
Primary	Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 2	Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.	4 to 7 days after Dose 2
Primary	Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 2	Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 7 days after Dose 2
Primary	Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	0 to 3 days after Dose 2
Primary	Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	4 to 7 days after Dose 2
Primary	Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	0 to 7 days after Dose 2
Primary	Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 2	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.	0 to 3 days after Dose 2
Primary	Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 2	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.	4 to 7 days after Dose 2
Primary	Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 2	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.	0 to 7 days after Dose 2
Primary	Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 2	Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 3 days after Dose 2
Primary	Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 2	Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.	4 to 7 days after Dose 2
Primary	Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 2	Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 7 days after Dose 2
Primary	Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 3	Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 3 days after Dose 3
Primary	Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 3	Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.	4 to 7 days after Dose 3
Primary	Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 3	Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 7 days after Dose 3
Primary	Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 3	Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 3 days after Dose 3
Primary	Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 3	Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.	4 to 7 days after Dose 3
Primary	Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 3	Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 7 days after Dose 3
Primary	Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	0 to 3 days after Dose 3
Primary	Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	4 to 7 days after Dose 3
Primary	Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	0 to 7 days after Dose 3
Primary	Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 3	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.	0 to 3 days after Dose 3
Primary	Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 3	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.	4 to 7 days after Dose 3
Primary	Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 3	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.	0 to 7 days after Dose 3
Primary	Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 3	Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 3 days after Dose 3
Primary	Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 3	Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.	4 to 7 days after Dose 3
Primary	Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 3	Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 7 days after Dose 3
Primary	Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 4	Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 3 days after Dose 4
Primary	Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 4	Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.	4 to 7 days after Dose 4
Primary	Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 4	Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 7 days after Dose 4
Primary	Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 4	Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 3 days after Dose 4
Primary	Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 4	Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.	4 to 7 days after Dose 4
Primary	Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 4	Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 7 days after Dose 4
Primary	Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	0 to 3 days after Dose 4
Primary	Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	4 to 7 days after Dose 4
Primary	Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	0 to 7 days after Dose 4
Primary	Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 4	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.	0 to 3 days after Dose 4
Primary	Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 4	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.	4 to 7 days after Dose 4
Primary	Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 4	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.	0 to 7 days after Dose 4
Primary	Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 4	Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 3 days after Dose 4
Primary	Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 4	Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.	4 to 7 days after Dose 4
Primary	Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 4	Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 7 days after Dose 4
Primary	Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After All Doses	Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 3 days after all doses
Primary	Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After All Doses	Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.	4 to 7 days after all doses
Primary	Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After All Doses	Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 7 days after all doses
Primary	Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After All Doses	Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 3 days after all doses
Primary	Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After All Doses	Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.	4 to 7 days after all doses
Primary	Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After All Doses	Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 7 days after all doses
Primary	Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After All Doses	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	0 to 3 days after all Doses
Primary	Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After All Doses	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	4 to 7 days after all Doses
Primary	Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After All Doses	Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.	0 to 7 days after all Doses
Primary	Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After All Doses	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.	0 to 3 days after all Doses
Primary	Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After All Doses	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.	4 to 7 days after all Doses
Primary	Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After All Doses	Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.	0 to 7 days after all Doses
Primary	Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After All Doses	Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 3 days after all doses
Primary	Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After All Doses	Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.	4 to 7 days after all doses
Primary	Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After All Doses	Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.	0 to 7 days after all doses

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