A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Infants and Young Children

Pneumococcal Infections Clinical Trial

Official title:

A PHASE 3 OPEN-LABEL TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN INFANTS AND YOUNG CHILDREN IN CHINA WHO ARE NAIVE TO PNEUMOCOCCAL VACCINATION

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03574389
• Other study ID #: B1851178
• Status: Completed
• Phase: Phase 3
• Start date: June 23, 2018
• Est. completion date: October 13, 2023

Study information

• Verified date: November 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and immunogenicity of 13-valent Pneumococcal conjugate vaccine in Chinese infant and young children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 936
• Est. completion date: October 13, 2023
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Days to 5 Years

Eligibility

Inclusion Criteria:

• Evidence of a personally signed and dated ICD indicating that the parent(s)/legal guardian has been informed of all pertinent aspects of the study.

• Aged 6 weeks (42 days) to <6 years at the time of consent.

• Healthy infants and children as determined by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria:

• Participation in other studies involving investigational drug(s)/vaccine(s) since birth (Cohort 1 only) or in the 6 months prior to study entry (Cohorts 2, 3, and 4) and/or during study participation.

• Other acute or chronic medical or psychiatric condition, including recent laboratory abnormality, that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

• Vaccination with licensed or investigational pneumococcal vaccine.

• Previous vaccination with licensed or investigational Hib vaccine.

Related Conditions & MeSH terms

• Pneumococcal Conjugate Vaccine
• Pneumococcal Infections

Intervention

Biological:
• 13vPnC
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
• Hib
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose

Locations

Country	Name	City	State
China	Huaiyin District Center for Disease Prevention and Control	Huaian	Jiangsu
China	Guanyun County Disease Control and Prevention	Lianyungang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1	Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken 1 month after the infant series in Cohort 1 and the last dose 13vPnC in Cohorts 2, 3, 4. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.	Cohort 1: 1 month after the 3rd dose of 13vPnC (infant series dose). Cohort 2, 3, 4: 1 month after the last dose of 13vPnC.
Primary	Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 2	Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (decreased appetite, drowsiness and irritability) were recorded for 7 days after each investigational product vaccination.	Within 7 Days After Each Vaccination
Primary	Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 3	Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (decreased appetite, drowsiness and irritability) were recorded for 7 days after each investigational product vaccination.	Within 7 Days After Each Vaccination
Primary	Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 4	Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (fatigue, headache, vomiting, diarrhea, muscle pain and joint pain) were recorded for 7 days after each investigational product vaccination.	Within 7 Days After Each Vaccination
Primary	Number of Participants With Adverse Event (AE) From the Signing of the Informed Consent Document (ICD) to 1 Month After the Last Vaccination in Cohorts 2, 3, 4	An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.	From the signing of ICD to 1 month after the last vaccination (13vPnC or Hib) in Cohort 2, 3 and 4.
Primary	Number of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From 1 Month to 6 Months After the Last Vaccination in Cohorts 2, 3, 4	Number of participants with NDCMCs from 1 month after the last study vaccination (13vPnC or Hib vaccine) to 6 months after the last study vaccination in Cohorts 2, 3, and 4. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.	From 1 month to 6 months (5 months) after the last vaccination in Cohorts 2,3,4.
Primary	Number of Participants With SAE From the Signing of the ICD to 6 Months After the Last Vaccination in Cohorts 2, 3, 4	An SAE was any untoward medical occurrence at any dose that resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or considered to be an important medical event.	From the signing of ICD to 6 month after the last vaccination (13vPnC or Hib) in Cohorts 2, 3 and 4.
Secondary	The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1.	Serotype-specific OPA titers to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in a randomly selected subset of about 50 participants receiving 13vPnC from the blood samples taken 1 month after the infant series in Cohort 1 and the last 13vPnC vaccination in each of the 3 cohorts. GMT and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.	Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohort 2, 3, 4: 1 month after the last dose of 13vPnC.
Secondary	The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.	Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken before vaccination and 1 month after vaccination in each of the 3 cohorts. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.	Cohort 2, 3, 4: Before Vaccination and 1 Month After the Last Dose
Secondary	The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.	Serotype-specific OPA titers to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in a randomly selected subset of approximately 50 participants receiving 13vPnC and approximately 25 participants receiving Hib vaccine from the blood samples taken before vaccination and 1 month after the last 13vPnC vaccination in each of the 3 cohorts.	Cohort 2, 3, 4: Before Vaccination and 1 Month After the Last Dose
Secondary	Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration =0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).	Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken 1 month after the infant series in Cohort 1 and the last dose of vaccination (13vPnC or Hib vaccine) in Cohorts 2, 3, 4.	Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohorts 2, 3, 4: 1 month after the last dose of 13vPnC and Hib Vaccine.
Secondary	Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer = Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).	Serotype-specific OPA titers to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in a randomly selected subset of about 50 participants receiving 13vPnC from the blood samples taken 1 month after the infant series in Cohort 1 and the last vaccination (13vPnC or Hib vaccine) in each of the 3 cohorts.	Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohorts 2, 3, 4: 1 month after the last dose of 13vPnC and Hib Vaccine.
Secondary	Number of Participants With AE From the Signing of the ICD to 1 Month After the Infant Series in Cohort 1	An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.	From the signing of ICD to 1 month after the 3rd dose of 13vPnC in Cohort 1.
Secondary	Number of Participants With NDCMCs From 1 Month After Vaccination 3 to Vaccination 4 in Cohort 1	Number of Participants With NDCMCs from 1 month after vaccination 3 to vaccination 4 in Cohort 1. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.	From 1 month after Vaccination 3 to Vaccination 4.
Secondary	Number of Participants With AE From Toddler Dose Until 1 Month After the Toddler Dose in Cohort 1	Number of Participants With AEs from vaccination 4 to 1 month after vaccination 4 in Cohort 1. An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.	From Vaccination 4 to 1 month after Vaccination 4 in Cohort 1.
Secondary	Number of Participants With NDCMCs From 1 Month to 6 Months After the Toddler Dose in Cohort 1	Number of Participants With NDCMCs from 1 month after vaccination 4 to 6 months after vaccination 4 in Cohort 1. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.	From 1 month to 6 months (5 months) after Vaccination 4 in Cohort 1.
Secondary	Number of Participants With SAE From the Signing of the ICD to 6 Months After the Toddler Dose in Cohort 1	Number of Participants With SAEs from the signing of the ICD to 6 months after vaccination 4. An SAE was any untoward medical occurrence at any dose that resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or considered to be an important medical event.	From the Signing of the ICD to 6 Months After the Vaccination 4.

External Links

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