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NCT02119104 Clinical Trial

Prevenar (13v) Infant Drug Use Investigation

Infants Clinical Trial

Official title:
Prevenar (13v) Infant Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02119104
Other study ID # B1851122
Secondary ID
Status Completed
Phase N/A
First received March 5, 2014
Last updated July 18, 2016
Start date March 2014
Est. completion date May 2016

Study information
Verified date July 2016
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The purpose of this study is to investigate post marketing use and safety of Prevnar ( 13v) in infants vaccinated for the first time at the age of 2 months, inclusive, to 7 months, exclusive.

Description:

The investigation will be conducted using the continuous investigation method, with which a satisfying registration conditions will be continuously registered until the number of contracted cases is reached.

Recruitment information / eligibility
Status Completed
Enrollment 1087
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 2 Months to 6 Months
Eligibility Inclusion Criteria:

- Vaccinees who meet all of the following conditions at the time of the first vaccination among infants who use Prevenar 13 in accordance with the indication, and dosage and administration of the vaccine will be included in the investigation:

- Infants aged 2 months, inclusive, to 7 months, exclusive

- Infants with no history of administration of pneumococcal vaccines including Prevenar 13

- Infants expected to receive 4 vaccinations

Exclusion Criteria:

- Vaccines must not be performed if the vaccinee corresponds to any of the following:

- Persons in whom a past history of anaphylaxis due to an ingredient of Prevenar 13 or diphtheria toxoid is evident

- Persons with evident pyrexia

- Persons who evidently have serious acute diseases

- Besides the persons listed above, persons who are in a status inappropriate for immunization

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Prevenar (13v)
Prevenar (13v)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Number of the participants with adverse reaction 52 weeks (MAX) Yes
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