Postlicensure Observational Safety Study of 13vPnC Administered to Infants and Toddlers

Pfizer

Status: Completed

Conditions: Pneumococcal Disease

Treatments: Other: No Intervention

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01128426

6096A1-4002

B1851044

Details and patient eligibility

About

The purpose of the study is to expand the understanding of the safety profile of 13vPnC in routine use following licensure and introduction of the vaccine.

Enrollment: 53,902 patients

Sex: All

Ages: 2 months to 3 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Infants starting vaccination with 13vPnC in the first 6 months of life who are members of the Northern California Kaiser Permanente healthcase system and who receive at least 1 dose of 13vPnC during the study observation period will be included. Infants must not have had 7vPnC at the time of 13vPnC dose administration.

Exclusion criteria

• Infants and children who were previously vaccinated with any number of doses of 7vPnC will be excluded.

Trial design

53,902 participants in 1 patient group

1

Treatment:

Other: No Intervention