Prevenar13 Post Market Surveillance

Pfizer

Status: Completed

Conditions: Healthy

Treatments: Biological: 13-valent pneumococcal vaccine

Study type: Observational

Funder types: Industry

Identifiers

NCT01509105

6096A1-4029

B1851057 (Other Identifier)

Details and patient eligibility

About

It is an observational multi-center study to assess the safety profile of Prevenar13 used among Korean children in the routine clinical setting following a licensure and introduction of the vaccine. This study is designed to fulfill regulatory requirement for any new drug authorized by KFDA.

Full description

non-randomization, non-probability sampling

Enrollment: 649 patients

Sex: All

Ages: 6 weeks to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants and children aged 6 weeks to 5 years, whose legally authorized representatives of patients agree to provide written informed consent form (data privacy statement).

Exclusion criteria

• Infants and children who are not indicated and/or contraindicated for the Prevenar13 usage will not be included.

Trial design

649 participants in 1 patient group

Group1

Treatment:

Biological: 13-valent pneumococcal vaccine