Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)

Pfizer

Status: Completed

Conditions: Streptococcus Pneumoniae; Pneumococcal Vaccine

Treatments: Biological: 7-valent vaccine injection

Study type: Observational

Funder types: Industry

Identifiers

NCT01521897

0887X1-4447

B1841005 (Other Identifier)

Details and patient eligibility

About

This surveillance aims to figure out 1) use-results, 2) occurrence of adverse events, and 3) factors affecting safety in terms of the safety in infants starting to receive Prevenar at the age of more than 2 and less than 7 months in routine medical practice.

This surveillance will specifically focus on the occurrence of the following:

1. Local reactions at the injection site
2. Systemic reactions for each concomitant vaccine (especially fever more than 39C°)

Full description

This surveillance will be conducted using a continuous surveillance system, in which each physician enrolls patients who meet the enrollment criteria continuously until the contract sample size is reached.

Enrollment: 1,143 patients

Sex: All

Ages: 2 months to 2 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants at the age of more than 2 and less than 7 months
• Infants who have been vaccinated with Prevenar for the first time
• Infants expected to complete four vaccinations with Prevenar

Exclusion criteria

Vaccination with Prevenar must not be given to any of the following;

• History of evident anaphylactic reaction to any component of Prevenar or diphtheria toxoid
• Evident pyrexia
• Evident serious acute disease
• Any other infants or children ineligible for vaccination

Trial design

1,143 participants in 1 patient group

7-valent vaccine injection

Description:

Infants starting to receive Prevenar at the age of more than 2 and less than 7 months

Treatment:

Biological: 7-valent vaccine injection