Post Market Surveillance for Infanrix™

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Diphtheria; Tetanus; Acellular Pertussis

Treatments: Biological: GSK Biologicals' Infanrix™

Study type: Observational

Funder types: Industry

Identifiers

NCT00908115

208355/128

Details and patient eligibility

About

The purpose of this study was to investigate the following questions through post-marketing surveillance:

• Unknown/Unexpected adverse events and the serious adverse events.
• The circumstances in which the adverse events occurred under the practical application.
• Factors considered to have influence on safety.
• Factors considered to have influence on efficacy.
• Miscellaneous - Facts about mechanism, efficacy and safety which were not clearly known due to the inherent problems of the drugs.

Enrollment: 1,258 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

All children receiving Infanrix™ were eligible for this survey.

Exclusion Criteria:

Trial design

1,258 participants in 1 patient group

Infanrix Group

Description:

Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).

Treatment:

Biological: GSK Biologicals' Infanrix™