Database Surveillance Safety Study of PENTACEL® Vaccine

Sanofi

Status: Completed

Conditions: Diphtheria; Pertussis; Tetanus; Haemophilus Influenzae

Treatments: Biological: DTaP-IPV/Hib; Biological: Other DTap Vaccines

Study type: Observational

Funder types: Industry

Identifiers

NCT00804284

M5A11

Details and patient eligibility

About

The objective for this study is to characterize the safety profile of PENTACEL® vaccine for identification of potential vaccine-related adverse events not currently associated with PENTACEL® vaccine administration.

Full description

The study will be conducted at Kaiser Permanente Northern California and will commence with first use of licensed PENTACEL® vaccine within that organization.

Vaccination databases will be reviewed to identify Diphtheria and tetanus toxoid with acellular pertussis (DTaP) vaccinations of accrued subjects. Medical encounter, emergency room, hospitalization, laboratory, state death reporting, and related databases will be reviewed to identify medical care events.

Enrollment: 62,538 patients

Sex: Male

Ages: 6 weeks to 24 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Receipt of DTaP vaccine during the study period by a previously unvaccinated child

Exclusion criteria

• None

Trial design

62,538 participants in 2 patient groups

Pentacel Group

Description:

Infants initiated on PENTACEL® vaccine

Treatment:

Biological: DTaP-IPV/Hib

Other DTap vaccines Group

Description:

Infants initiated on other DTaP vaccines

Treatment:

Biological: Other DTap Vaccines