Retrospective Survey of Safety of Fourth Dose Pentacel® in Children

Sanofi

Status: Completed

Conditions: Haemophilus Infection; Diphtheria; Polio; Tetanus; Pertussis

Study type: Observational

Funder types: Industry

Identifiers

NCT00772369

M5A08

Details and patient eligibility

About

The purpose of this survey is to collect selected safety data.

Primary Objective:

To collect selected safety data at 6 months following the 4th dose of the Pentacel® series.

Full description

This is a retrospective survey to collect selected safety data at 6 months following the 4th dose of Pentacel® in children residing in the Canadian Province of British Columbia who have received the 4th dose of the Pentacel® series before their 2nd birthday.

Enrollment: 3,214 patients

Sex: All

Ages: 12 to 24 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children residing in the Canadian Province of British Columbia who have received the 4th dose of the Pentacel® series before their 2nd birthday.
• Written Informed Consent and Telephone consent from the parent(s) or guardian(s).
• Able to comply with the survey procedures.

Exclusion criteria

• Fourth dose of the Pentacel® series received on or after the child's 2nd birthday.