Retrospective Survey of Safety of Fourth Dose Pentacel™ in Children - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00772369

Purpose

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.

Condition	Phase
Diphtheria Pertussis Haemophilus Infection Tetanus Polio	Phase IV

MedlinePlus related topics: Diphtheria Tetanus Whooping Cough

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	Retrospective Safety Survey of Selected Events in the 6 Months Following the 4th Dose of the Pentacel™ Vaccination Series in Children

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Safety: To provide information concerning the safety of Pentacel™ [ Time Frame: 6 months post 4th dose vaccination ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	3214
Study Start Date:	September 2003
Study Completion Date:	April 2005
Primary Completion Date:	April 2004 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility

Ages Eligible for Study:	12 Months to 24 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Children residing in the Canadian Province of British Columbia who have received the 4th dose of the Pentacel™ series before their 2nd birthday

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772369

Locations

Canada, British Columbia

Vancouver, British Columbia, Canada, V5Z 4R4

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Monitor

Sanofi Pasteur Inc.

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Sanofi Pasteur Inc. ( Medical Monitor )
Study ID Numbers:	M5A08
Study First Received:	October 13, 2008
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00772369
Health Authority:	Canada: Health Canada

Keywords provided by Sanofi-Aventis:

Pertussis
Whooping cough
Diphtheria

Tetanus
Haemophilus influenzae
Poliovirus Types 1, 2, and 3.

Study placed in the following topic categories:

Haemophilus Infections
Bacterial Infections
Haemophilus influenzae
Whooping Cough
Cough
Diphtheria
Tetanus
Whooping cough

Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Poliomyelitis
Influenza, Human
Clostridium Infections

Additional relevant MeSH terms:

Bordetella Infections
Pasteurellaceae Infections
Corynebacterium Infections
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 14, 2009