Retrospective Survey of Safety of Fourth Dose Pentacel® in Children

Completed

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

• Registration Number: NCT00772369
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

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.

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.

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2004-04
• Study Completion: 2005-04
• Study First Submitted: 2008-10-13
• Study First Submitted QC: 2008-10-13
• Study First Posted: 2008-10-15
• Results First Submitted: 2010-03-15
• Results First Submitted QC: 2010-03-15
• Results First Posted: 2010-04-02
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-20
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3214

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series	6 months post 4th dose vaccination	Positive response is a 'Yes' to any of the following questions: 1. Has your child been admitted to a hospital?; 2. Has your child experienced an illness that made you fear for his/her life (life-threatening episode) that required attendance to the Emergency Room or a Physician's office?; 3. Has your child developed a medical condition that required 3 or more office or emergency room visits for that condition?; 4. Has your child been diagnosed by a physician as having: Low blood count or low platelet count? Swelling or redness of the joints? Asthma? Diabetes? Autism?
Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine.	6 Months post 4th dose vaccination	SAE: any untoward medical occurrence with the following outcomes: * death,; * a life-threatening adverse drug experience (as confirmed by the investigators),; * inpatient hospitalization or prolongation of existing hospitalization,; * a persistent or significant disability/incapacity, or; * a congenital anomaly/birth defect. Medical conditions that required 3 or more office or emergency room visits, and diagnosis by a physician of low blood cell count or low platelet count, swelling or redness of the joints, asthma, diabetes, or autism were also solicited. (MedDRA Version 6.0)