Retrospective Survey of Safety of Fourth Dose Pentacel® in Children

Tetanus Clinical Trial

Official title:

Retrospective Safety Survey of Selected Events in the 6 Months Following the 4th Dose of the Pentacel® Vaccination Series in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772369
• Other study ID #: M5A08
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2008
• Last updated: January 20, 2014
• Start date: September 2003
• Est. completion date: April 2005

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3214
• Est. completion date: April 2005
• Est. primary completion date: April 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 24 Months

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Infection
• Haemophilus Infections
• Pertussis
• Polio
• Tetanus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series	Positive response is a 'Yes' to any of the following questions: Has your child been admitted to a hospital?; 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?; Has your child developed a medical condition that required 3 or more office or emergency room visits for that condition?; 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?	6 months post 4th dose vaccination	Yes
Primary	Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine.	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)	6 Months post 4th dose vaccination	Yes

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