Retrospective Survey of Safety of Fourth Dose Pentacel® in Children

January 20, 2014 updated by: Sanofi Pasteur, a Sanofi Company

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

3214

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4R4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series
Time Frame: 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?
6 months post 4th dose vaccination
Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine.
Time Frame: 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)
6 Months post 4th dose vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (ACTUAL)

April 1, 2004

Study Completion (ACTUAL)

April 1, 2005

Study Registration Dates

First Submitted

October 13, 2008

First Submitted That Met QC Criteria

October 13, 2008

First Posted (ESTIMATE)

October 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2014

Last Update Submitted That Met QC Criteria

January 20, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M5A08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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