Retrospective Safety Survey of Selected Events in the 6 Months Following the 4th Dose of the Pentacel® Vaccination Series in Children
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diphtheria
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Enrollment
- 3214
- Primary Endpoint
- Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
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?
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)