Retrospective Survey of Safety of Fourth Dose Pentacel® in Children
The purpose of this survey is to collect selected safety data.
To collect selected safety data at 6 months following the 4th dose of the Pentacel® series.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Retrospective Safety Survey of Selected Events in the 6 Months Following the 4th Dose of the Pentacel® Vaccination Series in Children|
- 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 ] [ Designated as safety issue: Yes ]
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?
- 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 ] [ Designated as safety issue: Yes ]
SAE: any untoward medical occurrence with the following outcomes:
- 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)
|Study Start Date:||September 2003|
|Study Completion Date:||April 2005|
|Primary Completion Date:||April 2004 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772369
|Canada, British Columbia|
|Vancouver, British Columbia, Canada, V5Z 4R4|
|Study Director:||Medical Monitor||Sanofi Pasteur Inc.|