Retrospective Survey of Safety of Fourth Dose Pentacel® in Children
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|ClinicalTrials.gov Identifier: NCT00772369|
Recruitment Status : Completed
First Posted : October 15, 2008
Results First Posted : April 2, 2010
Last Update Posted : February 14, 2014
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.
|Condition or disease|
|Diphtheria Pertussis Haemophilus Infection Tetanus Polio|
|Study Type :||Observational|
|Actual Enrollment :||3214 participants|
|Official Title:||Retrospective Safety Survey of Selected Events in the 6 Months Following the 4th Dose of the Pentacel® Vaccination Series in Children|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||April 2004|
|Actual Study Completion Date :||April 2005|
- 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:
- 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 ]
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00772369
|Canada, British Columbia|
|Vancouver, British Columbia, Canada, V5Z 4R4|
|Study Director:||Medical Monitor||Sanofi Pasteur Inc.|