Trial record 1 of 1 for:
M5A08
Retrospective Survey of Safety of Fourth Dose Pentacel® in Children
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00772369 |
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Recruitment Status :
Completed
First Posted : October 15, 2008
Results First Posted : April 2, 2010
Last Update Posted : February 14, 2014
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Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
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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.
| Condition or disease |
|---|
| Diphtheria Pertussis Haemophilus Infection Tetanus Polio |
| Study Type : | Observational |
| Actual Enrollment : | 3214 participants |
| 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 |
| Study Start Date : | September 2003 |
| Actual Primary Completion Date : | April 2004 |
| Actual Study Completion Date : | April 2005 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Vaccines
Drug Information available for:
Pentacel
Primary Outcome Measures :
- 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:
- 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)
Information from the National Library of Medicine
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| Ages Eligible for Study: | 12 Months to 24 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| 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
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.
Information from the National Library of Medicine
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
Locations
| Canada, British Columbia | |
| Vancouver, British Columbia, Canada, V5Z 4R4 | |
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
| Study Director: | Medical Monitor | Sanofi Pasteur Inc. |
Additional Information:
| Responsible Party: | Sanofi Pasteur, a Sanofi Company |
| ClinicalTrials.gov Identifier: | NCT00772369 |
| Other Study ID Numbers: |
M5A08 |
| First Posted: | October 15, 2008 Key Record Dates |
| Results First Posted: | April 2, 2010 |
| Last Update Posted: | February 14, 2014 |
| Last Verified: | January 2014 |
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
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Pertussis Whooping cough Diphtheria |
Tetanus Haemophilus influenzae Poliovirus Types 1, 2, and 3. |
Additional relevant MeSH terms:
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Whooping Cough Tetanus Diphtheria Haemophilus Infections Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses |
Infections Respiratory Tract Infections Respiratory Tract Diseases Clostridium Infections Gram-Positive Bacterial Infections Corynebacterium Infections Actinomycetales Infections Pasteurellaceae Infections |