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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
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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

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
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





Primary Outcome Measures :
  1. 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?


  2. 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)



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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     History of Changes
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 ):
Pertussis
Whooping cough
Diphtheria
Tetanus
Haemophilus influenzae
Poliovirus Types 1, 2, and 3.

Additional relevant MeSH terms:
Whooping Cough
Tetanus
Diphtheria
Haemophilus Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Pasteurellaceae Infections