Retrospective Survey of Safety of Fourth Dose Pentacel® in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00772369
First received: October 13, 2008
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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 Phase
Diphtheria
Pertussis
Haemophilus Infection
Tetanus
Polio
Phase 4

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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)


Enrollment: 3214
Study Start Date: September 2003
Study Completion Date: April 2005
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   12 Months to 24 Months
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00772369     History of Changes
Other Study ID Numbers: M5A08
Study First Received: October 13, 2008
Results First Received: March 15, 2010
Last Updated: January 20, 2014
Health Authority: Canada: Health Canada

Keywords provided by Sanofi:
Pertussis
Whooping cough
Diphtheria
Tetanus
Haemophilus influenzae
Poliovirus Types 1, 2, and 3.

Additional relevant MeSH terms:
Diphtheria
Haemophilus Infections
Whooping Cough
Poliomyelitis
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Bordetella Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations

ClinicalTrials.gov processed this record on August 21, 2014