Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    M5A08
Previous Study | Return to List | Next Study

Retrospective Survey of Safety of Fourth Dose Pentacel® in Children

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
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 )

Tracking Information
First Submitted Date October 13, 2008
First Posted Date October 15, 2008
Results First Submitted Date March 15, 2010
Results First Posted Date April 2, 2010
Last Update Posted Date February 14, 2014
Study Start Date September 2003
Actual Primary Completion Date April 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 1, 2010)
  • 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?
  • 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)
Original Primary Outcome Measures
 (submitted: October 13, 2008)
Safety: To provide information concerning the safety of Pentacel™ [ Time Frame: 6 months post 4th dose vaccination ]
Change History Complete list of historical versions of study NCT00772369 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Retrospective Survey of Safety of Fourth Dose Pentacel® in Children
Official Title Retrospective Safety Survey of Selected Events in the 6 Months Following the 4th Dose of the Pentacel® Vaccination Series in Children
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.

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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Diphtheria
  • Pertussis
  • Haemophilus Infection
  • Tetanus
  • Polio
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 13, 2008)
3214
Original Actual Enrollment Same as current
Actual Study Completion Date April 2005
Actual Primary Completion Date April 2004   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Months to 24 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT00772369
Other Study ID Numbers M5A08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor Sanofi Pasteur, a Sanofi Company
Collaborators Not Provided
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date January 2014