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Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

Last updated on November 19, 2019

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Study Location
Albi, , 81000 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
42-98 days
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy 2-month-old infants.

- Available for the entire study period.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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· Known contraindication to vaccines.

NCT00366678
Pfizer
Completed
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

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Descriptive Information
Brief Title  ICMJE Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Official Title  ICMJE A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in France.
Brief SummaryThe purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccines in France.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Vaccines, Pneumococcal
Intervention  ICMJE
  • Biological: 13-valent pneumococcal conjugate vaccine
    Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.
  • Biological: 7-valent pneumococcal conjugate vaccine
    Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.
  • Drug: Pentavac
    The Pentavac was administered by intramuscular injection 0.5 ml into the anterolateral thigh muscle of the right leg at 2, 3, and 4 months (infant series) and 12 months of age (toddler dose).
Study Arms  ICMJE
  • Experimental: 13-valent pneumococcal conjugate vaccine
    13-valent pneumococcal conjugate vaccine
    Interventions:
    • Biological: 13-valent pneumococcal conjugate vaccine
    • Drug: Pentavac
  • Active Comparator: 7-valent pneumococcal conjugate vaccine
    7-valent pneumococcal conjugate vaccine
    Interventions:
    • Biological: 7-valent pneumococcal conjugate vaccine
    • Drug: Pentavac
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2012)
613
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion DateNovember 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy 2-month-old infants.
  • Available for the entire study period.

Exclusion criteria:

· Known contraindication to vaccines.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 42 Days to 98 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00366678
Other Study ID Numbers  ICMJE 6096A1-008
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyWyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor France, [email protected]
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateJuly 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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