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

Last updated on May 12, 2018

FOR MORE INFORMATION
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.
Show details

· Known contraindication to vaccines.

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

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Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
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.
The 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Vaccines, Pneumococcal
  • 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).
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
613
November 2008
November 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion criteria:

· Known contraindication to vaccines.

Sexes Eligible for Study: All
42 Days to 98 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00366678
6096A1-008
No
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For France, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
July 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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