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Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Fayetteville, Arkansas, 72703 United States
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

- Previous vaccination with any vaccine before the start of the study.

- Known contraindication to vaccination.

NCT00373958
Pfizer
Completed
Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine

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Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine
A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability and Immunologic Noninferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC) and to compare the immune response to concomitant vaccines administered with 13vPnC and 7vPnC.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Vaccines, Pneumococcal
  • Biological: 13 valent pneumococcal conjugate vaccine
    1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
  • Biological: 7vPnc pneumococcal conjugate vaccine
    1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
  • Experimental: 13vPnC vaccine
    Intervention: Biological: 13 valent pneumococcal conjugate vaccine
  • Active Comparator: 7vPnC vaccine
    Intervention: Biological: 7vPnc pneumococcal conjugate vaccine


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
666
June 2008
June 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion criteria:

  • Previous vaccination with any vaccine before the start of the study.
  • Known contraindication to vaccination.
Sexes Eligible for Study: All
42 Days to 98 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00373958
6096A1-004
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
January 2013

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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