You are here

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Benton, Arkansas, 72019 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 duration of the study and reachable by telephone

- Able to complete two blood drawing procedures during the study

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Previous vaccination, contraindication or history of allergic reaction to vaccines or
vaccine components

- Bleeding disorder, immune deficiency or significant chronic or congenital disease

- Previous receipt of blood products or immune globulin

NCT00444457
Pfizer
Completed
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants
A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Three Lots of 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States
The purpose of this study will be to evaluate safety, tolerability and immunogenicity of three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied for consistency of the immune response, as well as for non-inferiority and safety as compared to 7-valent Pneumococcal Conjugate Vaccine.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Vaccines, Pneumococcal
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
    0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.
  • Biological: 7vPnC
    0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.
  • Experimental: 1
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Experimental: 2
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Experimental: 3
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Active Comparator: 4
    Intervention: Biological: 7vPnC


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1712
June 2009
June 2009   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • Healthy 2 month old infants
  • Available for the duration of the study and reachable by telephone
  • Able to complete two blood drawing procedures during the study

Exclusion criteria:

  • Previous vaccination, contraindication or history of allergic reaction to vaccines or vaccine components
  • Bleeding disorder, immune deficiency or significant chronic or congenital disease
  • Previous receipt of blood products or immune globulin
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
 
 
NCT00444457
6096A1-3005
Not Provided
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
Wyeth is now a wholly owned subsidiary of Pfizer
October 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]



Call Now