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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Brazil

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Curitiba, , 80060-900 Brazil
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Conjugate Vaccine Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-54
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy 1 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 vaccine or
vaccine components

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

- Previous receipt of blood products or immune globulin

NCT00676091
Pfizer
Completed
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Brazil

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Pfizer Clinical Trials Contact Center

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[email protected]

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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Brazil
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 Brazil
The purpose of this study will be to analyze 13-valent pneumococcal vaccine given to healthy infants in Brazil for safety and tolerability, and to determine the immune response to the vaccines.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Vaccines, Pneumococcal Conjugate Vaccine
  • Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
  • Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnc)
  • Experimental: 13vPnC
    13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
    Intervention: Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
  • Active Comparator: 7vPnC
    7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
    Intervention: Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnc)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
354
September 2009
September 2009   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • Healthy 1 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 vaccine 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
up to 54 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00676091
6096A1-012
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
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
August 2011

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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