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

Last updated on December 2, 2019

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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Descriptive Information
Brief Title  ICMJE Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Brazil
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 Brazil
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Vaccines, Pneumococcal Conjugate Vaccine
Intervention  ICMJE
  • Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
  • Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnc)
Study Arms  ICMJE
  • 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)
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: May 7, 2008)
354
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion DateSeptember 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE up to 54 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00676091
Other Study ID Numbers  ICMJE 6096A1-012
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyWyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
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
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateAugust 2011

ICMJE     Data element required by the

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

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