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Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan

Last updated on November 14, 2019

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Study Location
Pfizer Investigational Site
Taipei, , 100 Taiwan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vaccines, Pneumococcal Conjugate Vaccine
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 (42 to 98 days)

- Available for the entire study period (14 months)

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

- Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib
vaccines

- A previous anaphylactic reaction to any vaccine or vaccine-related component.

NCT00688870
Pfizer
Completed
Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan

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Descriptive Information
Brief Title  ICMJE Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan
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 Taiwan
Brief SummaryThe purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Taiwan.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Vaccines
  • Pneumococcal Conjugate Vaccine
Intervention  ICMJE
  • Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
    13vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.
  • Biological: 7-valent pneumococcal conjugate vaccine (7vPnC)
    7vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.
Study Arms  ICMJE
  • Experimental: 1
    13vPnC
    Intervention: Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
  • Active Comparator: 2
    7vPnC
    Intervention: Biological: 7-valent pneumococcal conjugate vaccine (7vPnC)
Publications *Huang LM, Lin TY, Juergens C. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccines in Taiwan. Vaccine. 2012 Mar 9;30(12):2054-9. doi: 10.1016/j.vaccine.2011.12.054. Epub 2011 Dec 22.


*   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: June 2, 2008)
168
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion DateMarch 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy 2-month-old infants (42 to 98 days)
  • Available for the entire study period (14 months)

Exclusion Criteria:

  • Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib vaccines
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 42 Days to 98 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00688870
Other Study ID Numbers  ICMJE 6096A1-3004
B1851005
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyWyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateOctober 2011

ICMJE     Data element required by the

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

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