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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00688870
Recruitment Status : Completed
First Posted : June 3, 2008
Results First Posted : May 12, 2011
Last Update Posted : November 2, 2011
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE May 29, 2008
First Posted Date  ICMJE June 3, 2008
Results First Submitted Date  ICMJE January 13, 2011
Results First Posted Date  ICMJE May 12, 2011
Last Update Posted Date November 2, 2011
Study Start Date  ICMJE June 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2011)
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series. [ Time Frame: 1 month after the infant series (7 months of age) ]
Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Original Primary Outcome Measures  ICMJE
 (submitted: June 2, 2008)
To assess the pneumococcal immune responses induced by 13vPnC relative to those induced by 7vPnC when measured 1 month after the infant series; and to assess safety by incidence rates of injections site reactions, systemic events and adverse events [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2011)
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose [ Time Frame: 1 month after toddler dose (16 months of age) ]
Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2008)
To assess the pneumococcal immune responses induced by 13vPnC relative to those induced by 7vPnC when measured 1 month after the toddler dose [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Summary The 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 Description Not 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 Date March 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 Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth 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 Center Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP