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Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea

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ClinicalTrials.gov Identifier: NCT00689351
Recruitment Status : Completed
First Posted : June 3, 2008
Results First Posted : January 11, 2011
Last Update Posted : June 28, 2011
Sponsor:
Information provided by:
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 December 10, 2010
Results First Posted Date  ICMJE January 11, 2011
Last Update Posted Date June 28, 2011
Study Start Date  ICMJE June 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2011)
Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series [ Time Frame: 1 month after the infant series (7 months of age) ]
Percentage of participants achieving predefined antibody threshold ≥0.35 Mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) was calculated for 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).
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 Complete list of historical versions of study NCT00689351 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2011)
Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose [ Time Frame: 1 month after the toddler dose (13 months of age) ]
Percentage of participants achieving predefined antibody threshold ≥0.35Mcg/mL along with the corresponding 95% CI was calculated for 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). Exact 2-sided CI was based on the observed percentage of participants.
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 Korea
Official Title  ICMJE Phase 2, 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 Korea
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 Korea.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Vaccine
Intervention  ICMJE
  • Biological: 13-valent pneumococcal conjugate vaccine
    13vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.
  • Biological: 7-valent pneumococcal conjugate vaccine
    7vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.
Study Arms  ICMJE
  • Experimental: 1
    13vPnC
    Intervention: Biological: 13-valent pneumococcal conjugate vaccine
  • Active Comparator: 2
    7vPnC
    Intervention: Biological: 7-valent pneumococcal conjugate vaccine
Publications * Kim DS, Shin SH, Lee HJ, Hong YJ, Lee SY, Choi KM, Oh CE, Kim KH, Juergens C, Patterson S, Giardina PC, Gruber WC, Emini EA, Scott DA. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given to korean children receiving routine pediatric vaccines. Pediatr Infect Dis J. 2013 Mar;32(3):266-73. doi: 10.1097/INF.0b013e3182748bb6.

*   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)
180
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 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 vaccine with pneumococcal, diptheria, tetanus, pertussis, polio or Hib vaccine
  • A previous severe 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 Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00689351
Other Study ID Numbers  ICMJE 6096A1-010
B1851001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Wyeth, Inc
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 June 2011

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