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Trial record 1 of 1 for:    NCT00452790
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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India

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ClinicalTrials.gov Identifier: NCT00452790
Recruitment Status : Completed
First Posted : March 27, 2007
Results First Posted : November 15, 2010
Last Update Posted : March 24, 2011
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE March 23, 2007
First Posted Date  ICMJE March 27, 2007
Results First Submitted Date  ICMJE October 13, 2010
Results First Posted Date  ICMJE November 15, 2010
Last Update Posted Date March 24, 2011
Study Start Date  ICMJE June 2007
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2010)
  • 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 (18 weeks of age) ]
    Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 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 19 A) are presented.
  • Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series. [ Time Frame: 1 month after the infant series (18 weeks of age) ]
    Percentage of participants achieving a predefined antibody level (measured in enzyme-linked immunosorbent assay [ELISA] units per mL [EU/mL]) along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% CI for concomitant antigens pertussis (PT, FHA and PRN) are presented.
Original Primary Outcome Measures  ICMJE
 (submitted: March 26, 2007)
To assess the pneumococcal immune responses induced by 13vPnC relative to the pneumococcal immune responses induced by 7vPnC, when measured 1 month after the infant series.
Change History Complete list of historical versions of study NCT00452790 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2010)
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 the toddler dose (13 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, 2-sided 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 19 A) are presented.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India
Official Title  ICMJE A Phase 3, Randomised, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Paediatric Vaccinations in India
Brief Summary The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in India.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Infections
Intervention  ICMJE
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
    1 dose at 6, 10, 14 weeks and 12 months of age
  • Biological: 7 valent pneumococcal conjugate vaccine
    1 dose at 6, 10, 14 weeks and 12 months of age
Study Arms  ICMJE
  • Experimental: A
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Active Comparator: B
    Intervention: Biological: 7 valent pneumococcal conjugate vaccine
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: February 1, 2010)
708
Original Enrollment  ICMJE
 (submitted: March 26, 2007)
330
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Healthy infants aged 6 weeks (42-72 days) at time of enrolment
  2. Available for the entire study period

Exclusion Criteria

  1. Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis or Hib vaccines
  2. A previous anaphylactic reaction to any vaccine or vaccine-related component
  3. Contraindication to vaccination with pneumococcal, Hib, diphtheria, tetanus, pertussis, polio, hepatitis B or measles vaccines
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Days to 72 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00452790
Other Study ID Numbers  ICMJE 6096A1-011
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (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 Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date March 2011

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