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Study Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization

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ClinicalTrials.gov Identifier: NCT00508742
Recruitment Status : Completed
First Posted : July 30, 2007
Results First Posted : July 13, 2012
Last Update Posted : May 10, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 26, 2007
First Posted Date  ICMJE July 30, 2007
Results First Submitted Date  ICMJE June 12, 2012
Results First Posted Date  ICMJE July 13, 2012
Last Update Posted Date May 10, 2013
Study Start Date  ICMJE December 2007
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2012)
Percentage of Participants With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age [ Time Frame: Month 7 through Month 24 ]
A new acquisition was defined as the detection of a serotype (here 6A' [6A + 6C] or 19A), once a participant was fully vaccinated (one month after dose 3), that had not been detected previously in the baseline samples at 2, 4, 6 months of age.
Original Primary Outcome Measures  ICMJE
 (submitted: July 27, 2007)
Primary comparison is culture findings in subjects receiving 13vPnC relative to those receiving 7vPnC. Primary endpoint is proportion of subjects with a new acquisition of either serotype 6A or 19A 1 month after the infant series to 24 months of age.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2012)
Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age [ Time Frame: Month 7, 12, 13, 18, 24 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2007)
Secondary endpoints are the proportion of cultures testing positive for serotypes 6A or 19A of s. pneumoniae as a group measured at 18 months of age and from 1 month after the infant series to 24 months of age.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization
Official Title  ICMJE A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization With Vaccine Serotypes of Streptococcus Pneumoniae in Healthy Infants in Israel.
Brief Summary This study is designed to assess the impact of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) on nasopharyngeal colonization with Streptococcus pneumoniae in healthy infants.
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 2, 4, 6 and 12 months of age
    Other Name: 13vPnC
  • Biological: 7 valent pneumococcal conjugate vaccine
    1 dose at 2, 4, 6 and 12 months of age
    Other Name: 7vPnC
Study Arms  ICMJE
  • Experimental: 1
    13 valent pneumococcal conjugate vaccine
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Active Comparator: 2
    7 valent pneumococcal conjugate vaccine
    Intervention: Biological: 7 valent pneumococcal conjugate vaccine
Publications *

*   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: October 8, 2009)
1866
Original Estimated Enrollment  ICMJE
 (submitted: July 27, 2007)
1864
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy infants aged 2 months (42-98 days) at time of enrolment.
  • Available for the entire study period and whose parent/legal guardian can be reached by telephone.

Exclusion Criteria:

  • Previous vaccination with licensed or investigational pneumococcal vaccine.
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination with a pneumococcal conjugate vaccine.
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 Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00508742
Other Study ID Numbers  ICMJE 6096A1-3006
B1851007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2013

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