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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00508742
First received: July 26, 2007
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

This study is designed to assess the impact of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) on nasopharyngeal colonization with Streptococcus pneumoniae in healthy infants.


Condition Intervention Phase
Pneumococcal Infections
Biological: 13-valent Pneumococcal Conjugate Vaccine
Biological: 7 valent pneumococcal conjugate vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 1866
Study Start Date: December 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
13 valent pneumococcal conjugate vaccine
Biological: 13-valent Pneumococcal Conjugate Vaccine
1 dose at 2, 4, 6 and 12 months of age
Other Name: 13vPnC
Active Comparator: 2
7 valent pneumococcal conjugate vaccine
Biological: 7 valent pneumococcal conjugate vaccine
1 dose at 2, 4, 6 and 12 months of age
Other Name: 7vPnC

  Eligibility

Ages Eligible for Study:   42 Days to 98 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508742

Locations
Israel
Pfizer Investigational Sites (7)
Beer-Sheva, Israel, 84101
Pfizer Investigational Site
Ksaife, Israel
Pfizer Investigational Site
Rahat, Israel
Pfizer Investigational Site
Rahat A, Israel
Pfizer Investigational Site
Segev Shalom, Israel
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00508742     History of Changes
Other Study ID Numbers: 6096A1-3006, B1851007
Study First Received: July 26, 2007
Results First Received: June 12, 2012
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Nasopharyngeal Colonization
Streptococcus pneumoniae
Healthy Infants
Vaccines
Pneumococcal Conjugate Vaccine

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 15, 2014