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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014