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

Phase 3

Completed

• Conditions: Pneumococcal Infections
• Interventions: Biological: 13-valent Pneumococcal Conjugate Vaccine; Biological: 7 valent pneumococcal conjugate vaccine

• Registration Number: NCT00508742
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2007-07-26
• Study First Submitted QC: 2007-07-27
• Study First Posted: 2007-07-30
• Study Start: 2007-12
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Results First Submitted: 2012-06-12
• Results First Submitted QC: 2012-06-12
• Results First Posted: 2012-07-13
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-06
• Last Update Posted: 2013-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1866

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	13-valent Pneumococcal Conjugate Vaccine	13 valent pneumococcal conjugate vaccine
2	7 valent pneumococcal conjugate vaccine	7 valent pneumococcal conjugate vaccine

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
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	Month 7, 12, 13, 18, 24

Trial Locations

Locations (2)

Pfizer Investigational Site; 🇮🇱 Segev Shalom, Israel

Pfizer Investigational Sites (7); 🇮🇱 Beer-Sheva, Israel