Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India

Phase 3

Completed

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

• Registration Number: NCT00452790
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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 available

Study Timeline

• Study First Submitted: 2007-03-23
• Study First Submitted QC: 2007-03-26
• Study First Posted: 2007-03-27
• Study Start: 2007-06
• Primary Completion: 2009-10
• Study Completion: 2010-02
• Results First Submitted: 2010-10-13
• Results First Submitted QC: 2010-10-13
• Results First Posted: 2010-11-15
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-22
• Last Update Posted: 2011-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 708

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	13-valent Pneumococcal Conjugate Vaccine	-
B	7 valent pneumococcal conjugate vaccine	-

Primary Outcome Measures

Name	Time	Method
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.	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.
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.	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.	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.