MedTrace Logo

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

NCT00452790 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 708

Last updated 2011-03-24

Study results available
· View outcomes & findings →

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.

Conditions

  • Pneumococcal Infections

Interventions

BIOLOGICAL

13-valent Pneumococcal Conjugate Vaccine

1 dose at 6, 10, 14 weeks and 12 months of age

BIOLOGICAL

7 valent pneumococcal conjugate vaccine

1 dose at 6, 10, 14 weeks and 12 months of age

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Wyeth is now a wholly owned subsidiary of Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
72 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-10-31
Completion
2010-02-28

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00452790 on ClinicalTrials.gov