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COMPLETED
NCT00452790
PHASE3

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

Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

View on ClinicalTrials.gov

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.

Official title: A Phase 3, Randomised, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Paediatric Vaccinations in India

Key Details

Gender

All

Age Range

42 Days - 72 Days

Study Type

INTERVENTIONAL

Enrollment

708

Start Date

2007-06

Completion Date

2010-02

Last Updated

2026-09-21

Healthy Volunteers

Yes

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

Locations (12)

Sector-12, Chandigarh, India

Sector-32 B, Chandigarh, India

Bangalore, Karnataka, India

Bangalore, Karnataka, India

Mumbai, Maharashtra, India

Pune, Maharashtra, India

Pune, Maharashtra, India

Pune, Maharashtra, India

Rajinder Nagar, New Delhi, India

Ludhiana, Punjab, India

Chennai, Tamil Nadu, India

Vellore, Tamil Nadu, India