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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
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
Conditions
Interventions
13-valent Pneumococcal Conjugate Vaccine
1 dose at 6, 10, 14 weeks and 12 months of age
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