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Completed
NCT00452790
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India
Conditions: Pneumococcal Infections
Sex: All
Ages: 42 Days – 72 Days
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 708
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Location: Sector-12 Chandigarh
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.
Eligibility Criteria
Inclusion Criteria
1. Healthy infants aged 6 weeks (42-72 days) at time of enrolment
2. Available for the entire study period
Exclusion Criteria
1. Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis or Hib vaccines
2. A previous anaphylactic reaction to any vaccine or vaccine-related component
3. Contraindication to vaccination with pneumococcal, Hib, diphtheria, tetanus, pertussis, polio, hepatitis B or measles vaccines
Source: ClinicalTrials.gov (NCT00452790). StuddyBuddy aggregates publicly available trial information.