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

Wyeth

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Infections

Treatments: Biological: 7 valent pneumococcal conjugate vaccine; Biological: 13-valent Pneumococcal Conjugate Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00452790

6096A1-011

Details and patient eligibility

About

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.

Enrollment: 708 patients

Sex: All

Ages: 42 to 72 days old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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708 participants in 2 patient groups

A

Experimental group

Treatment:

Biological: 13-valent Pneumococcal Conjugate Vaccine

B

Active Comparator group

Treatment:

Biological: 7 valent pneumococcal conjugate vaccine