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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

708 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Pneumococcal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Group Type EXPERIMENTAL

13-valent Pneumococcal Conjugate Vaccine

Intervention Type BIOLOGICAL

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

B

Group Type ACTIVE_COMPARATOR

7 valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

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

Interventions

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13-valent Pneumococcal Conjugate Vaccine

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

Intervention Type BIOLOGICAL

7 valent pneumococcal conjugate vaccine

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

42 Days

Maximum Eligible Age

72 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes