Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

Wyeth

Status and phase: Completed; Phase 3

Conditions: Vaccines, Pneumococcal

Treatments: Biological: 13-valent pneumococcal conjugate vaccine; Drug: Pentavac; Biological: 7-valent pneumococcal conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00366678

6096A1-008

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccines in France.

Enrollment: 613 patients

Sex: All

Ages: 42 to 98 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy 2-month-old infants.
• Available for the entire study period.

Exclusion criteria

· Known contraindication to vaccines.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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613 participants in 2 patient groups

13-valent pneumococcal conjugate vaccine

Experimental group

Description:

13-valent pneumococcal conjugate vaccine

Treatment:

Drug: Pentavac

Biological: 13-valent pneumococcal conjugate vaccine

7-valent pneumococcal conjugate vaccine

Active Comparator group

Description:

7-valent pneumococcal conjugate vaccine

Treatment:

Biological: 7-valent pneumococcal conjugate vaccine

Drug: Pentavac