Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants

Wyeth

Status and phase: Completed; Phase 3

Conditions: Vaccines, Pneumococcal

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00474539

6096A1-3007

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 paediatric vaccinations in Spain.

Enrollment: 449 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

• Previous vaccination with any vaccine before the start of the study
• Known contraindication to vaccination

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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449 participants in 2 patient groups

1

Experimental group

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine

2

Active Comparator group

Treatment:

Biological: 7-valent pneumococcal conjugate vaccine