Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan

Wyeth

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Conjugate Vaccine; Vaccines

Treatments: Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); Biological: 7-valent pneumococcal conjugate vaccine (7vPnC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00688870

6096A1-3004

2008-004766-40 (EudraCT Number)

B1851005

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), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Taiwan.

Enrollment: 168 patients

Sex: All

Ages: 42 to 98 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy 2-month-old infants (42 to 98 days)
• Available for the entire study period (14 months)

Exclusion criteria

• Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib vaccines
• A previous anaphylactic reaction to any vaccine or vaccine-related component.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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168 participants in 2 patient groups

1

Experimental group

Description:

13vPnC

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

2

Active Comparator group

Description:

7vPnC

Treatment:

Biological: 7-valent pneumococcal conjugate vaccine (7vPnC)