Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea

Wyeth

Status and phase: Completed; Phase 2

Conditions: Pneumococcal Vaccine

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00689351

6096A1-010

B1851001

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 Korea.

Enrollment: 180 patients

Sex: All

Ages: 42 to 98 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Previous vaccine with pneumococcal, diptheria, tetanus, pertussis, polio or Hib vaccine
• A previous severe 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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180 participants in 2 patient groups

1

Experimental group

Description:

13vPnC

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine

2

Active Comparator group

Description:

7vPnC

Treatment:

Biological: 7-valent pneumococcal conjugate vaccine