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

Wyeth

Status and phase: Completed; Phase 3

Conditions: Vaccines, Pneumococcal Conjugate Vaccine

Treatments: Biological: 13vPnC

Study type: Interventional

Funder types: Industry

Identifiers

NCT00574795

6096A1-3003

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in infants of Japanese descent.

Enrollment: 193 patients

Sex: All

Ages: 2 to 6 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy 2 to 6 month-old infant
• Available for entire study period

Exclusion criteria

• Previous vaccination with licensed or investigational pneumococcal vaccine.
• Previous anaphylactic reaction to any vaccine or vaccine-related component.
• Contraindication to vaccination with a pneumococcal conjugate vaccine.
• Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
• Known or suspected immune deficiency or suppression.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)