Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Diphtheria; Tetanus; Acellular Pertussis

Treatments: Biological: Hiberix; Biological: Infanrix; Biological: Infanrix™/Hib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00412854

104567

Details and patient eligibility

About

This study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese infants 3, 4 & 5 months of age, in terms of safety and immunogenicity.

Enrollment: 660 patients

Sex: All

Ages: 90 to 120 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A male or female between, and including, 90 and 120 days of age at the time of the first vaccination,
• written informed consent obtained from the parent or guardian of the subject

Exclusion criteria

• Subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenzae disease can not participate,
• Subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or Haemophilus influenzae type b diseases can not participate.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)