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

GlaxoSmithKline (GSK) logo

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

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)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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