Immunogenicity, Antibody Persistence and Safety of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX) Vaccines.

GlaxoSmithKline (GSK)

Status and phase

Terminated

Phase 4

Conditions

Diphtheria

Tetanus

Acellular Pertussis

Treatments

Biological: INFANRIX

Biological: BOOSTRIX

Biological: HAVRIX

Study type

Interventional

Funder types

Industry

Identifiers

NCT00544271

263855/035

Details and patient eligibility

About

To evaluate the immunogenicity, persistence of antibodies and reactogenicity of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX), when administered to subjects 18-20 months old, compared with not giving a booster DTP vaccine at 18-20 months. Study double blinded for the two DTP vaccines and single blinded for the control arm.

Enrollment

720 patients

Sex

All

Ages

18 to 20 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female children between and including 18 -20 months of age at the time of the vaccination.
Completed a primary vaccination course with DTPa (INFANRIX) vaccine at 2, 4, and 6 months.
Written informed consent obtained before study entry from the parents or guardians of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion criteria

Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the administration of the study vaccine dose, or planned use during the study period.
Evidence of previous or intercurrent diphtheria, tetanus, or pertussis disease, or of vaccination against any of these diseases since completion of the primary course of DTPa (INFANRIX) vaccine.