Assessment of GSK Biologicals' Tdap Candidate Vaccine Administered as a Booster (6th Dose) in Terms of Immunogenicity and Safety to Children and Adolescents Previously Vaccinated With Five Doses of an Acellular Pertussis-containing Vaccine.

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Diphtheria

Tetanus

Acellular Pertussis

Treatments

Biological: Prophylaxis: Diphtheria, tetanus and pertussis

Study type

Interventional

Funder types

Industry

Identifiers

NCT00263679

100406/004

Details and patient eligibility

About

The aims of this study are to evaluate the safety and immunogenicity of a booster dose of GSK Biological's candidate Tdap vaccine containing 0.3 mg Al when administered to healthy school children and adolescents (9-13 years of age) previously vaccinated with five consecutive doses of Pa-containing vaccine. The inclusion of hepatitis A vaccine (Havrix®) as a control vaccine enables this study to be conducted in a double-blinded in terms of immunogenicity and safety assessments.

Enrollment

321 patients

Sex

All

Ages

9 to 13 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects previously enrolled and vaccinated in GSK Biologicals' studies APV-118 and APV-120 and who were 9 through 13 years of age

Exclusion criteria

Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period.
Chronic administration or planned administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period
Administration of immunoglobulins and/or blood products within 3 months prior to vaccination