Comparison of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP and IPV Separately Administered Vaccines in Terms of Immune Response and Safety

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Diphtheria

Tetanus

Acellular Pertussis

Treatments

Biological: Prophylaxis: Diphtheria, tetanus, pertussis, poliovirus type 1, type 2 and type 3

Study type

Interventional

Funder types

Industry

Identifiers

NCT00263692

213503/047

Details and patient eligibility

About

The aims of this study are to compare the immunogenicity and safety of the GSK Biologicals' combined DTaP-IPV vaccine with separate administration of DTaP and IPV vaccines, when administered as a fifth dose of acellular pertussis vaccine to children aged 4 to 6 years when co-administered with MMR vaccine in subjects who had previously received four doses of Infanrix, three doses of poliovirus-containing vaccine and MMR vaccination.

Enrollment

401 patients

Sex

All

Ages

4 to 6 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy children between and including 4 and 6 years of age.
Previously received 4 doses of GSK Biologicals' DTaP, 3 doses of IPV vaccine and 1 dose of measles, mumps, and rubella vaccine.

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.