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

Condition(s) targeted: Prophylaxis: Diphtheria, Tetanus, Pertussis, Poliovirus Type 1, Type 2 and Type 3

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

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
clinical trials, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: Open, Randomized, Phase II, Clinical Trial to Compare the Immunogenicity and Safety of a Booster Dose of GSK Biologicals' DTaP-IPV Vaccine (Infanrix®-IPV) Co-Administered With a Booster Dose of Merck and Company's M-M-R®II, to That of Separate Injections of GSK Biologicals' DTaP Vaccine (Infanrix®), Aventis Pasteur's IPV (IPOL®) and M-M-R®II Administered as Booster Doses to Healthy Children 4 to 6 Years of Age.

Study design: Prevention, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome: Immunogenicity after vaccination.

Secondary outcome: Immunogenicity and safety after vaccination.

Detailed description: "• Two parallel groups randomized with balanced allocation (1: 1).

- Investigational: DTaP-IPV vaccine.

- Control: US-licensed DTaP (Infanrix) and US-licensed IPV (IPOL) administered in separate

injections.

- Two study visits one month apart for all subjects with a blood draw at each visit.

- Fifteen-day post-vaccination follow-up period for solicited local and solicited general

symptoms.

- Forty-three day post-vaccination follow-up period for solicited general symptoms

specific to MMR vaccination.

- Thirty-one day post-vaccination follow-up period for unsolicited adverse events.

- Extended Safety Follow-up Phase through six months after vaccination."

Minimum age: 4 Years. Maximum age: 6 Years. Gender(s): Both.

Criteria:

"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."

Oakland, California, United States

Starting date: November 2002
Last updated: December 8, 2005