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

Completed · Phase 2

Conditions studied: Diphtheria, Acellular Pertussis, Tetanus

In brief

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.

Key facts

Study ID

NCT00263692

Run by

GlaxoSmithKline

People needed

401

Starts

2002-11-01

Expected to finish

2004-09-01

Last updated by the study team

2016-09-15

Who can join

Age: 4 and older, up to 6. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Jonesboro, Arkansas, United States
• GSK Investigational Site — Fountain Valley, California, United States
• GSK Investigational Site — Oakland, California, United States
• GSK Investigational Site — Torrance, California, United States
• GSK Investigational Site — Marietta, Georgia, United States
• GSK Investigational Site — Woodstock, Georgia, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — New Orleans, Louisiana, United States
• GSK Investigational Site — Ruston, Louisiana, United States
• GSK Investigational Site — Berlin, New Jersey, United States
• GSK Investigational Site — Whitehouse Station, New Jersey, United States
• GSK Investigational Site — Endwell, New York, United States
• GSK Investigational Site — Stony Brook, New York, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Mechanicsville, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.