Comparison of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP and IPV Separately Administered Vaccines in Terms of Immune Response and Safety
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00263692
First received: December 8, 2005
Last updated: June 21, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prophylaxis: Diphtheria, Tetanus, Pertussis, Poliovirus |
Biological: Prophylaxis: Diphtheria, tetanus, pertussis, poliovirus type 1, type 2 and type 3 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
| 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. |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Immunogenicity after vaccination.
Secondary Outcome Measures:
- Immunogenicity and safety after vaccination.
| Enrollment: | 401 |
| Study Start Date: | November 2002 |
| Study Completion Date: | September 2004 |
| Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 4 Years to 6 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263692
Locations
| United States, Arkansas | |
| GSK Investigational Site | |
| Jonesboro, Arkansas, United States, 72401 | |
| United States, California | |
| GSK Investigational Site | |
| Fountain Valley, California, United States, 92708 | |
| GSK Investigational Site | |
| Oakland, California, United States, 94612 | |
| GSK Investigational Site | |
| Torrance, California, United States, 90502 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Marietta, Georgia, United States, 30062 | |
| GSK Investigational Site | |
| Woodstock, Georgia, United States, 30188 | |
| United States, Illinois | |
| GSK Investigational Site | |
| Chicago, Illinois, United States, 60614 | |
| United States, Louisiana | |
| GSK Investigational Site | |
| New Orleans, Louisiana, United States, 70128 | |
| GSK Investigational Site | |
| Ruston, Louisiana, United States, 71270 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Whitehouse Station, New Jersey, United States, 08889 | |
| United States, New York | |
| GSK Investigational Site | |
| Stony Brook, New York, United States, 11794 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15241 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Mechanicsville, Virginia, United States, 23111 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
Publications:
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00263692 History of Changes |
| Other Study ID Numbers: | 213503/047 |
| Study First Received: | December 8, 2005 |
| Last Updated: | June 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diphtheria Whooping Cough Tetanus Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
Bordetella Infections Gram-Negative Bacterial Infections Respiratory Tract Infections Infection Respiratory Tract Diseases Clostridium Infections |
ClinicalTrials.gov processed this record on May 19, 2013