Comparison of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP and IPV Separately Administered Vaccines in Terms of Immune Response and Safety
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ClinicalTrials.gov Identifier: NCT00263692 |
Recruitment Status
:
Completed
First Posted
: December 9, 2005
Last Update Posted
: September 15, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diphtheria Acellular Pertussis Tetanus | Biological: Prophylaxis: Diphtheria, tetanus, pertussis, poliovirus type 1, type 2 and type 3 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 401 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (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. |
Study Start Date : | November 2002 |
Actual Primary Completion Date : | September 2004 |
Actual Study Completion Date : | September 2004 |
- Immunogenicity after vaccination.
- Immunogenicity and safety after vaccination.

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Ages Eligible for Study: | 4 Years to 6 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263692
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 | |
Berlin, New Jersey, United States, 08009 | |
GSK Investigational Site | |
Whitehouse Station, New Jersey, United States, 08889 | |
United States, New York | |
GSK Investigational Site | |
Endwell, New York, United States, 13760 | |
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 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Study Data/Documents: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register
Publications:
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00263692 History of Changes |
Other Study ID Numbers: |
213503/047 |
First Posted: | December 9, 2005 Key Record Dates |
Last Update Posted: | September 15, 2016 |
Last Verified: | September 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site. |
Additional relevant MeSH terms:
Diphtheria Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections |
Bacterial Infections Vaccines Immunologic Factors Physiological Effects of Drugs |