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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Immunogenicity after vaccination.

Secondary Outcome Measures :

1. Immunogenicity and safety after vaccination.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	4 Years to 6 Years (Child)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Clinical Study Report 

Identifier: 213503/047
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: 213503/047
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: 213503/047
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 213503/047
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 213503/047
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 213503/047
For additional information about this study please refer to the GSK Clinical Study Register

Publications:

Black S, Friedland LR, Schuind A, Howe B; GlaxoSmithKline DTaP-IPV Vaccine Study Group. Immunogenicity and safety of a combined DTaP-IPV vaccine compared with separate DTaP and IPV vaccines when administered as pre-school booster doses with a second dose of MMR vaccine to healthy children aged 4-6 years. Vaccine. 2006 Aug 28;24(35-36):6163-71. Epub 2006 Apr 21.

Weston WM, Klein NP. Kinrix: a new combination DTaP-IPV vaccine for children aged 4-6 years. Expert Rev Vaccines. 2008 Nov;7(9):1309-20. doi: 10.1586/14760584.7.9.1309. Review.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00263692 History of Changes
Other Study ID Numbers:	213503/047
First Posted:	December 9, 2005
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