Immune Response & Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccine. - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00148941

Purpose

"The aims of this trial are to demonstrate the consistency of three manufacturing lots of GSK Biologicals' DTaP-IPV candidate vaccine in terms of immunogenicity and to evaluate non-inferiority of GSK Biologicals' DTaP-IPV vaccine with respect to immunogenicity and safety compared to the control vaccines (separate injections of GSK Biologicals' DTaP vaccine [Infanrix] and Aventis Pasteur's IPV vaccine [IPOL]) when administered as a 5th dose of DTaP and a 4th dose of inactivated poliovirus vaccine in subjects 4 to 6 years of age. Vaccines will be co-administered with the second dose of M-M-RII, which is recommended at this age. Concomitant administration of a US-licensed influenza vaccine will be allowed according to seasonal availability of vaccine and at the discretion of the investigator."

Condition	Intervention	Phase
Poliomyelitis Diphtheria Pertussis Prophylaxis Tetanus	Biological: Diphtheria, tetanus, pertussis, poliovirus type 1, 2 & 3	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Safety, Immunogenicity&Consistency of 3 Manufacturing Lots of DTaP-IPV Vaccine vs Separate Injections of GSK Biologicals' DTaP + Aventis Pasteur's IPV Admd as Booster Doses to Healthy Children 4-6 Yrs, Each Co-admd With Merck's MMR Vaccine

Resource links provided by NLM:

MedlinePlus related topics: Diphtheria Polio and Post-Polio Syndrome Tetanus Whooping Cough

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Lot-to-lot consistency: immunogenicity one month post-vaccination:
Anti-D antibody concentrations, anti-T antibody concentrations, anti-PT antibody concentrations, anti-FHA antibody concentrations, anti-PRN antibody concentrations, anti-poliovirus type 1, type 2 and type 3 antibody titers.
Non-inferiority: immunogenicity one month post-vaccination:
Anti-D booster response, anti-T booster response, anti-PT booster response, anti-FHA booster response, anti-PRN booster response, anti-poliovirus type 1, type 2 and type 3 antibody titers
Safety:
incidence of increased circumferential swelling at the DTaP-containing vaccine injection site within 4 days after vaccination.

Secondary Outcome Measures:

Immunogenicity one month after vaccination:
Anti-D antibody concentration, anti-T antibody concentration, anti-PT antibody concentration, anti-FHA antibody concentration, anti-PRN antibody concentration, anti-poliovirus type 1, type 2 and type 3 booster response
Safety:
Safety and reactogenicity of the study vaccines in all groups during the entire study period

Enrollment:	4087
Study Start Date:	January 2005
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Detailed Description:

Investigational groups: 3, each receive one of 3 lots of DTaP-IPV vaccine.
Control: US-licensed DTaP (Infanrix) + US-licensed IPV (IPOL) vaccines administered in separate injections.
Two study visits one month apart for a subset of subjects (Safety and Immunogenicity subset) with a blood draw at each visit. All other subjects will have one visit.
A telephone contact 4-6 days after vaccination for all subjects, a telephone contact 31-38 days after vaccination for the Safety only subset and a telephone contact for all subjects during the extended safety follow-up phase (5 months following the active phase).

Eligibility

Ages Eligible for Study:	4 Years to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male or female child between and including 4 and 6 years of age at the time of vaccination.
Subjects should have received 4 doses of GSK DTaP (primary vaccination course with booster dose in the second year of life) and 3 doses of IPV during the first 2 years of life and vaccination against measles, mumps, and rubella in the second year of life.

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.
Administration or planned administration of a vaccine not foreseen by the study protocol within 30 days of study vaccination and ending at Day 30.
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 or planned administration during the study period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148941

Locations

United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
Antioch, California, United States, 94509
GSK Investigational Site
Daly City, California, United States, 94015
GSK Investigational Site
Fairfield, California, United States, 94533
GSK Investigational Site
Fremont, California, United States, 94538
GSK Investigational Site
Fresno, California, United States, 93726
GSK Investigational Site
Hayward, California, United States, 94545
GSK Investigational Site
North Pleasanton, California, United States, 94588
GSK Investigational Site
Oakland, California, United States, 94611
GSK Investigational Site
Redwood City, California, United States, 94063
GSK Investigational Site
Richmond, California, United States, 94801
GSK Investigational Site
Roseville, California, United States, 95661
GSK Investigational Site
Sacramento, California, United States, 95825
GSK Investigational Site
Sacramento, California, United States, 95823
GSK Investigational Site
San Francisco, California, United States, 94115
GSK Investigational Site
San Jose, California, United States, 95119
GSK Investigational Site
San Ramon, California, United States, 94583
GSK Investigational Site
Santa Clara, California, United States, 95051
GSK Investigational Site
Santa Rosa, California, United States, 95403
GSK Investigational Site
Vacaville, California, United States, 95688
GSK Investigational Site
Vallejo, California, United States, 94589
GSK Investigational Site
Walnut Creek, California, United States, 94596
United States, Ohio
GSK Investigational Site
Columbus, Ohio, United States, 43214
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:

Black S, Friedland LR, Ensor K, Weston WM, Howe B, Klein NP. Diphtheria-tetanus-acellular pertussis and inactivated poliovirus vaccines given separately or combined for booster dosing at 4-6 years of age. Pediatr Infect Dis J. 2008 Apr;27(4):341-6.

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. Review.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00148941 History of Changes
Other Study ID Numbers:	213503/048
Study First Received:	September 7, 2005
Last Updated:	February 2, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diphtheria
Whooping Cough
Poliomyelitis
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Clostridium Infections

ClinicalTrials.gov processed this record on February 09, 2012