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

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
Prophylaxis Diphtheria Tetanus Pertussis Poliovirus Type 1,2 & 3	Biological: Diphtheria, tetanus, pertussis, poliovirus type 1, 2 & 3	Phase III

MedlinePlus related topics:

Diphtheria Tetanus Whooping Cough

ChemIDplus related topics:

Measles-Mumps-Rubella Vaccine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

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

Estimated Enrollment:	4200
Study Start Date:	January 2005

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, California

	Fairfield, California, United States, 94533

	Fresno, California, United States, 93726

	Fremont, California, United States, 94538

	Hayward, California, United States, 94545

	Roseville, California, United States, 95661

	San Jose, California, United States, 95119

	Sacramento, California, United States, 95823

	Santa Rosa, California, United States, 95403

	San Fransisco, California, United States, 94115

	Vallejo, California, United States, 94580

	Vacaville, California, United States, 95688

	Antioch, California, United States, 94509

	Oakland, California, United States, 94611

	Pleasantton, California, United States, 94588

	Richmond, California, United States, 94801

	Sana Clara, California, United States, 95051

	Walnut Creek, California, United States, 94596

	Redwood City, California, United States, 94063

	Daly City, California, United States, 94015

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	Clinical Trials	GlaxoSmithKline

More Information

Study ID Numbers:	213503/048
First Received:	September 7, 2005
Last Updated:	November 6, 2006
ClinicalTrials.gov Identifier:	NCT00148941
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections

Gram-Positive Bacterial Infections

Respiratory Tract Diseases

Respiratory Tract Infections

Cough

Whooping Cough

Healthy

Diphtheria

Tetanus

Whooping cough

Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Bordetella Infections

Corynebacterium Infections

Infection

Actinomycetales Infections

ClinicalTrials.gov processed this record on September 05, 2008

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