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



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:4 - 6
Updated:10/14/2017
Start Date:January 2005
End Date:December 2006

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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

"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."

- 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).

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.
We found this trial at
23
sites
Vacaville, California 95688
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Vacaville, CA
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Antioch, California 94509
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Antioch, CA
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Columbus, Ohio 43219
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Columbus, OH
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Daly City, California 94015
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Daly City, CA
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Fairfield, California 94533
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Fairfield, CA
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Fremont, California 94538
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Fremont, CA
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Fresno, California 93720
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Fresno, CA
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Hayward, California 94545
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Hayward, CA
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Little Rock, Arkansas 72205
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Little Rock, AR
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Mechanicsville, Virginia 23111
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Mechanicsville, VA
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North Pleasanton, California 94588
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North Pleasanton, CA
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Oakland, California 94611
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Oakland, CA
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Redwood City, California 94063
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Redwood City, CA
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Richmond, California 94801
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Richmond, CA
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Roseville, California 95678
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Roseville, CA
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Sacramento, California 95815
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Sacramento, CA
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San Francisco, California 94115
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San Francisco, CA
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San Jose, California 95116
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San Jose, CA
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San Ramon, California 94583
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San Ramon, CA
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Santa Clara, California 95051
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Santa Clara, CA
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Santa Rosa, California 95403
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Santa Rosa, CA
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Vallejo, California 94589
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Vallejo, CA
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Walnut Creek, California 94596
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Walnut Creek, CA
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