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 |
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."
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).
- 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
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