Tetanus Clinical Trial
Official title:
Safety, Immunogenicity and Consistency of 3 Manufacturing Lots of DTaP-IPV Vaccine Versus Separate Injections of GSK Biologicals' DTaP + Aventis Pasteur's IPV Administered as Booster Doses to Healthy Children 4-6 Years, Each Co-administered 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 the 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).
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