Tetanus Clinical Trial
Official title:
Immunogenicity and Safety Study of Kinrix® Co-administered With Varivax®
The purpose of the study is to evaluate the immunogenicity and safety of Kinrix when co-administered with varicella (Varivax® [varicella virus vaccine live], Merck and Company) and (measles mumps rubella) MMR vaccines, compared to Kinrix co-administered with MMR vaccine alone. Both Kinrix and the second dose of Varivax are indicated in children 4-6 years of age, and there is great potential for the vaccines to be given concurrently. The aim of this trial is to demonstrate that co-administered Varivax does not negatively affect the immunogenicity or reactogenicity of Kinrix.
Subjects 4-6 years of age will be randomized into two groups to receive either Kinrix,
Varivax and M-M-RII on day 0 (Group 1) or Kinrix and M-M-RII on day 0 and Varivax at month
1(Group 2).
All subjects in both groups to provide blood samples prior to vaccination on day 0 and at
month 1 (for Group 2, blood sampling is prior to vaccination with Varivax).
Duration of the study will be approximately 6 months for each subject with a safety telephone
contact 6 months after vaccinations.
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