Tetanus Clinical Trial
Official title:
Safety & Immunogenicity of a Booster Dose of dTPa Vaccine (Boostrix®) Co-admnd. With Aventis Pasteur's Meningococcal (Serogroups A, C, Y and W-135) Polysaccharide Vaccine (Menactra™) vs Admn. of Either Vaccine Alone in Healthy Adolescents
New immunization recommendations in the US include vaccination of adolescents against pertussis and meningococcal disease. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommends that Tdap (Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine Adsorbed) and MCV4 (Meningococcal conjugate vaccine against serotypes A, C, Y and W-135) vaccines be administered to adolescents at the same office visit if vaccination with both vaccines is indicated. Therefore, this study is designed to evaluate the safety and immunogenicity of a booster vaccination with Boostrix co-administered with Menactra as compared to the administration of either vaccine alone in healthy adolescents 11 - 18 years of age.
A phase IV, randomized, partially blinded multicenter study to evaluate the safety and
immunogenicity of a booster vaccination with GlaxoSmithKline's tetanus toxoid, reduced
diphtheria toxoid and acellular pertussis vaccine, adsorbed [Tdap Boostrix®] co-administered
intramuscularly with Aventis-Pasteur's meningococcal (serogroups A, C, Y and W-135)
polysaccharide diphtheria toxoid conjugate vaccine (Menactra™) as compared to the
administration of either vaccine alone in healthy adolescents 11-18 years of age.
"Experimental design: Prospective, randomized, controlled multicenter study with three
groups:
Group 1: Boostrix + Menactra on Day 0, blood samples at Month 0 and Month 1 Group 2: Boostrix
on Day 0, Menactra at Month 1, blood samples at Month 0, Month 1, and Month 2 Group 3:
Menactra on Day 0, Boostrix at Month 1, blood samples at Month 0, Month 1 and Month 2
Treatment allocation: randomized 1:1:1 Type of study: self-contained Duration of the study:
Approximately one month for each subject in Group 1 and approximately two months for each
subject in the Group 2 and Group 3."
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