NCT00282295

US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,344 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 11 Years – 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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."

Conditions

• Acellular Pertussis
• Tetanus
• Diphtheria

Interventions

Type	Name	Description
BIOLOGICAL	Boostrix®	GlaxoSmithKline (GSK) Biologicals' registered tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.
BIOLOGICAL	Menactra™	Aventis Pasteur's me ningococcal polysaccharide diphtheria toxoid conjugate vaccine containing Neisseria meningitidis serogroups, A, C, Y and W-135.

Timeline

• Start date: 2006-01-25
• Primary completion: 2006-08-08
• Completion: 2006-08-08
• First posted: 2006-01-26
• Last updated: 2018-08-17
• Results posted: 2017-03-16

Locations

24 sites across 1 country: United States