NCT01424644

A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in Adolescents

A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine (Tdap, Boostrix®) and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine (Gardasil®) in Healthy Adolescents When Administered With MenACWY Conjugate Vaccine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 801 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 11 Years – 18 Years
• Healthy volunteers: Accepted

Summary

The main objective is to determine whether immune responses to Tdap (GlaxoSmithKline, Boostrix®) and HPV vaccine (Merck \& Co., Inc., Gardasil®) when administered concomitantly with MenACWY are comparable to responses elicited by these vaccines when given alone.

Conditions

• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	Placebo + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine	All three vaccines were administered concomitantly. Quadrivalent Human Papillomavirus \[Types 6, 11, 16, 18\] Recombinant Vaccine is GARDASIL®. Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine(Tdap) is Boostrix®.
BIOLOGICAL	MenACWY-CRM Conjugate Vaccine + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine	All three vaccines were administered concomitantly. MenACWY-CRM contains diphtheria-like toxoid as carrier for the capsular polysaccharides. Quadrivalent Human Papillomavirus \[Types 6, 11, 16, 18\] Recombinant Vaccine is GARDASIL®. Reduced Diphtheria Toxoid,Acellular Pertussis Vaccine(Tdap) is Boostrix®.

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2011-08-29
• Last updated: 2014-02-14
• Results posted: 2014-02-14

Locations

20 sites across 2 countries: United States, Italy