NCT00518180

A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents

A Phase 3, Single-Center, Open-label, Controlled, Randomized Study to Evaluate the Safety and Immunogenicity of Novartis Men ACWY Vaccine Administered Either Alone or Concomitantly With a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine in Healthy Adolescents

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,620 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 11 Years – 18 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents

Conditions

• Meningococcal Meningitis
• Human Papillomavirus Infection
• Pertussis
• Tetanus

Interventions

Type	Name	Description
BIOLOGICAL	Novartis Meningococcal ACWY Conjugate Vaccine	One dose of vaccine administered intramuscularly
BIOLOGICAL	Tdap Vaccine	One dose of vaccine administered intramuscularly
BIOLOGICAL	Novartis Meningococcal ACWY Conjugate Vaccine	One dose of vaccine administered intramuscularly

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-04-01
• Completion: 2008-10-01
• First posted: 2007-08-20
• Last updated: 2016-05-18
• Results posted: 2010-10-04

Locations

1 site across 1 country: Costa Rica