NCT00329901

Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years

A Phase 3, Multi-Center, Observer Blind, Controlled, Randomized Study to Compare the Immunogenicity and Safety of the Concomitant Administration of a Combined Tetanus, Reduced Diphtheria, and Acellular Pertussis (Tdap) Vaccine and Chiron (Now Novartis) Meningococcal ACWY Conjugate Vaccine, With Either One Dose of Acellular Pertussis (Tdap) Vaccine, or One Dose of Chiron (Now Novartis) Meningococcal ACWY Conjugate Vaccine, in Healthy Subjects Aged 11-25 Years

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,072 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 11 Years – 25 Years
• Healthy volunteers: Accepted

Summary

Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years

Conditions

• Meningococcal Disease
• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal ACWY conjugate vaccine (MenACWY-CRM)
BIOLOGICAL	Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap)
BIOLOGICAL	saline placebo	4.5 mg sodium chloride per 0.5 ml dose

Timeline

• Start date: 2006-04-01
• Primary completion: 2007-05-01
• Completion: 2007-12-01
• First posted: 2006-05-25
• Last updated: 2014-06-18
• Results posted: 2014-06-18

Locations

14 sites across 1 country: Italy