NCT01466387

A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults

A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 552 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study compares the safety and immunogenicity profile of several travel vaccines given alone or concomitantly with MenACWY-CRM to healthy adults.

Conditions

• Meningococcal Disease
• Meningococcal Meningitis
• Typhoid
• Yellow Fever
• Rabies
• Japanese Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	Typhoid Vi Polysaccharide Vaccine	One dose of typhoid Vi polysaccharide vaccine.
BIOLOGICAL	Yellow Fever Vaccine	One dose of yellow fever vaccine.
BIOLOGICAL	Japanese Encephalitis Vaccine	Two doses of Japanese Encephalitis Vaccine.
BIOLOGICAL	Rabies Vaccine	Three doses of Rabies vaccine.
BIOLOGICAL	MenACWY-CRM Vaccine	One dose of MenACWY-CRM vaccine.

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-11-08
• Last updated: 2014-03-11
• Results posted: 2014-03-11

Locations

5 sites across 2 countries: Czechia, Germany