NCT01193907

Safety and Immunogenicity of Three Formulations of Vi-CRM197 Vaccine Against S. Typhi in Adults (18-40 Years Old)

A Phase 2, Randomized, Observer-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of Three Formulations of the Novartis Vaccines Institute for Global Health (NVGH) Glycoconjugate Vaccine Against S. Typhi in Adult Subjects 18 to 40 Years of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This trial is aimed to evaluate the safety and immunogenicity profiles of three formulations of Vi-CRM197 conjugate vaccine against S. Typhi in healthy human adults in comparison with the currently licensed Vi polysaccharide vaccine

Conditions

• Typhoid Fever

Interventions

Type	Name	Description
BIOLOGICAL	NVGH Vi-CRM197 12.5 mcg	1 dose of 0.5 mL
BIOLOGICAL	NVGH Vi-CRM197 5.0 mcg	1 dose of 0.5 mL
BIOLOGICAL	NVGH Vi-CRM197 1.25 mcg	1 dose of 0.5 mL
BIOLOGICAL	Vi-polysaccharide vaccine	1 dose of 0.5 mL containing 25 mcg of Vi polysaccharide

Timeline

• Start date: 2010-10-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-09-02
• Last updated: 2014-01-17
• Results posted: 2012-04-03

Locations

1 site across 1 country: Belgium