NCT01438996

Extension Study of H01_04TP to Evaluate the Booster Response Induced by Vi-CRM197 in Adults

A Phase 2, Open-label, Single-center, Extension Study to Evaluate the Booster Response Induced by Vi-CRM197 After Priming With Either Vi-CRM197 or Typherix Administered in Adult Subjects in H01_04TP Study (NCT01193907)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 42 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the immunogenicity and the kinetics of the anti-Vi antibody response following secondary vaccination with the Novartis Vaccines Institute for Global Health (NVGH) Vi-CRM197 vaccine in healthy adults previously vaccinated with either the NVGH Vi-CRM197 or Vi-polysaccharide (Typherix) in the H01\_04TP study (NCT01193907) and the immunogenicity and the kinetics of the anti-Vi antibody response following primary vaccination with the NVGH Vi-CRM197 vaccine in naïve healthy adults.

Conditions

• Typhoid Fever

Interventions

Type	Name	Description
BIOLOGICAL	NVGH Vi-CRM197	Vi-CRM197 glycoconjugated vaccine

Timeline

• Start date: 2011-10-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-09-22
• Last updated: 2014-03-24
• Results posted: 2014-03-24

Locations

1 site across 1 country: Belgium