NCT01437267

Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants

A Phase 2, Randomized, Controlled, Observer Blind, Single Center Study of the Safety, Reactogenicity and Immunogenicity of the NVGH Glycoconjugate Vaccine Against S. Typhi in Children, Older Infants and Infants

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 6 Weeks – 59 Months
• Healthy volunteers: Accepted

Summary

This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in children and infants from various age groups in the Philippines where Typhoid Fever is highly endemic and an efficacious vaccine against this disease is very much needed.

Conditions

• Typhoid Fever

Interventions

Type	Name	Description
BIOLOGICAL	Vi-CRM197 vaccine
BIOLOGICAL	Pneumococcal conjugate vaccine
BIOLOGICAL	Vi Polysaccharide (PS) vaccine

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-09-20
• Last updated: 2014-04-10
• Results posted: 2014-04-10

Locations

1 site across 1 country: Philippines