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

Phase 2

Completed

• Conditions: Typhoid Fever
• Interventions: Biological: NVGH Vi-CRM197

• Registration Number: NCT01438996
• Lead Sponsor: Novartis

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-19
• Study First Submitted QC: 2011-09-21
• Study First Posted: 2011-09-22
• Study Start: 2011-10
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2013-12-16
• Status Verified: 2014-02
• Results First Submitted QC: 2014-02-04
• Last Update Submitted: 2014-02-04
• Results First Posted: 2014-03-24
• Last Update Posted: 2014-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NVGH Vi-CRM/NVGH Vi-CRM	NVGH Vi-CRM197	One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
Vi-PS/NVGH Vi-CRM	NVGH Vi-CRM197	One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
NVGH Vi-CRM	NVGH Vi-CRM197	One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults

Primary Outcome Measures

Name	Time	Method
Anti-Vi ELISA Geometric Mean Concentration (GMC)	At 3 days after vaccination	To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 3 after vaccination as as measured by enzyme-linked immunosorbent assay (ELISA)
Anti-Vi ELISA GMC	At 28 days after vaccination	To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 28 after vaccination as as measured by ELISA
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers	At 28 days after vaccination as compared to baseline

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Any (Local, Systemic and Other) Post Vaccination Reaction	During the 7-day period after vaccination	Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia, fatigue and fever.
Number of Subjects Reporting AE	During the 28-day period after vaccination	AE during 28 days after vaccination(including solicited reactions during 7 days after vaccination)
Number of Subjects Reporting Serious Adverse Events (SAEs)	During the 28-day period after vaccination

Trial Locations

Locations (1)

Centre for the Evaluation of Vaccination (CEV); 🇧🇪 Antwerp, Wilrijk, Belgium