At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 88 enrolled
Drug / intervention
NVGH Vi-CRM197 12.5 mcg +3 morebiological
Likely dose
NVGH Vi-CRM197 12.5 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating NVGH Vi-CRM197 12.5 mcg, NVGH Vi-CRM197 5.0 mcg, and 2 other interventions for Typhoid Fever. Completed, enrolled 88 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTyphoid Fever
CountriesBelgium
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2010
Enrollment StartOct 2010
Primary CompletionNov 2010
TodayJul 2026
First PostedSep 2, 2010
Enrollment StartOct 1, 2010
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.8 years ago
Interventions
NVGH Vi-CRM197 12.5 mcgbiological
1 dose of 0.5 mL
NVGH Vi-CRM197 5.0 mcgbiological
1 dose of 0.5 mL
NVGH Vi-CRM197 1.25 mcgbiological
1 dose of 0.5 mL
Vi-polysaccharide vaccinebiological
1 dose of 0.5 mL containing 25 mcg of Vi polysaccharide