Trials / Completed
CompletedNCT01123941
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old)
A Phase I, Randomized, Single-Blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of the NVGH Glycoconjugate Vaccine Against S. Typhi in Adult Subjects 18 to 40 Years of Age.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (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 a new Vi-CRM197 conjugate vaccine against S. Typhi in healthy human adults in comparison with the currently licensed Vi polysaccharide vaccine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Typherix | 1 dose, 0.5 mL containing 25 mcg of Vi polysaccharide |
| BIOLOGICAL | NVGH Vi-CRM197 | 1 dose of 0.5 mL containing 25 mcg of Vi-CRM |
Timeline
- Start date
- 2010-05-01
- Primary completion
- 2010-06-01
- Completion
- 2010-11-01
- First posted
- 2010-05-14
- Last updated
- 2014-01-17
- Results posted
- 2012-06-13
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT01123941. Inclusion in this directory is not an endorsement.