Trials / Completed
CompletedNCT01229176
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants
A Phase 2a, Randomized, Controlled, Observer Blind, Age De-Escalation, Multicenter and Multinational Study of the Safety, Reactogenicity and Immunogenicity of the NVGH Glycoconjugate Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- Novartis · Industry
- Sex
- All
- Age
- 6 Weeks – 45 Years
- Healthy volunteers
- Accepted
Summary
This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in subjects from various age groups in India and Pakistan where Typhoid Fever is highly endemic and an efficacious vaccine against this disease is very much needed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Vi-CRM197 vaccine | |
| BIOLOGICAL | Vi Polysaccharide (PS) vaccine | |
| BIOLOGICAL | Pneumococcal conjugate vaccine |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2012-06-01
- Completion
- 2012-06-01
- First posted
- 2010-10-27
- Last updated
- 2014-05-01
- Results posted
- 2014-04-10
Locations
2 sites across 2 countries: India, Pakistan
Source: ClinicalTrials.gov record NCT01229176. Inclusion in this directory is not an endorsement.