| Protocol No: | ECCT/16/02/06 | Date of Protocol: | 04-11-2015 |
| Study Title: | A Phase 2a, observer blind, randomized, controlled, Single Center Study to evaluate the Safety, Reactogenicity and Immunogenicity of 2 doses of the GVGH 1790GAHB Vaccine against Shigella sonnei, administered intramuscularly in Adult Subjects from a country endemic for shigellosis [GVGH study H03_04TP] |
| Study Objectives: | |
| Laymans Summary: | |
| Abstract of Study: | Shigellosis remains a major health problem in developing countries with approximately 100 million cases per year mostly in children ≤5 years. Antibiotic resistance of Shigella is increasing and no vaccine is currently available against shigellosis. The purpose of H03_04TP study is to evaluate the safety and the immunogenicity of two different doses (25 μg and 100 μg) of the GVGH S. sonnei 1790GAHB vaccine in healthy adults and represents the first step towards testing of the GMMA vaccine in the vaccine target population of children from developing countries where shigellosis is endemic. |