Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00613665 | Safety and Immunogenicity of Chiron's Investigational H. Pylori Vaccine in Healthy Adults | PHASE1 | COMPLETED | 113 | — | — | Feb 1, 2001 | Apr 1, 2002 | Jun 11, 2013 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| 5 | PLACEBO_COMPARATOR | - |
| 6 | EXPERIMENTAL | - |
| 7 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| helicobacter pylori vaccine | BIOLOGICAL | Experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 10 micrograms of each antigen, 0,1,2 month schedule (alum control was administered at 4 months), administered intramuscularly |
| Placebo | BIOLOGICAL | Nine subjects, alum control (placebo comparator), 0,1,2,4 month schedule (served as control for arms 1-4), administered intramuscularly |
Inclusion Criteria: * Healthy * Ages 18-40 * Negative for H. pylori infection * Contraception for females Exclusion Criteria: * Present or past H. pylori infection * Medically significant gastroduodenal disease * Recent corticosteroid use * Bleed diathesis * Use of antibiotics used to treat H. py...