At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 63 enrolled
Drug / intervention
H.pylori vaccines +1 morebiological
Likely dose
Not stated in 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.
Phase I/II, Randomized, Observer-blind, Placebo-controlled, Single-Center Study of the Tolerability, Immunogenicity, and Efficacy of an Novartis' Investigational H. Pylori Vaccine in H. Pylori-Negative Adults
In Brief
A Phase 1 clinical trial evaluating H.pylori vaccines and Placebo Vaccine for Helicobacter Pylori Infection. Completed, enrolled 63 participants across 1 site.
Detailed Summary
To study the safety, immunogenicity and efficacy of an investigational H. pylori vaccine, compared with placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHelicobacter Pylori Infection
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2008
Enrollment StartOct 2008
Primary CompletionMar 2010
Study CompletionApr 2010
TodayJul 2026
First PostedAug 15, 2008
Enrollment StartOct 1, 2008
Primary CompletionMar 1, 2010
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.9 years ago
Interventions
H.pylori vaccinesbiological
1 dose of H.pylori vaccine at 0, 1, and 2 months
Placebo Vaccinebiological
Placebo Vaccine at 0, 1, and 2 months