NCT00736476

Efficacy and Safety of an H.Pylori Vaccine in H.Pylori-Negative Adults

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To study the safety, immunogenicity and efficacy of an investigational H. pylori vaccine, compared with placebo.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
BIOLOGICAL	H.pylori vaccines	1 dose of H.pylori vaccine at 0, 1, and 2 months
BIOLOGICAL	Placebo Vaccine	Placebo Vaccine at 0, 1, and 2 months

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-03-01
• Completion: 2010-04-01
• First posted: 2008-08-15
• Last updated: 2017-02-28
• Results posted: 2017-02-28

Locations

1 site across 1 country: Germany