Phase I, Randomized, Controlled, Single-blind, Dose-Ranging and Schedule-Finding Study of the Safety, Tolerability, and Immunogenicity of Chiron Helicobacter Pylori Vaccine in Healthy, Helicobacter Pylori-negative Adults

NCT00613665 Phase 1 COMPLETED

This study was designed to investigate the safety and immunogenicity of Chiron's investigational H. pylori (HP3) vaccine

Details

Lead sponsor	Novartis Vaccines
Phase	Phase 1
Status	COMPLETED
Enrolment	113
Start date	2001-02
Completion	2002-04

Conditions

• Helicobacter Pylori
• Gastritis
• Gastric Cancer
• Gastroduodenal Ulcers
• Lymphoma

Interventions

• helicobacter pylori vaccine
• helicobacter pylori vaccine
• helicobacter pylori vaccine
• helicobacter pylori vaccine
• Placebo
• helicobacter pylori vaccine
• helicobacter pylori vaccine

Primary outcomes

• Safety measures: injection site and systemic reactions — 5 months

Countries

Germany