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
Phase 1
18 Years
40 Years
18 Years
40 Years
Not Enrolling
Both
Helicobacter Pylori, Gastritis, Gastric Cancer, Gastroduodenal Ulcers, Lymphoma
Both
Helicobacter Pylori, Gastritis, Gastric Cancer, Gastroduodenal Ulcers, Lymphoma
Trial Information
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
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. pylori infection
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Outcome Measure:
Safety measures: injection site and systemic reactions
Outcome Time Frame:
5 months
Safety Issue:
Yes
Principal Investigator
Novartis Vaccines
Investigator Role:
Study Chair
Investigator Affiliation:
Novartis Vaccines
Authority:
United States: Institutional Review Board
Study ID:
HPP002
NCT ID:
NCT00613665
Start Date:
February 2001
Completion Date:
April 2002
Related Keywords:
- Helicobacter Pylori
- Gastritis
- Gastric Cancer
- Gastroduodenal Ulcers
- Lymphoma
- Gastritis
- Lymphoma
- Stomach Neoplasms
- Peptic Ulcer
- Ulcer
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