Status:

COMPLETED

Safety and Immunogenicity of Chiron's Investigational H. Pylori Vaccine in Healthy Adults

Lead Sponsor:

Novartis Vaccines

Conditions:

Helicobacter Pylori

Gastritis

Eligibility:

All Genders

18-40 years

Phase:

PHASE1

Brief Summary

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

Eligibility Criteria

Inclusion

  • Healthy
  • Ages 18-40
  • Negative for H. pylori infection
  • Contraception for females

Exclusion

  • Present or past H. pylori infection
  • Medically significant gastroduodenal disease
  • Recent corticosteroid use
  • Bleed diathesis
  • Use of antibiotics used to treat H. pylori infection

Key Trial Info

Start Date :

February 1 2001

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2002

Estimated Enrollment :

113 Patients enrolled

Trial Details

Trial ID

NCT00613665

Start Date

February 1 2001

End Date

April 1 2002

Last Update

June 11 2013

Active Locations (1)

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1

Universitaetsklinikum Charité

Berlin, Germany, 10117