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

NCT00736476 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2017-02-28

Study results available
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Summary

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

Conditions

  • Helicobacter Pylori Infection

Interventions

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

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines · Novartis Vaccines

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-03-31
Completion
2010-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00736476 on ClinicalTrials.gov