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

Novartis

Status and phase: Completed; Phase 1

Conditions: Helicobacter Pylori Infection

Treatments: Biological: Placebo Vaccine; Biological: H.pylori vaccines

Study type: Interventional

Funder types: Industry

Identifiers

NCT00736476

2007-003511-31

V99P2

Details and patient eligibility

About

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

Enrollment: 63 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• adults 18 - 40 years of age in good health
• HP uninfected
• not pregnant and agree to use birth control throughout the study (females who can become pregnant)

Exclusion criteria

• remote or current HP infection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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63 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Biological: H.pylori vaccines

2

Placebo Comparator group

Treatment:

Biological: Placebo Vaccine