Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects

A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of a Single Oral Dose Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00498654

Enrollment

180

Registered

2007-07-10

Start date

2007-07-31

Completion date

2008-06-30

Last updated

2008-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Typhoid Fever

Keywords

Prevention of Typhoid Fever in Adult Travelers

Brief summary

The purpose of this trial is to examine the safety and immunogenicity of Ty800 oral vaccine in healthy adult subjects.

Interventions

BIOLOGICALTy800 (Salmonella typhi) Oral Vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy Males or Females aged 18 to 55 years, inclusive * Capable of understanding and complying with the protocol requirements and be available for the duration of the protocol

Exclusion criteria

* History of malignancy, immunocompromised conditions or currently receiving immunosuppressive treatment including systemic steroids * History of Typhoid Fever infection, vaccination against typhoid fever or participation in a Clinical Trial using S.typhi organism at any time * History of travel to a typhoid endemic region within the last 5 years or history of raising a child from an endemic area. Endemic regions are South and East Asia, the Indian Subcontinent, Africa and Central and South America including Mexico * History of persistent diarrhea, blood in stool, peptic ulcer disease, or inflammatory bowel disease * Allergies or sensitivities to antibiotics, notably quinolones, penicillins, sulfonamides, cefalosporins and chloramphenicol, and components of the buffer solution, notably aspartame. * People who are commercial food handlers, day care workers, or health care workers involved in direct patient care. Also people with young children under 2 years of age at home or household contacts who are immunocompromised, pregnant or breast-feeding

Design outcomes

Primary

Measure	Time frame
Immunogenicity	Baseline through Day 14
Reactogenicity	Baseline through Month 1 follow-up

Secondary

Measure	Time frame
Longterm safety and immunogenicity	Month 1 to 6 post-dosing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026