Who is sponsoring NCT01405521?

NCT01405521 is sponsored by University of Oxford.

What condition does NCT01405521 study?

NCT01405521 studies Typhoid Fever, Enteric Fever, Typhoid.

What drugs are being tested in NCT01405521?

Interventions: Vaccine placebo (excipients only), Ty21a, M10ZH09 vaccine.

What is the status of NCT01405521?

NCT01405521 is currently COMPLETED.

Last reviewed 2023-05-03 · How we verify

Understanding Typhoid Disease After Vaccination: a Single Centre, Randomised, Doubleblind, Placebo Controlled Study to Evaluate M01ZH09 in a Healthy Adult Challenge Model, Using Ty21a Vaccine as a Positive Control.

NCT01405521 Phase 2 COMPLETED

Using an established model of human typhoid infection, whereby healthy adults are deliberately infected with typhoid-causing bacteria, the investigators will determine how effective a new oral typhoid vaccine (M01ZH09) is in preventing infection. A previously licensed oral typhoid vaccine (Ty21a) will be used to make sure the challenge model used works properly.

Details

Lead sponsor	University of Oxford
Phase	Phase 2
Status	COMPLETED
Enrolment	99
Start date	2011-10-07
Completion	2022-05-06

Conditions

Typhoid Fever
Enteric Fever
Typhoid

Interventions

Vaccine placebo (excipients only)
Ty21a
M10ZH09 vaccine

Primary outcomes

Diagnosis of typhoid fever — 2 weeks after typhoid challenge
Typhoid fever defined as development of Gram negative bacteraemia after day 5 or temperature over 38C persisting for 12 hours or more. Typhoid challenge defined as ingestion of virulent S. Typhi (Quailes strain).

Countries

United Kingdom