Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Jeremy Farrar


Contact details

The Hospital for Tropical Diseases
Oxford University Clinical Research Unit
190 Ben Ham Tu
Ho Chi Minh City
District 5
Viet Nam
+84 (0)8 923 7954

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title



Study hypothesis

The purpose of the study is to determine the safety and immunogenicity of the oral vaccine M01ZH09 in healthy, paediatric, Asian subjects prior to initiating field trials in an endemic area.

Ethics approval

The trial has received full ethical approval from the OXTREC committee (ref: 021-06) and the local Institutional Review Board (The Hospital for Tropical Diseases, Ho Chi Minh City, Viet Nam). The approval dates are 25th July 2006, for conditional approval, and final unconditional approval was received on the 18th October 2006.

Study design

Randomised, placebo-controlled, single-blind, single dose study.

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Typhoid fever prophylaxis


Subjects deemed eligible after screening will be randomised to receive an oral dose of either active vaccine or matching placebo.

Safety will be monitored by:
1. Diary recordings of body temperature
2. Assessment of Adverse Events (AEs)
3. Vital signs
4. Stool samples for microbiological analyses
5. Urine dipstick tests
6. Immunogenicity will be assessed in all subjects using an Enzyme-Linked ImmunoSorbent Assay (ELISA) method for serum Immunoglobulin G (IgG) and serum Immunoglobulin A (IgA) in all subjects. Enzyme-Linked Immunosorbent SPOT (ELISPOT) tests will be conducted on samples from subjects aged 11 to 14 years of age.

Intervention type



Not Specified

Drug names

M01ZH09 typhoid vaccine (oral live S. typhi [Ty2 aroC- ssaV-] ZH9)

Primary outcome measure

The proportion of subjects reporting Serious Adverse Events (SAEs) attributed to the study medication.

Secondary outcome measures

Safety - the proportion of subjects:
1. Experiencing an elevated body temperature, of 38.5°C or greater, in the 14 days following dosing, attributed to study medication
2. Demonstrating persistent faecal shedding of the vaccine strain
3. Withdrawn from the study due to adverse events, including bacteraemia, attributed to study medication
4. With clinically significant changes in laboratory parameters, from day zero to any time post dosing, which are attributed to study medication

1. Develop a positive immune response to S. typhi LipoPolySaccharide (LPS) as assessed by an increase in S. typhi LPS specific IgG
2. Develop a positive immune response to S. typhi LPS as assessed by an increase S.typhi LPS specific IgA
3. At day seven, have more than or equal to 4 Antibody-Secreting Cells (ASCs) per 10^6 Peripheral Blood Mononuclear Cells (PBMC), secreting IgA specific for S. typhi LPS detected by ELISPOT assay (subjects over ten years of age)

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Healthy paediatric subjects aged five to 14 years
2. Are able and willing to take part in the trial
3. Parents or guardians give written permission for their child’s participation, following a detailed explanation of the study

Participant type


Age group



Not Specified

Target number of participants


Participant exclusion criteria

1. Any clinically significant medical or psychiatric condition or abnormal laboratory results on screening, which preclude participation in the study
2. A body weight under 17 kg (five to ten year olds), or under 27 kg (11 to 14 year olds)
3. A confirmed pregnancy, or are breast feeding
4. A known hypersensitivity to two or more of the following antibiotics: ciprofloxacin, azithromycin or trimethoprim-sulfamethoxazole, or have used antibiotics/antibacterials within 14 days prior to administration of study medication
5. A known hypersensitivity to any component of the vaccine or bicarbonate solution, phenylketonuria or those who have experienced anaphylactic shock after any vaccination
6. Received Vivotif, in the last ten years or any other vaccine against S. typhi, in the last five years, or who have ever suffered from typhoid fever
7. Direct contact with patients in special care units or immuno-compromised individuals, a positive bacterial culture of their faecal sample, obtained at the screening visit, for any Salmonella species, a known impairment of immune function or family members who are Human Immunodeficiency Virus (HIV) positive
8. A significant acute febrile illness at time of dosing chronic diseases, a current problem of substance abuse or who are currently or recently involved in a clinical study

Recruitment start date


Recruitment end date



Countries of recruitment

Viet Nam

Trial participating centre

The Hospital for Tropical Diseases
Ho Chi Minh City
District 5
Viet Nam

Sponsor information


Emergent Product Development UK Ltd (UK)

Sponsor details

545 Eskdale Road
Winnersh Triangle
RG41 5TU
United Kingdom
+44 (0)118 944 3300

Sponsor type




Funder type


Funder name

The Wellcome Trust (UK) (grant ref: 075596)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

1. 2010 results in

Publication citations

  1. Results

    Tran TH, Nguyen TD, Nguyen TT, Ninh TT, Tran NB, Nguyen VM, Tran TT, Cao TT, Pham VM, Nguyen TC, Tran TD, Pham VT, To SD, Campbell JI, Stockwell E, Schultsz C, Simmons CP, Glover C, Lam W, Marques F, May JP, Upton A, Budhram R, Dougan G, Farrar J, Nguyen VV, Dolecek C, A randomised trial evaluating the safety and immunogenicity of the novel single oral dose typhoid vaccine M01ZH09 in healthy Vietnamese children., PLoS ONE, 2010, 5, 7, e11778, doi: 10.1371/journal.pone.0011778.

Additional files

Editorial Notes