Expired Study
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South Miami, Florida 33143


Purpose:

This study is to investigate the safety, tolerability and immunogenicity of the typhoid fever vaccine candidate M01ZH09 manufactured at commercial scale, at a new manufacturing facility. The vaccine will be delivered as a single oral dose to healthy, typhoid vaccine-naïve adults.


Study summary:

This was a randomised, double-blind, placebo-controlled, single dose, dose escalation study with 4 dosing cohorts. Within each cohort, 45 evaluable subjects were planned (36 subjects receiving M01ZH09, 9 receiving placebo).


Criteria:

Inclusion Criteria: - healthy adult subjects aged 18 to 50 years inclusive, who are able and willing to give informed consent, following a detailed explanation of participation in protocol - available for the duration of the study and available for scheduled and potential additional visits Exclusion Criteria: - women who are pregnant, breast-feeding or of childbearing potential and unwilling to use a reliable method of contraception throughout the study period - history of anaphylactic shock following vaccination by any route have phenylketonuria - hypersensitivity to any component of the vaccine or are hypersensitive to two of the following antibiotics: ciprofloxacin, azithromycin, ampicillin, trimethoprim sulfamethoxazole - received antibiotic medication within 14 days prior to dosing - received any vaccine within 4 weeks prior to dosing or plan to receive a vaccine within 4 weeks after dosing - received any vaccine against Salmonella typhi (licensed or investigational) or ever suffered from typhoid fever - subjects who test positive for hepatitis B, hepatitis C, HIV or human leucocyte antigen B-27 - known or suspected history of liver or active gall bladder disease, ongoing gastro-intestinal disease or abnormality - commercial food handlers or health care workers with direct contact with high risk patients or who have household contacts with immuno-compromised individuals, pregnant women or children less than 2 years of age - subjects who have a clinically significant amount of protein or haemoglobin in their urine or abnormality of their haematology or serum biochemistry parameters - impairment of immune function or those receiving or have received cytotoxic drugs in the 6 months prior to study entry - subjects who use antacids, proton pump inhibitors or H2 blockers on a regular basis or have consumed proton pump inhibitors or H2 blockers within 24 hours prior to dosing - acute infections (including fever of 37.5 degrees Celsius or greater) on the day of dosing. - subjects with chronic disease (e.g Crohn's disease, inflammatory bowel disease, diabetes) who cannot withstand a 3 hour fast - substance abuse or a history of substance abuse that might interfere with participation in the study - body mass index (BMI) is less than 19 or greater than 34 kg per m2 - clinically significant medical condition that precludes participation in the study - subjects who have participated in an interventional clinical trial within 60 days of dosing


NCT ID:

NCT00679172


Primary Contact:

Study Director
Stephen Lockhart, DM
Emergent BioSolutions


Backup Contact:

N/A


Location Contact:

South Miami, Florida 33143
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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