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.
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Number and Proportion of Subjects Reporting Suspected Unexpected Serious Adverse Reactions.
Timeframe: From start of dosing to 28 days post-dosing.
Number and Proportion of Subjects Experiencing Symptomatic Fever.
Timeframe: From start of dosing to 14 days post-dosing.
Number of Subjects Having Clinically Significant Changes in Laboratory Test Parameters.
Timeframe: From start of dosing to 28 days post-dosing.
Number of Subjects Reporting Treatment-related TEAEs.
Timeframe: From start of dosing to 28 days post-dosing.
Number and Proportion of Subjects Experiencing Bacteraemia.
Timeframe: From start of dosing to 28 days post-dosing.
Number of Subjects Having Shedding in Stool of Salmonella Typhi (S. Typhi) (Ty2 aroC-ssaV-) ZH9.
Timeframe: Beyond 7 days post-dosing through 14 days post-dosing (Cohorts 1-3) or through 21 days post-dosing (Cohort 4).
Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgG and/or IgA Antibodies for S. Typhi Lipopolysaccharide (LPS).
Timeframe: From baseline (pre-dose) to Days 14 or 28 (IgG) or to Days 7 or 14 (IgA).