NCT00679172Phase 2Completed

Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2008-12Actual

Enrollment · participants187Actual

Source updated2024-04-09Last update listed in the registry record

Version history

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Study details

Conditions studied: Typhoid
Treatments or interventions studied: type: BIOLOGICAL; name: Dose of 5.0 x 10^9 CFU (Cohort 1); type: BIOLOGICAL; name: Dose of 7.5 x 10^9 CFU (Cohort 2); type: BIOLOGICAL; name: Dose of 1.1 x 10^10 CFU (Cohort 3); type: BIOLOGICAL; name: Dose of of 1.7 x 10^10 CFU (Cohort 4)
Primary outcomes · main study measures: Read the study measures
measure: Number and Proportion of Subjects Reporting Suspected Unexpected Serious Adverse Reactions.; description: Number and proportion of subjects reporting suspected unexpected serious adverse reactions (SUSARs).; timeFrame: From start of dosing to 28 days post-dosing.; measure: Number and Proportion of Subjects Experiencing Symptomatic Fever.; description: Number and proportion of subjects experiencing symptomatic (e.g., chills, rigors, sweating, headache, myalgia etc.) elevated body temperature of 38.0°C or more in the 14 days following dosing.; timeFrame: From start of dosing to 14 days post-dosing.; measure: Number of Subjects Having Clinically Significant Changes in Laboratory Test Parameters.; description: Number of subjects having clinically significant changes in clinical laboratory test parameters.; timeFrame: From start of dosing to 28 days post-dosing.; measure: Number of Subjects Reporting Treatment-related TEAEs.; description: Number of subjects having TEAEs considered by the principal investigator to be "possibly" or "probably" related to treatment.; timeFrame: From start of dosing to 28 days post-dosing.; measure: Number and Proportion of Subjects Experiencing Bacteraemia.; description: Number and proportion of subjects experiencing a proven bacteraemia attributed to the vaccine strain S. typhi (Ty2 aroC-ssaV-) ZH9.; timeFrame: From start of dosing to 28 days post-dosing.; measure: Number of Subjects Having Shedding in Stool of Salmonella Typhi (S. Typhi) (Ty2 aroC-ssaV-) ZH9.; description: Number of subjects having shedding in stool of S. typhi (Ty2 aroC-ssaV-) ZH9. Subjects were evaluated beyond Day 14 only in Cohort 4.; timeFrame: Beyond 7 days post-dosing through 14 days post-dosing (Cohorts 1-3) or through 21 days post-dosing (Cohort 4).; measure: 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).; description: Number and proportion of subjects with increase of 70% (fold change of 1.7) in S. typhi LPS-specific serum IgG at Days 14 or 28 AND/OR increase of 50% (fold change of 1.5) in S. typhi LPS-specific serum IgA at Days 7 or 14. Serum IgG and IgA were assayed using enzyme-linked immunosorbent assay (ELISA).; timeFrame: From baseline (pre-dose) to Days 14 or 28 (IgG) or to Days 7 or 14 (IgA).
History coverage: Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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