CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 187 enrolled
Drug / intervention
Dose of 5.0 x 10^9 CFU (Cohort 1) +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00679172
NCT00679172Phase 2Completed
CompareCT.gov

A Randomised, Double-blind, Placebo-controlled, Single Dose, Dose Escalation Study to Determine the Immunogenicity, Safety and Tolerability of S. Typhi (Ty2 aroC-ssaV-) ZH9 at Doses of 5.0 x 10E9 CFU, 7.5 x 10E9 CFU, 1.1 x 10E10 and 1.7 x 10E10 CFU and 1.7 x 10E10 CFU, Following Oral Administration to Healthy, Typhoid Vaccine naïve Subjects in the USA.

Emergent BioSolutions·interventional·Posted May 16, 2008·Updated Apr 9, 2024

In Brief

A Phase 2 clinical trial evaluating Dose of 5.0 x 10^9 CFU (Cohort 1), Dose of 7.5 x 10^9 CFU (Cohort 2), and 3 other interventions for Typhoid. Completed, enrolled 187 participants across 3 sites.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTyphoid
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 16, 2008
Enrollment StartMay 1, 2008
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 18.1 years ago

Interventions

Dose of 5.0 x 10^9 CFU (Cohort 1)biological

S. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration

Dose of 7.5 x 10^9 CFU (Cohort 2)biological

S. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration

Dose of 1.1 x 10^10 CFU (Cohort 3)biological

S. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration

Dose of of 1.7 x 10^10 CFU (Cohort 4)biological

S. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration

Placebo (Cohorts 1-4 pooled)other

Excipients only, single dose, oral administration