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| Sponsored by: |
Emergent BioSolutions |
| Information provided by: | Emergent BioSolutions |
| ClinicalTrials.gov Identifier: | NCT00679172 |
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.
| Condition | Intervention | Phase |
|
Typhoid |
Biological: M01ZH09 Other: Placebo |
Phase II |
| MedlinePlus related topics: | Fever |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study |
| Official Title: | 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. |
| Estimated Enrollment: | 200 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1.: Experimental |
Biological: M01ZH09
Live attenuated typhoid vaccine, single dose, oral administration
|
| 2: Placebo Comparator |
Other: Placebo
Excipients only
|
Eligibility
| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ron Budhram | +44 (0)118 944 3300 | clindev@ebse.com |
| United States, Florida | |||||
| Miami Research Associates | Recruiting | ||||
| South Miami, Florida, United States, 33143 | |||||
| Contact: Eric Sheldon 305-279-0015 ext 4223 esheldon@miamiresearch.com | |||||
| Principal Investigator: Eric Sheldon | |||||
| United States, Maryland | |||||
| John Hopkins Bloomberg School of Public Health | Recruiting | ||||
| Baltimore, Maryland, United States, 21205 | |||||
| Contact: Clayton Harro 410-614-4937 charro@jhsph.edu | |||||
| Principal Investigator: Clayton Harro | |||||
| United States, Vermont | |||||
| Unit of Infectious Diseases, University of Vermont College of Medicine | Recruiting | ||||
| Burlington, Vermont, United States, 05405 | |||||
| Contact: Beth Kirkpatrick 802-656-5822 Beth.kirkpatrick@uvm.edu | |||||
| Principal Investigator: Beth Kirkpatrick | |||||
| Emergent BioSolutions |
| Study Director: | Stephen Lockhart, DM | Emergent BioSolutions |
More Information
| Responsible Party: | Emergent BioSolutions ( Stephen Lockhart ) |
| Study ID Numbers: | MS01.13 |
| First Received: | May 14, 2008 |
| Last Updated: | July 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00679172 |
| Health Authority: | United States: Food and Drug Administration |
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