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Sponsored by: |
Emergent BioSolutions |
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Information provided by: | Emergent BioSolutions |
ClinicalTrials.gov Identifier: | NCT00679172 |
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 |
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Typhoid |
Biological: M01ZH09 Other: Placebo |
Phase II |
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 |
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1.: Experimental |
Biological: M01ZH09
Live attenuated typhoid vaccine, single dose, oral administration
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2: Placebo Comparator |
Other: Placebo
Excipients only
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Stephen Lockhart, DM | Emergent BioSolutions |
Responsible Party: | Emergent BioSolutions ( Stephen Lockhart ) |
Study ID Numbers: | MS01.13 |
Study First Received: | May 14, 2008 |
Last Updated: | July 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00679172 |
Health Authority: | United States: Food and Drug Administration |
Bacterial Infections Fever Enterobacteriaceae Infections Salmonella Infections Typhoid |
Healthy Typhoid fever Typhoid Fever Gram-Negative Bacterial Infections |