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| Sponsor: | Institut Pasteur |
|---|---|
| Information provided by: | Institut Pasteur |
| ClinicalTrials.gov Identifier: | NCT00210288 |
Purpose
The purpose of this study is to assess the immune response produced by two doses of SC599 vaccine compared to placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Shigella Infection |
Biological: SC599 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Comparative Double Blind Placebo-Controlled Study of Immunogenicity and Safety of Two Doses 10^5 and 10^7 CFU of SC599 Oral Vaccine, a Live Attenuated Shigella Dysenteriae 1 Vaccine Strain in Healthy Human Adult Volunteers |
| Estimated Enrollment: | 111 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | October 2006 |
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: Christine Sadorge | +33 (0) 1 40 61 38 26 | csadorge@pasteur.fr |
| France | |
| CIC de Vaccinologie Cochin Pasteur | Recruiting |
| 75679 Paris Cedex 14, France | |
| Contact: Dr Odile Launay, MD +33 (0)1 44 07 15 41 odile.launay@cch.ap-hop-paris.fr | |
| United Kingdom | |
| Dept of Cellular and Molecular Medicine, St George's Hospital Vaccine Institute | Recruiting |
| London, United Kingdom, SW17 0QT | |
| Contact: Dr David Lewis, MD +44 20 8725 5826 sgif300@sgul.ac.uk | |
| Principal Investigator: | Dr Odile Launay, MD | Hôpital Cochin - Bâtiment Modulaire, France |
| Principal Investigator: | Dr David Lewis, MD | St George's Hospital Vaccine Institute, UK |
More Information
| Study ID Numbers: | RBM 2004.20 |
| Study First Received: | September 13, 2005 |
| Last Updated: | October 19, 2005 |
| ClinicalTrials.gov Identifier: | NCT00210288 History of Changes |
| Health Authority: | France:Agence Française de sécurité des Produits de Santé (Afssaps); United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Healthy Volunteer Shigella Oral Vaccine Double Blind |
Placebo Immunogenicity Safety |
|
Bacterial Infections Digestive System Diseases Gastrointestinal Diseases Dysentery Enterobacteriaceae Infections |
Dysentery, Bacillary Intestinal Diseases Gastroenteritis Infection Gram-Negative Bacterial Infections |