| Add to balance / Manage account | User: | Log out |
| Prospect News home > News index > List of issuers A > Headlines for Acambis plc > News item |
Acambis starts phase 3 trial of vaccine for Japanese encephalitis
New York, Nov. 15 - Acambis plc said it has begun pivotal phase 3 trials of its vaccine against Japanese encephalitis.
The trials are being carried out in Australia under a Clinical Trial Exemption license issued by the Australian Therapeutic Goods Administration and in the United States under a Food and Drug Administration Investigational New Drug Application.
In total, 2,800 healthy adults will participate in the studies, which have been designed to provide comprehensive safety data and to test the non-inferiority of ChimeriVax-JE to JE-VAX, a licensed Japanese encephalitis vaccine, by statistical comparison of immunogenicity.
The efficacy study, involving 800 subjects, will also test clinical consistency of three commercial-scale batches of ChimeriVax-JE manufactured in house at Acambis' Canton, Mass., facility.
The other 2,000 subjects will participate in the safety study.
Acambis said it is on track to submit a product license application for ChimeriVax-JE for travelers and endemic populations in the first half of 2007.
Acambis also plans to conduct clinical trials in India with a view to submitting a product license application for ChimeriVax-JE for populations where the disease is endemic.
Acambis said there is a global public health need for a single-dose, convenient and affordable vaccine against Japanese encephalitis, a need that is particularly significant in endemic regions where such a vaccine could represent a major contribution to preventing Japanese encephalitis in children.
Acambis is a Cambridge, England, developer of vaccines to prevent and treat infectious diseases.
© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere.
For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.