Phase 3 multicentre travellers' diarrhoea vaccine study

• Research type

  Research Study

• Full title

  A Phase Three, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travellers’ Diarrhoea Vaccine System.

• IRAS ID

  14898

• Sponsor organisation

  Intercell AG

• Eudract number

  2008-008726-75

• Research summary

  The sponsor of this study is testing an experimental vaccine patch to prevent travellers?? diarrhoea. The vaccine patch is used with a new method of vaccination on the skin called transcutaneous immunization (TCI) that can deliver the vaccine to the body without using a needle. This new method uses a device that prepares the skin to receive the vaccine patch. Both the device and the vaccine patch are a part of the Travellers?? Diarrhoea (TD) Vaccine System. The vaccine patch will be administered to healthy volunteers aged between 18 and 64 years old who intend to travel to Mexico or Guatemala for at least 7 days. Researchers will look at the immune responses (how the body recognises and defends itself against germs) and safety associated with vaccination using the TD Vaccine System.Volunteers will document AEs via diaries throughout vaccination & surveillance phases. All AEs will be evaluated at all visits. After arrival at the destination country volunteers will be monitored for 17 days, even if they only stay for 7 days. Six months after this surveillance phase they will have a final safety assessment & be given a questionnaire to evaluate the incidence of new-onset IBS (follow-up phase).This is a study to evaluate how well the Travellers' Diarrhoea Vaccine System can help prevent people from getting moderate to severe travellers?? diarrhoea caused by a bowel toxic bacteria known as Escherichia coli (E.Coli). It is also to evaluate how much the Travellers' Diarrhoea Vaccine System can lessen symptoms and characteristics of travellers?? diarrhoea and reduce the amount of gastrointestinal (GI: refers to stomach or intestines), illness experienced and other related symptoms. It is also hoped to evaluate the body??s immune response to the patch after vaccination and the safety of the vaccine.The study will last approximately 2 years.

• REC name

  HSC REC B

• REC reference

  09/NIR03/4

• Date of REC Opinion

  10 Mar 2009

• REC opinion

  Further Information Favourable Opinion