Oxford Vaccine Group University of Oxford Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Headington, Oxford OX3 7LE
Tel/Fax: 01865 857420 [email protected] www.ovg.ox.ac.uk
Dear Student, Parent or Guardian, The Oxford Vaccine Group is seeking healthy volunteers aged from 10 to 18 years to take part in a Clinical Trial of a new Meningococcal Group B vaccine. Type B Meningococcus is the major cause of meningococcal meningitis (inflammation of the brain) and septicaemia (blood poisoning) in the UK. These severe diseases are thankfully rare, but are most common in young children and young adults compared to other age groups. An effective vaccine for type C meningococcus was introduced in to the routine immunisation schedule more than a decade ago. A vaccine against meningococcus B has recently been approved for use in the European Union, but is not yet widely available. A new, slightly different vaccine is being developed (called bivalent rLP2086) that we hope will help prevent illness caused by meningococcus type B (MenB). The Oxford Vaccine Group is involved in conducting this very large study that will include more than 3,600 children and young adults worldwide.
If you/your child take part in the study, you/your child would be asked to attend a clinic on five occasions – three vaccination visits and two more visits to have a blood sample taken. Participants allocated to the “MenB” group would receive three doses of the study vaccine (rLP2086) over a six month period. Those allocated to the “control” group would receive two doses of an approved vaccine against Hepatitis A virus and one dose of saline (a placebo or “dummy” solution), also over a six month period. If you/your child are interested in taking part and would like more information then please contact the research team:
Oxford Vaccine Group University of Oxford Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Headington, Oxford OX3 7LE Tel/Fax: 01865 857420 [email protected] www.ovg.ox.ac.uk Alternatively, you can complete the reply slip and return it in the stamped addressed envelope provided. Please note that The Oxford Vaccine Group do not have your contact details. The Abingdon School kindly agreed to distribute this letter on our behalf.
Thank you for taking the time to read this letter.
Yours sincerely
Professor Andrew Pollard Study Chief Investigator Study Principal Investigator Professor of Paediatric Infection and Immunity Honorary Consultant Paediatrician
B1971009; Invitation Letter UK (Oxford) 11/YH/0385 - Version 1 dated 18/04/2013 1 of 2
Reply slip
I would potentially be interested in taking part and would like to know more about the study.
Student’s name: ______
Parent’s name: ______
Student’s DOB: ______
Address: ______
______
Email: ______
Home phone: ______
Mobile phone: ______
Preferred mode of contact? Letter / email / home telephone / mobile phone
Best time to telephone (if applicable): ______
B1971009; Invitation Letter UK (Oxford) 11/YH/0385 - Version 1 dated 18/04/2013 2 of 2