A new vaccine for babies which adds protection against hepatitis B

• Research type

  Research Study

• Full title

  A phase III open-label randomised study, to evaluate the immunogenicity and safety of the concomitant administration of V419 (PR5I) given at 2, 3 and 4 months of age with two types of meningococcal serogroup C conjugate (MCC) vaccines given at 3 and 4 months of age, and followed by the administration at 12 months of age of a combined Haemophilus influenzae type b-MCC vaccine.

• IRAS ID

  86663

• Contact name

  Adam Finn

• Sponsor organisation

  Sanofi Pasteur MSD S.N.C.

• Eudract number

  2011-002413-11

• Research summary

  The current UK immunisation schedule recommends vaccination against diphtheria (bacterial respiratory infection), tetanus (lockjaw), pertussis (whooping cough), poliomyelitis (polio) and Haemophilus flunzae type b. This study will test a new vaccine developed by Sanofi Pasteur MSD, which aims to prevent hepatitis B (liver disease) in addition to the diseases mentioned above. It is an open label trial - participants will know which vaccine they receive. We will recruit 284 healthy infants (46-74 days old) from around 10 sites in the UK. Participants will be randomly assigned (like flipping a coin) to one of two groups, with an equal chance of being in either group:- All children will be given the new vaccine (PR5I). - All children will receive a vaccine against Meningitis type C (MenC). Two MenC vaccines will be used (MCC-TT and MCC-CRM). Half the children will receive MCC-TT and half will receive MCC-CRM. Both of these MenC vaccines are already used in the UK and the immunisation schedule recommends that babies should be given one or other of these vaccines. - In addition, all children will receive their other routine vaccines against pneumonia, Haemophilus flunzae type b/meningitis type C (Hib/MenC vaccine) and measles/mumps/rubella (MMR) in line with UK recommendations. Each child will be in the study for about 11 months. They will have a total of 6 study visits to receive their vaccinations and have 5 blood samples taken to check their protection levels after immunisation. Their parent/guardian will be asked to complete a diary card after each vaccination visit to record the child??s temperature and any adverse effects. The study will investigate how well the children are protected against the diseases prevented by the new combination vaccine, as well as the MenC and Hib/MenC vaccines. It will also evaluate the safety of giving the new vaccine alongside the MenC and Hib/MenC vaccines.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  11/SW/0328

• Date of REC Opinion

  7 Feb 2012

• REC opinion

  Further Information Favourable Opinion