Can We Reduce the Number of Vaccine Injections for Children?

• Research type

  Research Study

• Full title

  An open label randomised controlled study to evaluate the induction of immune memory following infant vaccination with a glyco-conjugate Neisseria meningitidis serogroup C vaccine and to assess the immunological impact of administering routine infant immunisations in consistent versus alternating limbs

• IRAS ID

  36849

• Contact name

  Andrew J Pollard

• Sponsor organisation

  University of Oxford

• Eudract number

  2009-016579-31

• ISRCTN Number

  n/a

• Research summary

  This is a study to evaluate a reduced dose schedule for Meningococcal serogroup C (MenC) vaccination for infants. Currently in the UK, children receive priming MenC vaccines at 3 and 4 months of age and a combination Hib-MenC booster at 12 months of age. There is some evidence that fewer doses of priming vaccines may improve antibody responses following the booster dose. Fewer doses will also mean fewer injections for children and reduced costs to the NHS. We would like to compare the current schedule with one group of children who will receive only a single dose of MenC vaccine at 3 months, and another group who will not receive any priming doses of MenC vaccine in infancy. All groups will receive the 12 month Hib-MenC booster. The antibody responses to each of these schedules will be compared at several time points by doing blood tests (at age 5months, 12months, 12months and 6 days and 13months). The three study groups will receive all other routine infant immunisations according to the current UK schedule. Embedded in this trial will be a pilot study comparing the effect of administering sequential immunisations into consistent limbs or alternating limbs. At present immunisations are administered ad hoc by practitioners into either limb at each time point. Theoretically, administering the same immunisation into the same limb for every dose may improve the immune response. Each of the study groups will be split into 2: one to receive all doses of the same immunisation into consistent limbs, the other to receive immunisations into different limbs at each dose. The immune response to the pneumococcal vaccine will be used to compare differences. This is a randomised controlled trial, but not blinded as participants will know which immunisations they are to receive.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  10/H0604/7

• Date of REC Opinion

  14 Jan 2010

• REC opinion

  Favourable Opinion