Baby Vaccine Study (Sched3)

The study's primary objective is to assess antibody response to the pneumococcal vaccine after the final infant vaccinations at approximately 13 months of age, and secondary objectives include antibody response following meningococcal B and C vaccines, tetanus, diphtheria and pertussis vaccines. In addition, the effect of maternal pertussis vaccination in pregnancy on infant immune response to vaccines, the prevalence of carriage of pneumococcal serotypes at 12 and 18 months of age and reactogenecity following each vaccine will be assessed. 200 healthy children who have not yet received their routine infant immunisations will be enrolled between 8 and 12 weeks old. Participants will be randomised into one of two groups with differing vaccine schedules. Children in both groups will receive their routine immunisations with the following changes: the addition of 3 doses of a meningococcal B vaccine at 2, 4 and 12 months and a meningococcal C vaccine at 12 months only (instead of a dose at 3 and 12 months). The 2 groups will differ by the number of doses of the 13-valent pneumococcal vaccine (PCV13); to be given either at 2, 4, and 12 months of age (as currently given in the routine schedule) or at 3 and 12 months of age. Each participant will have 2 blood tests: at 5 and 13 months of age, and 2 nose swabs: at 12 and 18 months of age to address the objectives of the study. Parents will be asked to complete a health diary to record any adverse events in the 7 days following vaccinations and a continuous thermometer (ibutton) will be used to record the temperature for 24 hours after each vaccination. If the blood samples at 13 months reveal antibody titres that are below the level indicative of protection, a recommendation will be made for booster vaccinations.