Baby Vaccine Study (Sched3)
Condition: Infectious Diseases
MeSH terms: Communicable Diseases; Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This multicentre, parallel group, block randomised clinical trial aims to investigate the
      post booster antibody response in UK infants given a reduced priming schedule of
      meningococcal serogroup B vaccine and 13 valent pneumococcal conjugate vaccine. It will
      provide information about how best to include the meningococcal B vaccine (likely to be
      introduced late 2015) into the routine immunisation schedule.

      The UK Department of Health provides a routine vaccination schedule for children in the UK
      and are advised by the Joint Committee on Vaccination and Immunisation (JCVI). The Department
      of Health have announced that the meningococcal B vaccine (Bexsero) be introduced to the
      routine schedule as a 2+1 schedule. Cost effectiveness could also be improved by removing the
      current MenC conjugate vaccine dose given at 3 months of age. There is no published
      immunogenicity data for Bexsero when given at 2, 4 and 12 months of age (2+1 schedule) and
      with concomitant Infanrix/IPV/Hib which has now replaced Pediacel in the infant programme.

      This change to the schedule would result in three injections at 2, 4 and 12 months, and given
      previous reluctance among parents for three injections at one visit, an option to reduce
      PCV13 to a 1+1 schedule (priming dose at 3 months and booster at 12 months) will be assessed
      in this study.
    

Detailed description: 
      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.
    

Intervention name(s): DTaP/IPV/Hib vaccine; 13 valent Pneumococcal Conjugate Vaccine; Rotavirus vaccine; 4-component Meningococcal B vaccine; Meningococcal C/Hib vaccine (MenC/Hib vaccine); Measles/Mumps/Rubella Vaccine (MMR vaccine)
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Given at 2, 3 and 4 months to Group 1 and 2; Given at 2,4 and 12 months in group 1, given at 3 and 12 months in group 2; Given at 2 and 3 months to Group 1 and 2; Given at 2, 4 and 12 months to Group 1 and 2; Given at 12 months to Group1 and 2; Given at 13 months to Groups 1 and 2
Other intervention name(s): Infanrix-IPV-Hib; PCV 13; Prevenar; Rotarix; Bexsero; Menitorix; Priorix; MMR II
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: infant immunisations; vaccines; paediatric; pneumococcal; meningococcal