Study to Evaluate the Immune Response of United Kingdom (UK) Infants Receiving DTaP/Hib/IPV, Meningococcal C Conjugate and Pneumococcal Conjugate Vaccines, Antibody Persistence and Responses to Booster Doses in the Second Year of Life
Condition: Meningococcal Infections; Pneumococcal Infections
MeSH terms: Infections; Communicable Diseases; Pneumococcal Infections; Meningococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is:

      To assess whether there are differences in antibody persistence eight months post primary
      (pre-booster) or in responses to the booster with regard to the Meningococcal C Conjugate
      (MCC) vaccine given in infancy.

      To examine levels of diphtheria and tetanus antibody pre- and post-booster, with regard to
      the carrier proteins contained in the conjugate vaccines.
    

Detailed description: 
      There is a well recognised benefit in reducing the number of injections included in an
      immunisation programme, particularly for infants where delivery of many antigens in the first
      few months of life is essential in providing protection against deadly diseases. Reducing the
      number of injections would reduce distress to infants, parents and healthcare workers, make
      the schedule as cost effective as possible and would give greater flexibility to include
      vaccination against novel antigens in the future.

      The UK recommended immunisation schedule up to 13 months of age was revised from 4 September
      2006 so that infants receive three doses of Pediacel (diphtheria, tetanus, whooping cough,
      Hib and polio containing vaccine), two doses of Prevenar (pneumococcal vaccine, PNC) and two
      doses of meningococcal C vaccine, MCC, which can be one of three licensed products,
      Meningitec, Menjugate or NeisVacC. Previous studies have however shown that these three MCC
      products behave quite differently from each other when given with other vaccines and under
      different dose schedules. To that end the two products which seem viable as single dose
      options under the UK schedule, Menjugate and NeisvacC, will be included in this study.

      Assessment of the absolute number of doses of vaccine needed to protect against disease
      essential in maximising the efficiency of the schedule and this study will further examine
      the dose requirement for meningococcal C conjugate (MCC) vaccine where there are data to
      suggest that this would be possible, both in the published peer reviewed literature and in an
      ongoing study conducted by our group. This study will be the first to test this under the
      accelerated UK schedule and in the presence of pneumococcal conjugate vaccine. This study
      also includes a booster phase where children receive a dose of MCC, PNC and Hib in the second
      year of life in accordance with the national schedule. There is a need for boosters in the
      second year of life to increase circulating antibody which has dropped significantly by a
      year of age. As expected, responses to boosting have been shown to be significantly higher
      than those achieved after primary immunisation with variation between products following a
      similar pattern to that seen with the primary series.

      The current study is designed to allow assessment of a single dose of MCC vaccine given at
      three months of age for the two products that have shown potential to afford protection in
      the ongoing study above. In the previous study the first dose was given at two months of age
      and as responses tend to improve with age it is anticipated that this single dose being given
      later will result in higher antibodies than seen in the above study.

      The aim of this study will be to provide data on which to base a decision about a further
      reduction in MCC vaccination in infancy from two doses to a single dose which would afford
      the benefits discussed above.
    

Intervention name(s): NeisVacC (Meningococcal C conjugate vaccine); Menjugate (Meningococcal C conjugate vaccine)
Intervention type(s): Biological; Biological
Intervention description(s): Dosage; Dosage
Other intervention name(s): Meningococcal C conjugate vaccine; Neis-vacC; Meningococcal C conjugate vaccine; Menjugate
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: meningococcal serogroup C vaccine; reduced dose; meningococcal serogroup C conjugate vaccine; pneumococcal conjugate vaccine