A Phase 2/3, Open Label, Randomised Study of the Safety, Reactogenicity and Immunogenicity of a Single Dose of Novartis Meningococcal ACWY (Menveo) or GSK Meningococcal ACWY Conjugate Vaccine in Adolescents Primed With Meningitec, Menjugate or Neisvac-C in Preschool Vaccination (PRIME)

NCT01192997 Phase 2/Phase 3 COMPLETED

There is evidence of waning immunity in individuals vaccinated against meningitis C as part of the UK infant immunisation schedule. The intention of this study is to contact participants of a previous NVEC (National Vaccine Evalutaion Consortium) clinical trial (a PreSchool Men C trial, in which participants were randomised to receive Meningitec, Menjugate or Neisvac-C). They will be invited to enrol and will be randomised to receive one of two quadrivalent meningococcal ACWY vaccines, to look at the boosting effect they may confer.

Details

Lead sponsor	Public Health England
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	91
Start date	2012-06
Completion	2014-03

Conditions

• Meningococcal Meningitis

Interventions

• Menveo
• MenACWY-TT

Primary outcomes

• Response to meningococcal components of the vaccines by serum bactericidal antibody — December 2013
  Percentage of participants with serogroup-specific rabbit Serum Bactericidal Antibody (rSBA) titres ≥ 8 at one month post vaccination, for each of the serogroups A, C, W135 and Y. (This titre of rSBA is a documented correlate of protection for meningococcal conjugate vaccines)

Countries

United Kingdom