No specific medical condition(s) - responses to vaccination against meningococcal disease. MedDRA version: 19.0 Level: PT Classification code 10027199 Term: Meningitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Menveo
Product Name: Menveo
Pharmaceutical Form: Powder and solvent for solution for injection in pre-filled syringe
INN or Proposed INN: Me
Sponsors
Public Health England
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Individual is willing and able to give written informed consent for participation. • Individual was originally enrolled in the randomised parallel group study of quadrivalent meningococcal vaccination. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 93 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Known bleeding diathesis (or any condition that may be associated with a prolonged bleeding time). • Any other significant condition or circumstance which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary outcome measure is the antibody level measured in the blood sample against the four meningitis strains included in the vaccine given in the study that commenced in 2010, ACWY.;Timepoint(s) of evaluation of this end point: Single blood test in the current study. Results from the previous study will be used int he calculation of the number of fold changes over time.; Main Objective: Technical version: • To estimate and compare the serogroup A, C, Y and W-specific antibody titres following ~4-5 years after vaccination with either the Glaxosmithkline or Pfizer quadrivalent meningococcal vaccines and comparison between vaccines and over time. Lay version: To measure how much antibody against each of the four meningitis strains included in the vaccines is still in the blood 4-5 years after vaccination with the quadrivalent vaccine and to compare this between the two groups in the original study. ; Secondary Objective: Technical version: 1 Percentage of subjects with serogroup A, C, W and Y rSBA titres = 8 and =128. 2 Meningococcal serogroup A, C, W and Y-specific IgG geometric mean concentration and = 4 fold rise compared to baseline, as measured by IgG ELISA at all time points where sera are available for analysis. 3. Tetanus and diphtheria-specific IgG geometric mean concentrations (GMCs) and percentage of subjects with IgG concentration = 0.1 IU/ml. Lay version: 1 The percentage of participants who have antibody levels in the blood against the four strains of meningitis included in the vaccine above the two set levels that are routinely used to measure protection, 8 and 128. 2 The average levels in the two groups of antibodies in the blood against the four meningitis strains in the vaccine and what proportion of them rose by more than four times the | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): n/a | — |
Countries
United Kingdom
Contacts
Public ContactJo Southern
Public Health England
Outcome results
None listed