Prevention of meningococcal infection MedDRA version: 9.1 Level: LLT Classification code 10027274 Term: Meningococcal infection MedDRA version: 9.1 Level: LLT Classification code 10046859 Term: Vaccination
Conditions
Interventions
Product Name: Novartis meningococcal ACWY conjugate vaccine
Pharmaceutical Form: Powder and solvent for solution for injection
Sponsors
University Hospitals Bristol NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent for the study to be performed according to the study schedule. • Adults 18-45 years scheduled to undergo routine tonsillectomy. • Availability for all the visits scheduled in the study. • Ability to understand the written information provided. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Tonsillectomy for allergic conditions - Tonsil required for histopathological or other examination - Receipt of any vaccination, or investigational agent, within 90 days of enrolment to the study or the expectation of receiving any investigational agent or any vaccines prior to the day planned for SBA blood draw (Day 28+7days). Exception for group 4 for whom the expectation of receiving any investigational agent or any vaccines is not allowed until tonsillectomy (Day 42 +/-3 days). Influenza vaccine may be administered up to 15 days prior to study vaccination and no less than 15 days after study vaccination - Receipt of immunosuppressive therapy within the 30 days prior to enrolment (systemic or inhaled corticosteroids administered for more than 5 days, or any cancer chemotherapy, during any of the 30 days prior to enrolment). Topical steroids will be allowed. - A history of meningococcal infection or close contact with a proven index case within the previous 60 days - Pregnancy or plans to become pregnant during study - Breast feeding - Any chronic cardiac, respiratory, gastrointestinal, renal, neurological or psychiatric condition or a history of drug or alcohol dependence. - Any confirmed or suspected immunodeficiency (congenitial or acquired) - Administration of immunoglobulins or any other blood products within one year of study enrolment or planned administration during the study period - Receipt of immunostimulant medication - Donation of blood products within two months of study enrolment or plan to donate blood products within two months of study completion - History of anaphylactic shock or an allergic reaction to a previous vaccination or to any vaccine component. - Acute infectious illness or fever (oral temperature > 38.0°C) during the three days preceding study enrolment. - Significant acute infections requiring systemic antibiotic treatment within the past 14 days - Lack of availability for any planned visit during the study period - Bleeding diathesis, or any condition that may be associated with a prolonged bleeding time; - Known cytogenic disorders - Any condition which, in the opinion of the clinical research team, in discussion with the chief investigator, may interfere with the evaluation of the study objectives for any reason. - Any previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) with the exception of meningococcal serogroup C conjugate vaccines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to describe the number of polysaccharide and carrier protein specific antibody secreting cells identified in the tonsils following immunisation with the quadrivalent meningococcal conjugate vaccine ; Secondary Objective: Secondary objectives include describing the number of polysaccharide and carrier protein specific memory B-cells in the tonsils following immunisation with the quadrivalent meningococcal conjugate vaccine and the immunophenotype of these cells. ;Primary end point(s): The primary endpoint for the study is the number of polysaccharide and carrier protein specific antibody secreting cells identified in the tonsils following immunisation with the quadrivalent meningococcal conjugate vaccine | — |
Countries
United Kingdom
Outcome results
None listed