Meningococcal serogroup C infection
Conditions
Interventions
Trade Name: NeisVacC
Product Name: NeisVacC
Pharmaceutical Form: Injection*
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Written informed consent for the study to be performed according to the study schedule.-Adults between 18 and 40 years.-Available throughout the study period.-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: -Receipt of any vaccination or investigational agent within 50 days of enrolment to the study.-Chronic administration (defined as treatment for more than 14 days) of any immunosuppressant or immune modifying drug (topical or inhaled steroids will be excluded from this definition). -A history of meningococcal infection or contact with a proven index case within 60 days of enrolment to the study.-Pregnancy or plans to become pregnant during the study. -Breast feeding.-Any chronic cardiac, respiratory, gastrointestinal, renal, neurological or psychiatric condition.-Any confirmed or suspected immunodeficiency (congenital or acquired).-Administration of immunoglobulins or any other blood products within one-year of study enrolment or planned administration during the study period.-History of anaphylactic shock or allergic reaction to a previous vaccination or to any vaccine component.-Acute illness or fever during the three days preceding study enrolment-Lack of availability at any time during the study period.-Any other condition which, in the opinion of the clinical research fellow (EC), may interfere with the evaluation of the study objectives for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Describe the characteristics of the antibody secreting cell (ASC) response generated in the circulation following immunization describing the changes occurring in ASC number and immunophenotype over time. ;Secondary Objective: Assess the relationship between ASC number and serum and salivary antibody levels;Primary end point(s): Quantification of the number of antibody secreting cells generated in the blood following the intramuscular immunisation of 21 healthy adult volunteers | — |
Countries
United Kingdom
Outcome results
None listed