The Novartis Meningococcal A, C, W-135 and Y vaccine is intended for prevention of meningitis and/or septicemia caused by Neisseria meningitidis serogroups A, C, W-135 and Y. MedDRA version: 9.1 Level: LLT Classification code 10028911 Term: Neisseria meningitidis infection NOS
Conditions
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Participant is willing and able to give informed consent for participation after the nature of the study has been explained; - Male or Female, aged 18- 50 years inclusive; - In good health as determined by: a) medical history b) history-directed physical examination c) clinical judgment of the investigator -Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter -Able (in the Investigators opinion) and willing to comply with all study requirements. -Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study. 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: - Are unwilling or unable to give written informed consent to participate in the study; - Have previously received any meningococcal vaccine; - Have previously been diagnosed with laboratory confirmed meningococcal disease; - Have a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component; - Have a known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example): a) receipt of any immunosuppressive therapy b) Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy* (*prednisolone or equivalent for more than two consecutive weeks within the past 3 months). - Have a suspected or known HIV infection or HIV related disease; - Have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months - Have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time; - Have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. - Participation in another clinical trial investigating a vaccine, a drug, a medical device, or a medical procedure - Pregnancy as confirmed by a positive pregnancy test - Currently breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether meningococcal serogroup A specific SBA geometric mean titres (GMTs) are significantly higher at 7 days after immunisation with MenACWY than 7 days after immunisation with MenACWY PS.;Secondary Objective: To determine whether meningococcal serogroup C, W-135 and Y specific SBA GMTs are significantly higher at 7 days after immunisation with MenACWY than 7 days after immunisation with MenACWY PS. To compare specific plasma cells, memory B cells and SBA GMTs at -7 days, and memory B cells and SBA GMTs at 28 days after a first and second dose of MenACWY conjugate vaccine. -7 days, and memory B cell and SBA levels at 28 days after the MenACWY conjugate vaccine given to participants with or without previous MenACWY PS immunisation. -at day 7, and memory B cell and SBA GMTs 28 days following a booster dose of MenACWY conjugate vaccine in adults previously vaccinated with MenACWY PS or MenACWY. To compare the memory B cell, plasma cell and SBA response to the serogroup A component of the polysaccharide ACWY vaccine to that of the other serogroups (C, W135 and Y) after MenACWY and MenACWY PS. To investigate the effect of genetic polymorphisms on immune response to the Men ACWY vaccine.;Primary end point(s): The primary endpoint will be whether the SBA GMT at day 7 following MenACWY is = 30% greater than that observed at day 7 following MenACWY PS. | — |
Countries
United Kingdom
Outcome results
None listed