A single centre, open-label, randomised clinical trial to investigate Meningococcal serogroup A, C, W-135 and Y saccharide specific B cell response to a primary and a booster dose of the Meningococcal ACWY conjugate vaccine and to a primary dose of the ACWY polysaccharide vaccine followed by a booster dose of the Meningococcal ACWY conjugate vaccine administered to adult volunteers - MENINGOCOCCAL SEROGROUP ACWY B CELL ADULT STUDY

Phase 1

• Conditions: 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: 9.1Level: LLTClassification code 10028911Term: Neisseria meningitidis infection NOS

• Registration Number: EUCTR2007-001349-17-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-09
• Last Update Posted: 31 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified