Study of Meninigococcal Conjugate Vaccine Containing Serogroups A,C,Y,W and X (MCV5) in Healthy Adults
Condition: Meningococcal Vaccines
Intervention: Adjuvanted MCV-5; Non-Adjuvanted MCV-5; Menactra®
Intervention description: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM), and 125 μg Al3+adjuvant.; Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, and 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM).; Menactra® vaccine was a clear to slightly turbid solution supplied in a 0.5 mL single dose vial. Each 0.5 mL dose of vaccine was formulated in sodium phosphate buffered isotonic sodium chloride solution to contain four mcg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 μg of diphtheria toxoid protein carrier and residual amounts of formaldehyde of less than 2.66 μg (0.000532%), by calculation.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to evaluate the safety of adjuvanted and
      non-adjuvanted formulations of MCV-5 vaccine. The secondary objective is to assess the immune
      response of adjuvanted and non-adjuvanted formulations of MCV-5 vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18-45 years

          -  Written informed consent of volunteers

          -  Healthy as established by medical history, laboratory evaluation and screening
             evaluations

          -  Participants are able to understand and comply with planned study procedures and be
             available for all study visits

          -  Female subjects must be of non-childbearing potential (defined as surgically sterile
             or postmenopausal for more than 1 year), or if of childbearing potential must be
             practicing abstinence or using an effective licensed method of birth control

        Exclusion Criteria:

          -  Previous vaccination against Neisseria meningitidis.

          -  Known exposure to Neisseria meningitidis in the past.

          -  History of meningitis or seizures or any neurological or psychiatric disorder.

          -  Administration of any other vaccine within 30 days prior or after administration of
             study vaccines.

          -  Use of any investigational or non-registered drug or vaccine within 30 days prior to
             the administration of study vaccines or planned during the study.

          -  History of allergic disease or known hypersensitivity to any component of the three
             study vaccines.

          -  History of Serious Adverse Reactions following administration of Tetanus Toxoid,
             Diphtheria Toxoid or CRM containing vaccines.

          -  History of Guillan-Barré syndrome.

          -  Confirmed or suspected immunosuppressive or immune-deficient condition. 10. A family
             history of congenital or hereditary immunodeficiency.

          -  Chronic administration (defined as more than 14 days) of immune-suppressants or other
             immune-modifying agents within six months prior to administration of study vaccine.

          -  12. Laboratory confirmed infection of either hepatitis B virus (HBs Ag positive on
             ELISA), hepatitis C virus (anti-HCV positive on ELISA as well as PCR) or human
             immunodeficiency virus (HIV on ELISA).

          -  Major congenital defects or serious chronic illness.

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal
             functional abnormality, as determined by medical history, physical examination or
             laboratory screening tests.

          -  Known bleeding disorders.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the administration of study vaccines or planned administration during the
             vaccine period.

          -  History (within the past year) or signs of alcohol or substance abuse.

          -  Pregnancy or lactation.

          -  A Body Mass Index (BMI) equal to or above 30.

          -  Any other condition, which in the opinion of the investigator, might interfere with
             the study objectives, jeopardize the safety or rights of the participant or making it
             unlikely the participant could complete the protocol.