Study of Meninigococcal Conjugate Vaccine Containing Serogroups A,C,Y,W and X (MCV5) in Healthy Adults

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.