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

Completed · Phase 1

Conditions studied: Meningococcal Vaccines

In brief

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.

Key facts

Study ID

NCT02810340

Run by

PATH

People needed

60

Starts

2016-08-01

Expected to finish

2017-10-13

Last updated by the study team

2021-06-09

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Center for Vaccine Development — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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