Conjugate Vaccine Against Meningococcus C a Brazilian Project

This is an interventional prevention trial for Serogroup C Meningococcal Meningitis focused on measuring Meningococcal Vaccines, Immunogenicity, Reactogenicity and Safety of Vaccine Read More

Inclusion Criteria:

• Be current on the national calendar own vaccination for the age group (except for meningitis C vaccine - see exclusion criteria).
• Available for monitoring throughout the study period.
• Willing to provide name, address, telephone number and other information so that we can contact the person if necessary (eg in case of missing the scheduled visit).
• Willing to strictly follow the study protocol.
• Legal Responsible and research participants with the ability to understand and sign the free and informed consent and the informed free consent term, according to the particularities of the age groups.
• Understand the impossibility to participate in another clinical trial during the time you are participating in the study.
• intellectual level or that of his legal guardian (if applicable according to age research participant) for the filling in the forms for registration of signs and symptoms at home.

Exclusion Criteria:

• Previous vaccination against meningococcus
• Personal history of meningitis of any kind.
• Personal history of anaphylaxis, asthma, urticaria or other hypersensitivity reaction to previous vaccinations or who have allergies or hypersensitivity to the study vaccine components.
• Use of allergy shots with antigens within 14 days or less prior to vaccination.
• Immunoglobulin Use in the last 12 months prior to vaccination.
• Use of blood products in the 12 months prior to vaccination.
• Use of any type of vaccine within 30 days before study vaccination.
• The use of injectable vaccines least 30 days after the vaccination study.
• Chronic use of any medication, except homeopathic medicines, medication trivial as saline nasal use and vitamins, and birth control.
• Prior use of immunosuppressant or cytotoxic medication. individuals are acceptable to have made use of this type of medication not immunosuppressant doses for over 6 months as nasal steroids for allergic rhinitis or topical steroids for uncomplicated dermatitis.
• In use of systemic treatment with high doses of steroids (for example, 1 mg / kg / day of prednisone for at least 14 days, or equivalent) or history of chronic use of high power inhaled corticosteroids (e.g., 800 ug per fluticasone day).
• Use of any type of medication in clinical trials over a period of one year prior to vaccination.
• Personal history of neurological, cardiovascular, respiratory, hepatic, renal, hematologic, rheumatic or autoimmune clinically significant (diseases that have led to hospitalization or prolonged treatment).
• Personal history of bleeding disorders diagnosed by a physician or account of capillary fragility (eg. Bruising or bleeding without justifiable cause).
• Personal history of seizures.
• personal history of psychiatric disease that hinders adherence to protocol, such as psychosis, obsessive-compulsive neuroses, bipolar disorder being treated, diseases that require treatment with lithium and suicidal ideas in the past 5 years prior to enrollment.
• Personal history of active malignant disease (eg any type of cancer) or treated you can use during the study.
• Personal history of sickle cell anemia.
• Asplenia (absence of spleen or removal thereof).
• HIV positive or history of any immunosuppressive disease.
• Pregnancy or breastfeeding. Additional criteria for female participants of childbearing age: negative pregnancy test prior to application of doses of vaccines.
• The presence of any disorder that, in the opinion of the principal investigator, may interfere with the evaluation of the study objectives.
• Inability to collect blood for evaluation of pre-vaccine based (baseline).