Study to Evaluate the Immunogenicity, Reatogenicity and Safety of Double Viral Vaccine (MR) for Measles and Rubella

This is a Phase II-III, controlled, randomized and double blind for the evaluation of a double viral vaccine anti measles and rubella (MR), which is under the development at Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil, for use in human beings. 432 eligible volunteers (11-month-old infants), will be vaccinated and monitored for local and systemic adverse events and immunogenicity. The study will last 11 months in total.

Inclusion criteria

• Both sex;
• Good health (no significant medical history);
• 11 months of age on the first dose of vaccine;
• To be up-to-date with the national vaccination calendar;
• Availability for follow-up throughout the study period;
• Willing to provide name, address, telephone and other contact information in order to be contacted, whenever needed (example: in case of missing any scheduled visit, contact for confirmation of scheduling a visit, urgent safety notifications);
• Willing to strictly follow the study protocol;
• At least one legal guardian of the research participants must be able to understand and sign the informed consent form;
• Legal guardians by the research participants who can understand the child's inability to participate in another clinical trial during the time they are participating in the study;
• Legal guardian with intellectual capacity to fill out the signs of signs and symptoms at home.

Exclusion criteria

• Previous vaccination against measles and rubella;
• Personal history of measles or rubella;
• Personal history of anaphylactic shock, asthma, urticaria or other hypersensitivity reaction to previous vaccinations, or who are allergic or hypersensitive to vaccine components of the study;
• Use of antiallergic injections with antigens within 14 days or less prior to vaccination;
• Use of immunoglobulin in the last 12 months prior to vaccination;
• Use of blood products in the last 12 months prior to vaccination;
• Use of any type of vaccine less than 30 days prior to study vaccination;
• Use of injectable vaccines less than 42 days after study vaccination;
• Chronic use of any medications (except homeopathic medicines and trivial medication such as saline and vitamins);
• Previous use of immunosuppressive or cytotoxic medication;
• Use of systemic therapy with high doses of steroids;
• Use of any type of medication in a clinical trial within 12 months prior to vaccination;
• Personal history of clinically significant neurological, cardiovascular, respiratory, hepatic, renal, haematological, rheumatologic or autoimmune diseases;
• Personal history of coagulopathies diagnosed by a physician or report of capillary fragility;
• Personal history of seizures;
• Personal history of an active (eg any cancer) or treated malignant disease that may recur during the study;
• Personal history of sickle cell anemia;
• Asplenia (absence of spleen or removal of the spleen);
• HIV positive or history of any immunosuppressive disease;
• Presence of any disorder which, in the opinion of the principal investigator, may interfere with the evaluation of the study objectives;
• Legal guardian with limited capacity for adherence to the study, according to the researcher's evaluation;
• Impossibility of blood collection for pre-vaccine evaluation.