Serological Study in Children 12 to 23 Months Vaccinated With MMR (Measles, Mumps and Rubella)

The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Status: Completed

Conditions: Rubella; Mumps; Measles

Treatments: Biological: MMR (Mumps, Measles and Rubella)

Study type: Observational

Funder types: Other

Identifiers

NCT01874457

ASCLIN/002/2008

Details and patient eligibility

About

On a previous study conducted in Brazil. The MMR vaccine from 2 different producers had a mumps seroconversion much lower (71%) than the expected 95%, according to the package insert. This could indicate that a substantial proportion of children was not protected after MMR dose.

Full description

Given the above and considering: (1) future clinical study with the MMR vaccine produced entirely in Bio-Manguinhos/Fiocruz from technology transfer from GlaxoSmithKline (GSK), (2) the importance to the National Immunization Program (NIP) to provide the population a MMR vaccine to ensure high protection against mumps, similar to what occurs with measles and rubella components, it was considered essential to conduct a preliminary immunogenicity assessment of the MMR vaccine produced by BioManguinhos.

Enrollment: 150 patients

Sex: All

Ages: 12 to 24 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children of both sexes;
• Age between 12 months to 23 months and 29 days;
• Child in good health, with no significant past medical history;
• Have completed blood sampling before vaccination;
• Have not been vaccinated with MMR.
• Agreement by parents/tutors with the child's participation in the study and signing of the Informed Consent Form (ICF);
• Parents/Tutors provide name, address, telephone number and other information for the contact if necessary;
• Parents/Tutors able to understand the risks of the experiment, although minimal;
• Parents/Tutors able to understand and sign the informed consent form.
• Availability of return for collecting post-vaccination samples.

Exclusion criteria

• Children with a history of measles, rubella and / or mumps.
• Having received MMR vaccine previously, as documented in vaccination card.
• Having received a transfusion of blood or blood products, including immunoglobulins, within last 12 months.
• Skin lesions at sites of venipuncture.
• Child subject to abnormal bleeding after injections.
• Use within 6 months of corticosteroids (excluding topical or aerosol) and immunosuppressants.