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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Serological Study of Measles, Mumps and Rubella in Children 12 to 23 Months Vaccinated With MMR (Measles, Mumps and Rubella) in Health Centers Where a Phase III Study Should be Conducted

Conditions
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Mumps, Rubella, Measles

Intervention / Treatment
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* Biological: MMR (Mumps, Measles and Rubella)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: MMR (Mumps, Measles and Rubella)|MMR (Mumps, Measles and Rubella)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunoresponse after first dose | Assess the immunoresponse for measles, mumps and rubella after vaccination with MMR in children 12-23 months and 29 days old, in the routine of National Immunization Program (NIP) in health units in the city of Rio de Janeiro. | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunoresponse after revaccination | To evaluate the immunoresponse after revaccination of children who did not seroconvert for any of the three components of the vaccine. | 42 days |