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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-08-31

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.

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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.

Conditions

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Mumps Rubella Measles

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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MMR (Mumps, Measles and Rubella)

Intervention Type BIOLOGICAL

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.

Minimum Eligible Age

12 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes