Measles Clinical Trial
Official title:
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
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | August 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 12 Months to 24 Months |
Eligibility |
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. |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Brazil | Bio-Manguinhos/Fiocruz | Rio de Janeiro |
Lead Sponsor | Collaborator |
---|---|
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | 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 | Yes |
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