Status:
COMPLETED
Serological Study in Children 12 to 23 Months Vaccinated With MMR (Measles, Mumps and Rubella)
Lead Sponsor:
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Conditions:
Mumps
Rubella
Eligibility:
All Genders
12-24 years
Brief Summary
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 indic...
Detailed 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 t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01874457
Start Date
May 1 2008
End Date
August 1 2009
Last Update
June 17 2013
Active Locations (1)
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1
Bio-Manguinhos/Fiocruz
Rio de Janeiro, Rio de Janeiro, Brazil, 21040-360