Comparative Study of the Immunogenicity of MMR (Measles, Mumps and Rubella) Single Dose and Multidose Presentations

Launched by THE IMMUNOBIOLOGICAL TECHNOLOGY INSTITUTE (BIO-MANGUINHOS) / OSWALDO CRUZ FOUNDATION (FIOCRUZ) · Jan 24, 2013

Keywords

ClinConnect Summary

Study Design

This is a clinical trial Phase IV, randomized, single-blind, with two arms:

* MMR (TV) combined measles, mumps and rubella vaccine produced in Bio-Manguinhos, applied to healthy children 12 to 23 months. Multidose presentation, only from one batch.
* MMR (GSK-TV), produced by GlaxoSmithKline, the same age. Monodose presentation, only from one batch.

Locations of the study

* CMS Heitor Beltrão - Tijuca
* CMS Milton Fontess Magarão - Engenho de Dentro
* CMS Waldyr Franco - Bangu

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Children of both sexes.
• • Age between 12 and 23 months and 29 days.
• • Child in good health, without significant personal morbid history, such as genetic syndromes, epilepsy, diabetes, severe infections and immune dysfunctions.
• • Concordance of the father or mother, or legal guardian, with the child's participation in the study, and signing the Informed Consent Form (ICF).
• • Disposition of the father or mother, or legal guardian, to provide name, address, telephone number and other information so you can get in touch with this (s) if necessary.
• • Responsible able understand the risks of the experiment that, although minimal, there.
• • Responsible able to understand and sign the informed consent form. If the charge is not able to sign (illiterate) the ICF may be signed by an impartial witness who has followed the whole procedure.
• • Availability return to collect post-vaccination - The subjects of research may not be participating in another clinical trial during this study.
• • Not having received the vaccine Immunization Schedule in the last 30 days.
• • Not receiving another vaccine until harvest 2, 42 days after vaccination with MMR.
• • Non-inclusion criteria
• • Children with a history of measles, rubella and or mumps.
• • Having previously received MMR vaccination documented in book (eg in situations of conducting national campaign or blocking vaccination before suspected cases of the disease).
• • Have received injectable vaccines of live attenuated (eg. Yellow fever vaccine) - in this case, defer vaccination with MMR after 30 days of the last live attenuated vaccine administered.
• • Having received a transfusion of blood or blood products, including immunoglobulins, less than 1 year.
• • Skin lesions at sites of venipuncture.
• • Child subject to abnormal bleeding after injections.
• • Use the last 6 months in immunosuppressive doses of corticosteroids and other immunosuppressants.
• • Fever or the day of inclusion in the 3 days prior to the inclusion in this case may be rescheduled for inclusion after 14 days the fever subsides.
• • Use of antibiotic on the day of inclusion or in the last 7 days prior to the date of inclusion - in this case, may be rescheduled for inclusion after 14 days of the last day of antibiotic use.
• • Any significant abnormality on physical examination the day of enrollment.
• • Hypersensitivity known systemic neomycin or any other component of the vaccine.
• • Guy with a history of severe allergy, anaphylaxis to egg proteins