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Study of Immunogenicity, Reactogenicity and Safety of the Combined Measles, Mumps and Rubella Vaccine Produced by Bio-Manguinhos/Fiocruz in Children 12-15 Months of Age, Followed by Tetraviral Vaccine in Children 15-18 Months.
It is a clinicaltrial Phase III , randomized, double -blind , 4-arm (390 each one): This study will include 1560 children and will use 3 batches of vaccine produced by Bio - Manguinhos with viral bulk of GSK combined measles , mumps and rubella applied in healthy children 12-15 months of age, and 01 batch of MMR to reference( GSK ), applied in healthy children aged 12-15 months old . The vaccine is administered as MMR 1st dose. Two hypotheses are tested : 1. Consistency of production ( equivalence between batches )of 3 batches of vacines(TV1, TV2 , TV3 Bio- Manguinhos). Noninferiority vaccine Bio TV (Fiocruz, Rio de Janeiro), ie, the measles, mumps and rubella in Brazil is as immunogenic and safe as the measles, mumps and rubella reference, already used in routine NIP (production Bio-Manguinhos/FIOCRUZ with viral concentrate, bulk, GSK). The MMR vaccine (Bio-TV) will have the same composition (vaccine strains) and the same method of production of MMR (TV-GSK): Wistar RA27 / 3 rubella, Schwarz strain of measles vaccine, and strain RIT 4385 - derived from the Jeryl Lynn strain of mumps vaccine. As 2nd dose, children receive the vaccine tetraviral measles-mumps-rubella-varicella, aged 15-18 months, according to the guidance of the National Immunization Program. 2. Noninferiority vaccine Bio TV (Fiocruz, Rio de Janeiro):the measles, mumps and rubella vaccine in Brazil is as immunogenic and safe as the measles, mumps and rubella reference, already used in routine NIP (production Bio-Manguinhos/FIOCRUZ with viral concentrate, bulk, GSK). Returns for blood sampling will be scheduled for 51 days, ranging from 42 to 60 days after dose of MMR vaccine dose and after tetraviral. We will colect the firt blood sample before the first vaccination too. It will describe the major adverse events observed after vaccination , comparing their frequency in groups of MMR vaccine with the Brazilian reference vaccine .
Details
| Lead sponsor | The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 1560 |
| Start date | 2015-02 |
| Completion | 2016-07 |
Conditions
- Measles
- Mumps
- Rubella
- Varicella
Interventions
- MMR Bio-Manguinhos
- MMR GlaxoSmithKline
Primary outcomes
- Immunogenicity comparing the 3 lots of MMR vaccine produced totally in Brazil and reference vaccine. — Thirty days after MMR vaccine
Difference seroprotection for each of the antigens in the vaccines under test and reference vaccines or greater - 10%, one-tailed analysis. More precisely, the lower limit of 95% of the difference between the seroprotection rates in the vaccine test and reference vaccine should be greater than 10% (e.g. 4%, -3%, etc. .) evaluate the immunogenicity• Ratio of the geometric mean titers for each of the antigens ≥ 0.5 (for Bio-Manguinhos vaccine and reference vaccine). The analysis of non-inferiority will take into account three batches of vaccines TV1, TV2, TV3 and that will be compared together with the reference vaccine, if any consistency of production batches. This procedure is performed in the 2nd serology after vaccination. - Safety — Thirty days after MMR vaccine
Parents or guardians will take home the diary for recording adverse events. They will receive training on how to complete the diary of adverse events in health facilities where children are vaccinated after the first dose of MMR. They will receive a ruler and a mercury thermometer to check for adverse events and a pen for note. The diary of adverse events should be completed during the 10 days after vaccination •Adverse events will be compared for each of vaccines (TV1, TV2, TV3 and reference vaccine) and for each dose. Will determine the percentage of subjects with a report of any symptoms (solicited or unsolicited) during the 30 days of follow-up after vaccination. Are tabulated the percentages of subjects with adverse events (for the overall incidence of any symptom, for the incidence of any local symptoms and the incidence of any general symptoms). The comparison between groups will be made by the chi-square test with a significance level of 0.05. - Determine the consistency of production — Thirty days after MMR vaccine
Difference seroprotection for each of the antigens in the vaccines under test and reference vaccines or greater - 10%, one-tailed analysis. More precisely, the lower limit of 95% of the difference between the seroprotection rates in the vaccine test and reference vaccine should be greater than 10% (e.g. 4%, -3%, etc. .) evaluate the immunogenicity• Ratio of the geometric mean titers for each of the antigens ≥ 0.5 (for Bio-Manguinhos vaccine and reference vaccine). The analysis of non-inferiority will take into account three batches of vaccines TV1, TV2, TV3 and that will be compared together with the reference vaccine, if any consistency of production batches. This procedure is performed in the 2nd serology after vaccination.
Countries
Brazil