A Phase 3 interventional study of MMR Bio-Manguinhos and MMR GlaxoSmithKline in Measles, Mumps and Rubella, sponsored by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz). Completed at 1 site in Brazil. Open to participants aged 12 Months to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-11.
Sponsored by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) · Phase 3, Interventional, and Health services research
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 :
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.
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 .
Status:Not yet recruiting: participants are not yet being recruited
Parents or guardians, potential participants to the study, will be identified by the field staff of the project and invited to an interview host, which will be presented in the study objectives, the necessary procedures (vaccine, blood collection and pre-vaccination postvaccination, interviews, etc..), their frequency, duration, benefits and risks of the study. It will also read and discussed the Informed Consent Form (ICF).
It will be made Serology, pre-and post-vaccination, using the technique of enzyme immunoassay (ELISA DadeBehring / SIEMENS) for measles, rubella, mumps and varicella, with titration of specific IgG antibodies in the Laboratory of Respiratory Virus / IOC / Fiocruz;
Titration of neutralizing antibodies to measles and mumps, pre and post vaccination (by Plaque Reduction Neutralization Test, PRNT) in samples that are successful seronegative. Will be held at LATEV / Bio-Manguinhos / Fiocruz.
Control of adverse events after application of vaccine will be made by means of annotations that should be completed by a responsible journal and analyzed by the doctor. They will be have a number phone 24 hours to contact with the doctor.
The monitors will visit the initiation of the study (day 0), regular visits during the study and a visit closing soon after completion of the study. Monitors should review the FRC, comparing them with source documents to verify the accuracy of data collection, assess adherence to good clinical practice and ensure that the study data are complete, accurate and integers. Monitors should make sure of the existence of time, space and qualified personnel in the days of monitoring visits.
Plan for data analysis
The consistency of production batches (equivalence) .Upper and lower limits of the confidence intervals of 95% of the difference in seroprotection results for each of the three pairs of contrasting antigens lots (three batches compared in pairs) between -10% and +10%, two-tailed analysis.
. ratio of the geometric mean titers for each of the antigens between 0.5 and 2. The 3 lots will be considered to be consistent in terms of TMG to a particular vaccine component, if all three 95% CI of the ratio of two-tailed paired TMG are between 0.5 and 2.
Non-inferiority
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.
134 studies on the registry are indexed under Measles; 17 are open to participants now.
This study's enrollment of 1,560 is above the median of 852 across 105 interventional studies indexed under Measles.
Browse Measles studies →The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm 1:1170 children will receive MMR Bio-Manguinhos, 3 diferents lots
Biological: MMR Bio-Manguinhos
Arm 2:390 children will receive MMR GlaxoSmithKline
Biological: MMR GlaxoSmithKline
1170 children will receive 100% produced by Bio-Manguinhos, 3 diferents lots. Application of a 0.5 ml dose, subcutaneous 390 children will receive 0,5 ml, subcutaneous, MMR GlaxoSmithKline
Also known as: MMR GlaxoSmithKline
390 children will receive 0,5 ml MMR GlaxoSmithKline
Also known as: MMR Bio-Manguinhos
Immunogenicity comparing the 3 lots of MMR vaccine produced totally in Brazil and reference 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.
Time frame: Thirty days after MMR vaccine
Safety
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.
Time frame: Thirty days after MMR vaccine
Determine the consistency of production
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.
Time frame: Thirty days after MMR vaccine
Adverse events after tetraviral
Describe the major adverse events observed after vaccination.Their parents or guardians will take home the diary for recording adverse events.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.requency in the vaccine groups tetraviral.
Time frame: Three months after MMR vaccine
Seroconversion after vaccine tetraviral( measles, mumps,rubella and varicela)
Compare tetraviral seroconversion after MMR vaccine
Time frame: Four months after MMM vaccine
The record gives a start of Feb 2015, a primary completion of Dec 2015 and a completion of Jul 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)