MeaslesPhase 3NCT01991899
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.
A Phase 3 study testing MMR Bio-Manguinhos and MMR GlaxoSmithKline in people with Measles and Mumps, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 18 monthsHealthy volunteers can take part
- What is being tested?
- MMR Bio-Manguinhos and MMR GlaxoSmithKline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,560 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2015to Jul 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children of both sexes
- Age between 12 to 15 months .
- Child in good health , without significant past medical history personal , such as genetic syndromes , epilepsy , diabetes , severe infections and immune dysfunctions .
- Consent of father or mother , or legal guardian of the child to participate in the study and signing the Informed Consent Form.
- Disposition of the father or mother, or legal guardian to provide name, address, phone and other information so you can get in touch with this, if necessary .
- The responsible person be able to understand the risks of the experimente
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- The responsible person be able to understand and sign the informed consent form . If the charge is not able to sign ( illiterate ) the IC may be signed by an impartial witness who has followed the entire procedure .
- Availability return to collect post-vaccination - The research subjects may not be participating in another clinical study during this study.
- Not having received injectable live virus vaccine in the last 30 days.
Who cannot join
- - Children with a history of measles, rubella and / or mumps .
- Have received MMR or tetraviral previously documented in book vaccination ( eg . : In situations of conducting national campaign or blocking vaccination before suspected cases ).
- Have received a blood transfusion , including immunoglobulins , less than 1year .
- Skin lesions at sites of venipuncture .
- Child subject to abnormal bleeding after injections .
- Using the last 6 months at doses of corticosteroids and other immunosuppressive immunosuppressants.
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- Fever on the day of inclusion or in the 3 days prior to the inclusion in this case may be rescheduled for inclusion 14 days after fever subsides .
- Antibiotic use on the day of inclusion or in the last 7 days prior to inclusion - in this case , may be rescheduled for inclusion after 14 days from the last day of antibiotic use .
- Significant abnormality on physical examination the day of enrollment . Known systemic hypersensitivity to neomycin or any other component of the vaccine .
- Individuals with a history of severe allergy , anaphylaxis to egg proteins .
- Have received live attenuated vaccine , as the vaccine for yellow fever in the 30 days prior to vaccination with MMR and the 2nd and 3rd collections .
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- 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 .
Read the detailed description
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
- 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. .)
- ratio of the geometric mean titers for each of the antigens ≥ 0.5 (for vaccines and vaccine Bio-Manguinhos reference).
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.
- Being tested
- MMR Bio-Manguinhos, MMR GlaxoSmithKline
- Keywords
- Measles, mumps and rubella vaccine, Tetraviral vaccine, Immunogenicity, Reactogenicity and Safety, Consistency of production
- Medical subject headings
- Measles, Mumps, Rubella, Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMR Bio-ManguinhosBiological
Also called 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
MMR GlaxoSmithKlineBiological
Also called MMR Bio-Manguinhos
390 children will receive 0,5 ml MMR GlaxoSmithKline
| Study group | Role | What they receive |
|---|---|---|
| MMR Bio-Manguinhos | Experimental | Arm 1:1170 children will receive MMR Bio-Manguinhos, 3 diferents lots Receives: Biological: MMR Bio-Manguinhos |
| MMR GlaxoSmithKline | Active comparator | Arm 2:390 children will receive MMR GlaxoSmithKline Receives: Biological: MMR GlaxoSmithKline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Thirty days after MMR vaccine
Secondary outcomes (2)
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.
Measured: Three months after MMR vaccine
Seroconversion after vaccine tetraviral( measles, mumps,rubella and varicela)
Compare tetraviral seroconversion after MMR vaccine
Measured: Four months after MMM vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startFeb 2015
- Primary completionDec 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeaslesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,560 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Eliane Matos Santos, Principal investigator, The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991899
- Sponsor's protocol ID
- ASCLIN/002/2013
- Status last verified
- Jul 2016
- First submitted
- 8 Nov 2013
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01991899
- Acronym / sponsor ID
- ASCLIN/002/2013
- Keywords
- Measles, mumps and rubella vaccine, Tetraviral vaccine, Immunogenicity, Reactogenicity and Safety, Consistency of production
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,560 participants (actual)
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)University, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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 .
Detailed description
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
- 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. .)
- ratio of the geometric mean titers for each of the antigens ≥ 0.5 (for vaccines and vaccine Bio-Manguinhos reference).
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMR Bio-Manguinhos | Experimental | Biological: MMR Bio-ManguinhosArm 1:1170 children will receive MMR Bio-Manguinhos, 3 diferents lots |
| MMR GlaxoSmithKline | Active comparator | Biological: MMR GlaxoSmithKlineArm 2:390 children will receive MMR GlaxoSmithKline |
Who may qualify
- Ages
- 12 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children of both sexes
- Age between 12 to 15 months .
- Child in good health , without significant past medical history personal , such as genetic syndromes , epilepsy , diabetes , severe infections and immune dysfunctions .
- Consent of father or mother , or legal guardian of the child to participate in the study and signing the Informed Consent Form.
- Disposition of the father or mother, or legal guardian to provide name, address, phone and other information so you can get in touch with this, if necessary .
Key exclusion criteria (11 listed)
- - Children with a history of measles, rubella and / or mumps .
- Have received MMR or tetraviral previously documented in book vaccination ( eg . : In situations of conducting national campaign or blocking vaccination before suspected cases ).
- Have received a blood transfusion , including immunoglobulins , less than 1year .
- Skin lesions at sites of venipuncture .
- Child subject to abnormal bleeding after injections .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMR Bio-ManguinhosAlso: MMR GlaxoSmithKline1170 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 | Biological | MMR Bio-Manguinhos |
| MMR GlaxoSmithKlineAlso: MMR Bio-Manguinhos390 children will receive 0,5 ml MMR GlaxoSmithKline | Biological | MMR GlaxoSmithKline |
Primary outcome
Immunogenicity comparing the 3 lots of MMR vaccine produced totally in Brazil and reference vaccine.
Time frame: 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
Time frame: 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
Time frame: 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.
2 secondary outcomes
Adverse events after tetraviral
Time frame: Three months after MMR vaccine
Seroconversion after vaccine tetraviral( measles, mumps,rubella and varicela)
Time frame: Four months after MMM vaccine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eliane Matos Santos principal investigator
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MMR Bio-Manguinhos and MMR GlaxoSmithKline in people with Measles and Mumps, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity comparing the 3 lots of MMR vaccine produced totally in Brazil and reference vaccine. (time frame: Thirty days after MMR vaccine). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2016.