RubellaPhase 2/3BIOMRNCT03148990

Study to Evaluate the Immunogenicity, Reatogenicity and Safety of Double Viral Vaccine (MR) for Measles and Rubella

A Phase 2/3 study testing Measles and Rubella vaccine and Measles, Mumps and Rubella vaccine in people with Rubella and Measles, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 11 to 11 monthsHealthy volunteers can take part
Conditions the study is for: Rubella, Measles
What is being tested?: Measles and Rubella vaccine and Measles, Mumps and Rubella vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 432 participants
Where: 2 sitesBrazil
Study dates: 20 Nov 2018to 12 Aug 2020
Phase: Phase 2/3
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 11 to 11 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Both sex;
Good health (no significant medical history);
11 months of age on the first dose of vaccine;
To be up-to-date with the national vaccination calendar;
Availability for follow-up throughout the study period;
Willing to provide name, address, telephone and other contact information in order to be contacted, whenever needed (example: in case of missing any scheduled visit, contact for confirmation of scheduling a visit, urgent safety notifications);

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Willing to strictly follow the study protocol;
At least one legal guardian of the research participants must be able to understand and sign the informed consent form;
Legal guardians by the research participants who can understand the child's inability to participate in another clinical trial during the time they are participating in the study;
Legal guardian with intellectual capacity to fill out the signs of signs and symptoms at home.

Who cannot join

Previous vaccination against measles and rubella;
Personal history of measles or rubella;
Personal history of anaphylactic shock, asthma, urticaria or other hypersensitivity reaction to previous vaccinations, or who are allergic or hypersensitive to vaccine components of the study;
Use of antiallergic injections with antigens within 14 days or less prior to vaccination;
Use of immunoglobulin in the last 12 months prior to vaccination;
Use of blood products in the last 12 months prior to vaccination;

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Use of any type of vaccine less than 30 days prior to study vaccination;
Use of injectable vaccines less than 42 days after study vaccination;
Chronic use of any medications (except homeopathic medicines and trivial medication such as saline and vitamins);
Previous use of immunosuppressive or cytotoxic medication;
Use of systemic therapy with high doses of steroids;
Use of any type of medication in a clinical trial within 12 months prior to vaccination;
Personal history of clinically significant neurological, cardiovascular, respiratory, hepatic, renal, haematological, rheumatologic or autoimmune diseases;
Personal history of coagulopathies diagnosed by a physician or report of capillary fragility;
Personal history of seizures;
Personal history of an active (eg any cancer) or treated malignant disease that may recur during the study;
Personal history of sickle cell anemia;
Asplenia (absence of spleen or removal of the spleen);
HIV positive or history of any immunosuppressive disease;
Presence of any disorder which, in the opinion of the principal investigator, may interfere with the evaluation of the study objectives;
Legal guardian with limited capacity for adherence to the study, according to the researcher's evaluation;
Impossibility of blood collection for pre-vaccine evaluation.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda (CPCLIN)
Natal, Rio Grande do Norte, 59.025-050
Secretaria Municipal de Saúde do Estado do Rio de Janeiro
Rio de Janeiro, 21040900

Other trials in Brazil

About this study

Official title: A Phase II / III, Clinical Trial to Evaluate the Immunogenicity, Reatogenicity and Safety of Double Viral Vaccine (MR) for Measles and Rubella, Produced by Bio-Manguinhos / Fiocruz in 11-month-old Infants.

Measles and rubella are highly contagious acute viral diseases. As per WHO, several evidences demonstrate the benefit for providing the universal access to vaccines containing measles and rubella antigens, mainly due to, respectively, mortality in children and malformations in fetuses. This is a Phase I-III, Controlled, randomized and double blind for the evaluation double viral vaccine anti-measles and rubella (MR), which is developed and produced at Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil, for use in human beings. 432 eligible volunteers (11-month-old infants), will be vaccinated and monitored for local and systemic adverse events and titration of antibodies. The study will last 11 months in total.

Read the detailed description

This is a Phase II-III, controlled, randomized and double blind for the evaluation of a double viral vaccine anti measles and rubella (MR), which is under the development at Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil, for use in human beings. 432 eligible volunteers (11-month-old infants), will be vaccinated and monitored for local and systemic adverse events and immunogenicity. The study will last 11 months in total.

Conditions: Rubella, Measles
Being tested: Measles and Rubella vaccine, Measles, Mumps and Rubella vaccine
Keywords: Double Viral Vaccine Measles and Rubella, Safety Efficacy Imunogenicity
Medical subject headings: Rubella, Measles

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Measles and Rubella vaccineBiological
Administration of the experimental vaccine (MR).
Measles, Mumps and Rubella vaccineBiological
Administration of the comparator vaccine (MMR).

Study groups in NCT03148990
Study group	Role	What they receive
Measles and Rubella vaccine	Experimental	Biological/Vaccine: Administration of the experimental vaccine (Measles and Rubella). Receives: Biological: Measles and Rubella vaccine
Measles, Mumps and Rubella vaccine	Active comparator	Biological/Vaccine: Administration of the comparator vaccine (Measles, Mumps and Rubella). Receives: Biological: Measles, Mumps and Rubella vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Immunogenicity analysis of the study vaccine
To evaluate imune response between post and pre-vaccination antibodies.
Measured: 42 days after the 1st dose of MR or MMR

Secondary outcomes (1)

Reatogenicity analysis of the study vaccine
To assess the occurrence of serious adverse events among individuals who received MR and MMR vaccines.
Measured: 30 days after the 1st dose of MR or MMR

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 201812 Aug 2020

First posted11 May 2017
Study start20 Nov 2018
Primary completion12 Aug 2020
Study completion12 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for RubellaStudies 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 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Two intervention groups (MR vaccine and MMR vaccine), with 1 dose of vaccine in each group.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 432 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03148990
Sponsor's protocol ID: ASCLIN 002/2017
Acronym: BIOMR
Status last verified: May 2019
First submitted: 9 May 2017
Last updated: 13 Aug 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Pediatric Heart Transplantation Patients
Heart Transplant Infection Prevention
Not yet recruitingPhase 3
A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Given to Healthy Children 4 to 6 Years of Age
Measles, Mumps
RecruitingPhase 3
A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Administered as Intramuscular Injection to Healthy Children 15 Months to 6 Years of Age
Measles, Measles-Mumps-Rubella+Chickenpox Vaccine
RecruitingPhase 3
A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age
Chickenpox
RecruitingObservational study
Is a Third Dose of MMRV Vaccine Beneficial for the Adult Population in Alberta?
Vaccination Failure, Vaccine Response Impaired

All Rubella trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II / III, Clinical Trial to Evaluate the Immunogenicity, Reatogenicity and Safety of Double Viral Vaccine (MR) for Measles and Rubella, Produced by Bio-Manguinhos / Fiocruz in 11-month-old Infants.
ClinicalTrials.gov ID: NCT03148990
Acronym / sponsor ID: BIOMR / ASCLIN 002/2017
Conditions: Rubella, Measles
Keywords: Double Viral Vaccine Measles and Rubella, Safety Efficacy Imunogenicity
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 432 participants (actual)
Lead sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)University, hospital or other
Collaborators: Oswaldo Cruz Foundation
Study start: 20 Nov 2018 (actual)
Primary completion: 12 Aug 2020 (actual)
Study completion: 12 Aug 2020 (actual)
First posted: 11 May 2017 (actual)
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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Two intervention groups (MR vaccine and MMR vaccine), with 1 dose of vaccine in each group.

Arm	Type	Receives
Measles and Rubella vaccine	Experimental	Biological: Measles and Rubella vaccineBiological/Vaccine: Administration of the experimental vaccine (Measles and Rubella).
Measles, Mumps and Rubella vaccine	Active comparator	Biological: Measles, Mumps and Rubella vaccineBiological/Vaccine: Administration of the comparator vaccine (Measles, Mumps and Rubella).

Who may qualify

Ages: 11 to 11 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (10 listed)

Both sex;
Good health (no significant medical history);
11 months of age on the first dose of vaccine;
To be up-to-date with the national vaccination calendar;
Availability for follow-up throughout the study period;

Key exclusion criteria (22 listed)

Previous vaccination against measles and rubella;
Personal history of measles or rubella;
Personal history of anaphylactic shock, asthma, urticaria or other hypersensitivity reaction to previous vaccinations, or who are allergic or hypersensitive to vaccine components of the study;
Use of antiallergic injections with antigens within 14 days or less prior to vaccination;
Use of immunoglobulin in the last 12 months prior to vaccination;

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
Measles and Rubella vaccineAdministration of the experimental vaccine (MR).	Biological	Measles and Rubella vaccine
Measles, Mumps and Rubella vaccineAdministration of the comparator vaccine (MMR).	Biological	Measles, Mumps and Rubella vaccine

Primary outcome

Immunogenicity analysis of the study vaccine
Time frame: 42 days after the 1st dose of MR or MMR
To evaluate imune response between post and pre-vaccination antibodies.

1 secondary outcome

Reatogenicity analysis of the study vaccine
Time frame: 30 days after the 1st dose of MR or MMR

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 13 Aug 2020.
Individual participant dataSharing planned: No

Related trials for Rubella

RecruitingPhase 4
Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Pediatric Heart Transplantation Patients
Heart Transplant Infection Prevention
Not yet recruitingPhase 3
A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Given to Healthy Children 4 to 6 Years of Age
Measles, Mumps
RecruitingPhase 3
A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Administered as Intramuscular Injection to Healthy Children 15 Months to 6 Years of Age
Measles, Measles-Mumps-Rubella+Chickenpox Vaccine
RecruitingPhase 3
A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age
Chickenpox
RecruitingObservational study
Is a Third Dose of MMRV Vaccine Beneficial for the Adult Population in Alberta?
Vaccination Failure, Vaccine Response Impaired

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.

Kleber G Luz, PhD principal investigator

Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 22 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 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 analysis of the study vaccine (time frame: 42 days after the 1st dose of MR or MMR). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03148990.

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 13 Aug 2020.