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CompletedNCT03148990BIOMRUpdated Aug 13, 2020

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

A Phase 2/3 interventional study of Measles and Rubella vaccine and Measles, Mumps and Rubella vaccine in Rubella and Measles, sponsored by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz). Completed at 2 sites in Brazil. Open to participants aged 11 Months to 11 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-13.

Sponsored by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
432
Allocation
Randomized
Ages
11 Months to 11 Months
Sex
All
01

Study summary

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.

02

Conditions studied

  • Rubella
  • Measles

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Keywords

  • Double Viral Vaccine Measles and Rubella
  • Safety Efficacy Imunogenicity
03

In context

Rubella

85 studies on the registry are indexed under Rubella; 11 are open to participants now.

This study's enrollment of 432 is below the median of 801 across 71 interventional studies indexed under Rubella.

Browse Rubella studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
11 Months to 11 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • 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);
  • Willing to strictly follow the study protocol;
  • At least one legal guardian of the research participants must be able to understand and sign the 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.

Exclusion criteria

Exclusion Criteria:

  • Previous vaccination against measles and rubella;
  • Personal history of measles or rubella;
  • Personal history of anaphylactic shock, asthma, urticaria or other 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;
  • 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 or cytotoxic medication;
  • Use of systemic therapy with high doses of ;
  • Use of any type of medication in a clinical trial within 12 months prior to vaccination;
  • Personal history of neurological, cardiovascular, respiratory, hepatic, renal, haematological, rheumatologic or 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);
  • 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.
Terms in these criteria, in plain language(7)

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.

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.

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.

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.

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.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
432 participants (actual)

Study arms

  • Experimental
    Measles and Rubella vaccine

    Biological/Vaccine: Administration of the experimental vaccine (Measles and Rubella).

    Biological: Measles and Rubella vaccine

  • Active comparator
    Measles, Mumps and Rubella vaccine

    Biological/Vaccine: Administration of the comparator vaccine (Measles, Mumps and Rubella).

    Biological: Measles, Mumps and Rubella vaccine

Interventions

  • BiologicalMeasles and Rubella vaccine

    Drug pages: Measles Vaccine · Rubella Vaccine

    Administration of the experimental vaccine (MR).

  • BiologicalMeasles, Mumps and Rubella vaccine

    Administration of the comparator vaccine (MMR).

06

What researchers measure

Primary outcomes

  1. Immunogenicity analysis of the study vaccine

    To evaluate imune response between post and pre-vaccination antibodies.

    Time frame: 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.

    Time frame: 30 days after the 1st dose of MR or MMR

07

Study locations

2 sites
  • Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda (CPCLIN)
    Natal, Rio Grande Do Norte 59.025-050, Brazil
  • Secretaria Municipal de Saúde do Estado do Rio de Janeiro
    Rio de Janeiro, 21040900, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2018 to primary completion in Aug 2020, 20 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 9, 2017
First posted
May 11, 2017
StartActual
Nov 20, 2018
Primary completionActual
Aug 12, 2020
CompletionActual
Aug 12, 2020
Last update
Aug 13, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03148990
Lead sponsor
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Collaborators
Oswaldo Cruz Institute
Responsible party
Sponsor
First posted
May 11, 2017
Start date
Nov 20, 2018
Primary completion
Aug 12, 2020
Completion
Aug 12, 2020
Last update
Aug 13, 2020

Study contacts

Kleber G Luz, PhD
principal investigator · Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Measles Vaccine · Rubella Vaccine

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