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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

Who can participate

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

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 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.

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 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;
  • 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.
04

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

    Administration of the experimental vaccine (MR).

  • BiologicalMeasles, Mumps and Rubella vaccine

    Administration of the comparator vaccine (MMR).

05

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

06

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
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

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 ↗

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