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

NCT03148990 | Completed Phase 2 DMC

• 1 other identifier: ASCLIN 002/2017
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Rubella; Measles

Keywords

Double Viral Vaccine Measles and Rubella; Safety Efficacy Imunogenicity

Outcome Measures

Primary Outcomes (1)

• Immunogenicity analysis of the study vaccine

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

  42 days after the 1st dose of MR or MMR

Secondary Outcomes (1)

• Reatogenicity analysis of the study vaccine

  30 days after the 1st dose of MR or MMR

Study Arms (2)

Measles and Rubella vaccine

EXPERIMENTAL

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

Biological: Measles and Rubella vaccine

Measles, Mumps and Rubella vaccine

ACTIVE COMPARATOR

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

Biological: Measles, Mumps and Rubella vaccine

Interventions

Measles and Rubella vaccine BIOLOGICAL

Administration of the experimental vaccine (MR).

Measles and Rubella vaccine

Measles, Mumps and Rubella vaccine BIOLOGICAL

Administration of the comparator vaccine (MMR).

Measles, Mumps and Rubella vaccine

Eligibility Criteria

• Age: 11 Months - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Both sex;
• Good health (no significant medical history);
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz): lead
• Oswaldo Cruz Institute: collaborator

Study Sites (2)

Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda (CPCLIN)

Natal, Rio Grande do Norte, 59.025-050, Brazil

Location

Secretaria Municipal de Saúde do Estado do Rio de Janeiro

Rio de Janeiro, 21040900, Brazil

Location

MeSH Terms

Conditions

Rubella; Measles

Interventions

Rubella Vaccine; Measles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

Rubivirus Infections; Togaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined; Measles Vaccine; Mumps Vaccine

Study Officials

• Kleber G Luz, PhD

  Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two intervention groups (MR vaccine and MMR vaccine), with 1 dose of vaccine in each group.

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 11, 2017
• Study Start: November 20, 2018
• Primary Completion: August 12, 2020
• Study Completion: August 12, 2020
• Last Updated: August 13, 2020

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)