Comparative Study of the Immunogenicity of MMR (Measles, Mumps and Rubella) Single Dose and Multidose Presentations (MMR)

July 7, 2016 updated by: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Comparative Study of the Immunogenicity of MMR (Measles, Mumps and Rubella), Single Dose and Multidose Presentations in Children 12 to 23 Months of Age.

Whether the lower immunogenicity of the mumps component obtained in clinical studies with the MMR in Brazil, due to the multidose presentation. Investigations were made on factors that could interfere with immunogenicity of mumps component, as the kits used for the immunoassay method, and potency of the vaccine, but no explanation was found. This study aimed to investigate the hypothesis that the lower immunogenicity of the mumps component of the MMR Bio-Manguinhos vaccine, is due to the multidose presentation.

The Main objetctive is evaluate the immunogenicity of MMR after one dose in children 12 to 23 months of life, comparing the performances multidose vial (10 doses per vial of vaccine produced in Bio-Manguinhos/Fiocruz through technology transfer from GlaxoSmithKline Laboratory - GSK) and single dose vial (1 dose per vial of vaccine produced by GSK).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Design

This is a clinical trial Phase IV, randomized, single-blind, with two arms:

  • MMR (TV) combined measles, mumps and rubella vaccine produced in Bio-Manguinhos, applied to healthy children 12 to 23 months. Multidose presentation, only from one batch.
  • MMR (GSK-TV), produced by GlaxoSmithKline, the same age. Monodose presentation, only from one batch.

Locations of the study

  • CMS Heitor Beltrão - Tijuca
  • CMS Milton Fontess Magarão - Engenho de Dentro
  • CMS Waldyr Franco - Bangu

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil
        • CMS Heitor Beltrão

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children of both sexes.
  • Age between 12 and 23 months and 29 days.
  • Child in good health, without significant personal morbid history, such as genetic syndromes, epilepsy, diabetes, severe infections and immune dysfunctions.
  • Concordance of the father or mother, or legal guardian, with the child's participation in the study, and signing the Informed Consent Form (ICF).
  • Disposition of the father or mother, or legal guardian, to provide name, address, telephone number and other information so you can get in touch with this (s) if necessary.
  • Responsible able understand the risks of the experiment that, although minimal, there.
  • Responsible able to understand and sign the informed consent form. If the charge is not able to sign (illiterate) the ICF may be signed by an impartial witness who has followed the whole procedure.
  • Availability return to collect post-vaccination - The subjects of research may not be participating in another clinical trial during this study.
  • Not having received the vaccine Immunization Schedule in the last 30 days.
  • Not receiving another vaccine until harvest 2, 42 days after vaccination with MMR.

Non-inclusion criteria

  • Children with a history of measles, rubella and or mumps.
  • Having previously received MMR vaccination documented in book (eg in situations of conducting national campaign or blocking vaccination before suspected cases of the disease).
  • Have received injectable vaccines of live attenuated (eg. Yellow fever vaccine) - in this case, defer vaccination with MMR after 30 days of the last live attenuated vaccine administered.
  • Having received a transfusion of blood or blood products, including immunoglobulins, less than 1 year.
  • Skin lesions at sites of venipuncture.
  • Child subject to abnormal bleeding after injections.
  • Use the last 6 months in immunosuppressive doses of corticosteroids and other immunosuppressants.
  • Fever or the day of inclusion in the 3 days prior to the inclusion in this case may be rescheduled for inclusion after 14 days the fever subsides.
  • Use of antibiotic on the day of inclusion or in the last 7 days prior to the date of inclusion - in this case, may be rescheduled for inclusion after 14 days of the last day of antibiotic use.
  • Any significant abnormality on physical examination the day of enrollment.
  • Hypersensitivity known systemic neomycin or any other component of the vaccine.
  • Guy with a history of severe allergy, anaphylaxis to egg proteins

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multidose
Multidose from MMR Vaccine produced by Bio-Manguinhos/Fiocruz
Biological: MMR Vaccine
Administration of MMR Vaccine by Bio-Manguinhos or MMR Vaccine by GlaxoSmithKline
Active Comparator: Singledose
Singledose from MMR (GSK-TV), produced by GlaxoSmithKline
Biological: MMR Vaccine
Administration of MMR Vaccine by Bio-Manguinhos or MMR Vaccine by GlaxoSmithKline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whether the lower immunogenicity of the mumps component obtained in clinical studies with the MMR in Brazil, due to the multidose presentation.
Time Frame: 42 days after vaccination, blood samples will be done to determine the levels of antibodies to all three components of the MMR Vaccine
Before vaccination study and about 42 days after, shall be taken blood samples to determine the levels of antibodies to all three components of the MMR (measles, mumps and rubella). Antibody titers are measured by enzyme immunoassay (cut off point of 231 units/ml for mumps, 4 IU/ml for rubella and 150 IU /ml measles) and neutralization test plaque reduction for measles (cut off point of 0.20 IU/mL for measles).
42 days after vaccination, blood samples will be done to determine the levels of antibodies to all three components of the MMR Vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 21, 2013

First Submitted That Met QC Criteria

January 24, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Estimate)

July 11, 2016

Last Update Submitted That Met QC Criteria

July 7, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Asclin 003/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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