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

Primary Purpose

Measles, Mumps, Rubella

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
MMR Vaccine
Sponsored by
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Measles focused on measuring Measles, Mumps, Rubella

Eligibility Criteria

12 Months - 23 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CMS Heitor Beltrão

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multidose

Singledose

Arm Description

Multidose from MMR Vaccine produced by Bio-Manguinhos/Fiocruz

Singledose from MMR (GSK-TV), produced by GlaxoSmithKline

Outcomes

Primary Outcome Measures

Whether the lower immunogenicity of the mumps component obtained in clinical studies with the MMR in Brazil, due to the multidose presentation.
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).

Secondary Outcome Measures

Full Information

First Posted
January 21, 2013
Last Updated
July 7, 2016
Sponsor
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
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1. Study Identification

Unique Protocol Identification Number
NCT01777529
Brief Title
Comparative Study of the Immunogenicity of MMR (Measles, Mumps and Rubella) Single Dose and Multidose Presentations
Acronym
MMR
Official Title
Comparative Study of the Immunogenicity of MMR (Measles, Mumps and Rubella), Single Dose and Multidose Presentations in Children 12 to 23 Months of Age.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Measles, Mumps, Rubella
Keywords
Measles, Mumps, Rubella

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multidose
Arm Type
Experimental
Arm Description
Multidose from MMR Vaccine produced by Bio-Manguinhos/Fiocruz
Arm Title
Singledose
Arm Type
Active Comparator
Arm Description
Singledose from MMR (GSK-TV), produced by GlaxoSmithKline
Intervention Type
Biological
Intervention Name(s)
MMR Vaccine
Intervention Description
Administration of MMR Vaccine by Bio-Manguinhos or MMR Vaccine by GlaxoSmithKline
Primary Outcome Measure Information:
Title
Whether the lower immunogenicity of the mumps component obtained in clinical studies with the MMR in Brazil, due to the multidose presentation.
Description
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).
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
CMS Heitor Beltrão
City
Rio de Janeiro
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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