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

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ClinicalTrials.gov Identifier: NCT01777529
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Tracking Information
First Submitted Date  ICMJE January 21, 2013
First Posted Date  ICMJE January 29, 2013
Last Update Posted Date July 11, 2016
Study Start Date  ICMJE October 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2013)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Study of the Immunogenicity of MMR (Measles, Mumps and Rubella) Single Dose and Multidose Presentations
Official Title  ICMJE Comparative Study of the Immunogenicity of MMR (Measles, Mumps and Rubella), Single Dose and Multidose Presentations in Children 12 to 23 Months of Age.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Measles
  • Mumps
  • Rubella
Intervention  ICMJE Biological: MMR Vaccine
Administration of MMR Vaccine by Bio-Manguinhos or MMR Vaccine by GlaxoSmithKline
Study Arms  ICMJE
  • Experimental: Multidose
    Multidose from MMR Vaccine produced by Bio-Manguinhos/Fiocruz
    Intervention: Biological: MMR Vaccine
  • Active Comparator: Singledose
    Singledose from MMR (GSK-TV), produced by GlaxoSmithKline
    Intervention: Biological: MMR Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2013)
240
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 23 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01777529
Other Study ID Numbers  ICMJE Asclin 003/2012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Study Sponsor  ICMJE The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP