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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Sponsor:
Information provided by (Responsible Party):
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
ClinicalTrials.gov Identifier:
NCT01777529
First received: January 21, 2013
Last updated: January 24, 2013
Last verified: November 2012
  Purpose

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).


Condition Intervention Phase
Measles
Mumps
Rubella
Biological: MMR Vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz):

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. [ 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 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 240
Study Start Date: October 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   12 Months to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777529

Contacts
Contact: Maria das Graças Ribeiro, Tavares 94223705 maria.tavares@bio.fiocruz.br

Locations
Brazil
CMS Heitor Beltrão Recruiting
Rio de Janeiro, Brazil
Contact: Maria das Graças Ribeiro, Tavares    55 21 94223705    maria.tavares@bio.fiocruz.br   
Contact: Eliane Matos dos Santos    55 21 38827062    ematos@bio.fiocruz.br   
Sponsors and Collaborators
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
  More Information

No publications provided

Responsible Party: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
ClinicalTrials.gov Identifier: NCT01777529     History of Changes
Other Study ID Numbers: Asclin 003/2012
Study First Received: January 21, 2013
Last Updated: January 24, 2013
Health Authority: Brazil: Nacional Health Surveillance Agency
Brazil: National Committee of Ethics in Research
Brazil: Ethics Committee

Keywords provided by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz):
Measles
Mumps
Rubella

Additional relevant MeSH terms:
Measles
Mumps
Parotitis
Rubella
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Rubulavirus Infections
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Sialadenitis
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on July 23, 2014