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

NCT01777529 | Completed Phase 4 DMC

• 1 other identifier: Asclin 003/2012
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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).

Conditions

Measles; Mumps; Rubella

Keywords

Measles; Mumps; Rubella

Outcome Measures

Primary Outcomes (1)

• 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).

  42 days after vaccination, blood samples will be done to determine the levels of antibodies to all three components of the MMR Vaccine

Study Arms (2)

Multidose

EXPERIMENTAL

Multidose from MMR Vaccine produced by Bio-Manguinhos/Fiocruz

Biological: MMR Vaccine

Singledose

ACTIVE COMPARATOR

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

Biological: MMR Vaccine

Interventions

MMR Vaccine BIOLOGICAL

Administration of MMR Vaccine by Bio-Manguinhos or MMR Vaccine by GlaxoSmithKline

Multidose; Singledose

Eligibility Criteria

• Age: 12 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

CMS Heitor Beltrão

Rio de Janeiro, Rio de Janeiro, Brazil

Location

MeSH Terms

Conditions

Measles; Mumps; Rubella

Interventions

Measles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Rubulavirus Infections; Parotitis; Parotid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Rubivirus Infections; Togaviridae Infections

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2013
• First Posted: January 29, 2013
• Study Start: October 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 11, 2016

Record last verified: 2016-07

Locations

BR (1)