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

NCT01777529 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2016-07-11

No results posted yet for this study

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

Interventions

BIOLOGICAL

MMR Vaccine

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

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-01-31
Completion
2013-12-31

Countries

  • Brazil

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01777529 on ClinicalTrials.gov