Measles Clinical Trial
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.
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).
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04183114 -
Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study)
|
Phase 2/Phase 3 | |
| Completed |
NCT00092430 -
Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine (V221-016)
|
Phase 3 | |
| Completed |
NCT02196285 -
Study to Evaluate Safety and Imunogenicity of Double Viral Vaccine (MR) for Measles and Rubella
|
Phase 1 | |
| Completed |
NCT00384397 -
A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers
|
Phase 3 | |
| Completed |
NCT00313950 -
Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine
|
Phase 4 | |
| Completed |
NCT00402831 -
ProQuad® Intramuscular vs Subcutaneous
|
Phase 3 | |
| Completed |
NCT00560755 -
Safety Study of ProQuad® rHA in Infants (V221-037)
|
Phase 3 | |
| Completed |
NCT01878435 -
Randomized Controlled Trial of the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya
|
N/A | |
| Terminated |
NCT00258726 -
Immune Responses to Two Dose Varivax +/- MMR-II
|
Phase 1/Phase 2 | |
| Completed |
NCT00109278 -
A Measles, Mumps, and Rubella Investigational Vaccine Trial (V205C-010)(COMPLETED)
|
Phase 2 | |
| Not yet recruiting |
NCT05771779 -
Co-administration Study of OCV, TCV and MR
|
Phase 3 | |
| Completed |
NCT02880865 -
Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella (MMR) Vaccine
|
Phase 4 | |
| Completed |
NCT01681992 -
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life
|
Phase 3 | |
| Completed |
NCT00751348 -
Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136
|
Phase 3 | |
| Completed |
NCT01702428 -
Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age
|
Phase 3 | |
| Completed |
NCT00969436 -
Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM
|
Phase 3 | |
| Completed |
NCT00566527 -
Comparative Study of Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA (V221-038)
|
Phase 3 | |
| Completed |
NCT00127010 -
Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases
|
Phase 3 | |
| Completed |
NCT00388440 -
Assess GSK Biologicals' MMR Vaccine (Priorix) When Given to Healthy Children at the Age of 12 to 18 Months in Singapore.
|
Phase 4 | |
| Completed |
NCT03148990 -
Study to Evaluate the Immunogenicity, Reatogenicity and Safety of Double Viral Vaccine (MR) for Measles and Rubella
|
Phase 2/Phase 3 |