Measles Clinical Trial
Official title:
Blinded, Randomized Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Measles-mumps-rubella-varicella Candidate Vaccine Given to Healthy Children During the Second Year of Life
This is a study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy children in their second year of life.
Status | Completed |
Enrollment | 0 |
Est. completion date | June 2006 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 11 Months to 13 Months |
Eligibility |
Inclusion Criteria: - A male or female subject between 11-13 months of age (i.e. from 11 month birthday until the day before the 14 month birthday) at the time of the first vaccination. Exclusion Criteria: - History of previous measles, mumps, rubella and/or varicella vaccination or disease, or known exposure to any of these diseases within 30 days prior to the start of the trial - Planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each vaccination |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Belgium | GSK Investigational Site | Brussel | |
Belgium | GSK Investigational Site | Leuven | |
Germany | GSK Investigational Site | Bad Saulgau | Baden-Wuerttemberg |
Germany | GSK Investigational Site | Bindlach | Bayern |
Germany | GSK Investigational Site | Bochum | Nordrhein-Westfalen |
Germany | GSK Investigational Site | Boennigheim | Baden-Wuerttemberg |
Germany | GSK Investigational Site | Brunsbuettel | Schleswig-Holstein |
Germany | GSK Investigational Site | Cham | Bayern |
Germany | GSK Investigational Site | Detmold | Nordrhein-Westfalen |
Germany | GSK Investigational Site | Dortmund | Nordrhein-Westfalen |
Germany | GSK Investigational Site | Ehingen | Baden-Wuerttemberg |
Germany | GSK Investigational Site | Eschwege | Hessen |
Germany | GSK Investigational Site | Espelkamp | Nordrhein-Westfalen |
Germany | GSK Investigational Site | Flensburg | Schleswig-Holstein |
Germany | GSK Investigational Site | Frankenthal | Rheinland-Pfalz |
Germany | GSK Investigational Site | Fulda | Hessen |
Germany | GSK Investigational Site | Gluecksburg | Schleswig-Holstein |
Germany | GSK Investigational Site | Herford | Nordrhein-Westfalen |
Germany | GSK Investigational Site | Hille | Nordrhein-Westfalen |
Germany | GSK Investigational Site | Husum | Schleswig-Holstein |
Germany | GSK Investigational Site | Kehl | Baden-Wuerttemberg |
Germany | GSK Investigational Site | Kirchzarten | Baden-Wuerttemberg |
Germany | GSK Investigational Site | Kleve-Materborn | Nordrhein-Westfalen |
Germany | GSK Investigational Site | Krefeld | Nordrhein-Westfalen |
Germany | GSK Investigational Site | Loehne | Nordrhein-Westfalen |
Germany | GSK Investigational Site | Ludwigsburg | Baden-Wuerttemberg |
Germany | GSK Investigational Site | Marbach | Baden-Wuerttemberg |
Germany | GSK Investigational Site | Minden | Nordrhein-Westfalen |
Germany | GSK Investigational Site | Muenchen | Bayern |
Germany | GSK Investigational Site | Muenchen | Bayern |
Germany | GSK Investigational Site | Muenster | Nordrhein-Westfalen |
Germany | GSK Investigational Site | Neuhaus am Rennweg | Thueringen |
Germany | GSK Investigational Site | Neumuenster | Schleswig-Holstein |
Germany | GSK Investigational Site | Niedernhausen | Hessen |
Germany | GSK Investigational Site | Oberkirch | Baden-Wuerttemberg |
Germany | GSK Investigational Site | Offenburg | Baden-Wuerttemberg |
Germany | GSK Investigational Site | Olching | Bayern |
Germany | GSK Investigational Site | Porta Westfalica | Nordrhein-Westfalen |
Germany | GSK Investigational Site | Schwaebisch-Hall | Baden-Wuerttemberg |
Germany | GSK Investigational Site | Stuttgart | Baden-Wuerttemberg |
Germany | GSK Investigational Site | Tauberbischofsheim | Baden-Wuerttemberg |
Germany | GSK Investigational Site | Tettnang | Baden-Wuerttemberg |
Germany | GSK Investigational Site | Trier | Rheinland-Pfalz |
Germany | GSK Investigational Site | Viersen | Nordrhein-Westfalen |
Germany | GSK Investigational Site | Weilheim | Bayern |
Germany | GSK Investigational Site | Werneck | Bayern |
Germany | GSK Investigational Site | Wolfenbuettel | Niedersachsen |
Netherlands | GSK Investigational Site | Rotterdam |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Belgium, Germany, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Antibody levels after vaccination | |||
Secondary | Safety of the study vaccines |
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 |
NCT00313950 -
Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine
|
Phase 4 | |
Completed |
NCT00384397 -
A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers
|
Phase 3 | |
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 | |
Completed |
NCT01777529 -
Comparative Study of the Immunogenicity of MMR (Measles, Mumps and Rubella) Single Dose and Multidose Presentations
|
Phase 4 | |
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 |
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 |