Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00127010
Other study ID # 103388
Secondary ID
Status Completed
Phase Phase 3
First received August 4, 2005
Last updated September 23, 2016
Start date November 2005
Est. completion date June 2006

Study information

Verified date September 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHP
Study type Interventional

Clinical Trial Summary

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.


Description:

This study included an active control group who received the licensed Priorix (measles, mumps, rubella [MMR] vaccine).


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Measles, Mumps, Rubella and Chickenpox (live vaccine)


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  Germany,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Antibody levels after vaccination
Secondary Safety of the study vaccines
See also
  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