Measles Clinical Trial
Official title:
An Open-label, Randomised, Comparative, Multi-centre Study of the Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA Administered to Healthy Children From 9 Months of Age
The primary study objectives are:
- To demonstrate that a 2-dose regimen of ProQuad® manufactured with recombinant Human
Albumin (rHA) administered at a 3-month interval to healthy children of 11 months of age
at the time of Dose 1 is as immunogenic as in healthy children of 12 months of age at
the time of Dose 1.
- To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month interval
to healthy children of 9 months of age at the time of Dose 1 is as immunogenic as in
healthy children of 12 months of age at the time of Dose 1.
- To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month interval
to healthy children of 11 months of age and 9 months of age at the time of Dose 1 is
well-tolerated compared to children of 12 months of age at the time of Dose 1.
The first primary hypothesis was that a 2-dose regimen of ProQuad® rHA, administered at a
3-month interval to children of 11 months of age, would be non-inferior in terms of antibody
response rates to measles, mumps, rubella, and varicella at Day 42 following Dose 2, to the
same regimen in children of 12 months of age at the time of Dose 1.
If the first primary hypothesis was demonstrated, the second primary hypothesis was that a
2-dose regimen of ProQuad® rHA, administered at a 3-month interval to children of 9 months of
age, would be non-inferior in terms of antibody response rates to measles, mumps, rubella,
and varicella at Day 42 following Dose 2, to the same regimen in children of 12 months of age
at the time of Dose 1.
The secondary study objectives are:
- To describe the antibody titres to measles, mumps, rubella and varicella at Day 42
following Dose 1 and Dose 2 of ProQuad® rHA administered to healthy children from 9
months of age.
- To evaluate the safety profile of Dose 1 and Dose 2 of ProQuad® rHA administered to
healthy children from 9 months of age.
n/a
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 |
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 |