Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
measles, mumps, and rubella virus vaccine live · 5 trials · 4 indications
Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \<120 mIU/mL) to Measles at Baseline
Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \<10 Ab units/mL) to Mumps at Baseline
Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \<10 IU/mL) to Rubella at Baseline
Antibody Response to Varicella-Zoster Virus (VZV) at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \<0.6 gpELISA units/mL) to VZV at Baseline
Antibody response to Diphtheria at 6 weeks postvaccination
Antibody response to Tetanus (tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA)) at 6 weeks postvaccination.
Antibody response to Pertussis Toxin (titers of pertussis toxin antibodies were measured with an indirect, noncompetitive EIA).
Antibody response to pertussis FHA(titers of pertussis filamentous hemagglutinin antibodies were measured with an indirect, noncompetitive EIA).
Antibody response to Hepatitis B (titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA)).
Antibody response to Haemophilus influenzae type B (Hib). (Anti-polyribosylribitol phosphate (PRP) was measured by radioimmunoassay (RIA) using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)
Postvaccination Observed Geometric Mean Titer of Antibody to Measles. (Titers measured using Measles ELISA.)
Postvaccination observed GMT of antibody to mumps. (Titers measured using mumps ELISA.)
Postvaccination Observed Geometric Mean Titer of Antibody to Rubella. (Titers measured using Rubella ELISA.)
Postvaccination Observed Geometric Mean Titer of Antibody to Varicella. (Titers measured using VZV gpELISA.)
Postvaccination Observed Geometric Mean Titer of Antibody to Diphtheria. (Titers measured using Vero Cell Culture Assay.)
Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Toxin (PT). Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).
Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Filamentous Hemagglutinin (FHA). (Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).)
Postvaccination Observed Geometric Mean Titer of Antibody to Hepatitis B. (Titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA).)
Postvaccination observed GMT of antibody to Hib. (Anti-polyribosylribitol phosphate (PRP) was measured by RIA using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)
Postvaccination Observed Geometric Mean Titer of Antibody to Tetanus. (Titers of tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA).)
Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer \< 1.25 gpELISA units/mL at Baseline
Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \< 120 mIU/mL) to Measles at Baseline
Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \< 10 Ab units/mL) to Mumps at Baseline
Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \< 10 IU/mL) to Rubella at Baseline
Postvaccination observed Geometric Mean Titer of antibody to Varicella
Postvaccination observed Geometric Mean Titer of antibody to Measles.
Postvaccination observed Geometric Mean Titer of antibody to Mumps.
Postvaccination observed Geometric Mean Titer of antibody to Rubella
Subjects with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).
Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of \<0.6 gpELISA units/mL) to Varicella at Baseline
Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer \<1.25 gpELISA units
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | ProQuad + Tripedia + Comvax at Day 0 (Concomitant) |
| 2 | EXPERIMENTAL | ProQuad at Day 0, Tripedia + Comvax at Day 42(Nonconcomitant) |
| 3 | ACTIVE_COMPARATOR | Varivax + M-M-R II at Day 0, Tripedia + Comvax at Day 42 (Control) |
| 4 | ACTIVE_COMPARATOR | M-M-R II + Varivax |
| Name | Type | Description |
|---|---|---|
| Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live | BIOLOGICAL | A single 0.5 mL subcutaneous injection at Day 0 |
| Comparator: Tripedia | BIOLOGICAL | A single 0.5 mL intramuscular injection (at Day 0 or Day 42) |
| Comparator: Comvax | BIOLOGICAL | A single 0.5 mL intramuscular injection (at Day 0 or Day 42) |
| Comparator: Varivax | BIOLOGICAL | A single 0.5 mL subcutaneous injection at Day 0 |
| Comparator: M-M-R II | BIOLOGICAL | A single 0.5 mL subcutaneous injection at Day 0 |
| Comparator: Placebo | BIOLOGICAL | a single 0.5 mL subcutaneous placebo injection at Day 0 |
| measles, mumps, and rubella virus vaccine live | BIOLOGICAL | - |
| Comparator: Measles, Mumps, and Rubella Virus Vaccine Live | BIOLOGICAL | - |
| Comparator: PUVV | BIOLOGICAL | A single 0.5 mL subcutaneous injection at Day 0 |
Inclusion Criteria: * In good health * Negative clinical history of varicella, zoster, measles, mumps, rubella, diptheria, tetanus, pertussis, invasive Hib disease and hepatitis B * Had completed either a 2-dose primary series of PedvaxHIB or COMVAX or any 3-dose primary series of a licensed Hib va...
Measles, mumps, and rubella virus vaccine live is a vaccine used to prevent measles, along with mumps and rubella. It is studied in infectious disease and is given to healthy children from 12 months of age. The clinical program covers measles as its primary indication.
Measles, mumps, and rubella virus vaccine live is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the clinical trials evaluating this vaccine in healthy children.
Measles, mumps, and rubella virus vaccine live is in Phase 3 development. Five trials have been completed and none are currently active, with a total enrollment of 9,081 participants. The studies were randomized, double-blind, and actively controlled.
The clinical program includes completed trials NCT00986232, NCT00985153, NCT00984295, and NCT00975507. These studies enrolled healthy children from 12 months of age and evaluated dose selection, consistency lots, concomitant administration with other pediatric vaccines, and comparison with M-M-R II and VARIVAX.
Yes, measles, mumps, and rubella virus vaccine live is also known as MMR. Other alternative names include Measles, Mumps, Rubella and Varicella Virus Vaccine Live and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. It has also been listed as a comparator in studies.