Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00984295 | Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines | PHASE3 | COMPLETED | 1,913 | — | — | Jun 1, 2000 | Dec 1, 2001 | Aug 7, 2015 | - | — |
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).)
| 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) |
| 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 |
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...