Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ProQuad · 2 trials · 10 indications
The percentage of participants with seronegative baseline values who met antibody response criteria in Arm 1: ProQuad® + Infanrix® hexa and Arm 2: ProQuad® was determined. Post-vaccination antibody response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre \<255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre \<10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre \<10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre \<1.25 gpELISA units/mL. Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA).
The percentage of participants with seronegative baseline values who met antibody response criteria in Arm 1: ProQuad® + Infanrix® hexa and Arm 3: Infanrix® hexa was determined. Post-vaccination antibody response and baseline seronegativity criteria were as follows: Hepatitis B antibody titre ≥10 IU/mL and Haemophilus Influenzae Type b antibody titre ≥1 ug/mL. Hepatitis B antibody levels were determined using anti-HBs ORTHO ECi Immunodiagnostic Assay. Haemophilus Influenzae Type b antibody (anti-polyribosylribitol phosphate \[PRP\]) levels were determined with radioimmunoassay (RIA) or with enzyme immunoassay (EIA).
The GMT to pertussis were compared in Arm1: ProQuad® + Infanrix® hexa and Arm 3: Infanrix® hexa. Anti-pertussis toxin (anti-PT), anti-filamentous hemagglutinin (anti-FHA), and anti-pertactin (anti-PRN) were determined using ELISA on solid phase based on sandwich principle.
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
| Arm | Type | Description |
|---|---|---|
| ProQuad® + Infanrix® hexa | EXPERIMENTAL | Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42). |
| ProQuad® | ACTIVE_COMPARATOR | Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42). |
| Infanrix® hexa | ACTIVE_COMPARATOR | Pediatric (12 to 23 months of age) participants received Infanrix® hexa (booster dose) on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42). |
| 1 | EXPERIMENTAL | ProQuad + Placebo |
| 2 | ACTIVE_COMPARATOR | M-M-R II + Placebo |
| 3 | ACTIVE_COMPARATOR | M-M-R II + Varivax |
| Name | Type | Description |
|---|---|---|
| ProQuad® | BIOLOGICAL | Participants received a 0.5 mL subcutaneous injection of ProQuad® containing the following live attenuated virus strains: measles virus Enders' Edmonston strain (≥3.00 log10 50% cell culture infectious dose \[CCID\]50), mumps virus Jeryl Lynn™ (Level B) strain (≥4.30 log10 CCID50), rubella virus Wistar RA 27/3 strain (≥3.00 log10 CCID50), and varicella virus Oka/Merck strain (≥3.99 log10 plaque-forming units \[PFU\]). |
| Infanrix® hexa | BIOLOGICAL | Participants received a 0.5 mL intramuscular injection of Infanrix® hexa containing the following: diphtheria toxoid (≥30 IU), tetanus toxoid (≥40 IU), 3-component acellular pertussis (pertussis taxoid, filamentous haemagglutinin, and pertactin) (25 ug), Hepatitis B surface antigen recombinant (S protein) (10 ug), inactivated poliovirus types 1-3 (type 1: 40 D-antigen units; type 2: 8 D-antigen units; type 3: 32 D-antigen units), and Haemophilus influenzae type B (Hib) polysaccharide conjugate to tetanus toxoid (20-40 ug). |
| ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live) | BIOLOGICAL | A Single 0.5 mL subcutaneous injection at Day 1 |
| Comparator: M-M-R II | BIOLOGICAL | A Single 0.5 mL subcutaneous injection at Day 1 |
| Comparator: Varivax | BIOLOGICAL | A Single 0.5 mL subcutaneous injection at Day 1 |
| Comparator: Placebo | BIOLOGICAL | A Single 0.5 mL subcutaneous placebo injection at Day 1 |
Inclusion Criteria: * Healthy participants of either gender * Aged 12 to 23 months * No clinical history of measles, mumps, rubella, varicella and zoster * For Italy: Primary vaccination with the combined diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b v...
ProQuad is a vaccine used to prevent measles, mumps, rubella, and varicella (chickenpox). It is a combination vaccine developed by Merck & Company, Inc. (ticker MRK) that targets these four infectious diseases in a single product, and it is studied in healthy children.
ProQuad is made by Merck & Company, Inc., which trades under the ticker MRK. Merck is the developer of the combination measles, mumps, rubella, and varicella vaccine and sponsored the clinical study of the product in healthy children.
ProQuad has been evaluated in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The completed study was randomized, double-blind, and active-controlled, and enrolled 801 participants.
ProQuad has been studied in the Phase 3 trial NCT00985166, titled A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014). The trial enrolled 801 children aged 4 years and older, was randomized, double-blind, and active-controlled, and its status is completed.