Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ProQuad · 4 trials · 10 indications
The percentage of participants experiencing an AE(s) for up to 28 days after the second ProQuad® injection was determined.
The percentage of participants experiencing a vaccine-related AEs for up to 28 days after the second ProQuad® injection was determined.
The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 2.
The percentage of participants experiencing a unsolicited injection-site AE(s) were monitored for up to 28 days after the second ProQuad® injection.
Injection-site rashes of interest, including measles-like, rubella-like, and vesicular, were monitored for up to 28 days after the second ProQuad® injection.
Systemic AEs were monitored for up to 28 days after the second ProQuad® injection.
Vaccine-related systemic AEs were monitored for up to 28 days after the second ProQuad® injection.
Non-injection-site rashes of interest, including measles-like, rubella-like, varicella-like, and zoster-like rashes, were monitored for up to 28 days after the second ProQuad® injection.
The percentage of participants experiencing a mumps-like illness for up to 28 days after the second ProQuad® injection was determined.
Serious AEs ere defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event.
Vaccine-related SAEs were defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event.
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.
Antibody response rates were determined 6 weeks after the second dose of IM or SC ProQuad®. 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). Response rates were determined 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.
Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<255 mIU/mL) to Measles at Baseline.
Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<10 ELISA 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.
Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer \<1.25 gpELISA units/mL at Baseline
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 4
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 9V
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 14
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 18C
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 19F
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F
| Arm | Type | Description |
|---|---|---|
| ProQuad® | EXPERIMENTAL | Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle. |
| 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). |
| 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). |
| Intramuscular ProQuad® | EXPERIMENTAL | Participants will receive doses of ProQuad® by IM injection on Day 1 and Day 30 into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. |
| Subcutaneous ProQuad® | ACTIVE_COMPARATOR | Participants will receive doses of ProQuad® by SC injection on Day 1 and Day 30 in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. |
| 1 | EXPERIMENTAL | Group 1: ProQuad™ (V221) + PREVNAR™ (pneumococcal 7-valent conjugate vaccine) followed by ProQuad™ (Day 91) |
| 2 | EXPERIMENTAL | Group 2: PREVNAR™ followed by ProQuad™ (Day 43) followed by ProQuad™ (Day 133) |
| 3 | EXPERIMENTAL | Group 3: ProQuad™ followed by PREVNAR™ (Day 43), followed by ProQuad™ (Day 91) |
| Name | Type | Description |
|---|---|---|
| ProQuad® | BIOLOGICAL | ProQuad® manufactured with recombinant human albumin (rHA) is an investigational combined attenuated live virus vaccine for vaccination against measles, mumps, rubella and varicella viruses. |
| 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). |
| Comparator: ProQuad™ (V221) | BIOLOGICAL | 0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV) |
| Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine) | BIOLOGICAL | 0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine |
Inclusion Criteria: * Healthy subject of either gender, * Age from 12 to 22 months, * Negative clinical history of infection with measles, mumps, rubella, varicella or zoster, * Informed consent form signed by the parent(s) or by legal representative * Parent(s) or legal representative able to atte...
ProQuad is a vaccine used for measles and varicella (chickenpox). It is being studied in healthy infants aged 12 months and older for the prevention of these infectious diseases. The drug is currently in Phase 3 clinical development and is not yet approved by the FDA.
ProQuad is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting Phase 3 clinical trials to evaluate the vaccine's safety and immunogenicity in pediatric populations.
ProQuad is in Phase 3 clinical development. All three completed trials were Phase 3 studies, with a total enrollment of 4,820 participants. The vaccine is investigational and has not received FDA approval.
ProQuad has three completed Phase 3 trials: NCT00109343, a concomitant use study with pneumococcal conjugate vaccine; NCT00402831, comparing intramuscular vs subcutaneous administration; and NCT00560755, a safety study of ProQuad rHA in infants. All trials enrolled healthy infants aged 12 months and older.
ProQuad is a vaccine that covers measles, mumps, rubella, and varicella (MMRV). Clinical trials for ProQuad list conditions including measles, mumps, rubella, and varicella, indicating it is a combination vaccine for these four diseases.