Approval Probability
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ProQuad manufactured with recombinant Human Albumin · 1 trial · 4 indications
Immunogenicity response rates were compared in participants with baseline seronegativity from Arm 2 (received ProQuad® Dose 1 at 11 months) and Arm 3 (received ProQuad® Dose 1 at 12 months). 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 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.
Immunogenicity response rates were compared in participants with baseline seronegativity from Arm 1 (received ProQuad® Dose 1 at 9 months) and Arm 3 (received ProQuad® Dose 1 at 12 months). Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. 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.
The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 1.
The percentage of participants with unsolicited injection-site reactions after ProQuad® Dose 1 was determined.
The percentage of participants with systemic adverse events after ProQuad® Dose 1 was determined.
The percentage of participants with a rectal (or rectal equivalent) temperature ≥ 39.4°C after ProQuad® Dose 1 was determined.
| Arm | Type | Description |
|---|---|---|
| Arm 1: ProQuad® at 9 and 12 months | EXPERIMENTAL | Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 at 12 months of age. |
| Arm 2: ProQuad® at 11 and 14 months | EXPERIMENTAL | Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 at 14 months of age. |
| Arm 3: ProQuad at 12 and 15 months | ACTIVE_COMPARATOR | Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 at 15 months of age. |
| Name | Type | Description |
|---|---|---|
| ProQuad® manufactured with recombinant Human Albumin (rHA) | BIOLOGICAL | A 2-dose regimen of ProQuad® (0.5 mL per dose) given via subcutaneous injection into the deltoid muscle at a 3-month interval. Each dose contains measles virus Enders' Edmonston strain (live attenuated), mumps virus Jeryl Lynn™ (Level B) strain (live attenuated), rubella virus Wistar RA 27 or 3 strain (live attenuated), and varicella virus Oka or Merck strain (live attenuated). |
Inclusion Criteria: 1. Healthy subject of either gender of 9 months of age 2. Negative clinical history of measles, mumps, rubella, varicella or zoster 3. Informed consent form signed by both parents or legal representative 4. Parent(s) or legal representative able to attend all the scheduled visit...
ProQuad manufactured with recombinant Human Albumin is a vaccine being developed for the prevention of measles, as well as mumps, rubella, and varicella. It is a combination vaccine candidate intended for use in healthy volunteers, including children as young as 9 months of age, according to the clinical trial record.
ProQuad manufactured with recombinant Human Albumin is made by Merck & Company, Inc., which trades under the ticker MRK. Merck is the developer of this vaccine candidate and sponsored the Phase 3 clinical trial evaluating the product.
ProQuad manufactured with recombinant Human Albumin is in Phase 3 clinical development. The single registered trial for this vaccine candidate has been completed, and the drug is not yet approved. It remains an investigational product.
ProQuad manufactured with recombinant Human Albumin has been studied in one clinical trial, NCT00566527, titled "Comparative Study of Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA (V221-038)." This Phase 3 trial enrolled 1,620 participants and has been completed.
ProQuad manufactured with recombinant Human Albumin is a monoclonal antibody. It is designed to target the viruses that cause measles, mumps, rubella, and varicella, providing immunization against these infectious diseases.