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Also known as ProQuad® manufactured with recombinant Human Albumin (rHA)
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...