Primary objective: To describe the safety profile of a second dose of ProQuad® manufactured with recombinant human albumin (rHA) when administered to children in their second year of life. Secondary objectives: To describe the safety profile of a first dose of ProQuad® manufactured with rHA when administered to children in their second year of life.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
3,388
ProQuad® manufactured with recombinant human albumin (rHA) is an investigational combined attenuated live virus vaccine for vaccination against measles, mumps, rubella and varicella viruses.
Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2
The percentage of participants experiencing an AE(s) for up to 28 days after the second ProQuad® injection was determined.
Time frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Percentage of Participants Experiencing a Vaccine-related AE After ProQuad® Dose 2
The percentage of participants experiencing a vaccine-related AEs for up to 28 days after the second ProQuad® injection was determined.
Time frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2
The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 2.
Time frame: Up to Day 46 (for 4 days following ProQuad® Dose 2)
Percentage of Participants Experiencing a Unsolicited Injection-site AE After 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.
Time frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Percentage of Participants Experiencing a Injection-site Rash of Interest AE After ProQuad® Dose 2
Injection-site rashes of interest, including measles-like, rubella-like, and vesicular, were monitored for up to 28 days after the second ProQuad® injection.
Time frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 2
Systemic AEs were monitored for up to 28 days after the second ProQuad® injection.
Time frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
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Percentage of Participants Experiencing a Vaccine-related Systemic AE After ProQuad® Dose 2
Vaccine-related systemic AEs were monitored for up to 28 days after the second ProQuad® injection.
Time frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2
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.
Time frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Percentage of Participants Experiencing a Mumps-like Illness After ProQuad® Dose 2
The percentage of participants experiencing a mumps-like illness for up to 28 days after the second ProQuad® injection was determined.
Time frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Percentage of Participants Experiencing a Serious AE (SAE) After ProQuad® Dose 2
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.
Time frame: Up to Day 84 (up to 42 days after ProQuad® Dose 2)
Percentage of Participants Experiencing a Vaccine-related SAE After ProQuad® Dose 2
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.
Time frame: Up to Day 84 (up to 42 days after ProQuad® Dose 2)
Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 1
The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 1.
Time frame: From Day 1 to Day 4 (for 4 days following ProQuad® Dose 1)
Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 1
Unsolicited injection-site AEs were monitored for up to 28 days after the first ProQuad® injection.
Time frame: Up to Day 28 (28 days after ProQuad® Dose 1)
Percentage of Participants With ≥ 1 Rectal Temperature Reading ≥ 38.0° C After ProQuad® Dose 1
The percentage of participants with at least 1 rectal temperature reading ≥ 38.0° C was determined.
Time frame: Up to Day 28 (28 days after ProQuad® Dose 1)
Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 1
Systemic AEs were monitored for up to 28 days after the first ProQuad® injection.
Time frame: Up to Day 28 (28 days after ProQuad® Dose 1)