Safety Study of ProQuad® rHA in Infants (V221-037)

Phase 3

Completed

• Conditions: Varicella; Measles; Mumps; Rubella
• Interventions: Biological: ProQuad®

• Registration Number: NCT00560755
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-24
• Study First Submitted: 2007-11-19
• Study First Submitted QC: 2007-11-19
• Study First Posted: 2007-11-20
• Primary Completion: 2008-11-24
• Study Completion: 2008-11-24
• Status Verified: 2017-09
• Results First Submitted: 2017-09-18
• Results First Submitted QC: 2017-09-18
• Last Update Submitted: 2017-09-18
• Results First Posted: 2017-10-17
• Last Update Posted: 2017-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3388

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 attend all schedule visits with the subject and to understand and comply with the study procedures

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Exclusion Criteria

• Recent (≤ 3 days) history of febrile illness
• Prior receipt of measles, mumps, rubella and/or varicella vaccination, either alone or in any combination
• Recent (≤ 30 days) exposure to measles, mumps, rubella, varicella or zoster
• Prior known sensitivity/allergy to any component of the vaccine
• Severe chronic disease,
• Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic system
• Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
• Humoral or cellular immunodeficiency,
• Current immunosuppressive therapy
• Family history of congenital or hereditary immunodeficiency
• Hereditary problems of fructose intolerance
• Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
• Known active tuberculosis
• Recent (≤ 2 days) tuberculin test or scheduled tuberculin test through Visit 3
• Receipt of immunoglobulins or blood-derived products in the past 150 days
• Receipt of an inactivated vaccine in the past 14 days
• Receipt of a live vaccine in the past 28 days
• Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of study objectives
• Participation in another clinical study in the past 30 days

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ProQuad®	ProQuad®	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing a Vaccine-related SAE After ProQuad® Dose 2	Up to Day 84 (up to 42 days 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.
Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2	Up to Day 70 (up to 28 days after ProQuad® Dose 2)	The percentage of participants experiencing an AE(s) for up to 28 days after the second ProQuad® injection was determined.
Percentage of Participants Experiencing a Vaccine-related AE After ProQuad® Dose 2	Up to Day 70 (up to 28 days 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.
Percentage of Participants Experiencing a Vaccine-related Systemic AE After ProQuad® Dose 2	Up to Day 70 (up to 28 days after ProQuad® Dose 2)	Vaccine-related systemic AEs were monitored for up to 28 days after the second ProQuad® injection.
Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2	Up to Day 70 (up to 28 days 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.
Percentage of Participants Experiencing a Injection-site Rash of Interest AE After ProQuad® Dose 2	Up to Day 70 (up to 28 days 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.
Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 2	Up to Day 70 (up to 28 days after ProQuad® Dose 2)	Systemic AEs were monitored for up to 28 days after the second ProQuad® injection.
Percentage of Participants Experiencing a Mumps-like Illness After ProQuad® Dose 2	Up to Day 70 (up to 28 days 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.
Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2	Up to Day 46 (for 4 days following ProQuad® Dose 2)	The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 2.
Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 2	Up to Day 70 (up to 28 days 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.
Percentage of Participants Experiencing a Serious AE (SAE) After ProQuad® Dose 2	Up to Day 84 (up to 42 days 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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 1	From Day 1 to Day 4 (for 4 days following ProQuad® Dose 1)	The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 1.
Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 1	Up to Day 28 (28 days after ProQuad® Dose 1)	Systemic AEs were monitored for up to 28 days after the first ProQuad® injection.
Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 1	Up to Day 28 (28 days after ProQuad® Dose 1)	Unsolicited injection-site AEs were monitored for up to 28 days after the first ProQuad® injection.
Percentage of Participants With ≥ 1 Rectal Temperature Reading ≥ 38.0° C After ProQuad® Dose 1	Up to Day 28 (28 days after ProQuad® Dose 1)	The percentage of participants with at least 1 rectal temperature reading ≥ 38.0° C was determined.