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

Overview

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.

Full Title of Study: “An Open-label, Multi-centre Study of the Safety of a 2-dose Regimen of a Combined Measles, Mumps, Rubella and Varicella Live Vaccine (ProQuad®) Manufactured With Recombinant Human Albumin (rHA) When Administered to Children in Their Second Year of Life”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 24, 2008

Interventions

  • Biological: ProQuad®
    • ProQuad® manufactured with recombinant human albumin (rHA) is an investigational combined attenuated live virus vaccine for vaccination against measles, mumps, rubella and varicella viruses.

Arms, Groups and Cohorts

  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2
    • Time Frame: 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
    • Time Frame: 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 Solicited Injection-site AE After ProQuad® Dose 2
    • Time Frame: 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
    • Time Frame: 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 Injection-site Rash of Interest AE After ProQuad® Dose 2
    • Time Frame: 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
    • Time Frame: 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 Vaccine-related Systemic AE After ProQuad® Dose 2
    • Time Frame: 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
    • Time Frame: 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 Mumps-like Illness After ProQuad® Dose 2
    • Time Frame: 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 Serious AE (SAE) After ProQuad® Dose 2
    • Time Frame: 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.
  • Percentage of Participants Experiencing a Vaccine-related SAE After ProQuad® Dose 2
    • Time Frame: 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.

Secondary Measures

  • Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 1
    • Time Frame: 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 Unsolicited Injection-site AE After ProQuad® Dose 1
    • Time Frame: 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
    • Time Frame: 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.
  • Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 1
    • Time Frame: Up to Day 28 (28 days after ProQuad® Dose 1)
    • Systemic AEs were monitored for up to 28 days after the first ProQuad® injection.

Participating in This Clinical Trial

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 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

Gender Eligibility: All

Minimum Age: 12 Months

Maximum Age: 22 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anne FIQUET, MD, Study Director, MCM Vaccines B.V.

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