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

Primary Purpose

Measles, Mumps, Rubella

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ProQuad®
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Measles focused on measuring Prevention of: measles, mumps, rubella and varicella

Eligibility Criteria

12 Months - 22 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ProQuad®

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.

    Full Information

    First Posted
    November 19, 2007
    Last Updated
    September 18, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00560755
    Brief Title
    Safety Study of ProQuad® rHA in Infants (V221-037)
    Official Title
    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
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 24, 2007 (Actual)
    Primary Completion Date
    November 24, 2008 (Actual)
    Study Completion Date
    November 24, 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Measles, Mumps, Rubella, Varicella
    Keywords
    Prevention of: measles, mumps, rubella and varicella

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    3388 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ProQuad®
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    ProQuad®
    Intervention Description
    ProQuad® manufactured with recombinant human albumin (rHA) is an investigational combined attenuated live virus vaccine for vaccination against measles, mumps, rubella and varicella viruses.
    Primary Outcome Measure Information:
    Title
    Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2
    Description
    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)
    Title
    Percentage of Participants Experiencing a Vaccine-related AE After ProQuad® Dose 2
    Description
    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)
    Title
    Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2
    Description
    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)
    Title
    Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 2
    Description
    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)
    Title
    Percentage of Participants Experiencing a Injection-site Rash of Interest AE After ProQuad® Dose 2
    Description
    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)
    Title
    Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 2
    Description
    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)
    Title
    Percentage of Participants Experiencing a Vaccine-related Systemic AE After ProQuad® Dose 2
    Description
    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)
    Title
    Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2
    Description
    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)
    Title
    Percentage of Participants Experiencing a Mumps-like Illness After ProQuad® Dose 2
    Description
    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)
    Title
    Percentage of Participants Experiencing a Serious AE (SAE) After ProQuad® Dose 2
    Description
    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)
    Title
    Percentage of Participants Experiencing a Vaccine-related SAE After ProQuad® Dose 2
    Description
    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)
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 1
    Description
    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)
    Title
    Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 1
    Description
    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)
    Title
    Percentage of Participants With ≥ 1 Rectal Temperature Reading ≥ 38.0° C After ProQuad® Dose 1
    Description
    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)
    Title
    Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 1
    Description
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Months
    Maximum Age & Unit of Time
    22 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anne FIQUET, MD
    Organizational Affiliation
    MCM Vaccines B.V.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22772170
    Citation
    Ruger G, Gabutti G, Rumke H, Rombo L, Bernaola E, Diez-Domingo J, Martinon-Torres F, Hogh B, Konstantopoulos A, Fiquet A, Thomas S, Eymin C, Baudin M. Safety of a 2-dose regimen of a combined measles, mumps, rubella and varicella live vaccine manufactured with recombinant human albumin. Pediatr Infect Dis J. 2012 Nov;31(11):1166-72. doi: 10.1097/INF.0b013e318267fd8b. Erratum In: Pediatr Infect Dis J. 2012 Dec;31(12):1319.
    Results Reference
    derived

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

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