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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00560755 |
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Date of registration:
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19/11/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety Study of ProQuad® rHA in Infants (V221-037)
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Scientific title:
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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 |
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Date of first enrolment:
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October 24, 2007 |
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Target sample size:
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3388 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00560755 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Denmark
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Germany
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Greece
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Italy
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Netherlands
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Spain
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Sweden
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Contacts
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Name:
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Anne FIQUET, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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MCM Vaccines B.V. |
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Key inclusion & exclusion criteria
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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
Age minimum:
12 Months
Age maximum:
22 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Mumps
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Rubella
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Measles
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Varicella
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Intervention(s)
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Biological: ProQuad®
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Primary Outcome(s)
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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)]
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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)]
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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)]
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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)]
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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)]
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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)]
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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)]
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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)]
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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)]
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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)]
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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)]
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Secondary Outcome(s)
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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)]
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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)]
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Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 1
[Time Frame: Up to Day 28 (28 days after ProQuad® Dose 1)]
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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)]
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Secondary ID(s)
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MRV01C
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V221-037
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2007-002438-12
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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