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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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EUCTR |
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Last refreshed on:
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30 June 2019 |
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Main ID: |
EUCTR2007-000683-24-CZ |
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Date of registration:
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07/08/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phase II, double blind, randomized, comparative study of the immunogenicity and safety of GlaxoSmithKline Biologicals’ modified formulation varicella vaccine and Varilrix™ given as a 2 dose course in the second year of life - OKA-H-186
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Scientific title:
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Phase II, double blind, randomized, comparative study of the immunogenicity and safety of GlaxoSmithKline Biologicals’ modified formulation varicella vaccine and Varilrix™ given as a 2 dose course in the second year of life - OKA-H-186 |
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Date of first enrolment:
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18/04/2008 |
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Target sample size:
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240 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000683-24 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Czech Republic
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Hungary
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
A male or female between, and including, 11 and 21 months of age at the time of the first vaccination.
Written informed consent obtained from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Previous vaccination against varicella.
Known history of clinical varicella or exposure to varicella within 30 days prior to study start.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to the first study vaccine dose until 42 days after second study vaccine dose with the exception of oral polio vaccine (OPV) which can be given at any time and routine inactivated vaccines such as, pneumococcal, meningococcal or Haemophilus influenzae type b conjugate vaccines, inactivated influenza or diphtheria/tetanus-containing vaccines which can be administered up to eight days before each study vaccine dose.
Residence in the same household as a high risk person e.g. new-born infants (0-4 weeks of age), pregnant women who have a negative history of chickenpox, persons with known immunodeficiency
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
A family history of congenital or hereditary immunodeficiency.
Major congenital defects or serious chronic illness.
Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Axillary temperature <37.5°C / Rectal temperature <38°C).
Axillary temperature greater than or equal to 37.5°C / Rectal temperature greater than or equal to 38°C.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone greater than or equal to 0.5 mg/kg/day (or equivalent). Inhaled and topical steroids are allowed.)
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Primary vaccination against varicella in healthy children in their second year of life
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Intervention(s)
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Product Name: Varilrix HSA-free
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Live attenuated varicella virus (OKA strain)
Concentration unit: log10 PFU/dose log10 plaque forming unit(s)/dose
Concentration type: not less then
Concentration number: 3.3-
Trade Name: Varilrix
Product Name: Varilrix
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Live attenuated varicella virus (OKA strain)
Concentration unit: log10 PFU/dose log10 plaque forming unit(s)/dose
Concentration type: not less then
Concentration number: 3.3-
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Primary Outcome(s)
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Main Objective: To demonstrate the non-inferiority of Varilrix HSA-free vaccine as compared to Varilrix vaccines in terms of geometric mean titers (GMTs) of varicella antibodies 43 - 57 days after the first dose vaccination
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Primary end point(s): GMT ratio post-dose 1 for antibodies to varicella
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Secondary Objective: To assess the reactogenicity and safety of the study vaccine(s).
To assess the seroconversion rate for antibodies to varicella 43 to 57 days after the first dose vaccination.
To assess the seroconversion rate and GMTs for antibodies to varicella 43 to 57 days after the second dose vaccination.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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