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
- Conditions
- Primary vaccination against varicella in healthy children in their second year of life
- Registration Number
- EUCTR2007-000683-24-CZ
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 244
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
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.)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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;Secondary Objective: To assess the reactogenicity and safety of the study vaccine(s).<br>To assess the seroconversion rate for antibodies to varicella 43 to 57 days after the first dose vaccination.<br>To assess the seroconversion rate and GMTs for antibodies to varicella 43 to 57 days after the second dose vaccination.;Primary end point(s): GMT ratio post-dose 1 for antibodies to varicella
- Secondary Outcome Measures
Name Time Method