Vaccinating Healthy volunteers (Active immunization against varicella virus disease of healthy children in their second year of life). MedDRA version: 19.0 Level: PT Classification code 10069613 Term: Varicella immunisation System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 19.0 Level: LLT Classification code 10069628 Term: Varicella immunization System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 19.0 Level: LLT Classification code 10063
Conditions
Interventions
Trade Name: VARILRIX
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Live attenuated varicella virus (OKA strain)
Other descriptive name: VARICELLA VIRUS OKA/ME
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects’ parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. • A male or female between, and including, 12 and 23 months of age (i.e. 12 months to a day before 24 months) at the time of the first study vaccination. • Written informed consent obtained from the par-ent(s)/LAR(s) of the subject prior to performing any study specific procedure. • Subjects in stable health as determined by investigator’s clinical examination and assessment of subject’s medical history. • Subjects must have had prior administration of a dose of measles, mumps and rubella (MMR) vaccine at least 30 days (Day -31 or earlier) prior to study vaccination at Day 0 Are the trial subjects under 18? yes Number of subjects for this age range: 1220 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
Exclusion criteria: •Child in care. •Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the day of study vaccination (i.e., 30 days prior to Visit 1/Day 0) or planned use during the entire study period. •Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product. •Chronic administration (defined as 14 or more consecutive days) of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the first vaccine dose or any planned administration of immuno-suppressive and immune-modifying drugs during the entire study. ? -For corticosteroids, this will mean prednisone =0.5 mg/kg/day or equivalent. ? -Inhaled and topical steroids are allowed. •Planned administration/ administration of a live viral vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination at Visit 1/Day 0 until study end. Non study live viral vaccines can be administered at Visit 3 (Day 84) after completion of study procedures. •Planned administration/ administration of an inactivated vaccine not foreseen by the study protocol during the period starting 7 days prior to each vaccination (at Visit 1/Day 0 and Visit 2/Day 42) and ending 14 days after each vaccination. Outside of this period, non-study inactivated vaccines can be administered as per standard of care. •Administration of immunoglobulins and/or any blood prod-ucts during the period starting 180 days prior to the first vaccine dose or planned administration from the date of first study vaccination through the entire study. •History of varicella or zoster. •Known exposure to varicella/zoster during the period start-ing within 30 days prior to first study vaccination. •Previous vaccination against varicella. •Any confirmed or suspected immunosuppressive or im-munodeficient condition, based on medical history and physical examination (no laboratory testing required). •Subjects with blood dyscrasias, leukemia, and lymphomas of any type. •A family history of congenital or hereditary immunodefi-ciency •History of allergic disease or reactions likely to be exacer-bated by any component of the vaccines, including hyper-sensitivity to neomycin or latex. •Major congenital defects or serious chronic illness. •Acute disease and/or fever at the time of enrolment. - -Fever is defined as temperature =38. 0°C/100.4°F by any age appropriate route. - -Subjects with a minor illness without fever may be enrolled at the discretion of the investigator. •Active untreated tuberculosis based on medical history. •Any other condition which, in the opinion of the investigator, prevents the child from participating in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To assess the safety and reactogenicity of Varilrix HSA-free and Varilrix after each vaccination • To assess fever = 38.0°C (=100.4°F) occurring from Day 0 through Day 14 after each vaccination • To assess fever = 38.0°C (=100.4°F) temporally associ-ated with serious adverse events (SAEs) occurring from Day 0 through Day 14 after each vaccination • To assess the immunogenicity of Varilrix HSA-free and Varilrix in terms of seroresponse and GMCs for anti-varicella antibodies (anti-VZV) at Visit 2/Day 42 and Visit 3/Day 84 in an immunogenicity sub-cohort of subjects. ;Primary end point(s): Assessment of fever after varicella vaccination post Dose 1 Criteria: Occurrence of fever > 39.0 °C (>102.2°F).;Timepoint(s) of evaluation of this end point: From Day 0 through Day 14 after dose 1;Main Objective: • To demonstrate the safety profile (i.e. fever >39°C (>102.2°F)) of Varilrix HSA-free compared to Varilrix post Dose 1. Criteria: For the Varilrix HSA-free vaccine as compared to Varilrix, the upper limit of the 2-sided standardized asymptotic 95% CI for the group difference (Varilrix HSA-free minus Varilrix) in incidence of fever >39.0°C (>102.2°F) within 0-14 days after Dose 1 is equal to or below 5%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1. From Day 0 through Day 14 after each vaccination 2. 42 days after each vaccination 3. From Day 0 to Day 3 after each vaccination for solicited local symptoms. 42 days after each vaccination for solicited general symptoms 4. For 42 days after each vaccination day 5. From Day 0 through the end of study (Day 0 - Day 84);Secondary end point(s): 1. Assessment of fever after varicella vaccinations (Occurrence of fever = 38.0°C (=100.4°F) 2. Immune response to varicella vaccine post dose 1 (Day 42) and post dose 2 (Day 84) (immuno-subcohort). 3.Solicited local and general symptoms 4. Unsolicited adverse events 5. Serious adverse events | — |
Countries
Estonia, Germany, Mexico, Thailand, United Kingdom
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed