A safety and immune study of 2 types of GlaxoSmithKline’s varicella vaccines given as a 2-doses course to healthy children 12-23 months of age.
Trial overview
Number of subjects reporting fever
Timeframe: 15-days (Days 0-14) post Dose 1 of varicella vaccination
Number of subjects reporting fever
Timeframe: 15 days post each dose of varicella vaccination
Evaluation of immune response to varicella vaccine with respect to Anti Varicella Zoster Virus (Anti-VZV) antibody concentrations (immuno-sub cohort)
Timeframe: At Day 42 and Day 84 post vaccination
Number of subjects with a seroresponse to VZV (immuno sub cohort)
Timeframe: At Day 42 and Day 84 post vaccination
Number of subjects reporting solicited local symptoms
Timeframe: 4-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Number of subjects reporting fever
Timeframe: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Number of subjects reporting rash
Timeframe: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Number of subjects reporting febrile convulsions
Timeframe: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Number of subjects reporting unsolicited adverse events (AEs)
Timeframe: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Number of subjects reporting Serious Adverse Events (SAEs)
Timeframe: From Day 0 through the end of study (Day 84)
- 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.
- 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.
- 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 parent(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.
Subjects’ parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- 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 immunosuppressive and immune-modifying drugs during the entire study.
- For corticosteroids, this will mean prednisone ≥0.5 mg/kg/day or equivalent.
- 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 products 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 starting within 30 days prior to first study vaccination.
- Previous vaccination against varicella.
- Any confirmed or suspected immunosuppressive or immunodeficient 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 immunodeficiency
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including hypersensitivity 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.
- 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.
Child in care.
Inhaled and topical steroids are allowed.
Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.