Phase 3
N=1,231
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.
Chicken-pox Illness (Varicella Virus Disease) · Chickenpox
Bottom Line
View on ClinicalTrials.gov: NCT02570126 ↗Enrolled (actual)
1,231
Serious AEs
2.3%
Results posted
Oct 2017
Primary outcome: Primary: Number of Subjects Reporting Fever — 24; 32 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Varilrix HSA-free (Biological); Varilrix™ (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Fever |
205; 188; 40; 27; 72; 51 | — |
| SECONDARY Number of Subjects Reporting Fever |
205; 188; 40; 27; 72; 51 | — |
| SECONDARY Evaluation of Immune Response to Varicella Vaccine With Respect to Anti Varicella Zoster Virus (Anti-VZV) Antibody Concentrations (Immuno-sub Cohort) |
139.9; 146.0; 931.8; 1102.4 | — |
| SECONDARY Number of Subjects With a Seroresponse to VZV (Immuno Sub Cohort) |
184; 168; 174; 166; 180; 173 | — |
| SECONDARY Number of Subjects Reporting Solicited Local Symptoms |
75; 86; 2; 4; 149; 150 | — |
| SECONDARY Number of Subjects Reporting Fever |
205; 188; 40; 27; 72; 51 | — |
| SECONDARY Number of Subjects Reporting Rash |
89; 104; 32; 27; 7; 9 | — |
| SECONDARY Number of Subjects Reporting Febrile Convulsions |
1; 1; 0; 1; 0; 0 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events (AEs) |
270; 282; 223; 220 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs) |
13; 15 | — |
Summary
The purpose of this study is to evaluate the safety and immunogenicity of 2 formulations of GSK Biologicals' varicella vaccines given as a 2-dose course in the second year of life.
Eligibility 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 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.
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 immunosuppressive 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 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT02570126). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.