Phase 3
Completed 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
Source: ClinicalTrials.gov NCT02570126 ↗
Enrolled (actual)
1,231
Serious AEs
2.3%
Results posted
Oct 2017
Primary outcomePrimary: Number of Subjects Reporting Fever — 24; 32 Subjects
◆ Published Evidence
Emerging
3citations · ~0 / year
Safety and immunogenicity of a varicella vaccine without human serum albumin (HSA) versus a HSA-containing formulation administered in the second year of life: a phase III, double-blind, randomized study.
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.
Linked Publications
-
Safety and immunogenicity of a varicella vaccine without human serum albumin (HSA) versus a HSA-containing formulation administered in the second year of life: a phase III, double-blind, randomized study.
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 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 | — |
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) and the linked publication. 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. Informational only — not medical advice.