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Phase 3 N=1,231 Randomized Quadruple-blind Prevention

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

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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