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.
GSK Biologicals has removed human serum albumin (a stabilizer) from its varicella vaccine to minimize as much as possible the use of animal or human-derived products in the production of vaccines. The study is intended to provide information on the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' candidate varicella vaccine formulated without human serum albumin (HSA) in contrast to Varilrix™ (GSK) which contains HSA when both are used in a two-dose schedule, with the first and second doses given approximately 42 days apart in the second year of life. The immunogenicity sub-cohort will be comprised of approximately 400 subjects, representing approximately 100 subjects enrolled in each of the participating countries. Rationale for amendment 1: Sites in the UK can perform home visits. For subjects participating through home visits, the subject's parent(s) / Legally Acceptable Representative(s) \[LAR(s)\] will be requested to sign a Recruitment/Randomisation agreement to provide personal information and to agree to have their child randomised before providing written consent to participate in the study (to be provided at the 1st home visit).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,236
2 doses will be administered, one at Day 0 and the other at Day 42
2 doses will be administered, one at Day 0 and the other at Day 42
GSK Investigational Site
Tallinn, Estonia
Number of Subjects Reporting Fever
Fever was defined as axillary temperature above (\>) 39.0 °C (\> 102.2°F)
Time frame: 15-days (Days 0-14) post Dose 1 of varicella vaccination
Number of Subjects Reporting Fever
Fever was defined as axillary temperature greater than or equal to (≥) 38.0°C (≥ 100.4°F)
Time frame: 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)
Anti-VZY antibody concentrations were expressed in terms of Geometric Mean Concentrations (GMCs)
Time frame: At Day 42 and Day 84 post vaccination
Number of Subjects With a Seroresponse to VZV (Immuno Sub Cohort)
For VZV, seroresponse was defined as, post-vaccination anti-VZV antibody concentration ≥ 50 mIU/mL among subjects who were seronegative (antibody concentration below (\< ) 25 mIU/mL) before vaccination
Time frame: At Day 42 and Day 84 post vaccination
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed were pain, injection site redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = subject crying when limb was moved or as spontaneously painful. Grade 3 redness and swelling = above (\>) 20 mm
Time frame: 4-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Number of Subjects Reporting Fever
Any fever (≥ 38°C) = occurrence of any fever regardless of its intensity grade or relationship to vaccination. Grade 3 fever = temperature \> 39.5°C. Related fever = assessed by the investigator as causally related to study vaccination
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GSK Investigational Site
Tallinn, Estonia
GSK Investigational Site
Tartu, Estonia
GSK Investigational Site
Kehl, Baden-Wurttemberg, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, Germany
GSK Investigational Site
Tauberbischofsheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Aschaffenburg, Bavaria, Germany
GSK Investigational Site
Schönau am Königssee, Bavaria, Germany
GSK Investigational Site
Vellmar, Hesse, Germany
...and 13 more locations
Time frame: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Number of Subjects Reporting Rash
Any rash = occurrence of the specified solicited general symptom regardless of its intensity. Grade 3 rash = rash which prevented normal, everyday activities. Related rash = assessed by the investigator as causally related to study vaccination
Time frame: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Number of Subjects Reporting Febrile Convulsions
Any febrile convulsion = occurrence of the specified solicited general symptom regardless of its intensity. Grade 3 febrile convulsion = febrile convulsion which prevented normal, everyday activities. Related febrile convulsion = assessed by the investigator as causally related to study vaccination
Time frame: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination
Time frame: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination
Time frame: From Day 0 through the end of study (Day 84)