Clinical trial NCT00568334: Study of Two Formulations of GSK Biologicals' Varicella Vaccine
Official title: Study of Two Formulations of GSK Biologicals' Varicella Vaccine Given as a 2-dose Course in the Second Year of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Varicella
Keywords: chickenpox
varicella
two-dose schedule
second year of life
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-12-06
Enrollment: 244
Sex: ALL
Minimum age (years): 11
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate a modified formulation of GSK Biologicals' live attenuated varicella vaccine. In vivo pre-clinical data show this change has no negative impact on vaccine safety. This present study is undertaken to rule out any negative impact on the immunogenicity and safety of GSK Biologicals' live attenuated varicella virus vaccine.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
* A male or female between, and including, 11 and 21 months of age at the time of the first vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to the first study vaccine dose until 42 days after second study vaccine dose with the exception of oral polio vaccine (OPV) which can be given at any time and routine inactivated vaccines which can be administered up to eight days before each study vaccine dose.
* Previous vaccination against varicella.
* Known history of clinical varicella.
* Known exposure to varicella within 30 days prior to study start.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin.
* Major congenital defects or serious chronic illness.
* Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness.
* Axillary temperature ≥ 37.5°C / Rectal temperature ≥ 38°C.
* Residence in the same household as a high risk person e.g.: new-born infants (0-4 weeks of age), pregnant women who have a negative history of chickenpox, persons with known immunodeficiency

Primary outcomes:
measure: Antibody Titers Against Varicella Zoster Virus (VZV)
timeFrame: At 43-57 days after the first vaccine dose (Week 6)
measure: Antibody Concentrations Against Varicella Zoster Virus (VZV)
timeFrame: At 43-57 days after the first vaccine dose (Week 6)
Secondary outcomes:
measure: Number of Seroconverted Subjects for Varicella Antibodies
timeFrame: At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12)
measure: Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values
timeFrame: At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12)
measure: Antibody Titers Against Varicella Zoster Virus (VZV)
timeFrame: At 86-114 days after the second vaccine dose (Week 12)
measure: Antibody Concentrations Against Varicella Zoster Virus (VZV)
timeFrame: At 86-114 days after the second vaccine dose (Week 12)
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period following each dose
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 43-day (Days 0-42) post-vaccination period following each dose
measure: Number of Subjects With Any Unsolicited Adverse Event (AE)
timeFrame: Within the 43-day (Days 0-42) post-vaccination period following each dose
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Day 0 up to study end (Day 86-114)
Other outcomes:
Locations:
city: Nachod
country: Czechia
facility: GSK Investigational Site
city: Pardubice
country: Czechia
facility: GSK Investigational Site
city: Bordány
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Győr
country: Hungary
facility: GSK Investigational Site
city: Miskolc
country: Hungary
facility: GSK Investigational Site
city: Miskolc
country: Hungary
facility: GSK Investigational Site
city: Miskolc
country: Hungary
facility: GSK Investigational Site
city: Szeged
country: Hungary
facility: GSK Investigational Site
city: Zsombó
country: Hungary
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Prymula R, Simko R, Povey M, Kulcsar A. Varicella vaccine without human serum albumin versus licensed varicella vaccine in children during the second year of life: a randomized, double-blind, non-inferiority trial. BMC Pediatr. 2016 Jan 13;16:7. doi: 10.1186/s12887-016-0546-5.