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Study of Two Formulations of GSK Biologicals' Varicella Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00568334
First received: December 5, 2007
Last updated: April 13, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Varicella Biological: Varilrix (inactivated varicella vaccine) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Prevention
Official Title: Study of Two Formulations of GSK Biologicals' Varicella Vaccine Given as a 2-dose Course in the Second Year of Life

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Antibody Titers Against Varicella Zoster Virus (VZV) [ Time Frame: At 43-57 days after the first vaccine dose (Week 6) ]
    Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects [with anti-VZV titer below (<) 1:4].

  • Antibody Concentrations Against Varicella Zoster Virus (VZV) [ Time Frame: At 43-57 days after the first vaccine dose (Week 6) ]
    Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects [with anti-VZV concentration below (<) 25 mIU/mL].


Secondary Outcome Measures:
  • Number of Seroconverted Subjects for Varicella Antibodies [ Time Frame: At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12) ]
    Seroconversion/seroresponse (considering the IFA data) was defined as the appearance of anti-VZV antibodies [i.e. titer/concentration greater than or equal to (≥) the assay cut-off value of 1:4] in the sera of subjects who were seronegative before vaccination.

  • Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values [ Time Frame: At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12) ]
    Anti-VZV antibody concentrations greater than or equal to (≥) the assay cut-off values of: 25 mIU/mL, 50 mIU/mL and 75 mIU/mL have been assesssed by ELISA, in the sera of subjects who were seronegative before vaccination.

  • Antibody Titers Against Varicella Zoster Virus (VZV) [ Time Frame: At 86-114 days after the second vaccine dose (Week 12) ]
    Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects [with anti-VZV titer below (<) 1:4].

  • Antibody Concentrations Against Varicella Zoster Virus (VZV) [ Time Frame: At 86-114 days after the second vaccine dose (Week 12) ]
    Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects [with anti-VZV concentration below (<) 25 mIU/mL].

  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following each dose ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 43-day (Days 0-42) post-vaccination period following each dose ]
    Assessed solicited general symptoms were fever [defined as axillary fever ≥ 37.5 degrees Celsius (°C)] and generalized rash. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 fever = temperature above (>) 39.0°C after vaccination. Grade 3 rash = more than (>) 150 lesions. Related = considered by the investigator to be causally related to the study vaccination.

  • Number of Subjects With Any Unsolicited Adverse Event (AE) [ Time Frame: Within the 43-day (Days 0-42) post-vaccination period following each dose ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From Day 0 up to study end (Day 86-114) ]
    Serious adverse events (SAEs) assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.


Enrollment: 244
Actual Study Start Date: November 1, 2007
Study Completion Date: April 29, 2008
Primary Completion Date: March 18, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VARILRIX HSA-FREE GROUP
Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
Biological: Varilrix (inactivated varicella vaccine)
subcutaneously injection
Experimental: VARILRIX GROUP
Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
Biological: Varilrix (inactivated varicella vaccine)
subcutaneously injection

  Eligibility

Ages Eligible for Study:   11 Months to 21 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568334

Locations
Czech Republic
GSK Investigational Site
Nachod, Czech Republic, 547 01
GSK Investigational Site
Pardubice, Czech Republic, 532 03
Hungary
GSK Investigational Site
Bordány, Hungary, 6795
GSK Investigational Site
Budapest, Hungary, 1032
GSK Investigational Site
Budapest, Hungary, 1040
GSK Investigational Site
Budapest, Hungary, 1097
GSK Investigational Site
Budapest, Hungary, 1121
GSK Investigational Site
Győr, Hungary, 9024
GSK Investigational Site
Miskolc, Hungary, 3524
GSK Investigational Site
Miskolc, Hungary, 3528
GSK Investigational Site
Miskolc, Hungary, 3543
GSK Investigational Site
Szeged, Hungary, 6723
GSK Investigational Site
Zsombó, Hungary, 6792
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 109705
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 109705
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 109705
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 109705
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 109705
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 109705
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00568334     History of Changes
Other Study ID Numbers: 109705
Study First Received: December 5, 2007
Results First Received: April 13, 2017
Last Updated: April 13, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
chickenpox
varicella
two-dose schedule
second year of life

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2017