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: November 21, 2012
Last verified: November 2012
  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 (Chickenpox)
Biological: Varilrix (inactivated varicella vaccine)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:
  • GMT ratio for antibodies to varicella [ Time Frame: post-dose 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seroconversion rates for varicella antibodies [ Time Frame: post-dose 1 and post-dose 2 ] [ Designated as safety issue: No ]
  • GMTs for varicella antibodies [ Time Frame: post-dose 2 ] [ Designated as safety issue: No ]
  • Solicited symptoms after each vaccination (pain, redness, swelling: Day 0-3; fever; rash: Day 0-42) [ Time Frame: Day 0-3, Day 0-42 ] [ Designated as safety issue: No ]
  • Unsolicited AEs after each vaccination [ Time Frame: Day 0-42 ] [ Designated as safety issue: No ]
  • SAEs [ Time Frame: from dose 1 up to study end ] [ Designated as safety issue: No ]

Enrollment: 244
Study Start Date: November 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Varilrix (inactivated varicella vaccine)
    Other Name: Varilrix (inactivated varicella vaccine)
  Eligibility

Ages Eligible for Study:   11 Months to 21 Months
Genders Eligible for Study:   Both
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, 1097
GSK Investigational Site
Budapest, Hungary, 1121
GSK Investigational Site
Budapest, Hungary, 1040
GSK Investigational Site
Győr, Hungary, 9024
GSK Investigational Site
Miskolc, Hungary, 3528
GSK Investigational Site
Miskolc, Hungary, 3543
GSK Investigational Site
Miskolc, Hungary, 3524
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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00568334     History of Changes
Other Study ID Numbers: 109705
Study First Received: December 5, 2007
Last Updated: November 21, 2012
Health Authority: Czech Republic: State Institute for Drug Control

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

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
DNA Virus Infections
Herpesviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 22, 2014