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

December 5, 2007
November 21, 2012
November 2007
April 2008   (final data collection date for primary outcome measure)
GMT ratio for antibodies to varicella [ Time Frame: post-dose 1 ] [ Designated as safety issue: No ]
GMT ratio for antibodies to varicella [ Time Frame: post-dose 1 ]
Complete list of historical versions of study NCT00568334 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Seroconversion rates for varicella antibodies [ Time Frame: post-dose 1 and post-dose 2 ]
  • GMTs for varicella antibodies [ Time Frame: post-dose 2 ]
  • Solicited symptoms after each vaccination (pain, redness, swelling: Day 0-3; fever; rash: Day 0-42) [ Time Frame: Day 0-3, Day 0-42 ]
  • Unsolicited AEs after each vaccination [ Time Frame: Day 0-42 ]
  • SAEs [ Time Frame: from dose 1 up to study end ]
Not Provided
Not Provided
 
Study of Two Formulations of GSK Biologicals' Varicella Vaccine
Study of Two Formulations of GSK Biologicals' Varicella Vaccine Given as a 2-dose Course in the Second Year of Life

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Varicella (Chickenpox)
Biological: Varilrix (inactivated varicella vaccine)
Other Name: Varilrix (inactivated varicella vaccine)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
244
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
11 Months to 21 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Hungary
 
NCT00568334
109705
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP