Last updated: 07/17/2024 16:57:37

A safety and immune study of 2 types of GlaxoSmithKline’s varicella vaccines given as a 2-doses course to healthy children 12-23 months of age.

GSK study ID
200147
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Safety and immunogenicity study of 2 formulations of GSK Biologicals’ varicella vaccines given as a 2-dose course in the second year of life.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Number of subjects reporting fever

Timeframe: 15-days (Days 0-14) post Dose 1 of varicella vaccination

Secondary outcomes:

Number of subjects reporting fever

Timeframe: 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)

Timeframe: At Day 42 and Day 84 post vaccination

Number of subjects with a seroresponse to VZV (immuno sub cohort)

Timeframe: At Day 42 and Day 84 post vaccination

Number of subjects reporting solicited local symptoms

Timeframe: 4-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)

Number of subjects reporting fever

Timeframe: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)

Number of subjects reporting rash

Timeframe: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)

Number of subjects reporting febrile convulsions

Timeframe: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)

Number of subjects reporting unsolicited adverse events (AEs)

Timeframe: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)

Number of subjects reporting Serious Adverse Events (SAEs)

Timeframe: From Day 0 through the end of study (Day 84)

Interventions:
  • Biological/vaccine: Varilrix HSA-free
  • Biological/vaccine: Varilrix™
  • Enrollment:
    1236
    Primary completion date:
    2016-25-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Faust SN et al. (2019) Safety and immunogenicity of a varicella vaccine without human serum albumin (HSA) versus a HSA-containing formulation administered in the second year of life: a phase III, double-blind, randomized study. BMC Pediatr. 19(1):50. doi: 10.1186/s12887-019-1425-7.
    Medical condition
    Chicken-pox illness (varicella virus disease)
    Product
    SB208133
    Collaborators
    Not applicable
    Study date(s)
    November 2015 to October 2016
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 23 months
    Accepts healthy volunteers
    Yes
    • Subjects’ parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
    • A male or female between, and including, 12 and 23 months of age (i.e. 12 months to a day before 24 months) at the time of the first study vaccination.
    • Child in care.
    • Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the day of study vaccination (i.e., 30 days prior to Visit 1/Day 0) or planned use during the entire study period.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Aschaffenburg, Bayern, Germany, 63739
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bangkok, Thailand, 10330
    Status
    Study Complete
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 13055
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bristol, United Kingdom, BS2 8AE
    Status
    Study Complete
    Location
    GSK Investigational Site
    Detmold, Nordrhein-Westfalen, Germany, 32756
    Status
    Study Complete
    Location
    GSK Investigational Site
    Frankenthal, Rheinland-Pfalz, Germany, 67227
    Status
    Study Complete
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    Study documents

    Scientific result summary
    Available language(s): English
    Protocol
    Available language(s): English
    Clinical study report
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2016-25-10
    Actual study completion date
    2016-25-10

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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