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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2016-25-10
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
Location
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
Status
Study Complete
Location
GSK Investigational Site
London, United Kingdom, SW17 0RE
Status
Study Complete
Location
GSK Investigational Site
Merida, Yucatán, Mexico, 97070
Status
Study Complete
Location
GSK Investigational Site
Mexico city, Mexico, 04530
Status
Study Complete
Location
GSK Investigational Site
Neumuenster, Germany, 24534
Status
Study Complete
Location
GSK Investigational Site
Oxford, United Kingdom, OX3 7LJ
Status
Study Complete
Location
GSK Investigational Site
Schoenau am Koenigssee, Bayern, Germany, 83471
Status
Study Complete
Location
GSK Investigational Site
Solingen, Nordrhein-Westfalen, Germany, 42719
Status
Study Complete
Location
GSK Investigational Site
Southampton, United Kingdom, SO16 6YD
Status
Study Complete
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
Status
Study Complete
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70499
Status
Study Complete
Location
GSK Investigational Site
Tallinn, Estonia
Status
Study Complete
Location
GSK Investigational Site
Tallinn, Estonia, 10617
Status
Study Complete
Location
GSK Investigational Site
Tartu, Estonia, 50106
Status
Study Complete
Location
GSK Investigational Site
Tauberbischofsheim, Baden-Wuerttemberg, Germany, 97941
Status
Study Complete
Location
GSK Investigational Site
Vellmar, Hessen, Germany, 34246
Status
Study Complete
Location
GSK Investigational Site
Wurzen, Sachsen, Germany, 04808
Status
Study Complete

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
Completed
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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