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.

NCT02570126 | Completed Phase 3 Results

• 2 other identifiers: 2001472013-003535-30
• Study Type: interventional
• Target: 1,236
• Locations: 5 countries
• Sites: 23

Brief Summary

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.

Conditions

Chicken-pox Illness (Varicella Virus Disease); Chickenpox

Keywords

Immunogenicity; Varicella; Safety; Human serum albumin; Healthy children; 12 to 23 months

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Reporting Fever

  Fever was defined as axillary temperature above (\>) 39.0 °C (\> 102.2°F)

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

Secondary Outcomes (9)

• Number of Subjects Reporting Fever

  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)

  At Day 42 and Day 84 post vaccination

• Number of Subjects With a Seroresponse to VZV (Immuno Sub Cohort)

  At Day 42 and Day 84 post vaccination

• Number of Subjects Reporting Solicited Local Symptoms

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

• Number of Subjects Reporting Fever

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

Study Arms (2)

VAR_HSA_F Group

EXPERIMENTAL

2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), will be given to the subjects in this group. The vaccine will be administered subcutaneously in the triceps region of the left arm

Biological: Varilrix HSA-free

VAR Group

ACTIVE COMPARATOR

2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), will be given to the subjects in this group. The vaccine will be administered subcutaneously in the triceps region of the left arm

Biological: Varilrix™

Interventions

Varilrix HSA-free BIOLOGICAL

2 doses will be administered, one at Day 0 and the other at Day 42

VAR_HSA_F Group

Varilrix™ BIOLOGICAL

2 doses will be administered, one at Day 0 and the other at Day 42

VAR Group

Eligibility Criteria

• Age: 12 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
• Subjects in stable health as determined by investigator's clinical examination and assessment of subject's medical history.
• Subjects must have had prior administration of a dose of measles, mumps and rubella (MMR) vaccine at least 30 days (Day -31 or earlier) prior to study vaccination at Day 0.

You may not qualify if:

• 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.
• Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product.
• Chronic administration (defined as 14 or more consecutive days) of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the first vaccine dose or any planned administration of immunosuppressive and immune-modifying drugs during the entire study.
• For corticosteroids, this will mean prednisone ≥0.5 mg/kg/day or equivalent.
• Inhaled and topical steroids are allowed.
• Planned administration/ administration of a live viral vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination at Visit 1/Day 0 until study end. Non study live viral vaccines can be administered at Visit 3 (Day 84) after completion of study procedures.
• Planned administration/ administration of an inactivated vaccine not foreseen by the study protocol during the period starting 7 days prior to each vaccination (at Visit 1/Day 0 and Visit 2/Day 42) and ending 14 days after each vaccination. Outside of this period, non-study inactivated vaccines can be administered as per standard of care.
• Administration of immunoglobulins and/or any blood products during the period starting 180 days prior to the first vaccine dose or planned administration from the date of first study vaccination through the entire study.
• History of varicella or zoster.
• Known exposure to varicella/zoster during the period starting within 30 days prior to first study vaccination.
• Previous vaccination against varicella.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• Subjects with blood dyscrasias, leukemia, and lymphomas of any type.
• A family history of congenital or hereditary immunodeficiency

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (23)

GSK Investigational Site

Tallinn, 10617, Estonia

Location

GSK Investigational Site

Tallinn, Estonia

Location

GSK Investigational Site

Tartu, 50106, Estonia

Location

GSK Investigational Site

Kehl, Baden-Wurttemberg, 77694, Germany

Location

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, 70469, Germany

Location

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, 70499, Germany

Location

GSK Investigational Site

Tauberbischofsheim, Baden-Wurttemberg, 97941, Germany

Location

GSK Investigational Site

Aschaffenburg, Bavaria, 63739, Germany

Location

GSK Investigational Site

Schönau am Königssee, Bavaria, 83471, Germany

Location

GSK Investigational Site

Vellmar, Hesse, 34246, Germany

Location

GSK Investigational Site

Detmold, North Rhine-Westphalia, 32756, Germany

Location

GSK Investigational Site

Solingen, North Rhine-Westphalia, 42719, Germany

Location

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, 67227, Germany

Location

GSK Investigational Site

Wurzen, Saxony, 04808, Germany

Location

GSK Investigational Site

Berlin, 13055, Germany

Location

GSK Investigational Site

Neumünster, 24534, Germany

Location

GSK Investigational Site

Mérida, Yucatán, 97070, Mexico

Location

GSK Investigational Site

Mexico City, 04530, Mexico

Location

GSK Investigational Site

Bangkok, 10330, Thailand

Location

GSK Investigational Site

Bristol, BS2 8AE, United Kingdom

Location

GSK Investigational Site

London, SW17 0RE, United Kingdom

Location

GSK Investigational Site

Oxford, OX3 7LJ, United Kingdom

Location

GSK Investigational Site

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• Faust SN, Le Roy M, Pancharoen C, Weber MAR, Cathie K, Behre U, Bernatoniene J, Snape MD, Helm K, Medina Pech CE, Henry O, Baccarini C, Povey M, Gillard P. 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. 2019 Feb 7;19(1):50. doi: 10.1186/s12887-019-1425-7.

  PMID: 30732648 BACKGROUND

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 7, 2015
• Study Start: November 13, 2015
• Primary Completion: October 25, 2016
• Study Completion: October 25, 2016
• Last Updated: November 25, 2019
• Results First Posted: October 11, 2017

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

GB (4); ME (2); ES (3); TH (1); DE (13)