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.

NCT ID: NCT02570126

Last Updated: 2019-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-13
• Study Completion Date: 2016-10-25

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.

Detailed Description

GSK Biologicals has removed human serum albumin (a stabilizer) from its varicella vaccine to minimize as much as possible the use of animal or human-derived products in the production of vaccines. The study is intended to provide information on the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' candidate varicella vaccine formulated without human serum albumin (HSA) in contrast to Varilrix™ (GSK) which contains HSA when both are used in a two-dose schedule, with the first and second doses given approximately 42 days apart in the second year of life.

The immunogenicity sub-cohort will be comprised of approximately 400 subjects, representing approximately 100 subjects enrolled in each of the participating countries.

Rationale for amendment 1: Sites in the UK can perform home visits. For subjects participating through home visits, the subject's parent(s) / Legally Acceptable Representative(s) [LAR(s)] will be requested to sign a Recruitment/Randomisation agreement to provide personal information and to agree to have their child randomised before providing written consent to participate in the study (to be provided at the 1st home visit).

Conditions

Chicken-pox Illness (Varicella Virus Disease); Chickenpox

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

VAR_HSA_F Group

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

Group Type: EXPERIMENTAL

Varilrix HSA-free

Intervention Type: BIOLOGICAL

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

VAR Group

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

Group Type: ACTIVE_COMPARATOR

Varilrix™

Intervention Type: BIOLOGICAL

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

Interventions

Varilrix HSA-free

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

Intervention Type: BIOLOGICAL

Varilrix™

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including hypersensitivity to neomycin or latex.
• Major congenital defects or serious chronic illness.
• Acute disease and/or fever at the time of enrolment.

• Fever is defined as temperature ≥38. 0°C/100.4°F by any age appropriate route.
• Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
• Active untreated tuberculosis based on medical history.
• Any other condition which, in the opinion of the investigator, prevents the child from participating in the study.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 23 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tartu, , Estonia

GSK Investigational Site

Kehl, Baden-Wurttemberg, Germany

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, Germany

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, Germany

GSK Investigational Site

Tauberbischofsheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Aschaffenburg, Bavaria, Germany

GSK Investigational Site

Schönau am Königssee, Bavaria, Germany

GSK Investigational Site

Vellmar, Hesse, Germany

GSK Investigational Site

Detmold, North Rhine-Westphalia, Germany

GSK Investigational Site

Solingen, North Rhine-Westphalia, Germany

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, Germany

GSK Investigational Site

Wurzen, Saxony, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Neumünster, , Germany

GSK Investigational Site

Mérida, Yucatán, Mexico

GSK Investigational Site

Mexico City, , Mexico

GSK Investigational Site

Bangkok, , Thailand

GSK Investigational Site

Bristol, , United Kingdom

GSK Investigational Site

London, , United Kingdom

GSK Investigational Site

Oxford, , United Kingdom

GSK Investigational Site

Southampton, , United Kingdom

Countries

Estonia; Germany; Mexico; Thailand; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 30732648 (View on PubMed)

Other Identifiers

2013-003535-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

200147

Identifier Type: -

Identifier Source: org_study_id