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.

Chickenpox Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02570126
• Other study ID #: 200147
• Secondary ID: 2013-003535-30
• Status: Completed
• Phase: Phase 3
• Start date: November 13, 2015
• Est. completion date: October 25, 2016

Study information

• Verified date: November 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1236
• Est. completion date: October 25, 2016
• Est. primary completion date: October 25, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 23 Months

Eligibility

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.

Related Conditions & MeSH terms

• Chicken-pox Illness (Varicella Virus Disease)
• Chickenpox
• Herpes Zoster
• Virus Diseases

Intervention

Biological:
• Varilrix HSA-free
2 doses will be administered, one at Day 0 and the other at Day 42
• Varilrix™
2 doses will be administered, one at Day 0 and the other at Day 42

Locations

Country	Name	City	State
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
Germany	GSK Investigational Site	Aschaffenburg	Bayern
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Detmold	Nordrhein-Westfalen
Germany	GSK Investigational Site	Frankenthal	Rheinland-Pfalz
Germany	GSK Investigational Site	Kehl	Baden-Wuerttemberg
Germany	GSK Investigational Site	Neumuenster
Germany	GSK Investigational Site	Schoenau Am Koenigssee	Bayern
Germany	GSK Investigational Site	Solingen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Stuttgart	Baden-Wuerttemberg
Germany	GSK Investigational Site	Stuttgart	Baden-Wuerttemberg
Germany	GSK Investigational Site	Tauberbischofsheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Vellmar	Hessen
Germany	GSK Investigational Site	Wurzen	Sachsen
Mexico	GSK Investigational Site	Merida	Yucatán
Mexico	GSK Investigational Site	Mexico city
Thailand	GSK Investigational Site	Bangkok
United Kingdom	GSK Investigational Site	Bristol
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Oxford
United Kingdom	GSK Investigational Site	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Estonia,  Germany,  Mexico,  Thailand,  United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Subjects Reporting Fever	Fever was defined as axillary temperature greater than or equal to (=) 38.0°C (= 100.4°F)	15 days post each dose of varicella vaccination
Secondary	Evaluation of Immune Response to Varicella Vaccine With Respect to Anti Varicella Zoster Virus (Anti-VZV) Antibody Concentrations (Immuno-sub Cohort)	Anti-VZY antibody concentrations were expressed in terms of Geometric Mean Concentrations (GMCs)	At Day 42 and Day 84 post vaccination
Secondary	Number of Subjects With a Seroresponse to VZV (Immuno Sub Cohort)	For VZV, seroresponse was defined as, post-vaccination anti-VZV antibody concentration = 50 mIU/mL among subjects who were seronegative (antibody concentration below (< ) 25 mIU/mL) before vaccination	At Day 42 and Day 84 post vaccination
Secondary	Number of Subjects Reporting Solicited Local Symptoms	Solicited local symptoms assessed were pain, injection site redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = subject crying when limb was moved or as spontaneously painful. Grade 3 redness and swelling = above (>) 20 mm	4-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Secondary	Number of Subjects Reporting Fever	Any fever (= 38°C) = occurrence of any fever regardless of its intensity grade or relationship to vaccination. Grade 3 fever = temperature > 39.5°C. Related fever = assessed by the investigator as causally related to study vaccination	43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Secondary	Number of Subjects Reporting Rash	Any rash = occurrence of the specified solicited general symptom regardless of its intensity. Grade 3 rash = rash which prevented normal, everyday activities. Related rash = assessed by the investigator as causally related to study vaccination	43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Secondary	Number of Subjects Reporting Febrile Convulsions	Any febrile convulsion = occurrence of the specified solicited general symptom regardless of its intensity. Grade 3 febrile convulsion = febrile convulsion which prevented normal, everyday activities. Related febrile convulsion = assessed by the investigator as causally related to study vaccination	43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Secondary	Number of Subjects Reporting Unsolicited Adverse Events (AEs)	Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination	43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Secondary	Number of Subjects Reporting Serious Adverse Events (SAEs)	SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination	From Day 0 through the end of study (Day 84)