Study of Two Formulations of GSK Biologicals' Varicella Vaccine

NCT00568334 | Completed Phase 2 Results

• 1 other identifier: 109705
• Study Type: interventional
• Target: 244
• Locations: 2 countries
• Sites: 13

Brief Summary

The aim of this study is to evaluate a modified formulation of GSK Biologicals' live attenuated varicella vaccine. In vivo pre-clinical data show this change has no negative impact on vaccine safety. This present study is undertaken to rule out any negative impact on the immunogenicity and safety of GSK Biologicals' live attenuated varicella virus vaccine.

Conditions

Varicella

Keywords

chickenpox; varicella; two-dose schedule; second year of life

Outcome Measures

Primary Outcomes (2)

• Antibody Titers Against Varicella Zoster Virus (VZV)

  Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects \[with anti-VZV titer below (\<) 1:4\].

  At 43-57 days after the first vaccine dose (Week 6)

• Antibody Concentrations Against Varicella Zoster Virus (VZV)

  Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects \[with anti-VZV concentration below (\<) 25 mIU/mL\].

  At 43-57 days after the first vaccine dose (Week 6)

Secondary Outcomes (8)

• Number of Seroconverted Subjects for Varicella Antibodies

  At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12)

• Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values

  At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12)

• Antibody Titers Against Varicella Zoster Virus (VZV)

  At 86-114 days after the second vaccine dose (Week 12)

• Antibody Concentrations Against Varicella Zoster Virus (VZV)

  At 86-114 days after the second vaccine dose (Week 12)

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms

  During the 4-day (Days 0-3) post-vaccination period following each dose

Study Arms (2)

VARILRIX HSA-FREE GROUP

EXPERIMENTAL

Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).

Biological: Varilrix (inactivated varicella vaccine)

VARILRIX GROUP

EXPERIMENTAL

Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).

Biological: Varilrix (inactivated varicella vaccine)

Interventions

Varilrix (inactivated varicella vaccine) BIOLOGICAL

subcutaneously injection

VARILRIX GROUP; VARILRIX HSA-FREE GROUP

Eligibility Criteria

• Age: 11 Months - 21 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
• A male or female between, and including, 11 and 21 months of age at the time of the first vaccination.
• Written informed consent obtained from the parent or guardian of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to the first study vaccine dose until 42 days after second study vaccine dose with the exception of oral polio vaccine (OPV) which can be given at any time and routine inactivated vaccines which can be administered up to eight days before each study vaccine dose.
• Previous vaccination against varicella.
• Known history of clinical varicella.
• Known exposure to varicella within 30 days prior to study start.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin.
• Major congenital defects or serious chronic illness.
• Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness.
• Axillary temperature ≥ 37.5°C / Rectal temperature ≥ 38°C.
• Residence in the same household as a high risk person e.g.: new-born infants (0-4 weeks of age), pregnant women who have a negative history of chickenpox, persons with known immunodeficiency

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (13)

GSK Investigational Site

Náchod, 547 01, Czechia

Location

GSK Investigational Site

Pardubice, 532 03, Czechia

Location

GSK Investigational Site

Bordány, 6795, Hungary

Location

GSK Investigational Site

Budapest, 1032, Hungary

Location

GSK Investigational Site

Budapest, 1040, Hungary

Location

GSK Investigational Site

Budapest, 1097, Hungary

Location

GSK Investigational Site

Budapest, 1121, Hungary

Location

GSK Investigational Site

Győr, 9024, Hungary

Location

GSK Investigational Site

Miskolc, 3524, Hungary

Location

GSK Investigational Site

Miskolc, 3528, Hungary

Location

GSK Investigational Site

Miskolc, 3543, Hungary

Location

GSK Investigational Site

Szeged, 6723, Hungary

Location

GSK Investigational Site

Zsombó, 6792, Hungary

Location

Related Publications (1)

• Prymula R, Simko R, Povey M, Kulcsar A. Varicella vaccine without human serum albumin versus licensed varicella vaccine in children during the second year of life: a randomized, double-blind, non-inferiority trial. BMC Pediatr. 2016 Jan 13;16:7. doi: 10.1186/s12887-016-0546-5.

  PMID: 26762528 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 6, 2007
• Study Start: November 1, 2007
• Primary Completion: March 18, 2008
• Study Completion: April 29, 2008
• Last Updated: June 8, 2018
• Results First Posted: June 28, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

HU (11); CZ (2)