Overview

This trial is active, not recruiting.

Condition herpes zoster
Treatment gsk biologicals herpes zoster subunit (hz/su) vaccine (gsk 1437173a)
Phase phase 3
Sponsor GlaxoSmithKline
Start date December 2015
End date August 2016
Trial size 431 participants
Trial identifier NCT02581410, 201198

Summary

The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in adults ≥ 65 years of age with and without Zostavax® vaccination at least 5 years earlier.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Subjects ≥ 65 years of age who received Zostavax® ≥ 5 years earlier and will receive two doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
gsk biologicals herpes zoster subunit (hz/su) vaccine (gsk 1437173a)
2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.
(Active Comparator)
Subjects ≥ 65 years of age who never received Zostavax® and will receive two doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later).in this study.
gsk biologicals herpes zoster subunit (hz/su) vaccine (gsk 1437173a)
2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.

Primary Outcomes

Measure
Anti-gE humoral immunogenicity in terms of antibody concentrations.
time frame: At month 3
Occurrence of solicited local symptoms.
time frame: Within 7 days (Days 0-6) after each dose.
Occurrence of solicited general symptoms.
time frame: Within 7 days (Days 0-6) after each dose.
Occurrence of unsolicited symptoms (AEs).
time frame: Within 30 days (Days 0-29) after each dose.
Occurrence of serious adverse events (SAEs).
time frame: From Month 0 (dose 1) up to Month 3 (30 days post-dose 2).
Occurrence of AEs of specific interest (potential immune-mediated diseases [pIMDs]).
time frame: From Month 0 (dose 1) up to Month 3 (30 days post-dose 2).

Secondary Outcomes

Measure
Anti-gE humoral immunogenicity in terms of antibody concentrations.
time frame: At Months 0, 1, 3 and 14.
gE-specific CD4+ T-cell mediated immunogenicity.
time frame: At Months 0, 1, 3 and 14.
Occurrence of Serious Adverse Events (SAEs).
time frame: From Month 3 (30 days post-vaccination 2) up to Month 14 (12 months post-vaccination 2).
Occurrence of AEs of specific interest (pIMDs).
time frame: From Month 3 (30 days post-vaccination 2) up to Month 14 (12 months post-vaccination 2).

Eligibility Criteria

Male or female participants at least 65 years old.

Inclusion Criteria: - Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. - A male or female ≥ 65 years of age at the time of the first vaccination. - Written informed consent obtained from the subject prior to performing any study specific procedure. For the No prev-Zvax group only: • No previous vaccination with Zostavax. For the Prev-Zvax group only: • Previous vaccination with Zostavax ≥ 5 calendar years earlier. - Documentation indicating the date of previous Zostavax vaccination will be required. Exclusion Criteria: - Previous vaccination with Zostavax < 5 calendar years earlier and/or anyone that ever received more than a single dose of Zostavax. - Previous vaccination against VZV, administration of HZ/su vaccine or any other investigational or non-registered HZ vaccine (except Zostavax for the Prev-Zvax group). - Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period. - Chronic administration (defined as > 14 consecutive days) of immunosuppressants or other immune-modifying drugs in the period starting 6 months prior to the first dose of vaccine. (For corticosteroids, a prednisone dose of < 20 mg/day, or equivalent, is allowed.) Inhaled, topical and intra-articular corticosteroids are allowed. - Administration of long-acting immune-modifying drugs (e.g., infliximab) in the period starting 6 months prior to the first vaccine dose or expected administration at any time during the study period. - Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine in the period starting 8 days prior to and ending 14 days after either dose of study vaccine. - Current participation in or planned concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. - Planned administration of an HZ vaccine (including an investigational or non-registered vaccine) other than the study vaccine during the entire study. - History of HZ or any suspected HZ between the screening visit and Visit 1. - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine/product. - Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus [HIV] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders). - Acute disease and/or fever at the time of enrolment. - Fever is defined as temperature ≥ 37.5°C (99.5°F) by oral route, axillary or tympanic setting, or ≥ 38.0°C/100.4°F on rectal setting. The recommended route for recording temperature in this study will be oral. - Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. - Administration of immunoglobulins and/or any blood products in the period starting 3 months preceding the first dose of study vaccine or planned administration during the study period. - Significant underlying illness that, in the opinion of the investigator, would be expected to prevent completion of the study. - Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study. - Any condition which, in the judgment of the investigator, would make intramuscular (IM) injection unsafe.

Additional Information

Official title Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults ≥ 65 Years of Age With and Without Zostavax® Vaccination at Least 5 Years Earlier
Description The study will evaluate two parallel groups of 200 adults ≥ 65 YOA; one group (Prev-Zvax) with a previous Zostavax® vaccination at least 5 years earlier, versus the other group without a previous Zostavax® vaccination (No prev-Zvax). The goal of this study is to generate immunogenicity, safety and reactogenicity data for the respective vaccines.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.