Safety and Immunogenicity of the Zoster Vaccine GSK1437173A in Elderly Subjects

NCT ID: NCT00434577

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 715 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-14
• Study Completion Date: 2010-07-14

Brief Summary

Based on the results of a previous clinical PhaseI/II study, GSK1437173A is the lead GSK candidate Herpes Zoster (HZ) vaccine to prevent episodes of HZ (shingles). This phase II study will be subdivided into a primary study (108494) and three extension studies (108516, 108518 & 108520), consisting of one additional visit each at months 12, 24 and 36, respectively, from the first visit of the Zoster-003 primary study onwards. The aim of the primary 108494 study is to evaluate the immunogenicity & safety of different dosages of the GSK1437173A vaccine in healthy elderly population. The study population will be stratified by age. The primary objective of this trial is to select the best dosage of GSK1437173A. The aim of the extension studies is to evaluate the persistence of the immune response induced by the candidate HZ vaccine during a long term period.

No new subjects will be enrolled during the extension phases of the study.

Detailed Description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Herpes Zoster

Study Design

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

Study Groups

GSK1437173A _LD Group

Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.

Group Type: EXPERIMENTAL

Herpes Zoster vaccine GSK1437173A Low Dose

Intervention Type: BIOLOGICAL

Single or two-dose intramuscular injection.

GSK1437173A _MD Group

Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.

Group Type: EXPERIMENTAL

Herpes Zoster vaccine GSK1437173A Medium Dose

Intervention Type: BIOLOGICAL

Single or two-dose intramuscular injection.

GSK1437173A _HD Group

Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.

Group Type: EXPERIMENTAL

Herpes Zoster vaccine GSK1437173A High Dose

Intervention Type: BIOLOGICAL

Single or two-dose intramuscular injection.

Placebo + GSK1437173A _HD Group

Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.

Group Type: PLACEBO_COMPARATOR

Herpes Zoster vaccine GSK1437173A High Dose

Intervention Type: BIOLOGICAL

Single or two-dose intramuscular injection.

Placebo

Intervention Type: BIOLOGICAL

Single intramuscular injection

GSK1437173A_MODIFIED GROUP

Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.

Group Type: ACTIVE_COMPARATOR

Herpes Zoster vaccine GSK1437173A Modified

Intervention Type: BIOLOGICAL

Single or two-dose intramuscular injection.

Interventions

Herpes Zoster vaccine GSK1437173A Low Dose

Single or two-dose intramuscular injection.

Intervention Type: BIOLOGICAL

Herpes Zoster vaccine GSK1437173A Medium Dose

Single or two-dose intramuscular injection.

Intervention Type: BIOLOGICAL

Herpes Zoster vaccine GSK1437173A High Dose

Single or two-dose intramuscular injection.

Intervention Type: BIOLOGICAL

Herpes Zoster vaccine GSK1437173A Modified

Single or two-dose intramuscular injection.

Intervention Type: BIOLOGICAL

Placebo

Single intramuscular injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
• A male or female aged 60 years or older at the time of the first vaccination.
• Written informed consent obtained from the subject

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first injection with study vaccine, or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period, except inhaled and topical steroids are allowed.
• Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks of the first study vaccine injection, with the exception of the influenza vaccine, which can be administered 1 week preceding or 1 month after the first study vaccine injection.
• Previous vaccination against HZ.
• History of herpes zoster (Shingles).
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Acute disease at the time of enrolment.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by subject's medical history or physical examination as assessed by the investigator.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period.
• History of or current drug and/or alcohol abuse.

• Minimum Eligible Age: 60 Years
• 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

Hradec Králové, , Czechia

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Würzburg, Bavaria, Germany

GSK Investigational Site

Hanover, Lower Saxony, Germany

GSK Investigational Site

Cologne, North Rhine-Westphalia, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Amsterdam, , Netherlands

GSK Investigational Site

Rotterdam, , Netherlands

GSK Investigational Site

Eskilstuna, , Sweden

GSK Investigational Site

Uppsala, , Sweden

Countries

Czechia; Germany; Netherlands; Sweden

References

Chlibek R, Smetana J, Pauksens K, Rombo L, Van den Hoek JA, Richardus JH, Plassmann G, Schwarz TF, Ledent E, Heineman TC. Safety and immunogenicity of three different formulations of an adjuvanted varicella-zoster virus subunit candidate vaccine in older adults: a phase II, randomized, controlled study. Vaccine. 2014 Mar 26;32(15):1745-53. doi: 10.1016/j.vaccine.2014.01.019. Epub 2014 Feb 6.

Reference Type: BACKGROUND

PMID: 24508036 (View on PubMed)

Schwarz TF, Volpe S, Catteau G, Chlibek R, David MP, Richardus JH, Lal H, Oostvogels L, Pauksens K, Ravault S, Rombo L, Sonder G, Smetana J, Heineman T, Bastidas A. Persistence of immune response to an adjuvanted varicella-zoster virus subunit vaccine for up to year nine in older adults. Hum Vaccin Immunother. 2018 Jun 3;14(6):1370-1377. doi: 10.1080/21645515.2018.1442162. Epub 2018 Mar 21.

Reference Type: DERIVED

PMID: 29461919 (View on PubMed)

Study Documents

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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

Other Identifiers

108516

Identifier Type: OTHER

Identifier Source: secondary_id

108518

Identifier Type: OTHER

Identifier Source: secondary_id

108520

Identifier Type: OTHER

Identifier Source: secondary_id

2006-004863-69

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

108494

Identifier Type: -

Identifier Source: org_study_id