NCT01751165

Brief Summary

The purpose of this study is to assess the safety and immunogenicity of the GSK Biologicals' HZ vaccine 1437173A administered on either a 0,2-; 0,6- or 0,12-month schedule in adults aged 50 years or above, as the immunogenicity of the HZ vaccine administered at intervals longer than two months is not known.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
354

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2013

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

March 12, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2015

Completed
2 years until next milestone

Results Posted

Study results publicly available

March 31, 2017

Completed
Last Updated

October 18, 2018

Status Verified

June 1, 2018

Enrollment Period

1.2 years

First QC Date

December 13, 2012

Results QC Date

November 8, 2016

Last Update Submit

September 20, 2018

Conditions

Herpes Zoster

Keywords

≥ 50 years of ageHerpes zosterSafetyImmunogenicityAdults

Outcome Measures

Primary Outcomes (2)

  • Number of Subjects With Vaccine Response to Anti-glycoprotein E (Anti-gE) Antibodies as Determined by the Enzyme-linked Immunosorbent Assay (ELISA).

    Vaccine response was defined as: for initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. The objective required a comparison of VRR between 0,6-months and 0,12-months schedules.

    At one month (M1) after Dose 2

  • Concentrations of Antibodies Against Anti-gE as Determined by ELISA.

    At one month (M1) after Dose 2

Secondary Outcomes (10)

  • Concentrations of Antibodies Against Anti-gE as Determined by ELISA.

    Prior (PRE) to vaccination and twelve (M12) post Dose 2

  • Number of Subjects With Solicited Local Symptoms.

    During the 7 day period (Days 0-6) following each dose (D)

  • Number of Subjects With Solicited General Symptoms.

    During the 7 day period (Days 0-6) following each dose (D)

  • Number of Subjects With Unsolicited Adverse Events (AEs).

    During the 30 Days (Day 0-29) following vaccination

  • Number of Subjects With Serious Adverse Events (SAEs).

    From first vaccination up to one month (30 Days) post last vaccination

  • +5 more secondary outcomes

Study Arms (3)

HZ/su-0,2 Group

EXPERIMENTAL

Subjects will receive HZ/su vaccine on a 0,2-month schedule.

Biological: Herpes zoster vaccine GSK1437173A

HZ/su-0,6 Group

EXPERIMENTAL

Subjects will receive HZ/su vaccine on a 0,6-month schedule.

Biological: Herpes zoster vaccine GSK1437173A

HZ/su-0,12 Group

EXPERIMENTAL

Subjects will receive HZ/su vaccine on a 0,12-month schedule.

Biological: Herpes zoster vaccine GSK1437173A

Interventions

Herpes zoster vaccine GSK1437173ABIOLOGICAL

2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

HZ/su-0,12 GroupHZ/su-0,2 GroupHZ/su-0,6 Group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • A male or female aged 50 years or older at the time of the first vaccination.
  • Written informed consent obtained from the subject.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:
  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series.

You may not qualify if:

  • Use of any investigational or non-registered product other than the study vaccine 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. For corticosteroids, a prednisone dose of \< 20 mg/day, or equivalent, is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
  • Administration or planned administration of a live vaccine in the period starting 30 days before and ending 30 days after either dose of study vaccine.
  • Administration or planned administration of a non-replicating vaccine within eight days prior to or within 14 days after either dose of study vaccine.
  • Administration of long-acting immune-modifying drugs (e.g. infliximab) within six months prior to the first vaccine dose or expected administration at any time during the study period.
  • Previous vaccination against varicella or HZ (either registered product or participation in a previous vaccine study).
  • Planned administration during the study of an HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
  • History of HZ.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
  • 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) for oral, axillary or tympanic route, or ≥ 38.0°C (100.4°F) for rectal route. The preferred route for recording temperature in this study will be oral.
  • Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
  • Administration of immunoglobulins and/or any blood products within the three 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

GSK Investigational Site

Spring Valley, California, 91978, United States

Location

GSK Investigational Site

Wichita, Kansas, 67207, United States

Location

GSK Investigational Site

Uniontown, Pennsylvania, 15401, United States

Location

GSK Investigational Site

Tartu, 50106, Estonia

Location

Related Publications (1)

  • Lal H, Poder A, Campora L, Geeraerts B, Oostvogels L, Vanden Abeele C, Heineman TC. Immunogenicity, reactogenicity and safety of 2 doses of an adjuvanted herpes zoster subunit vaccine administered 2, 6 or 12 months apart in older adults: Results of a phase III, randomized, open-label, multicenter study. Vaccine. 2018 Jan 2;36(1):148-154. doi: 10.1016/j.vaccine.2017.11.019. Epub 2017 Nov 22.

    PMID: 29174683DERIVED

Related Links

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

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 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2012

First Posted

December 17, 2012

Study Start

March 12, 2013

Primary Completion

May 22, 2014

Study Completion

April 8, 2015

Last Updated

October 18, 2018

Results First Posted

March 31, 2017

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will share

IPD for this study will be made available via the Clinical Study Data Request site.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
More information

Locations

US(3)ES(1)