NCT02045836

Brief Summary

The purpose of this study is to assess the immunogenicity, reactogenicity and safety of the GSK Biologicals HZ/su candidate vaccine when its first dose is co-administered with Pneumovax 23™ vaccine in adults aged 50 years or older.The impact of HZ/su vaccine on Pneumovax 23™ vaccine immune response will also be evaluated.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
865

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2014

Geographic Reach
3 countries

9 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

January 23, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

March 5, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2015

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2016

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 5, 2017

Completed
Last Updated

May 14, 2021

Status Verified

April 1, 2021

Enrollment Period

1.3 years

First QC Date

January 23, 2014

Results QC Date

June 6, 2017

Last Update Submit

April 19, 2021

Conditions

Herpes ZosterHerpes Zoster Vaccine

Keywords

Pneumovax 23Co-administrationHerpes zosterImmunogenicitySafetyAdults

Outcome Measures

Primary Outcomes (5)

  • Number of Subjects With a Vaccine Response for Anti-gE Antibodies

    Vaccine response rate for anti-gE antibody concentrations, as determined by enzyme-linked immunosorbent assay (ELISA), in subjects from the Co-Ad group. Vaccine response 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

    At Month 3

  • Anti-glicoprotein E (gE) Antibody Concentrations

    Antibody concentrations were determined by ELISA, presented as geometric mean concentrations and expressed as milli international units per milliliter (mIU/mL).

    At one month post-dose 2 (Month 3 for the Co-Ad Group and Month 5 for the Control Group)

  • Anti-pneumococcal Antibody Titers

    Anti-pneumococcal antibody titers were presented as geometric mean titers (GMTs) for the 12 following serotypes as determined by Opsonophagocytic Assay (OPA): 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.

    At one month post-dose (Month 1)

  • Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups

    The Adjusted ratios of GMTs between groups (Control group and Co-Ad group) were presented for each individual pneumococcal conjugate serotype Opsonophagocytic Activity (OPA).

    At 1 month after vaccination

  • Adjusted GMCs Between Groups

    The Adjusted ratios of GMCs between groups (Control group and Co-Ad group) was presented for anti-gE antibody ELISA concentrations

    At 1 month after last vaccine dose

Secondary Outcomes (9)

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

    Within 7 days (Days 0 - 6) after each vaccination

  • Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine

    Within 7 days (Days 0 - 6) after vaccination

  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.

    During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

  • Number of Days With Any Solicited Local and General Symptoms

    Within 7 days (Days 0 - 6) after each vaccination

  • Number of Subjects With Unsolicited Adverse Events (AEs)

    From the first dose up to 30 days post last vaccination period

  • +4 more secondary outcomes

Study Arms (2)

Co-Ad Group

EXPERIMENTAL

Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.

Biological: Herpes Zoster vaccine GSK 1437173ABiological: Licensed pneumococcal polysaccharide conjugate vaccine (23-valent, adsorbed), Pneumovax 23™

Control Group

ACTIVE COMPARATOR

Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.

Biological: Herpes Zoster vaccine GSK 1437173ABiological: Licensed pneumococcal polysaccharide conjugate vaccine (23-valent, adsorbed), Pneumovax 23™

Interventions

Herpes Zoster vaccine GSK 1437173ABIOLOGICAL

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

Co-Ad GroupControl Group
Licensed pneumococcal polysaccharide conjugate vaccine (23-valent, adsorbed), Pneumovax 23™BIOLOGICAL

One dose administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Also known as: Pneumo 23™
Co-Ad GroupControl 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 with the study vaccine(s).
  • 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 2 months after completion of the vaccination series.

You may not qualify if:

  • Use of any investigational or non-registered product other than the study vaccines 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. A prednisone dose of \< 20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
  • Administration or planned administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine(s) and ending 30 days after the last dose of study vaccine. This includes any type of vaccine such as live, inactivated and subunit vaccines.
  • Administration of long-acting immune-modifying drugs within six months prior to the first vaccine dose or expected administration at any time during the study period.
  • Concurrently participating 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 vaccine/product.
  • Previous vaccination against Varicella-zoster virus (VZV) or HZ and/or planned administration during the study of an HZ or VZV vaccine other than the study vaccine.
  • History of HZ.
  • History of documented pneumococcal infection within 5 previous years.
  • Prior receipt of any pneumococcal vaccine or planned use of this vaccine during the study period, other than the study vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy .
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
  • Acute disease and/or fever at the time of enrolment.
  • Fever is defined as temperature ≥ 37.5°C /99.5°F by oral route. The preferred 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 within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

GSK Investigational Site

Golden, Colorado, 80401, United States

Location

GSK Investigational Site

Wichita, Kansas, 67207, United States

Location

GSK Investigational Site

Columbia, Maryland, 21045, United States

Location

GSK Investigational Site

Coquitlam, British Columbia, V3K 3P4, Canada

Location

GSK Investigational Site

Truro, Nova Scotia, B2N 1L2, Canada

Location

GSK Investigational Site

Greater Sudbury, Ontario, P3E 1H5, Canada

Location

GSK Investigational Site

Tallinn, 10117, Estonia

Location

GSK Investigational Site

Tallinn, 13619, Estonia

Location

GSK Investigational Site

Tartu, 50106, Estonia

Location

Related Publications (1)

  • Marechal C, Lal H, Poder A, Ferguson M, Enweonye I, Heineman TC, Herve C, Rheault P, Talli J, Wauters D, Oostvogels L. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine co-administered with the 23-valent pneumococcal polysaccharide vaccine in adults >/=50 years of age: A randomized trial. Vaccine. 2018 Jul 5;36(29):4278-4286. doi: 10.1016/j.vaccine.2018.05.110. Epub 2018 Jun 11.

    PMID: 29903674BACKGROUND

MeSH Terms

Conditions

Herpes Zoster

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

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

January 23, 2014

First Posted

January 27, 2014

Study Start

March 5, 2014

Primary Completion

July 2, 2015

Study Completion

June 17, 2016

Last Updated

May 14, 2021

Results First Posted

July 5, 2017

Record last verified: 2021-04

Locations

ES(3)US(3)CA(3)