Last updated: 04/20/2021 12:10:19

Study to evaluate immunogenicity and safety study of GSK Biologicals’ Herpes Zoster (HZ) vaccine GSK1437173A when co-administered with Pneumovax 23™ in adults aged 50 years and older

GSK study ID
116889
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Immunogenicity and safety study of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A when co-administered with Pneumovax 23™ in adults aged 50 years and older
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Number of subjects with a vaccine response for anti-gE antibodies

Timeframe: At Month 3

Anti-glicoprotein E (gE) antibody concentrations

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

Anti-pneumococcal antibody titers

Timeframe: At one month post-dose (Month 1)

Adjusted ratios of Geometric Mean Titers (GMTs) between groups

Timeframe: At 1 month after vaccination

Adjusted GMCs between groups

Timeframe: At 1 month after last vaccine dose

Secondary outcomes:

Number of subjects with any and Grade 3 solicited local symptoms, by dose

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

Number of subjects with solicited local symptoms, across doses, by vaccine

Timeframe: Within 7 days (Days 0 - 6) after vaccination

Number of subjects with any, Grade 3 and related solicited general symptoms.

Timeframe: 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

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

Number of subjects with unsolicited adverse events (AEs)

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

Number of subjects with serious adverse events (SAEs) [from the first dose up to 30 days post last vaccination period]

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

Number of subjects with serious adverse events (SAEs) [from 30 days post last vaccination up to study end]

Timeframe: From 30 days post last vaccination up to study end

Number of subjects with potential Immune Mediated Diseases (pIMDs) [from first vaccination up to 30 days post last vaccination]

Timeframe: From first vaccination up to 30 days post last vaccination (Month 0 – Month 3 for the Co-Ad Group & Month 0 – Month 5 for the Control Group)

Number of subjects with potential Immune Mediated Diseases (pIMDs) [during the period starting after 30 days post last vaccination up to study end]

Timeframe: During the period starting after 30 days post last vaccination up to study end (Month 3 – Month 14 for the Co-Ad Group & Month 5 – Month 16 for the Control Group)

Interventions:
Biological/vaccine: Herpes Zoster vaccine GSK 1437173A
Biological/vaccine: Licensed pneumococcal polysaccharide conjugate vaccine (23-valent, adsorbed), Pneumovax 23™
Enrollment:
865
Observational study model:
Not applicable
Primary completion date:
2015-02-07
Time perspective:
Not applicable
Clinical publications:
Maréchal C et al. (2018) 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. 36(29):4278-4286.
Medical condition
Herpes Zoster
Product
GSK1437173A
Collaborators
Not applicable
Study date(s)
March 2014 to June 2016
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
Yes
  • 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).
  • 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.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Columbia, Maryland, United States, 21045
Status
Study Complete
Location
GSK Investigational Site
Coquitlam, British Columbia, Canada, V3K 3P4
Status
Study Complete
Location
GSK Investigational Site
Golden, Colorado, United States, 80401
Status
Study Complete
Location
GSK Investigational Site
Sudbury, Ontario, Canada, P3E 1H5
Status
Study Complete
Location
GSK Investigational Site
Tallinn, Estonia, 10117
Status
Study Complete
Location
GSK Investigational Site
Tallinn, Estonia, 13619
Status
Study Complete
Location
GSK Investigational Site
Tartu, Estonia, 50106
Status
Study Complete
Location
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Status
Study Complete
Location
GSK Investigational Site
Wichita, Kansas, United States, 67207
Status
Study Complete

Study documents

Protocol
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2015-02-07
Actual study completion date
2016-17-06

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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