Clinical trial NCT02045836: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Herpes Zoster Vaccine
Keywords: Pneumovax 23
Co-administration
Herpes zoster
Immunogenicity
Safety
Adults
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-01-27
Enrollment: 865
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions before 2 months after the last dose of study vaccine.
* Any persons with cerebrospinal fluid (CSF) leaks, cochlear implants, chronic renal failure, nephrotic syndrome, and functional or anatomic asplenia.
* Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
* Any condition which, in the judgment of the investigator, would make intramuscular (IM) injection unsafe.

Primary outcomes:
measure: Number of Subjects With a Vaccine Response for Anti-gE Antibodies
timeFrame: At Month 3
measure: 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)
measure: Anti-pneumococcal Antibody Titers
timeFrame: At one month post-dose (Month 1)
measure: Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups
timeFrame: At 1 month after vaccination
measure: Adjusted GMCs Between Groups
timeFrame: At 1 month after last vaccine dose
Secondary outcomes:
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
timeFrame: Within 7 days (Days 0 - 6) after each vaccination
measure: Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine
timeFrame: Within 7 days (Days 0 - 6) after vaccination
measure: 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
measure: Number of Days With Any Solicited Local and General Symptoms
timeFrame: Within 7 days (Days 0 - 6) after each vaccination
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: From the first dose up to 30 days post last vaccination period
measure: 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
measure: 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
measure: 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)
measure: 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)
Other outcomes:
Locations:
city: Golden
country: United States
facility: GSK Investigational Site
state: Colorado
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Columbia
country: United States
facility: GSK Investigational Site
state: Maryland
city: Coquitlam
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Truro
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Sudbury
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.