Clinical trial NCT01954251: Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older
Official title: Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Keywords: FLU-D-QIV
Adults
Safety
Immunogenicity
co-administration
Herpes zoster
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-10-01
Enrollment: 829
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 immunogenicity, reactogenicity and safety of GSK Biologicals' HZ/su vaccine when its first dose is co-administered with the FLU-D-QIV vaccine in adults aged 50 years or older compared to administration of vaccines separately.


Eligibility criteria: Inclusion Criteria:

* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
* 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 (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent). 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) (HZ/su and/or FLU-D-QIV vaccines) and ending 30 days after the last dose of HZ/su vaccine.
* Administration of an influenza vaccine during the six months preceding entry into the study or planned administration up to the last blood sampling with the exception of the FLU-D-QIV vaccine given during this study.
* 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.
* 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 (pharmaceutical product or device).
* Previous vaccination against VZV or HZ and/or planned administration during the study of a VZV or HZ vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
* History of HZ.
* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, HIV infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* History of Guillain Barré syndrome.
* Hypersensitivity to latex.
* 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 on 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 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 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 injection unsafe.

Primary outcomes:
measure: Number of Subjects With Vaccine Response to Anti-gE Antibodies
timeFrame: At one month post-dose 2 (Month 3)
measure: Vaccine Response for Anti-gE Humoral Immunogenicity
timeFrame: At one month post-dose 2 (Month 3)
measure: Adjusted Geometric Mean ELISA Concentrations of Anti-gE Antibodies
timeFrame: At one month post-dose 2 (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group)
measure: FLU Haemagglutination Inhibition (HI) Antibody Titers
timeFrame: At Day 21 post vaccination
Secondary outcomes:
measure: Number of Subjects With FLU HI Antibody Titers ≥1:10
timeFrame: At Day 0 (PRE) and 21 post vaccination
measure: Number of Seroprotected Subjects With HI Antibody Titers ≥ 1:40
timeFrame: At Day 0 (PRE) and at Day 21 post vaccination
measure: FLU Haemagglutination Inhibition (HI) Antibody Titers
timeFrame: At Day 0 (PRE) and Day 21 post vaccination
measure: Number of Seroconverted Subjects in Terms of HI Antibodies
timeFrame: At Day 21 post vaccination
measure: Geometric Mean Ratio for Flu HI Antibodies Post-vaccination Titer
timeFrame: At Day 21 post vaccination
measure: Number of Subjects With Solicited Local Symptoms
timeFrame: Within 7 days (Days 0-6) after each vaccine dose
measure: Number of Subjects With Solicited Local Symptoms
timeFrame: Within 7 days (Days 0-6) across doses
measure: Number of Subjects With Solicited General Symptoms
timeFrame: Within 7 days (Days 0-6) after each vaccine dose
measure: Number of Subjects With Solicited General Symptoms
timeFrame: Within 7 days (Days 0-6) across doses
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During 30 days (Days 0-29) after vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From first vaccination up to Month 18 (study end)
measure: Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
timeFrame: From first vaccination up to Month 18 (study end)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Carnegie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Weinheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Floersheim
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Goch
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Dippoldiswalde
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Freiberg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Freital
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Luebeck
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Schwarz TF, Aggarwal N, Moeckesch B, Schenkenberger I, Claeys C, Douha M, Godeaux O, Grupping K, Heineman TC, Fauqued ML, Oostvogels L, Van den Steen P, Lal H. Immunogenicity and Safety of an Adjuvanted Herpes Zoster Subunit Vaccine Coadministered With Seasonal Influenza Vaccine in Adults Aged 50 Years or Older. J Infect Dis. 2017 Dec 12;216(11):1352-1361. doi: 10.1093/infdis/jix481.