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.

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2013-000372-15-DE
• Date of registration: 23/07/2013
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public 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.
• Scientific title: A phase III, randomized, open-label, multicentre clinical trial to assess the immunogenicity and safety of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A when co-administered with GSK Biologicals’ quadrivalent influenza vaccine FLU-D-QIV (GSK2321138A) versus separate administration of the two vaccines in adults aged 50 years and older. - ZOSTER-004
• Date of first enrolment: 02/10/2013
• Target sample size: 828
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000372-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: yes Other trial design description: co-administration If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Separate vaccination schedule Number of treatment arms in the trial: 2

Countries of recruitment

Canada, Germany, United States

Contacts

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

Key inclusion & exclusion 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 465
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 363

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 = to 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Healthy volunteers (Prevention of Herpes Zoster [HZ] and related complications in adults = 50 years of age [YOA ] and immunocompromised adults = 18 YOA.)
MedDRA version: 17.1 Level: PT Classification code 10019974 Term: Herpes zoster System Organ Class: 10021881 - Infections and infestations
MedDRA version: 17.1 Level: HLT Classification code 10019972 Term: Herpes viral infections System Organ Class: 10021881 - Infections and infestations

Intervention(s)

Product Name: Herpes Zoster vaccine GSK1437173A
Product Code: HZ/su or gE/AS01B
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: NA
Current Sponsor code: gE
Other descriptive name: gE antigen
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: Influsplit Tetra/Fluarix Tetra
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: NA
Other descriptive name: ANTIGENS OF THE INFLUENZA VIRUS A/CALIFORNIA/7/2009 (H1N1)-LIKE VIRUS PDM09
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-
INN or Proposed INN: NA
Other descriptive name: ANTIGENS OF THE INFLUENZA VIRUS A/VICTORIA/361/2011 (H3N2)-LIKE VIRUS
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-
INN or Proposed INN: NA
Other descriptive name: B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-
INN or Proposed INN: NA
Other descriptive name: B/BRISBANE/60/2008
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-

Primary Outcome(s)

Primary end point(s): A.HZ/su humoral immunogenicity:
-Vaccine response for anti-gE humoral immunogenicity, as determined by enzyme-linked immunosorbent assay (ELISA), in subjects from the HZ/su-FLU-D-QIV Co-Ad group.
-Anti-gE antibody concentrations as determined by ELISA.
B.FLU-D-QIV humoral immunogenicity:
-Serum HI antibody titres against the four influenza vaccine strains will be used to calculate GMTs.

Timepoint(s) of evaluation of this end point: A. at one month post-dose 2
B. at Day 21.

Main Objective: To evaluate the vaccine response rate (VRR) to the HZ/su vaccine (based on the humoral immune response) one month after the last vaccine dose in the HZ/su-FLU-D-QIV co-administration group.

To demonstrate non-inferiority in terms of humoral immune response of two doses of the HZ/su vaccine when FLU-D-QIV vaccine is co-administered with the first HZ/su vaccine dose compared to two doses of HZ/su vaccine given alone, one month after the last vaccine dose.

To demonstrate non-inferiority (in terms of HI antibody Geometric mean titres(GMTs)) of one dose of FLU-D-QIV vaccine when co-administered with the first HZ/su vaccine dose compared to one dose of FLU-D-QIV vaccine given alone, for the four strains included in FLU-D-QIV vaccine, at Day 21 post vaccination.

Secondary Objective: To demonstrate non-inferiority (in terms of HI antibody SCRs) of one dose of FLU-D-QIV vaccine when co-administered with the first HZ/su vaccine dose compared to one dose of FLU-D-QIV vaccine given alone,for the four strains included in FLU-D-QIV vaccine,at Day 21 post vaccination.

To assess the immunogenicity of FLU-D-QIV vaccine in terms of GMTs, Seroprotection Rate (SPR) at Days 0 and 21 and Seroconversion Rate (SCR) and Mean Geometric Increase (MGI) at Day 21. The assessment of SPR and SCR will be based on CBER’s criteria

To evaluate the safety and reactogenicity following administration of HZ/su and FLU-D-QIV vaccines,up to one month post last vaccination,and during the whole follow-up period.

Secondary Outcome(s)

Secondary end point(s): A.FLU-D-QIV humoral immune response:
Serum HI antibody titres against the four influenza vaccine strains will be used to calculate: Seropositivity rates, GMTs of HI antibody titres, SCR, MGI, SPR.
B.Occurrence of solicited local and general symptoms:
-Occurrence, intensity and duration of each solicited local symptom.
-Occurrence, intensity, duration and relationship to vaccination of each solicited general symptom.
C.Occurrence of unsolicited adverse events:
-Occurrence, intensity and relationship to vaccination of unsolicited AEs.
D.Occurrence of Serious Adverse Events (SAEs):
-Occurrence and relationship to vaccination of all SAEs.
E.Occurrence of potential Immune-Mediated Diseases (pIMDs):
-Occurrence and relationship to vaccination of any pIMDs.

Timepoint(s) of evaluation of this end point: A. SPR, GMT and SPR on Days 0 and 21; SCR and MGI on Day 21
B. within 7 days (Days 0-6) after each vaccination.
C. during 30 days (Days 0-29) after each vaccination.
D. and E.from first vaccination up to study end.

Secondary ID(s)

117036

Source(s) of Monetary Support

GlaxoSmithKline Biologicals