Healthy volunteers (Prevention of Herpes Zoster [HZ] and related complications in adults = 50 years of age [YOA ] and immunocompromised adults = 18 YOA.) MedDRA version: 17.0 Level: PT Classification code 10019974 Term: Herpes zoster System Organ Class: 10021881 - Infections and infestations MedDRA version: 17.0 Level: HLT Classification code 10019972 Term: Herpes viral infections System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
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: -
Current Sponsor code: gE
Oth
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion 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. 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 486 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 378
Exclusion criteria
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 > or equal 20 mg/day, or equivalent). A prednisone dose of or equal 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the vaccine response rate (VRR) to the HZ/su vaccine (based on humoral immune response) one month after the last vaccine dose in the HZ/su – Pneumovax 23 co-administration (Co-Ad) group. To demonstrate non-inferiority of the humoral immune response to two doses of the HZ/su vaccine when Pneumovax 23 is co-administered with the first HZ/su vaccine dose compared to two doses of HZ/su vaccine (administered separately from Pneumovax 23), one month after the last vaccine dose. To demonstrate non-inferiority of the humoral immune response to Pneumovax 23 when co-administered with HZ/su vaccine at first vaccine dose compared to Pneumovax 23 (administered separately from HZ/su), for the following 12 serotypes included in Pneumovax 23, one month after the vaccine dose: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.;Secondary Objective: To evaluate the safety and reactogenicity following administration of HZ/su and Pneumovax 23 vaccines, up to one month post last vaccination, and during the whole follow-up period.;Timepoint(s) of evaluation of this end point: A. at one month post-dose 2. B. at one month post-dose (Month 1);Primary end point(s): A.HZ/su immunogenicity: -Vaccine response for anti-gE humoral immunogenicity, as determined by ELISA, in subjects from the HZ/su – Pneumovax 23 Co-Ad group. -Anti-gE antibody concentrations as determined by ELISA. B.Pneumococcal vaccine immunogenicity: -Anti-pneumococcal antibody titers for the 12 following serotypes as determined by OPA : 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A.Occurrence of solicited local and general symptoms. -Occurrence, duration and intensity of each solicited local symptom. -Occurrence, duration, intensity and relationship to vaccination of each solicited general symptom. B.Occurrence of unsolicited Adverse Events (AEs). -Occurrence, intensity and relationship to vaccination of unsolicited AEs, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. C.Occurrence of Serious Adverse Events (SAEs). -Occurrence and relationship to vaccination of all SAEs. D.Occurrence of potential Immune Mediated Diseases (pIMDs). -Occurrence and relationship to vaccination of any pIMDs. ;Timepoint(s) of evaluation of this end point: A. within 7 days (Days 0 - 6) after each vaccination B. within 30 days (Days 0 - 29) after each vaccination C. and D. from first vaccination up to study end. | — |
Countries
Canada, Colombia, Estonia, United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed