Vaccination against HZ and its related complications in adults older than 50 years MedDRA version: 14.1 Level: PT Classification code 10019974 Term: Herpes zoster System Organ Class: 10021881 - Infections and infestations
Conditions
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. - 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 two 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 230 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 124
Exclusion criteria
Exclusion criteria: - Use of any investigational or non-registered product other than the study vaccine 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. For corticosteroids, a prednisone dose of < 20 mg/day, or equivalent, is allowed. Inhaled, topical and intra-articular corticosteroids are allowed. - Administration or planned administration of a live vaccine in the period starting 30 days before and ending 30 days after either dose of study vaccine. - Administration or planned administration of a non-replicating vaccine within eight days prior to or within 14 days after either dose of study vaccine. - 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. - Previous vaccination against varicella or HZ (either registered product or participation in a previous vaccine study). - Planned administration during the study of an HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine. - History of HZ. - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). - Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g. malignancy, human immunodeficiency virus [HIV] infection) or immunosuppressive/cytotoxic therapy (e.g. medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders). - 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) for 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 three months preceding the first dose of study vaccine or planned administration during the study period. - Significant underlying illness that, in the opinion of the investigator, would be expected to prevent completion of the study. - Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study. - Pregnant or lactating female. - Female planning to become pregnant during the entire treatment period and for two months after completion of the vaccination series, or planning to discontinue contraceptive precautions (if of childbearing potential).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To evaluate vaccine response rate (VRR) for anti-glyoprotein E (gE) humoral immune responses at one 1 month (mth) post-dose 2 (PD2) in the 0,6-mth and 0,12-mth schedule groups. *Criterion:The lower limit of the 97,5% confidence interval (CI) of the VRR for anti-gE ELISA antibody concentrations at 1 mth PD2 in the 0,6-mth or 0,12-mth schedule groups is at least 60% If the objectives are met for the 0,6-mth and 0,12-mth schedules, the following objective will be evaluated: -Non-inferiority in terms of anti-gE humoral immune response 1 mth PD2 given according to a 0,6-mth schedule compared to a 0,2-mth schedule and a 0,12-mth schedule compared to a 0,2-mth schedule Criteria for non-inferiority: *The upper limit of the 97,5% CI for the anti-gE ELISA geometric mean concentration (GMC) ratio (0,2-mth schedule over 0,6-mth schedule) at 1 mth PD2 is <1.5 *The upper limit of the 97,5% CI for the anti-gE ELISA GMC ratio (0,2-mth schedule over 0,12-mth schedule) at 1 mth PD2 is <1.5;Primary end point(s): - Anti-gE humoral immunogenicity in terms of antibody concentration: *Vaccine response for anti-gE humoral immunogenicity, as determined by ELISA *Anti-gE antibody concentrations, as determined by ELISA in all subjects The VRR for anti-gE is defined as the percentage of subjects who have at least: *a 4-fold increase in the anti-gE antibodies concentration as compared to the pre vaccination anti-gE antibodies concentration, for subjects who are seropositive at baseline, or *a 4-fold increase in the anti-gE antibodies concentration as compared to the anti gE antibodies cut-off value for seropositivity for subjects who are seronegative at baseline.;Secondary Objective: - To characterise anti-gE humoral immune responses for all study groups at all sampling time points. - To evaluate the safety and reactogenicity following administration of HZ/su vaccine up to one month post last vaccination, and during the whole follow-up period. ;Timepoint(s) of evaluation of | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Anti-gE humoral immunogenecity in terms of antibody concentrations: *Anti-gE antibody concentrations as determined by ELISA in all subjects - 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 - Occurrence of unsolicited symptoms: *Occurrence, intensity and relationship to vaccination of unsolicited AEs according to the Medical Dictionary for Regulatory Activities (MedDRA) classification - Occurrence of serious adverse events (SAEs): *Occurrence and relationship to vaccination of all SAEs - Occurrence of AEs of specific interest: *Occurrence of any potential immune mediated diseases (pIMDs);Timepoint(s) of evaluation of this end point: - Anti-gE humoral immunogenecity in terms of antibody concentrations: at Month 0, 3, 7, 13, 14, 18, 24 (depending on group) - Solicited symptoms: within 7 days (Days 0 to 6) after each vaccination - Unsolicited symptoms: during 30 days (Days 0 to 29) after each vaccination - SAEs: from first vaccination until study end (Month 14, 18 and 24, depending on group) - AEs of specific interest: from first vaccination until study end (Month 14, 18 and 24, depending on group) | — |
Countries
Estonia, United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed