None listed
Conditions
Interventions
Intervention1: GlaxoSmithKline Biologicals SA (GSK) lyophilized
formulation of the Herpes Zoster subunit vaccine
(HZ/su) (GSK1437173A): VZV gE - VZV gE(50micrograms) Powder for suspension for injectio
Sponsors
GlaxoSmithKline Biologicals SA GSK Rue de lInstitut Rixensart
Eligibility
Inclusion criteria
Inclusion criteria: All participants must satisfy ALL the following criteria at study entry 1 Participants and/or participants LAR 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) 2 A male or female aged 50 YOA or older at the time of the first study intervention 3 Healthy participants or medically stable patients as established by medical history and clinical examination before entering into the study 4 Female participants of non-childbearing potential may be enrolled in the study 5 Written or witnessed/thumb printed informed consent obtained from the participant and/or participants LAR(s) after the study has been explained according to local regulatory requirements and prior to performance of any study-specific procedure 6 Female participants of childbearing potential may be enrolled in the study if the participant- - has practiced adequate contraception for 1 month prior to study intervention administration and - has a negative pregnancy test on the day of study intervention administration and - has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study intervention administration series
Exclusion criteria
Exclusion criteria: The following criteria should be checked at the time of study entry. The potential participant MAY NOT be included in the study if ANY exclusion criterion applies 1 MEDICAL CONDITIONS Any other clinical condition that in the opinion of the investigator might pose additional risk to the participant due to participation in the study. • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s) or study materials or equipment. • Acute or chronic clinically significant pulmonary cardiovascular hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory screening tests. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). • History of HZ. • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g. life-threatening disease likely to limit survival to less than 4 years). 2 PRIOR CONCOMITANT THERAPY Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before first dose and ending 30 days after the last dose of study intervention administration with the exception of licensed pneumococcal vaccines and non-replicating vaccines (i.e. inactivated and subunit vaccines including inactivated and subunit influenza vaccines, with or without adjuvant for seasonal or pandemic flu) may be administered up until 8 days prior to Dose 1 and/or Dose 2 and/or at least 14 days after any dose of study intervention. • In case an emergency mass vaccination for an unforeseen public health threat (e.g. a pandemic) is recommended and/or organized by the public health authorities, outside the routine immunization programme, the time period described above can be reduced if necessary for that vaccine provided it is used according to local governmental recommendations and that the Sponsor is notified accordingly. • Planned administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab). • Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study intervention up to 1-month post-dose 2 (Month 3) or planned administration during the study period. • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose. For corticosteroids, this will mean prednisone equivalent or greater than 20 mg/day or equivalent is not allowed. Inhaled intra- articular and topical steroids are allowed. • Previous vaccination against varicella or HZ. 3 PRIOR/CONCURRENT CLINICAL STUDY EXPERIENCE Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non- investigational intervention (drug/invasive medical device). 4 OTHER EXC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the vaccine response rate (VRR) for anti-gE humoral immune response at 1-month post dose 2 (Month 3) of administration of HZ/suTimepoint: To determine the vaccine response rate (VRR) for anti-gE humoral immune response at 1-month post dose 2 (Month 3) of administration of HZ/su | — |
Secondary
| Measure | Time frame |
|---|---|
| To characterise anti-gE humoral immunogenicity response prior to the first study intervention administration (Day 1) and at 1-month post-second study intervention administration (Month 3) in both groups.Timepoint: Anti-gE antibody geometric mean concentrations (GMC) and seropositivity rate at pre-study intervention administration (Day 1) and 1-month post-dose 2 (Month 3). Mean geometric increase (MGI) at 1-month post- dose 2 (Month 3) compared to pre-study intervention administration (Day 1).;To evaluate safety and reactogenicity following administration of HZ/su or placebo from first dose up to 30 days post last dose.Timepoint: Solicited AEs: Number and percentage of participants reporting each solicited administration site and solicited systemic AEs within 7 days (Day 1 to Day 7) after each dose and overall. Unsolicited AEs: Number and percentage of participants reporting unsolicited AEs within 30 days (Day 1 to Day 30)after any dose. SAEs and pIMDs: No and percentage of participants reporting SAEs from Dose 1 (Day 1) up to 30 days post last dose. ;To evaluate safety following administration of HZ/su or placebo during the entire study period.Timepoint: SAE- Number and percentage of participants reporting SAEs from Dose 1 (Day 1) up to study end (phone contact Month 8). pIMDs- The number and percentage of participants reporting pIMDs from Dose 1 (Day 1) up to study end (phone contact Month 8).;To evaluate the anti-gE humoral response at 1- month post-dose 2 (Month 3) in recipients of HZ/su compared to PlaceboTimepoint: Anti-gE antibody concentration expressed as group geometric mean concentration (GMC) ratio at 1-month postdose 2 (Month 3). | — |
Countries
India
Contacts
Public ContactSwapnali A Raut
GlaxoSmithKline Pharmaceuticals Ltd
Outcome results
None listed