Trial name or title | 'Open‐label study to evaluate the safety and immunogenicity of GSK Biologicals' herpes zoster vaccine GSK1437173A in adults aged ≥ 50 years' |
Methods | Allocation: randomised Endpoint classification: efficacy study Intervention model: parallel assignment Masking: open‐label Primary purpose: prevention |
Participants | 354 healthy volunteers, 50 years and older, both genders |
Interventions | 1. HZ/su‐0,2 Group. Participants will receive HZ/su vaccine on a 0.2 month schedule 2. HZ/su‐0,6 Group. Participants will receive HZ/su vaccine on a 0.6 month schedule 3. HZ/su‐0,12 Group. Participants will receive HZ/su vaccine on a 0.12 month schedule |
Outcomes | Anti‐gE humoral immunogenicity in terms of antibody concentration, occurrence of solicited local and general symptoms, occurrence of unsolicited symptoms, occurrence of serious adverse events (SAEs), occurrence of AEs of specific interest |
Starting date | March 2013 |
Contact information | Please refer to this study by its ClinicalTrials.gov identifier: NCT01751165 |
Notes | This study is ongoing, but not recruiting participants. No publications provided Secondary ID: EudraCT number 2012‐004456‐11 or Study ID: 116697 |