Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Herpes Zoster subunit vaccine · 1 trial · 1 indication
A suspected case of HZ is defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ was confirmed by an algorithm that included Polymerase Chain Reaction (PCR) and the HZ Ascertainment Committee (HZAC) determination. The incidence rate (n/T) of confirmed HZ cases, expressed in terms of 1000 person-years rate, was calculated as the number of participants reporting at least one confirmed HZ case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 1000.
| Arm | Type | Description |
|---|---|---|
| HZ/su Group | EXPERIMENTAL | Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2. |
| Placebo Group | PLACEBO_COMPARATOR | Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2. |
| Name | Type | Description |
|---|---|---|
| Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A) | BIOLOGICAL | 2 doses of HZ/su vaccine were administered intramuscularly according to a 0,2 months vaccination schedule, at Day 1 and Month 2. |
| Placebo | DRUG | 2 doses of Placebo were administered intramuscularly according to a 0,2 months vaccination schedule, at Day 1 and Month 2. |
Inclusion Criteria: * Subjects and/or subject's LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol * Written informed consent obtained from the subject/subject's LAR(s) prior to performance of any study specific procedure. * A male or female ≥ ...