Table 2.
RZV group |
Placebo group |
VE |
||||||||
---|---|---|---|---|---|---|---|---|---|---|
Type | N | n | T (years) | IR (per 1000 person-years) | N | n | T (years) | IR (per 1000 person-years) | % (95% CI) | p-value |
Overall* | 2965 | 0 | 3752.3 | 0.0 | 2991 | 31 | 3769.0 | 8.2 | 100 (89.82–100) | <.0001 |
50–69 years | 2330 | 0 | 2957.0 | 0.0 | 2360 | 22 | 2981.8 | 7.4 | 100 (85.29–100) | |
≥ 70 years | 635 | 0 | 795.2 | 0.0 | 631 | 9 | 787.2 | 11.4 | 100 (60.90–100) |
*VE adjusted by age strata.
Note: the follow-up for each participant started (start date) 30 days after the second dose was administered and ended (stop date) at the time a herpes zoster episode was confirmed for the participant. For those participants without a confirmed herpes zoster episode, the follow-up ended at the last visit; at the last contact date for participants who withdrew from the study and did not have a confirmed herpes zoster episode; or on the date of the herpes zoster and/or varicella zoster virus vaccination that occurred outside of the study, if not preceded by an event.
T (years) is the sum of follow-up time at risk expressed in years for confirmed herpes zoster of all participants in the modified exposed set. The follow-up time at risk for confirmed herpes zoster per participant, expressed in days, is computed using the following formula: .
RZV group, participants receiving the adjuvanted recombinant zoster vaccine; placebo group, participants receiving placebo; VE, vaccine efficacy; N, number of participants included in each group; n, number of participants having at least one confirmed herpes zoster episode; T, sum of follow-up period; IR, incidence rate; CI, confidence interval.