Table 4.
Laboratory-Confirmed Symptomatic Influenza | Cumulative Incidence of Influenza | Relative Risk (95% CI) | Percent Relative Reduction (95% CI) | ||||||
---|---|---|---|---|---|---|---|---|---|
Inactivated Vaccine (N = 522) | Live Attenuated Vaccine (N = 519) | Placebo (N = 206) | Inactivated Vaccine vs. Placebo | Live Attenuated Vaccine vs. Placebo | Inactivated vs. Live Attenuated Vaccine | Inactivated Vaccine vs. Placebo | Live Attenuated Vaccine vs. Placebo | Inactivated vs. Live Attenuated Vaccine | |
no. of participants (%) | |||||||||
Culture positive | 7 (1.3) | 13 (2.5) | 12 (5.8) | 0.23 (0.08 to 0.63) | 0.43 (0.18 to 1.03) | 0.54 (0.18 to 1.44) | 77 (37 to 92) | 57 (−3 to 82) | 46 (−44 to 82) |
Real-time PCR positive | 10 (1.9) | 18 (3.5) | 15 (7.3) | 0.26 (0.11 to 0.63) | 0.48 (0.23 to 1.02) | 0.55 (0.23 to 1.26) | 74 (37 to 89) | 52 (−2 to 77) | 45 (−26 to 77) |
Culture or real-time PCR positive | 10 (1.9) | 21 (4.0) | 16 (7.8) | 0.25 (0.10 to 0.58) | 0.52 (0.26 to 1.07) | 0.47 (0.20 to 1.05) | 75 (42 to 90) | 48 (−7 to 74) | 53 (−5 to 80) |
Serologic positive† | 6 (1.6) | 20 (5.5) | 11 (7.5) | 0.22 (0.07 to 0.63) | 0.72 (0.33 to 1.67) | 0.30 (0.10 to 0.77) | 78 (37 to 93) | 28 (−67 to 67) | 70 (23 to 90) |
Culture or serologic positive† | 10 (2.7) | 21 (5.8) | 12 (8.2) | 0.33 (0.13 to 0.84) | 0.70 (0.33 to 1.57) | 0.47 (0.20 to 1.04) | 67 (16 to 87) | 30 (−57 to 67) | 53 (−4 to 80) |
Relative reduction in vaccine efficacy was defined as (1 − relative risk) × 100. CI denotes confidence interval, and PCR polymerase chain reaction.
These cases were reported for the per-protocol population, defined as the participants who provided all three annual blood specimens according to the timing specified in the protocol. In this population, 367 participants received the inactivated vaccine, 363 the live attenuated vaccine, and 146 placebo.