Seroconversion and Seroprotection Rates for Influenza Strains (Per-protocol Set for Flu Analysis)
| Influenza Strain . | Timepoint . | Co-Ad . | Control . | Differencea % (95% CI) . | ||||
|---|---|---|---|---|---|---|---|---|
| N . | n . | % (95% CI) . | N . | n . | % (95% CI) . | |||
| Hemagglutination assay | ||||||||
| Seroconversion rates | ||||||||
| A/Darwin (H3N2) | Post | 429 | 222 | 51.7 (46.9, 56.6) | 400 | 248 | 62.0 (57.0, 66.8) | 10.25 (3.50, 16.90) |
| A/Victoria (H1N1) | Post | 420 | 185 | 44.0 (39.2, 48.9) | 396 | 181 | 45.7 (40.7, 50.8) | 1.66 (−5.16, 8.47) |
| B/Victoria | Post | 429 | 74 | 17.2 (13.8, 21.2) | 400 | 70 | 17.5 (13.9, 21.6) | 0.25 (−4.92, 5.46) |
| B/Yamagata | Post | 428 | 79 | 18.5 (14.9, 22.5) | 400 | 77 | 19.3 (15.5, 23.5) | 0.79 (−4.54, 6.17) |
| Seroprotection rates | ||||||||
| A/Darwin (H3N2) | Pre | 469 | 49 | 10.4 (7.8, 13.6) | 449 | 48 | 10.7 (8.0, 13.9) | NA |
| Post | 442 | 281 | 63.6 (58.9, 68.1) | 400 | 284 | 71.0 (66.3, 75.4) | NA | |
| A/Victoria (H1N1) | Pre | 460 | 276 | 60.0 (55.4, 64.5) | 446 | 287 | 64.3 (59.7, 68.8) | NA |
| Post | 440 | 405 | 92.0 (89.1, 94.4) | 399 | 380 | 95.2 (92.7, 97.1) | NA | |
| B/Victoria | Pre | 469 | 467 | 99.6 (98.5, 99.9) | 449 | 449 | 100 (99.2, 100) | NA |
| Post | 442 | 442 | 100 (99.2, 100) | 400 | 400 | 100 (99.1, 100) | NA | |
| B/Yamagata | Pre | 468 | 467 | 99.8 (98.8, 100) | 449 | 444 | 98.9 (97.4, 99.6) | NA |
| Post | 442 | 442 | 100 (99.2, 100) | 400 | 400 | 100 (99.1, 100) | NA | |
| Microneutralization assay (post-hoc) | ||||||||
| Seroconversion rates | ||||||||
| A/Darwin (H3N2) | Post | 428 | 187 | 43.7 (38.9, 48.5) | 398 | 193 | 48.5 (43.5, 53.5) | 4.80 (−2.00, 11.57) |
| Seroprotection rates | ||||||||
| A/Darwin (H3N2) | Pre | 469 | 359 | 76.5 (72.4, 80.3) | 448 | 352 | 78.6 (74.5, 82.3) | NA |
| Post | 441 | 425 | 96.4 (94.2, 97.9) | 399 | 388 | 97.2 (95.1, 98.6) | NA | |
| Influenza Strain . | Timepoint . | Co-Ad . | Control . | Differencea % (95% CI) . | ||||
|---|---|---|---|---|---|---|---|---|
| N . | n . | % (95% CI) . | N . | n . | % (95% CI) . | |||
| Hemagglutination assay | ||||||||
| Seroconversion rates | ||||||||
| A/Darwin (H3N2) | Post | 429 | 222 | 51.7 (46.9, 56.6) | 400 | 248 | 62.0 (57.0, 66.8) | 10.25 (3.50, 16.90) |
| A/Victoria (H1N1) | Post | 420 | 185 | 44.0 (39.2, 48.9) | 396 | 181 | 45.7 (40.7, 50.8) | 1.66 (−5.16, 8.47) |
| B/Victoria | Post | 429 | 74 | 17.2 (13.8, 21.2) | 400 | 70 | 17.5 (13.9, 21.6) | 0.25 (−4.92, 5.46) |
| B/Yamagata | Post | 428 | 79 | 18.5 (14.9, 22.5) | 400 | 77 | 19.3 (15.5, 23.5) | 0.79 (−4.54, 6.17) |
| Seroprotection rates | ||||||||
| A/Darwin (H3N2) | Pre | 469 | 49 | 10.4 (7.8, 13.6) | 449 | 48 | 10.7 (8.0, 13.9) | NA |
| Post | 442 | 281 | 63.6 (58.9, 68.1) | 400 | 284 | 71.0 (66.3, 75.4) | NA | |
| A/Victoria (H1N1) | Pre | 460 | 276 | 60.0 (55.4, 64.5) | 446 | 287 | 64.3 (59.7, 68.8) | NA |
| Post | 440 | 405 | 92.0 (89.1, 94.4) | 399 | 380 | 95.2 (92.7, 97.1) | NA | |
| B/Victoria | Pre | 469 | 467 | 99.6 (98.5, 99.9) | 449 | 449 | 100 (99.2, 100) | NA |
| Post | 442 | 442 | 100 (99.2, 100) | 400 | 400 | 100 (99.1, 100) | NA | |
| B/Yamagata | Pre | 468 | 467 | 99.8 (98.8, 100) | 449 | 444 | 98.9 (97.4, 99.6) | NA |
| Post | 442 | 442 | 100 (99.2, 100) | 400 | 400 | 100 (99.1, 100) | NA | |
| Microneutralization assay (post-hoc) | ||||||||
| Seroconversion rates | ||||||||
| A/Darwin (H3N2) | Post | 428 | 187 | 43.7 (38.9, 48.5) | 398 | 193 | 48.5 (43.5, 53.5) | 4.80 (−2.00, 11.57) |
| Seroprotection rates | ||||||||
| A/Darwin (H3N2) | Pre | 469 | 359 | 76.5 (72.4, 80.3) | 448 | 352 | 78.6 (74.5, 82.3) | NA |
| Post | 441 | 425 | 96.4 (94.2, 97.9) | 399 | 388 | 97.2 (95.1, 98.6) | NA | |
Seroconversion rate was defined as the percentage of participants with a hemagglutination inhibition or microneutralization pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and a ≥ 4-fold increase in post-vaccination titer. Seroprotection rate was defined as the percentage of participants with a hemagglutination inhibition or microneutralization titer ≥1:40.
Abbreviations: CI, confidence interval; Co-Ad, group of participants who received RSVPreF3 OA and FLU-aQIV concomitantly on day 1; Control, group of participants who received FLU-aQIV on day 1 and RSVPreF3 OA on day 31; FLU-aQIV, adjuvanted inactivated seasonal quadrivalent influenza vaccine; N, for seroconversion rates: number of participants with both pre- (day 1) and post-FLU-aQIV vaccination (day 31) results available; for seroprotection rates: number of participants with results available at the indicated timepoint; NA, not assessed; n/%, number/percentage of participants who seroconverted or were seroprotected; pre, before FLU-aQIV vaccination (day 1); post, 1 month after FLU-aQIV vaccination (day 31); RSVPreF3 OA, respiratory syncytial virus (RSV) prefusion F protein-based vaccine.
aReference criterion for non-inferiority of co-administration versus sequential administration (descriptive secondary endpoint for hemagglutination inhibition, post-hoc exploratory analysis for microneutralization): upper limit of the 2-sided 95% CI for the difference in seroconversion rates (Control minus Co-Ad) was ≤10% at 1 m post-FLU-aQIV vaccination (ie, day 31 for both groups).
Seroconversion and Seroprotection Rates for Influenza Strains (Per-protocol Set for Flu Analysis)
| Influenza Strain . | Timepoint . | Co-Ad . | Control . | Differencea % (95% CI) . | ||||
|---|---|---|---|---|---|---|---|---|
| N . | n . | % (95% CI) . | N . | n . | % (95% CI) . | |||
| Hemagglutination assay | ||||||||
| Seroconversion rates | ||||||||
| A/Darwin (H3N2) | Post | 429 | 222 | 51.7 (46.9, 56.6) | 400 | 248 | 62.0 (57.0, 66.8) | 10.25 (3.50, 16.90) |
| A/Victoria (H1N1) | Post | 420 | 185 | 44.0 (39.2, 48.9) | 396 | 181 | 45.7 (40.7, 50.8) | 1.66 (−5.16, 8.47) |
| B/Victoria | Post | 429 | 74 | 17.2 (13.8, 21.2) | 400 | 70 | 17.5 (13.9, 21.6) | 0.25 (−4.92, 5.46) |
| B/Yamagata | Post | 428 | 79 | 18.5 (14.9, 22.5) | 400 | 77 | 19.3 (15.5, 23.5) | 0.79 (−4.54, 6.17) |
| Seroprotection rates | ||||||||
| A/Darwin (H3N2) | Pre | 469 | 49 | 10.4 (7.8, 13.6) | 449 | 48 | 10.7 (8.0, 13.9) | NA |
| Post | 442 | 281 | 63.6 (58.9, 68.1) | 400 | 284 | 71.0 (66.3, 75.4) | NA | |
| A/Victoria (H1N1) | Pre | 460 | 276 | 60.0 (55.4, 64.5) | 446 | 287 | 64.3 (59.7, 68.8) | NA |
| Post | 440 | 405 | 92.0 (89.1, 94.4) | 399 | 380 | 95.2 (92.7, 97.1) | NA | |
| B/Victoria | Pre | 469 | 467 | 99.6 (98.5, 99.9) | 449 | 449 | 100 (99.2, 100) | NA |
| Post | 442 | 442 | 100 (99.2, 100) | 400 | 400 | 100 (99.1, 100) | NA | |
| B/Yamagata | Pre | 468 | 467 | 99.8 (98.8, 100) | 449 | 444 | 98.9 (97.4, 99.6) | NA |
| Post | 442 | 442 | 100 (99.2, 100) | 400 | 400 | 100 (99.1, 100) | NA | |
| Microneutralization assay (post-hoc) | ||||||||
| Seroconversion rates | ||||||||
| A/Darwin (H3N2) | Post | 428 | 187 | 43.7 (38.9, 48.5) | 398 | 193 | 48.5 (43.5, 53.5) | 4.80 (−2.00, 11.57) |
| Seroprotection rates | ||||||||
| A/Darwin (H3N2) | Pre | 469 | 359 | 76.5 (72.4, 80.3) | 448 | 352 | 78.6 (74.5, 82.3) | NA |
| Post | 441 | 425 | 96.4 (94.2, 97.9) | 399 | 388 | 97.2 (95.1, 98.6) | NA | |
| Influenza Strain . | Timepoint . | Co-Ad . | Control . | Differencea % (95% CI) . | ||||
|---|---|---|---|---|---|---|---|---|
| N . | n . | % (95% CI) . | N . | n . | % (95% CI) . | |||
| Hemagglutination assay | ||||||||
| Seroconversion rates | ||||||||
| A/Darwin (H3N2) | Post | 429 | 222 | 51.7 (46.9, 56.6) | 400 | 248 | 62.0 (57.0, 66.8) | 10.25 (3.50, 16.90) |
| A/Victoria (H1N1) | Post | 420 | 185 | 44.0 (39.2, 48.9) | 396 | 181 | 45.7 (40.7, 50.8) | 1.66 (−5.16, 8.47) |
| B/Victoria | Post | 429 | 74 | 17.2 (13.8, 21.2) | 400 | 70 | 17.5 (13.9, 21.6) | 0.25 (−4.92, 5.46) |
| B/Yamagata | Post | 428 | 79 | 18.5 (14.9, 22.5) | 400 | 77 | 19.3 (15.5, 23.5) | 0.79 (−4.54, 6.17) |
| Seroprotection rates | ||||||||
| A/Darwin (H3N2) | Pre | 469 | 49 | 10.4 (7.8, 13.6) | 449 | 48 | 10.7 (8.0, 13.9) | NA |
| Post | 442 | 281 | 63.6 (58.9, 68.1) | 400 | 284 | 71.0 (66.3, 75.4) | NA | |
| A/Victoria (H1N1) | Pre | 460 | 276 | 60.0 (55.4, 64.5) | 446 | 287 | 64.3 (59.7, 68.8) | NA |
| Post | 440 | 405 | 92.0 (89.1, 94.4) | 399 | 380 | 95.2 (92.7, 97.1) | NA | |
| B/Victoria | Pre | 469 | 467 | 99.6 (98.5, 99.9) | 449 | 449 | 100 (99.2, 100) | NA |
| Post | 442 | 442 | 100 (99.2, 100) | 400 | 400 | 100 (99.1, 100) | NA | |
| B/Yamagata | Pre | 468 | 467 | 99.8 (98.8, 100) | 449 | 444 | 98.9 (97.4, 99.6) | NA |
| Post | 442 | 442 | 100 (99.2, 100) | 400 | 400 | 100 (99.1, 100) | NA | |
| Microneutralization assay (post-hoc) | ||||||||
| Seroconversion rates | ||||||||
| A/Darwin (H3N2) | Post | 428 | 187 | 43.7 (38.9, 48.5) | 398 | 193 | 48.5 (43.5, 53.5) | 4.80 (−2.00, 11.57) |
| Seroprotection rates | ||||||||
| A/Darwin (H3N2) | Pre | 469 | 359 | 76.5 (72.4, 80.3) | 448 | 352 | 78.6 (74.5, 82.3) | NA |
| Post | 441 | 425 | 96.4 (94.2, 97.9) | 399 | 388 | 97.2 (95.1, 98.6) | NA | |
Seroconversion rate was defined as the percentage of participants with a hemagglutination inhibition or microneutralization pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and a ≥ 4-fold increase in post-vaccination titer. Seroprotection rate was defined as the percentage of participants with a hemagglutination inhibition or microneutralization titer ≥1:40.
Abbreviations: CI, confidence interval; Co-Ad, group of participants who received RSVPreF3 OA and FLU-aQIV concomitantly on day 1; Control, group of participants who received FLU-aQIV on day 1 and RSVPreF3 OA on day 31; FLU-aQIV, adjuvanted inactivated seasonal quadrivalent influenza vaccine; N, for seroconversion rates: number of participants with both pre- (day 1) and post-FLU-aQIV vaccination (day 31) results available; for seroprotection rates: number of participants with results available at the indicated timepoint; NA, not assessed; n/%, number/percentage of participants who seroconverted or were seroprotected; pre, before FLU-aQIV vaccination (day 1); post, 1 month after FLU-aQIV vaccination (day 31); RSVPreF3 OA, respiratory syncytial virus (RSV) prefusion F protein-based vaccine.
aReference criterion for non-inferiority of co-administration versus sequential administration (descriptive secondary endpoint for hemagglutination inhibition, post-hoc exploratory analysis for microneutralization): upper limit of the 2-sided 95% CI for the difference in seroconversion rates (Control minus Co-Ad) was ≤10% at 1 m post-FLU-aQIV vaccination (ie, day 31 for both groups).
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