| Adverse Event . | Co-Ad N = 523 . | Control N = 522 . | ||
|---|---|---|---|---|
| n . | % (95% CI) . | n . | % (95% CI) . | |
| Unsolicited AEs within 30 d | ||||
| Any | 71 | 13.6 (10.8, 16.8) | 128 | 24.5 (20.9, 28.4) |
| Grade 3 | 1 | 0.2 (0.0, 1.1) | 6 | 1.1 (0.4, 2.5) |
| Related | 11 | 2.1 (1.1, 3.7) | 14 | 2.7 (1.5, 4.5) |
| Grade 3 related | 0 | 0.0 (0.0, 0.7) | 1 | 0.2 (0.0, 1.1) |
| Medically attended | 35 | 6.7 (4.7, 9.2) | 66 | 12.6 (9.9, 15.8) |
| SAEs and pIMDs up to study enda | ||||
| Any SAE | 21 | 4.0 (2.5, 6.1) | 36 | 6.9 (4.9, 9.4) |
| Related SAE | 0 | 0.0 (0.0, 0.7) | 1 | 0.2 (0.0, 1.1) |
| Fatal SAE | 0 | 0.0 (0.0, 0.7) | 6 | 1.1 (0.4, 2.5) |
| Any pIMD | 0 | 0.0 (0.0, 0.7) | 3 | 0.6 (0.1, 1.7) |
| Related pIMD | 0 | 0.0 (0.0, 0.7) | 1 | 0.2 (0.0, 1.1) |
| Adverse Event . | Co-Ad N = 523 . | Control N = 522 . | ||
|---|---|---|---|---|
| n . | % (95% CI) . | n . | % (95% CI) . | |
| Unsolicited AEs within 30 d | ||||
| Any | 71 | 13.6 (10.8, 16.8) | 128 | 24.5 (20.9, 28.4) |
| Grade 3 | 1 | 0.2 (0.0, 1.1) | 6 | 1.1 (0.4, 2.5) |
| Related | 11 | 2.1 (1.1, 3.7) | 14 | 2.7 (1.5, 4.5) |
| Grade 3 related | 0 | 0.0 (0.0, 0.7) | 1 | 0.2 (0.0, 1.1) |
| Medically attended | 35 | 6.7 (4.7, 9.2) | 66 | 12.6 (9.9, 15.8) |
| SAEs and pIMDs up to study enda | ||||
| Any SAE | 21 | 4.0 (2.5, 6.1) | 36 | 6.9 (4.9, 9.4) |
| Related SAE | 0 | 0.0 (0.0, 0.7) | 1 | 0.2 (0.0, 1.1) |
| Fatal SAE | 0 | 0.0 (0.0, 0.7) | 6 | 1.1 (0.4, 2.5) |
| Any pIMD | 0 | 0.0 (0.0, 0.7) | 3 | 0.6 (0.1, 1.7) |
| Related pIMD | 0 | 0.0 (0.0, 0.7) | 1 | 0.2 (0.0, 1.1) |
A grade 3 adverse event (AE) is an AE that prevents normal activity.
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, number of participants in the exposed set; n/%, number/percentage of participants in the indicated category; pIMD, potential immune-mediated disease; RSVPreF3 OA, respiratory syncytial virus (RSV) prefusion F protein-based vaccine; SAE, serious adverse event.
aApproximately 6 m after the last dose.
| Adverse Event . | Co-Ad N = 523 . | Control N = 522 . | ||
|---|---|---|---|---|
| n . | % (95% CI) . | n . | % (95% CI) . | |
| Unsolicited AEs within 30 d | ||||
| Any | 71 | 13.6 (10.8, 16.8) | 128 | 24.5 (20.9, 28.4) |
| Grade 3 | 1 | 0.2 (0.0, 1.1) | 6 | 1.1 (0.4, 2.5) |
| Related | 11 | 2.1 (1.1, 3.7) | 14 | 2.7 (1.5, 4.5) |
| Grade 3 related | 0 | 0.0 (0.0, 0.7) | 1 | 0.2 (0.0, 1.1) |
| Medically attended | 35 | 6.7 (4.7, 9.2) | 66 | 12.6 (9.9, 15.8) |
| SAEs and pIMDs up to study enda | ||||
| Any SAE | 21 | 4.0 (2.5, 6.1) | 36 | 6.9 (4.9, 9.4) |
| Related SAE | 0 | 0.0 (0.0, 0.7) | 1 | 0.2 (0.0, 1.1) |
| Fatal SAE | 0 | 0.0 (0.0, 0.7) | 6 | 1.1 (0.4, 2.5) |
| Any pIMD | 0 | 0.0 (0.0, 0.7) | 3 | 0.6 (0.1, 1.7) |
| Related pIMD | 0 | 0.0 (0.0, 0.7) | 1 | 0.2 (0.0, 1.1) |
| Adverse Event . | Co-Ad N = 523 . | Control N = 522 . | ||
|---|---|---|---|---|
| n . | % (95% CI) . | n . | % (95% CI) . | |
| Unsolicited AEs within 30 d | ||||
| Any | 71 | 13.6 (10.8, 16.8) | 128 | 24.5 (20.9, 28.4) |
| Grade 3 | 1 | 0.2 (0.0, 1.1) | 6 | 1.1 (0.4, 2.5) |
| Related | 11 | 2.1 (1.1, 3.7) | 14 | 2.7 (1.5, 4.5) |
| Grade 3 related | 0 | 0.0 (0.0, 0.7) | 1 | 0.2 (0.0, 1.1) |
| Medically attended | 35 | 6.7 (4.7, 9.2) | 66 | 12.6 (9.9, 15.8) |
| SAEs and pIMDs up to study enda | ||||
| Any SAE | 21 | 4.0 (2.5, 6.1) | 36 | 6.9 (4.9, 9.4) |
| Related SAE | 0 | 0.0 (0.0, 0.7) | 1 | 0.2 (0.0, 1.1) |
| Fatal SAE | 0 | 0.0 (0.0, 0.7) | 6 | 1.1 (0.4, 2.5) |
| Any pIMD | 0 | 0.0 (0.0, 0.7) | 3 | 0.6 (0.1, 1.7) |
| Related pIMD | 0 | 0.0 (0.0, 0.7) | 1 | 0.2 (0.0, 1.1) |
A grade 3 adverse event (AE) is an AE that prevents normal activity.
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, number of participants in the exposed set; n/%, number/percentage of participants in the indicated category; pIMD, potential immune-mediated disease; RSVPreF3 OA, respiratory syncytial virus (RSV) prefusion F protein-based vaccine; SAE, serious adverse event.
aApproximately 6 m after the last dose.
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