Table 6.
Safety profile of low-, medium-, and high-doses of PVRV-NG2, PVRV-NG, or HDCV for solicited and unsolicited reactions (safety analysis set).
| Participants experiencing at least one event | Low-dose PVRV-NG2 |
Medium-dose PVRV-NG2 |
High-dose PVRV-NG2 |
PVRV-NG |
HDCV |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n/N | % | 95% CI | n/N | % | 95% CI | n/N | % | 95% CI | n/N | % | 95% CI | n/N | % | 95% CI | |
| Solicited reactions | 40/79 | 50.6 | 39.1, 62.1 | 38/80 | 47.5 | 36.2, 59.0 | 44/80 | 55.0 | 43.5, 66.2 | 21/39 | 53.8 | 37.2, 69.9 | 28/39 | 71.8 | 55.1, 85.0 |
| Solicited injection site reactions | 29/79 | 36.7 | 26.1, 48.3 | 32/80 | 40.0 | 29.2, 51.6 | 38/80 | 47.5 | 36.2, 59.0 | 14/39 | 35.9 | 21.2, 52.8 | 24/39 | 61.5 | 44.6, 76.6 |
| Pain | 29/79 | 36.7 | 26.1, 48.3 | 32/80 | 40.0 | 29.2, 51.6 | 38/80 | 47.5 | 36.2, 59.0 | 14/39 | 35.9 | 21.2, 52.8 | 24/39 | 61.5 | 44.6, 76.6 |
| Erythema | 2/79 | 2.5 | 0.3, 8.8 | 1/80 | 1.3 | 0, 6.8 | 3/80 | 3.8 | 0.8, 10.6 | 1/39 | 2.6 | 0.1, 13.5 | 2/39 | 5.1 | 0.6, 17.3 |
| Swelling | 0/79 | 0 | 0, 4.6 | 1/80 | 1.3 | 0, 6.8 | 1/80 | 1.3 | 0, 6.8 | 1/39 | 2.6 | 0.1, 13.5 | 2/39 | 5.1 | 0.6, 17.3 |
| Solicited systemic reactions | 37/79 | 46.8 | 35.5, 58.4 | 27/80 | 33.8 | 23.6, 45.2 | 29/80 | 36.3 | 25.8, 47.8 | 17/39 | 43.6 | 27.8, 60.4 | 25/39 | 64.1 | 47.2, 78.8 |
| Fever | 0/78 | 0 | 0, 4.6 | 1/80 | 1.3 | 0, 6.8 | 2/80 | 2.5 | 0.3, 8.7 | 0/39 | 0 | 0, 9.0 | 0/39 | 0 | 0, 9.0 |
| Headache | 26/79 | 32.9 | 22.7, 44.4 | 12/80 | 15.0 | 8.0, 24.7 | 20/80 | 25.0 | 16.0, 35.9 | 9/39 | 23.1 | 11.1, 39.3 | 15/39 | 38.5 | 23.4, 55.4 |
| Malaise | 26/79 | 32.9 | 22.7, 44.4 | 13/80 | 16.3 | 8.9, 26.2 | 17/80 | 21.3 | 12.9, 31.8 | 11/39 | 28.2 | 15.0, 44.9 | 16/39 | 41.0 | 25.6, 57.9 |
| Myalgia | 25/79 | 31.6 | 21.6, 43.1 | 22/80 | 27.5 | 18.1, 38.6 | 20/80 | 25.0 | 16.0, 35.9 | 11/39 | 28.2 | 15.0, 44.9 | 19/39 | 48.7 | 32.4, 65.2 |
| Unsolicited reactions | |||||||||||||||
| Unsolicited AEs | 11/80 | 13.8 | 7.1, 23.3 | 11/80 | 13.8 | 7.1, 23.3 | 20/80 | 25.0 | 16.0, 35.9 | 10/39 | 25.6 | 13.0, 42.1 | 18/41 | 43.9 | 28.5, 60.3 |
| Immediatea unsolicited AE | 0/80 | 0 | 0, 4.5 | 1/80 | 1.3 | 0, 6.8 | 0/80 | 0 | 0, 4.5 | 0/39 | 0 | 0, 9.0 | 2/41 | 4.9 | 0.6, 16.5 |
| Unsolicited non-serious AE | 11/80 | 13.8 | 7.1, 23.3 | 11/80 | 13.8 | 7.1, 23.3 | 20/80 | 25.0 | 16.0, 35.9 | 10/39 | 25.6 | 13.0, 42.1 | 18/41 | 43.9 | 28.5, 60.3 |
| Grade 3 unsolicited non-serious AE |
1/80 | 1.3 | 0, 6.8 | 1/80 | 1.3 | 0, 6.8 | 1/80 | 1.3 | 0, 6.8 | 0/39 | 0 | 0, 9.0 | 0/41 | 0 | 0, 8.6 |
| Unsolicited non-serious systemic AE | 10/80 | 12.5 | 6.2, 21.8 | 11/80 | 13.8 | 7.1, 23.3 | 17/80 | 21.3 | 12.9, 31.8 | 10/39 | 25.6 | 13.0, 42.1 | 16/41 | 39.0 | 24.2, 55.5 |
| Grade 3 unsolicited non-serious systemic AE |
1/80 | 1.3 | 0, 6.8 | 1/80 | 1.3 | 0, 6.8 | 1/80 | 1.3 | 0, 6.8 | 0/39 | 0 | 0, 9.0 | 0/41 | 0 | 0, 8.6 |
| Unsolicited ARs | 2/80 | 2.5 | 0.3, 8.7 | 2/80 | 2.5 | 0.3, 8.7 | 5/80 | 6.3 | 2.1, 14.0 | 1/39 | 2.6 | 0.1, 13.5 | 8/41 | 19.5 | 8.8, 34.9 |
| Immediatea unsolicited AR | 0/80 | 0 | 0, 4.5 | 1/80 | 1.3 | 0, 6.8 | 0/80 | 0 | 0, 4.5 | 0/39 | 0 | 0, 9.0 | 2/41 | 4.9 | 0.6, 16.5 |
| Unsolicited non-serious AR | 2/80 | 2.5 | 0.3, 8.7 | 2/80 | 2.5 | 0.3, 8.7 | 5/80 | 6.3 | 2.1, 14.0 | 1/39 | 2.6 | 0.1, 13.5 | 8/41 | 19.5 | 8.8, 34.9 |
| Grade 3 unsolicited non-serious AR | 1/80 | 1.3 | 0, 6.8 | 0/80 | 0 | 0, 4.5 | 0/80 | 0 | 0, 4.5 | 0/39 | 0 | 0, 9.0 | 0/41 | 0 | 0, 8.6 |
| Unsolicited non-serious injection site AR | 1/80 | 1.3 | 0, 6.8 | 0/80 | 0 | 0, 4.5 | 4/80 | 5.0 | 1.4, 12.3 | 1/39 | 2.6 | 0.1, 13.5 | 3/41 | 7.3 | 1.5, 19.9 |
| Unsolicited non-serious systemic AR | 1/80 | 1.3 | 0, 6.8 | 2/80 | 2.5 | 0.3, 8.7 | 1/80 | 1.3 | 0, 6.8 | 0/39 | 0 | 0, 9.0 | 5/41 | 12.2 | 4.1, 26.6 |
| Grade 3 unsolicited non-serious systemic AR | 1/80 | 1.3 | 0, 6.8 | 0/80 | 0 | 0, 4.5 | 0/80 | 0 | 0, 4.5 | 0/39 | 0 | 0, 9.0 | 0/41 | 0 | 0, 8.6 |
| From D0 to Month 7b | |||||||||||||||
| AE leading to study discontinuationc | 1/80 | 1.3 | 0, 6.8 | 1/80 | 1.3 | 0, 6.8 | 0/80 | 0 | 0, 4.5 | 1/39 | 2.6 | 0.1, 13.5 | 2/41 | 4.9 | 0.6, 16.5 |
| SAE | 0/80 | 0 | 0, 4.5 | 0/80 | 0 | 0, 4.5 | 1/80 | 1.3 | 0, 6.8 | 0/39 | 0 | 0, 9.0 | 0/41 | 0 | 0, 8.6 |
| Death | 0/80 | 0 | 0, 4.5 | 0/80 | 0 | 0, 4.5 | 0/80 | 0 | 0, 4.5 | 0/39 | 0 | 0, 9.0 | 0/41 | 0 | 0, 8.6 |
| AESI | 0/80 | 0 | 0, 4.5 | 0/80 | 0 | 0, 4.5 | 0/80 | 0 | 0, 4.5 | 0/39 | 0 | 0, 9.0 | 0/41 | 0 | 0, 8.6 |
Safety analysis set is defined as the subset of participants who received a particular dose.
aOccurring within 30 minutes after a vaccination.
bAll events occurred between D0 and Month 7.
cIdentified in the termination form as SAE or other AE up to Month 7 (±3 days) or as an AE/SAE occurring within the time period of D0 to D28 (±3 days) and leading to termination.
Solicited reactions were collected within 7 days after each injection.
Solicited systemic reactions were collected between the first and the second injections, between the second and the third injections and within 7 days after the remaining injections.
Unsolicited AEs were collected between the first and the second injections, between the second and the third injections, between the third and the fourth injections, between the fourth and the fifth injections and up to 28 days after the last injection.
AE, adverse event; AESI, adverse event of special interest; AR, adverse reaction; CI, confidence intervals; N, number of participants with available data for the relevant endpoint; SAE, serious adverse event.