| . | NF135.C10 (n = 3) . | NF54 (n = 4) . | Smear and PCR Negative (n = 3) . | |||
|---|---|---|---|---|---|---|
| Adverse Event . | Events, No. . | Duration, Mean (SD), d . | Events, No. . | Duration, Mean (SD), d . | Events, No. . | Duration, Mean (SD), d . |
| Abdominal pain | 2 | 0 (0.0) | 0 | … | 0 | … |
| Arthralgia | 0 | … | 0 | … | 0 | … |
| Chills | 0 | … | 0 | … | 0 | … |
| Fatigue | 3 | 2.4 (1.9) | 1 | 3.0 (…) | 2 | 13.5 (9.3) |
| Fever | 1 | 0.2 (…) | 2 | 0.7 (0.8) | 0 | |
| Headache | 3 | 1.5 (2.4) | 4 | 2.3 (2.0) | 3 | 4.6 (3.8) |
| Itching | 0 | … | 4 | 3.1 (1.5) | 2 | 5.2 (0.3) |
| Malaise | 0 | … | 4 | 2.5 (3.3) | 0 | … |
| Myalgia | 1 | 2.7 (…) | 3 | 1.3 (1.4) | 2 | 2.7 (2.4) |
| Nausea | 1 | 0.1 (…) | 3 | 2 (2.0) | 1 | 0.0 (…) |
| Vomiting | 0 | … | 1 | 0.4 (…) | 0 | … |
| Any | 3 | 1.3 (1.7) | 4 | 2.2 (1.9) | 3 | 5.7 (5.8) |
| Grade 3 adverse event | ||||||
| Headache | 0 | … | 1 | 4.6 (…) | 0 | … |
| Malaise | 0 | … | 1 | 0.4 (…) | 0 | … |
| Vomiting | 0 | … | 1 | 0.4 (…) | 0 | … |
| Any | 0 | … | 1 | 1.8 (2.4) | 0 | … |
| . | NF135.C10 (n = 3) . | NF54 (n = 4) . | Smear and PCR Negative (n = 3) . | |||
|---|---|---|---|---|---|---|
| Adverse Event . | Events, No. . | Duration, Mean (SD), d . | Events, No. . | Duration, Mean (SD), d . | Events, No. . | Duration, Mean (SD), d . |
| Abdominal pain | 2 | 0 (0.0) | 0 | … | 0 | … |
| Arthralgia | 0 | … | 0 | … | 0 | … |
| Chills | 0 | … | 0 | … | 0 | … |
| Fatigue | 3 | 2.4 (1.9) | 1 | 3.0 (…) | 2 | 13.5 (9.3) |
| Fever | 1 | 0.2 (…) | 2 | 0.7 (0.8) | 0 | |
| Headache | 3 | 1.5 (2.4) | 4 | 2.3 (2.0) | 3 | 4.6 (3.8) |
| Itching | 0 | … | 4 | 3.1 (1.5) | 2 | 5.2 (0.3) |
| Malaise | 0 | … | 4 | 2.5 (3.3) | 0 | … |
| Myalgia | 1 | 2.7 (…) | 3 | 1.3 (1.4) | 2 | 2.7 (2.4) |
| Nausea | 1 | 0.1 (…) | 3 | 2 (2.0) | 1 | 0.0 (…) |
| Vomiting | 0 | … | 1 | 0.4 (…) | 0 | … |
| Any | 3 | 1.3 (1.7) | 4 | 2.2 (1.9) | 3 | 5.7 (5.8) |
| Grade 3 adverse event | ||||||
| Headache | 0 | … | 1 | 4.6 (…) | 0 | … |
| Malaise | 0 | … | 1 | 0.4 (…) | 0 | … |
| Vomiting | 0 | … | 1 | 0.4 (…) | 0 | … |
| Any | 0 | … | 1 | 1.8 (2.4) | 0 | … |
Reported solicited adverse events, collected throughout the postinoculation period, that were considered possibly, probably, or definitely related to the trial procedures.
Abbreviations: SD, standard deviation; PCR, polymerase chain reaction.
| . | NF135.C10 (n = 3) . | NF54 (n = 4) . | Smear and PCR Negative (n = 3) . | |||
|---|---|---|---|---|---|---|
| Adverse Event . | Events, No. . | Duration, Mean (SD), d . | Events, No. . | Duration, Mean (SD), d . | Events, No. . | Duration, Mean (SD), d . |
| Abdominal pain | 2 | 0 (0.0) | 0 | … | 0 | … |
| Arthralgia | 0 | … | 0 | … | 0 | … |
| Chills | 0 | … | 0 | … | 0 | … |
| Fatigue | 3 | 2.4 (1.9) | 1 | 3.0 (…) | 2 | 13.5 (9.3) |
| Fever | 1 | 0.2 (…) | 2 | 0.7 (0.8) | 0 | |
| Headache | 3 | 1.5 (2.4) | 4 | 2.3 (2.0) | 3 | 4.6 (3.8) |
| Itching | 0 | … | 4 | 3.1 (1.5) | 2 | 5.2 (0.3) |
| Malaise | 0 | … | 4 | 2.5 (3.3) | 0 | … |
| Myalgia | 1 | 2.7 (…) | 3 | 1.3 (1.4) | 2 | 2.7 (2.4) |
| Nausea | 1 | 0.1 (…) | 3 | 2 (2.0) | 1 | 0.0 (…) |
| Vomiting | 0 | … | 1 | 0.4 (…) | 0 | … |
| Any | 3 | 1.3 (1.7) | 4 | 2.2 (1.9) | 3 | 5.7 (5.8) |
| Grade 3 adverse event | ||||||
| Headache | 0 | … | 1 | 4.6 (…) | 0 | … |
| Malaise | 0 | … | 1 | 0.4 (…) | 0 | … |
| Vomiting | 0 | … | 1 | 0.4 (…) | 0 | … |
| Any | 0 | … | 1 | 1.8 (2.4) | 0 | … |
| . | NF135.C10 (n = 3) . | NF54 (n = 4) . | Smear and PCR Negative (n = 3) . | |||
|---|---|---|---|---|---|---|
| Adverse Event . | Events, No. . | Duration, Mean (SD), d . | Events, No. . | Duration, Mean (SD), d . | Events, No. . | Duration, Mean (SD), d . |
| Abdominal pain | 2 | 0 (0.0) | 0 | … | 0 | … |
| Arthralgia | 0 | … | 0 | … | 0 | … |
| Chills | 0 | … | 0 | … | 0 | … |
| Fatigue | 3 | 2.4 (1.9) | 1 | 3.0 (…) | 2 | 13.5 (9.3) |
| Fever | 1 | 0.2 (…) | 2 | 0.7 (0.8) | 0 | |
| Headache | 3 | 1.5 (2.4) | 4 | 2.3 (2.0) | 3 | 4.6 (3.8) |
| Itching | 0 | … | 4 | 3.1 (1.5) | 2 | 5.2 (0.3) |
| Malaise | 0 | … | 4 | 2.5 (3.3) | 0 | … |
| Myalgia | 1 | 2.7 (…) | 3 | 1.3 (1.4) | 2 | 2.7 (2.4) |
| Nausea | 1 | 0.1 (…) | 3 | 2 (2.0) | 1 | 0.0 (…) |
| Vomiting | 0 | … | 1 | 0.4 (…) | 0 | … |
| Any | 3 | 1.3 (1.7) | 4 | 2.2 (1.9) | 3 | 5.7 (5.8) |
| Grade 3 adverse event | ||||||
| Headache | 0 | … | 1 | 4.6 (…) | 0 | … |
| Malaise | 0 | … | 1 | 0.4 (…) | 0 | … |
| Vomiting | 0 | … | 1 | 0.4 (…) | 0 | … |
| Any | 0 | … | 1 | 1.8 (2.4) | 0 | … |
Reported solicited adverse events, collected throughout the postinoculation period, that were considered possibly, probably, or definitely related to the trial procedures.
Abbreviations: SD, standard deviation; PCR, polymerase chain reaction.
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