Table 3.
Summary of adverse events (AE) and fever‐related events in the safety populations after first/second dose of vaccine
| AEs in study safety cohorts | Cohort A (n = 703) % (n) | Cohort B (n = 875) % (n) | Cohort C (n = 398) % (n) | Total (n = 1976) % (n) |
|---|---|---|---|---|
| One or more AEs | 91·5 (643) | 87·7 (767) | 84·7 (337) | 88·4 (1747) |
| Eligible but did not receive dose two due to AE | 1·8 (13) | 0·8 (7) | 0 | 1·0 (20) |
| Solicited AEsa | 80·1 (563) | 78·2 (684) | 77·9 (310) | 78·8 (1557) |
| Any solicited local AEs | 43·4 (305) | 66·9 (585) | 70·6 (281) | 59·3 (1171) |
| Any solicited systemic AEs | 71·7 (504) | 46·6 (408) | 42·7 (170) | 54·8 (1082) |
| Unsolicited AEsb | 75·5 (531) | 59·5 (521) | 42·0 (167) | 61·7 (1219) |
| Deaths | 0 | 0 | 0 | 0 |
| Serious AEs (SAEs) | 2·7 (19) | 0·6 (5) | 0·5 (2) | 1·3 (26) |
| SAEs considered related to vaccinec | 0 | 0 | 0 | 0 |
| Withdrawal due to an SAE | 0 | 0 | 0 | 0 |
| New‐onset chronic illnesses (NOCIs)d | 1·4 (10) | 0·6 (5) | 0·5 (2) | 0·9 (17) |
| NOCIs considered related to vaccinec | 0·3 (2) | 0 | 0 | 0·1 (2) |
| Fever‐related events | ||||
| Subject unable to receive prescribed dose 2 due to severe fever AE following dose 1 | 1·8 (13) | 0·8 (7) | –e | 1·5 (20)f |
| Febrile convulsion following immunization | 0·1 (1) | 0 | 0 | 0·1 (1) |
a
Solicited AEs from day 0 to day 6 following vaccine.
b
Unsolicited AEs include: unsolicited AEs from day 0 to day 29 following vaccine and SAEs/NOCIs from day 0 to day 180 following the last dose of vaccine.
c
Related AEs are those assessed by an investigator as having a causality of unknown, possibly, probably or definitely related to study vaccine.
d
Three Cohort A children each had two NOCI events, meaning a total of 20 NOCIs were reported in 17 children.
e
Second dose not given to Cohort C.
f
Denominator: Cohort A and Cohort B subjects eligible for dose 2 (n = 1301).