Table 4.
Solicited and unsolicited safety events in infants and young children
|
Infants receiving nOPV2 |
Infants receiving bOPV |
Young children receiving nOPV2 |
Young children receiving bOPV |
||||||
|---|---|---|---|---|---|---|---|---|---|
| Number of events* | n/N (%) 95% CI | Number of events* | n/N (%) 95% CI | p value | Number of events* | n/N (%) 95% CI | Number of events* | n/N (%) 95% CI | |
| Any solicited adverse event within 7 days of vaccination† | |||||||||
| Any severity | 456 | 273/682‡ (40%) 36–44 | 80 | 47/102‡ (46%) 36–56 | .. | 149 | 98/300‡ (33%) 27–38 | 153 | 98/300‡ (33%) 27–38 |
| Severe | 0 | 0/682‡ (0%) 0–1 | 1 | 1/102‡ (1%) 0–5 | .. | 4 | 4/300‡ (1%) <1–3 | 2 | 2/300‡ (<1%) <1–2 |
| Unsolicited adverse event to 28 days of last vaccination | |||||||||
| Any severity | 1094 | 837/2007§ (42%) 40–44 | 197 | 161/338§ (48%) 42–53 | p=0·043¶ | 248 | 166/300§ (55%) 50–61 | 248 | 172/300§ (57%) 52–63 |
| Severe | 4 | 4/2007§ (<1%) 0–1 | 2 | 2/338§ (<1%) 0–2 | .. | 0 | 0/300§ (0%) 0–1 | 1 | 1/300§ (<1%)0–1 |
| Related unsolicited adverse event to 28 days of last dose | |||||||||
| Any severity | 14 | 14/2007§ (<1%) 0–1 | 3 | 3/338§ (<1%) 0–3 | .. | 0 | 0/300§ (0%) 0–1 | 0 | 0/300§ (0%) 0–1 |
| Severe | 0 | 0/2007§ (0%) 0–0 | 0 | 0/338§ (0%) 0–1 | .. | 0 | 0/300§ (0%) 0–1 | 0 | 0/300§ (0%) 0–1 |
| Serious adverse events | 18 | 17/2007§ (<1%) <1–1 | 5 | 5/338§ (2%) 1–3 | .. | 1 | 1/300§ (0%) 0–2 | 4 | 4/300§ (1%) 0–3 |
| Related serious adverse events | 0 | 0/2007§ (0%) 0–0 | 0 | 0/338§ (0%)0–1 | .. | 0 | 0/300§ (0%) 0–1 | 1 | 1/300§ (0%) 0–2 |
95% CIs calculated using the exact Clopper-Pearson method. bOPV=bivalent oral poliovirus vaccine. nOPV2=novel type 2 oral poliovirus vaccine.
Number of participants included in the analysis of the given population (reactogenicity or safety).
Fever (axillary temperature >37·5°C), vomiting, diarrhoea, irritability, decreased feeding, and decreased activity (including immediate solicited events occurring at 30 min post-dose in the reactogenicity population).
Reactogenicity population.
Safety population.
Fisher's exact two-tailed test of the rate of events between nOPV2 and bOPV. No other difference in event rates between nOPV2 and bOPV within the age cohorts was significant at the 5% significance level.