Safety and reactogenicity
nausea, hyperpigmentation, swelling, erythema, pain, headache, deaths
HYPERPIGMENTATION, ADVERSE EVENTS, ERYTHEMA, INDURATION, EVENTS
Overall, study vaccinations were well tolerated with acceptable reactogenicity; there were no deaths, serious AEs or study withdrawals due to adverse events. Two reported immediate reactions within 30 min of vaccination were mild cases of headache in the IPV group and nausea in the IPV + dmLT group. On the day of vaccination, 19 (63%) of 30 IPV recipients and 24 (80%) of 30 IPV + dmLT recipients reported a local reaction, all graded as mild or moderate in severity. The majority of these reactions consisted of mild pain at the injection site with only two cases of induration (one in each group), a single case of swelling (IPV group) and single cases of erythema and hyperpigmentation (both in the IPV + dmLT group). Reports of local reactions declined at similar rates in both groups over the subsequent three days (Frequencies of solicited local reactions and systemic adverse events in the study groups for 7 days after vaccination on Day 1.Frequencies of solicited systemic AEs were comparable in all three groups, reported by 40%, 43% and 30% of IPV, IPV + dmLT and bOPV groups on Day 1, respectively (Unsolicited AEs up to Day 28 were reported by 20 (67%) of the 30 IPV recipients, compared with 18 (60%) of the 30 IPV + dmLT recipients and 11 (55%) of 20 who received bOPV. Unsolicited AEs were mainly mild or moderate in severity; although there were 3 and 4 events described as severe after IPV and IPV + dmLT, respectively; only one of these was considered to be related to vaccination – a case of severe transient elevated aspartate aminotransferase (AST) in an IPV + dmLT vaccinee which spontaneously resolved 10 days after first being observed. There were no other clinically significant changes from baseline or differences between treatment groups in laboratory values, vital signs, or physical examinations (see 