Safety assessment
vomiting, abnormal crying, convulsions, drowsiness, loss of appetite, fever, erythema, pain, irritability
ADVERSE EVENTS, FEBRILE CONVULSION, ERYTHEMA, ENCEPHALOPATHY, HAND SWELLING, HYPOTONIC
Subjects were observed for 30 min after vaccination to assess the occurrence of any immediate adverse events (AEs). Participants were provided with diary cards, digital thermometers, and flexible rulers to record daily body temperature as well as solicited injection site (pain, erythema, and swelling) and systemic reactions (fever ≥ 38.0°C (≥ 100.4°F), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability) up to 7 days after each and any study vaccine dose, and other unsolicited AEs up to 28 days after each and any study vaccine dose. The subject’s parents / LAR were contacted by telephone 8–10 days after each vaccination to remind them to record safety information in their diary cards. Information on unsolicited AEs was collected. Investigators assessed the causal relationship of each unsolicited systemic AE/serious AE (SAE) with vaccination. Information on SAEs was collected and assessed throughout the study, from screening on day 0 until study completion. The following adverse events of special interest (AESIs) were defined based upon the prior experience with the use of marketed pentavalent combination vaccines including anaphylaxis/hypersensitivity, convulsions, including febrile convulsion, hypotonic hyporesponsive episode (HHE), and encephalopathy. These AESIs were considered as SAEs and reported to the sponsor between day 0 and until 28 days after the last vaccination.