PMID- 30084702 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20200310 IS - 2164-554X (Electronic) IS - 2164-5515 (Print) IS - 2164-5515 (Linking) VI - 14 IP - 12 DP - 2018 TI - A 6-year safety surveillance of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in South Korea. PG - 3019-3025 LID - 10.1080/21645515.2018.1502525 [doi] AB - In 2010, Korea introduced 10-valent pneumococcal conjugate vaccine for children aged 6 weeks to 5 years against invasive disease caused by Streptococcus pneumoniae serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F and cross-reactive 19A. The aim of this 6-year real-world study of 646 healthy Korean children from 16 centers vaccinated in routine practice is to monitor vaccine safety, as per Ministry of Food and Drug Safety regulations. Around 50% had a past or existing medical condition, 19.3% an existing condition and 7.6% received concomitant medication). Total of 489 recorded adverse events (AEs) were reported in 274 infants; 86% were mild and the rest moderate, only three were reported as serious. Most AEs (97.8%) were not related to vaccination; one case of injection-site swelling and of fever was related, two cases of fever were probably related, five cases of fever and one case each of diarrhea and coughing were possibly related. None of the serious AEs were related to vaccination. Of 11 adverse drug reactions (ADRs) in 10 subjects, none were serious. Overall, 263 subjects (40.7%) received medication (mainly antibiotics or antipyretics) for the treatment of an AE, of which 6 subjects were treated for an ADR. There was no difference in the incidence of AEs according to age, sex or concomitant vaccination. Subjects with an existing medical condition had significantly more AEs than those without any conditions (p = 0.03), but no differences regarding ADRs. Four-dose vaccination with PHiD-CV appears to have a clinically-acceptable safety profile for Korean children. ClinicalTrials.gov identifier: NCT01248988. FAU - Lee, Soon Min AU - Lee SM AUID- ORCID: 0000-0003-0174-1065 AD - a Department of Pediatrics, Gangnam Severance Hospital , Yonsei University College of Medicine , Seoul , Korea. FAU - Lee, Jang Hoon AU - Lee JH AUID- ORCID: 0000-0003-4765-9948 AD - b Department of Pediatrics , Ajou University School of Medicine , Suwon , Korea. FAU - Song, Eun Song AU - Song ES AUID- ORCID: 0000-0003-1056-2165 AD - c Department of Pediatrics , Chonnam National University Medical School , Gwangju , Korea. FAU - Kim, Sung Jin AU - Kim SJ AD - d GSK , Seoul , Korea. FAU - Kim, Joon Hyung AU - Kim JH AUID- ORCID: 0000-0002-6014-3543 AD - d GSK , Seoul , Korea. FAU - Jakes, Rupert W AU - Jakes RW AD - e GSK , Singapore , Singapore. FAU - Devadiga, Raghavendra AU - Devadiga R AD - f GSK , Bangalore , India. FAU - Park, Moon Sung AU - Park MS AUID- ORCID: 0000-0002-9101-3581 AD - b Department of Pediatrics , Ajou University School of Medicine , Suwon , Korea. LA - eng SI - ClinicalTrials.gov/NCT01248988 PT - Journal Article DEP - 20180829 PL - United States TA - Hum Vaccin Immunother JT - Human vaccines & immunotherapeutics JID - 101572652 PMC - PMC6343627 OTO - NOTNLM OT - 10-valent pneumococcal conjugate vaccine OT - Korea OT - PHiD-CV OT - safety EDAT- 2018/08/08 06:00 MHDA- 2018/08/08 06:01 PMCR- 2018/08/29 CRDT- 2018/08/08 06:00 PHST- 2018/08/08 06:00 [pubmed] PHST- 2018/08/08 06:01 [medline] PHST- 2018/08/08 06:00 [entrez] PHST- 2018/08/29 00:00 [pmc-release] AID - 1502525 [pii] AID - 10.1080/21645515.2018.1502525 [doi] PST - ppublish SO - Hum Vaccin Immunother. 2018;14(12):3019-3025. doi: 10.1080/21645515.2018.1502525. Epub 2018 Aug 29.