PMID- 31862195 OWN - NLM STAT- MEDLINE DCOM- 20210226 LR - 20210226 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 38 IP - 5 DP - 2020 Jan 29 TI - Immunogenicity and safety of Quadrivalent Influenza HA vaccine in Indonesian children: An open-labeled, bridging, clinical study. PG - 993-1000 LID - S0264-410X(19)31650-0 [pii] LID - 10.1016/j.vaccine.2019.12.008 [doi] AB - BACKGROUND: Influenza B (Yamagata/Victoria lineage) can cause severe forms of respiratory infection among the pediatric population as well as influenza A strains (H3N2/H1N1). Vaccination against all four strains is required to prevent infection and severe outcome. This study is the first study to assess the immunogenicity of Quadrivalent Influenza HA vaccine (QIV) and ascertain safety among children in Indonesia. METHODS: This is an open labeled, single arm, bridging clinical study involving unprimed healthy children 6-35 months of age (Group I) and 3-8 years of age (Group II). Subjects on both groups receiving two doses of QIV with a 28 days interval. Serology tests were performed on baseline and 28 days post-vaccination. Hemagglutination inhibition antibody titers were analyzed for Geometric Mean Titer (GMT), seroprotection, and seroconversion rates. Solicited reactions, unsolicited adverse events, and serious adverse events were observed up to 28 days post-vaccination. RESULTS: Out of 270 subjects enrolled, 269 subjects completed the study. Immunogenicity analysis were evaluated on 254 subjects. Seroprotection rates were >/=85% for all vaccine strains in both groups. Seroconversion of more than 4 folds for all strains occurred in both groups post-vaccination. In Group I, the increase of GMT for A/H1N1, A/H3N2, B/Texas, and B/Phuket was 12.5, 14.5, 8.2, and 6.4 folds, respectively. In Group II the increase of GMT for A/H1N1, A/H3N2, B/Texas, and B/Phuket was 14, 17, 10, and 8 folds, respectively. The majority of local adverse events (AEs) after the first and second immunizations were immediate injection-site pain (10.4% and 12.6%). The majority of systemic AEs after the first and second immunizations were delayed unsolicited AEs (14.8% and 14.9%). No vaccine-related serious adverse events or deaths were reported. CONCLUSION: The investigational QIV was immunogenic with an acceptable safety profile in children 6 months to 8 years of age. CLINICAL TRIAL REGISTRATION: NCT03336593. CI - Copyright (c) 2019 The Author(s). Published by Elsevier Ltd.. All rights reserved. FAU - Dhamayanti, Meita AU - Dhamayanti M AD - Department of Child Health, Faculty of Medicine Universitas Padjadjaran/Hasan Sadikin Hospital, Bandung, Indonesia. Electronic address: meita.dhamayanti@unpad.ac.id. FAU - Tarigan, Rodman AU - Tarigan R AD - Department of Child Health, Faculty of Medicine Universitas Padjadjaran/Hasan Sadikin Hospital, Bandung, Indonesia. FAU - Fadlyana, Eddy AU - Fadlyana E AD - Department of Child Health, Faculty of Medicine Universitas Padjadjaran/Hasan Sadikin Hospital, Bandung, Indonesia. FAU - Prasetyo, Dwi AU - Prasetyo D AD - Department of Child Health, Faculty of Medicine Universitas Padjadjaran/Hasan Sadikin Hospital, Bandung, Indonesia. FAU - Amalia, Nelly AU - Amalia N AD - Department of Child Health, Faculty of Medicine Universitas Padjadjaran/Hasan Sadikin Hospital, Bandung, Indonesia. FAU - Rusmil, Viramitha K AU - Rusmil VK AD - Department of Child Health, Faculty of Medicine Universitas Padjadjaran/Hasan Sadikin Hospital, Bandung, Indonesia. FAU - Sari, Rini Mulia AU - Sari RM AD - Surveillance and Clinical Trial Division, PT Bio Farma, Bandung, Indonesia. Electronic address: rini.mulia@biofarma.co.id. FAU - Bachtiar, Novilia Sjafri AU - Bachtiar NS AD - Surveillance and Clinical Trial Division, PT Bio Farma, Bandung, Indonesia. Electronic address: novilia@biofarma.co.id. FAU - Rusmil, Kusnandi AU - Rusmil K AD - Department of Child Health, Faculty of Medicine Universitas Padjadjaran/Hasan Sadikin Hospital, Bandung, Indonesia. FAU - Kartasasmita, Cissy B AU - Kartasasmita CB AD - Department of Child Health, Faculty of Medicine Universitas Padjadjaran/Hasan Sadikin Hospital, Bandung, Indonesia. LA - eng SI - ClinicalTrials.gov/NCT03336593 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20191217 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Antibodies, Viral) RN - 0 (Influenza Vaccines) RN - 0 (Vaccines, Inactivated) SB - IM MH - Antibodies, Viral/blood MH - Child MH - Child, Preschool MH - Hemagglutination Inhibition Tests MH - Humans MH - *Immunogenicity, Vaccine MH - Indonesia MH - Infant MH - Influenza A Virus, H1N1 Subtype/immunology MH - Influenza A Virus, H3N2 Subtype/immunology MH - Influenza B virus/immunology MH - Influenza Vaccines/*administration & dosage/adverse effects MH - *Influenza, Human/prevention & control MH - Vaccines, Inactivated/administration & dosage/adverse effects OTO - NOTNLM OT - Children OT - Immunogenicity OT - Indonesia OT - Quadrivalent Influenza Vaccine OT - Safety COIS- Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Meita Dhamayanti, Kusnandi Rusmil, Eddy Fadlyana, Rodman Tarigan, Dwi Prasetyo, Nelly Amalia, Viramitha, K Rusmil, Hadyana Sukandar, Cissy B Kartasasmita, received grant support through their institutions. Rini Mulia Sari and Novilia Sjafri Bachtiar are employees of PT Bio Farma at the time of this study and manuscript preparation. EDAT- 2019/12/22 06:00 MHDA- 2021/02/27 06:00 CRDT- 2019/12/22 06:00 PHST- 2019/05/30 00:00 [received] PHST- 2019/11/28 00:00 [revised] PHST- 2019/12/05 00:00 [accepted] PHST- 2019/12/22 06:00 [pubmed] PHST- 2021/02/27 06:00 [medline] PHST- 2019/12/22 06:00 [entrez] AID - S0264-410X(19)31650-0 [pii] AID - 10.1016/j.vaccine.2019.12.008 [doi] PST - ppublish SO - Vaccine. 2020 Jan 29;38(5):993-1000. doi: 10.1016/j.vaccine.2019.12.008. Epub 2019 Dec 17.