tetano
Editor, Senior Moderator
Vaccine. 2019 Dec 17. pii: S0264-410X(19)31650-0. doi: 10.1016/j.vaccine.2019.12.008. [Epub ahead of print] [h=1]Immunogenicity and safety of Quadrivalent Influenza HA vaccine in Indonesian children: An open-labeled, bridging, clinical study.[/h]
Dhamayanti M[SUP]1[/SUP], Tarigan R[SUP]2[/SUP], Fadlyana E[SUP]2[/SUP], Prasetyo D[SUP]2[/SUP], Amalia N[SUP]2[/SUP], Rusmil VK[SUP]2[/SUP], Sari RM[SUP]3[/SUP], Bachtiar NS[SUP]4[/SUP], Rusmil K[SUP]2[/SUP], Kartasasmita CB[SUP]2[/SUP].
[h=3]Author information[/h] 1 Department of Child Health, Faculty of Medicine Universitas Padjadjaran/Hasan Sadikin Hospital, Bandung, Indonesia. Electronic address: meita.dhamayanti@unpad.ac.id. 2 Department of Child Health, Faculty of Medicine Universitas Padjadjaran/Hasan Sadikin Hospital, Bandung, Indonesia. 3 Surveillance and Clinical Trial Division, PT Bio Farma, Bandung, Indonesia. Electronic address: rini.mulia@biofarma.co.id. 4 Surveillance and Clinical Trial Division, PT Bio Farma, Bandung, Indonesia. Electronic address: novilia@biofarma.co.id.
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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.
[h=4]METHODS:[/h] 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.
[h=4]RESULTS:[/h] 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.
[h=4]CONCLUSION:[/h] The investigational QIV was immunogenic with an acceptable safety profile in children 6 months to 8 years of age.
[h=4]CLINICAL TRIAL REGISTRATION:[/h] NCT03336593.
Copyright ? 2019 The Author(s). Published by Elsevier Ltd.. All rights reserved.
[h=4]KEYWORDS:[/h] Children; Immunogenicity; Indonesia; Quadrivalent Influenza Vaccine; Safety
PMID: 31862195 DOI: 10.1016/j.vaccine.2019.12.008
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Dhamayanti M[SUP]1[/SUP], Tarigan R[SUP]2[/SUP], Fadlyana E[SUP]2[/SUP], Prasetyo D[SUP]2[/SUP], Amalia N[SUP]2[/SUP], Rusmil VK[SUP]2[/SUP], Sari RM[SUP]3[/SUP], Bachtiar NS[SUP]4[/SUP], Rusmil K[SUP]2[/SUP], Kartasasmita CB[SUP]2[/SUP].
[h=3]Author information[/h] 1 Department of Child Health, Faculty of Medicine Universitas Padjadjaran/Hasan Sadikin Hospital, Bandung, Indonesia. Electronic address: meita.dhamayanti@unpad.ac.id. 2 Department of Child Health, Faculty of Medicine Universitas Padjadjaran/Hasan Sadikin Hospital, Bandung, Indonesia. 3 Surveillance and Clinical Trial Division, PT Bio Farma, Bandung, Indonesia. Electronic address: rini.mulia@biofarma.co.id. 4 Surveillance and Clinical Trial Division, PT Bio Farma, Bandung, Indonesia. Electronic address: novilia@biofarma.co.id.
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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.
[h=4]METHODS:[/h] 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.
[h=4]RESULTS:[/h] 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.
[h=4]CONCLUSION:[/h] The investigational QIV was immunogenic with an acceptable safety profile in children 6 months to 8 years of age.
[h=4]CLINICAL TRIAL REGISTRATION:[/h] NCT03336593.
Copyright ? 2019 The Author(s). Published by Elsevier Ltd.. All rights reserved.
[h=4]KEYWORDS:[/h] Children; Immunogenicity; Indonesia; Quadrivalent Influenza Vaccine; Safety
PMID: 31862195 DOI: 10.1016/j.vaccine.2019.12.008
Free full text