Immunogenicity and safety of Quadrivalent Influenza HA vaccine in Indonesian children: An open-labeled, bridging, clinical study

Dhamayanti, Meita; Tarigan, Rodman; Fadlyana, Eddy; Prasetyo, Dwi; Amalia, Nelly; Rusmil, Viramitha Kusnandi; Sari, Rini Mulia; Bachtıar, Novilia Sjafri; Rusmil, Kusnandi; Kartasasmita, Cissy B.

doi:10.1016/j.vaccine.2019.12.008

Cited by 3 publications

(3 citation statements)

References 19 publications

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“…The overall safety profile of QIV observed in this study is at least generally consistent with the findings of three large-scale, phase III randomized, controlled, global clinical trials of QIVs (VaxigripTetra [Sanofi], Influvac Tetra [Abbott], and Fluarix Quadrivalent [GlaxoSmithKline], respectively) in children aged 6–35 months [ 12 – 14 ], as well those of a smaller, single-arm bridging study of another QIV (PT Bio Farma) in Indonesia that included this age group [ 15 ]. Notably, in the three global clinical studies, the overall safety profile of QIVs was shown to be comparable with that of the non-influenza control vaccines [ 12 , 14 ], and aside from a slightly higher frequency of injection site reactions, with that of placebo also [ 13 ].…”

Section: Discussionsupporting

confidence: 75%

Post-Marketing Safety Surveillance of Quadrivalent Influenza Vaccine (VaxigripTetra) in Children Aged 6 to 35 Months in South Korea

Choe¹,

Talanova²,

Shin³

et al. 2023

Infect Dis Ther

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Introduction The quadrivalent inactivated split-virion influenza vaccine (QIV; VaxigripTetra ® ) was initially licensed in South Korea in 2017 for immunization against seasonal influenza in those aged ≥ 3 years, with the indicated age subsequently lowered to include those aged ≥ 6 months in 2018. Here, to comply with South Korean licensure requirements, we undertook a post-marketing surveillance study to assess the safety of QIV in children aged 6–35 months (i.e., extension of the previous age indication to include these young children) in routine clinical practice. Methods A multicenter, observational, active safety surveillance of children aged 6–35 months who received a single dose of QIV during a routine healthcare visit was undertaken in South Korea from 15 June 2018 to 14 June 2022. Solicited adverse events (AEs) and unsolicited non-serious AEs were recorded in diary cards, with serious adverse events (SAEs) notified to study investigators. Results This safety analysis included 676 participants. No AEs led to study termination, and no SAEs were reported. The most frequent solicited injection site reaction was pain in both the ≤ 23-month (12.2% [55/450]) and ≥ 24-month (15.5% [35/226]) age groups. The most frequent solicited systemic reactions were pyrexia and somnolence in the ≤ 23-month age group (6.0% [27/450] each), and malaise (10.6% [24/226]) in the ≥ 24-month age group. Overall, 208 (30.8%) participants experienced 339 unsolicited non-serious AEs, with nasopharyngitis the most common (14.1% [95/676]), and nearly all events (98.8% [335/339]) were considered unrelated to QIV. Grade 3 solicited reactions and unsolicited non-serious AEs were reported in five (0.7%) and three (0.4%) participants, respectively, all of whom recovered by day 7 after vaccination. Conclusion This active safety surveillance study confirms that QIV is well tolerated in children aged 6–35 months in routine clinical practice in South Korea. There were no safety concerns observed in these young children.

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Section: Discussionsupporting

confidence: 75%

Post-Marketing Safety Surveillance of Quadrivalent Influenza Vaccine (VaxigripTetra) in Children Aged 6 to 35 Months in South Korea

Choe¹,

Talanova²,

Shin³

et al. 2023

Infect Dis Ther

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“…This study was conducted on subjects aged 9–40 years, while a previous study by Dhamayanti et al was conducted on infants to children aged 8 years [15]. The HI data showed a strong serological response for each of the shared influenza strains in the QIV and TIV groups and the percentage of subjects in the QIV group achieving a serum HI titer ≥40.…”

Section: Discussionmentioning

confidence: 91%

Immunogenicity and safety of Quadrivalent Influenza HA vaccine compared with Trivalent Influenza HA vaccine and evaluation of Quadrivalent Influenza HA vaccine batch-to-batch consistency in Indonesian children and adults

Fadlyana

Dhamayanti

Girsang

et al. 2023

Preprint

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Background One of the newest strategies developed by the Global Influenza Strategy has been to broaden the composition of the current influenza vaccine formulations from trivalent products to quadrivalent products. This study aimed to assess the immunogenicity and safety of Quadrivalent Influenza HA vaccine (QIV) compared with Trivalent Influenza HA vaccine (TIV) and to evaluate three consecutive batches of QIV equivalence in Indonesian children and adults. Methods and findings This was an open-labeled, bridging clinical study involving unprimed healthy children and adults aged 9–40 years. A totalof 540 subjects were enrolled in this study and randomized into four arm groups. Each subject received one dose of TIV or QIV with three different batch codes. Serology tests were performed at baseline and 28 days after vaccination. Hemagglutination inhibition (HI) antibody titers were analyzed for Geometric Mean Titer (GMT), seroprotection, and seroconversion rates. Solicited, unsolicited, and serious adverse events were observed up to 28 days after vaccination. A total of 537 subjects completed the study per protocol and were analyzed for immunogenicity criteria. All randomized subjects were analyzed for safety criteria. The percentage of the subjects with anti-HI titer ≥1:40 28 days after QIV vaccination was 99.5% for A/H1N1; 99.5% for A/H3N2; 93.1% for B/Texas, and 99.0% for B/Phuket. The seroprotection, GMT, and seroconversion rates of QIV were not significantly different from those of TIV for the common vaccine strains (p > 0.01) and were significantly different from those of TIV for the added B/Phuket strains (p < 0.01). Most solicited injection-site and systemic reactions with either vaccine were mild to moderate and resolved within a few days. Conclusions QIV was immunogenic and well-tolerated and had immunogenicity and safety profiles compared with TIV for all common strains. The immunogenicity of the three batches of QIV was equivalent for the four strains.

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“…This study was conducted on subjects aged 9–40 years, while a previous study by Dhamayanti et al was conducted on infants to children aged 8 years [ 17 ]. The HI data showed a strong serological response for each of the shared influenza strains in the QIV and TIV groups and the percentage of subjects in the QIV group achieving a serum HI titer ≥40.…”

Section: Discussionmentioning

confidence: 99%

Immunogenicity and safety of Quadrivalent Influenza HA vaccine compared with Trivalent Influenza HA vaccine and evaluation of Quadrivalent Influenza HA vaccine batch-to-batch consistency in Indonesian children and adults

Fadlyana,

Dhamayanti,

Tarigan

et al. 2023

PLoS ONE

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One of the newest strategies developed by the Global Influenza Strategy has been to broaden the composition of the current influenza vaccine formulations from trivalent products to quadrivalent products. This study aimed to assess the immunogenicity and safety of Quadrivalent Influenza HA vaccine (QIV) compared with Trivalent Influenza HA vaccine (TIV) and to evaluate three consecutive batches of QIV equivalence in Indonesian children and adults. This was an experimental, randomized, double blind, four arm parallel group bridging study involving unprimed healthy children and adults aged 9–40 years. A total of 540 subjects were enrolled in this study and randomized into four arm groups. Each subject received one dose of TIV or QIV with three different batch codes. Serology tests were performed at baseline and 28 days after vaccination. Hemagglutination inhibition (HI) antibody titers were analyzed for Geometric Mean Titer (GMT), seroprotection, and seroconversion rates. Solicited, unsolicited, and serious adverse events were observed up to 28 days after vaccination. A total of 537 subjects completed the study per protocol and were analyzed for immunogenicity criteria. All randomized subjects were analyzed for safety criteria. The percentage of the subjects with anti-HI titer ≥1:40 28 days after QIV vaccination was 99.5% for A/H1N1; 99.5% for A/H3N2; 93.1% for B/Texas, and 99.0% for B/Phuket. The seroprotection, GMT, and seroconversion rates of QIV were not significantly different from those of TIV for the common vaccine strains (p > 0.01) and were significantly different from those of TIV for the added B/Phuket strains (p < 0.01). Most solicited injection-site and systemic reactions with either vaccine were mild to moderate and resolved within a few days. Antibody response to QIV were equivalence among vaccine batches and comparable between age groups for each of the 4 strains. QIV was immunogenic and well-tolerated and had immunogenicity and safety profiles compared with TIV for all common strains. The immunogenicity of the three batches of QIV was equivalent for the four strains. Trial registration. Clinical Trial registration: NCT03336593.

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Immunogenicity and safety of Quadrivalent Influenza HA vaccine in Indonesian children: An open-labeled, bridging, clinical study

Cited by 3 publications

References 19 publications

Post-Marketing Safety Surveillance of Quadrivalent Influenza Vaccine (VaxigripTetra) in Children Aged 6 to 35 Months in South Korea

Post-Marketing Safety Surveillance of Quadrivalent Influenza Vaccine (VaxigripTetra) in Children Aged 6 to 35 Months in South Korea

Immunogenicity and safety of Quadrivalent Influenza HA vaccine compared with Trivalent Influenza HA vaccine and evaluation of Quadrivalent Influenza HA vaccine batch-to-batch consistency in Indonesian children and adults

Immunogenicity and safety of Quadrivalent Influenza HA vaccine compared with Trivalent Influenza HA vaccine and evaluation of Quadrivalent Influenza HA vaccine batch-to-batch consistency in Indonesian children and adults

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