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Randomized Controlled Trial
. 2023 Aug 24;18(8):e0281566.
doi: 10.1371/journal.pone.0281566. eCollection 2023.

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

Eddy Fadlyana  1 , Meita Dhamayanti  1 , Rodman Tarigan  1 , Susantina Prodjosoewojo  2 , Andri Reza Rahmadi  2 , Rini Mulia Sari  3 , Kusnandi Rusmil  1 , Cissy B Kartasasmita  1
Affiliations
Randomized Controlled Trial

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

Eddy Fadlyana et al. PLoS One. .

Abstract

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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Conflict of interest statement

Novilia Sjafri Bachtiar and Rini Mulia Sari are employees of PT Bio Farma at the time of the conduct of this study and manuscript preparation. PT Bio Farma Indonesia was involved in the study design, data collection, data analysis and preparation of the manuscript. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Flow Chart for the participants enrollment.
Fig 2
Fig 2. Hemagglutination inhibition (HI) Geometric Mean Titers (GMT) before and 28 days after QIV and TIV immunization.
Fig 3
Fig 3. Intensity of reported local and systemic adverse events (AEs).
Fig 4
Fig 4. Intensity of reported local and systemic AEs on each QIV batch.
See this image and copyright information in PMC

References

    1. World Health Ogranization. Strategic Objectives and Actions. 2018. Available from: https://apps.who.int/iris/rest/bitstreams/1137738/retrieve (accessed March 30, 2020).
    1. Grohskopf LA, Sokolow LZ, Broder KR, Olsen SJ, Karron RA, Jernigan DB, Bresee JS. Prevention and control of seasonal influenza with vaccines. MMWR Recomm Rep 2016;65:1–54. doi: 10.15585/mmwr.rr6505a1 - DOI - PubMed
    1. World Health Ogranization. Weekly Epidemiological Record. WHO. 2012: 87(47): 461–76. Available from: https://apps.who.int/iris/bitstream/handle/10665/241994/WER8747.PDF?sequ... (accessed March 30, 2020).
    1. Hay AJ, Gregory V, Douglas AR, Lin YP. The evolution of human influenza viruses. R Soc 2001:1861–70. doi: 10.1098/rstb.2001.0999 - DOI - PMC - PubMed
    1. Ambrose CS, Levin MJ. The rationale for quadrivalent influenza vaccines. Hum Vaccin Immunother 2012;8:81–8. doi: 10.4161/hv.8.1.17623 - DOI - PMC - PubMed

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