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Domestic influenza vaccine production facilitates a sustainable supply for mitigating seasonal influenza and improves national health security by providing infrastructure and experience for pandemic vaccine production, if needed. A Phase III, double blind, randomized controlled trial was conducted from Sep 2019-Oct 2020 in healthy adults 18–64 years in Nakhon Phanom, Thailand. Randomization (3:3:1) compared study vaccine (Tri Fluvac), saline placebo, and an active comparator (licensed vaccine). Primary outcomes were superior efficacy compared to placebo based on RT-PCR-confirmed influenza virus infection within 12 months and non-inferiority compared to active comparator based on immunogenicity (HAI assay) at 28 days. Safety was also assessed. The trial enrolled 4,284 participants (Tri Fluvac = 1,836; placebo = 1,836; active comparator = 612). There were 29 RT-PCR positive influenza infections (10 Tri Fluvac, 5.5/1,000 PY; 19 placebo, 10.4/1,000PY; 0 comparator) for an absolute protective efficacy of 46.4 (95 % CI = −22.0–76.5) compared with placebo, but the power was 43.7 %. Seroconversion difference rates between Tri Fluvac and comparator at Day 28 were 1.74 (95 % CI: −2.77, 6.25), 2.22 (−2.40, 6.84), and −0.57 (−5.41, 4.27) for A(H1N1), A(H3N2), and B strains, respectively. Adverse and severe adverse events occurred in 175 (9.5 %) Tri Fluvac, 177 (10.8 %) placebo, and 66 (10.8 %) comparator arms (p-value = 0.437, Tri Fluvac vs. comparator) Tri Fluvac was well tolerated, and immunogenicity was non-inferior to the active comparator, meeting U.S. Food and Drug Administration (FDA) criteria for adult vaccine licensure. Few acute respiratory infections were reported during intense COVID-19 pandemic restrictions, resulting in insufficient power to evaluate clinical efficacy. [ABSTRACT FROM AUTHOR]

Abstract Background We conducted a two-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community-dwelling Thai adults aged ≥65 years during 2015–16 and 2016–17 influenza seasons. Methods In 2015, we enrolled a cohort of 3220 participants. Trained health volunteers collected baseline data and followed participants for two years with weekly surveillance for new or worsened cough with self-collection of nasal swabs. Vaccine effectiveness (VE) was estimated as 100% × (1- rate ratio of rRT-PCR -confirmed influenza) among vaccinated versus unvaccinated participants. Propensity score stratification was used to reduce differences between vaccinated and unvaccinated participants associated with access to and receipt of IIV3. Findings During 2015–16 and 2016–17, 1666 (52%) and 1498 (48%) participants received IIV3, respectively. The overall incidence of influenza during the two seasons was 14.3/1000 person-years among vaccinated participants and 20.2/1000 person-years among unvaccinated participants. VE was −4% (95% confidence interval [CI], −83%–40%) during 2015–16 when there was poor antigenic match between the dominant circulating A/H3N2 viruses and the vaccine strain, and 50% (95% CI, 12–71%) during 2016–17 when circulating and vaccine strains were well-matched. Of all three influenza subtypes in both years, significant protection was observed only against Influenza A/H3N2 during 2016–17 (VE, 49%; 95% CI, 3–73%). Interpretation During a season with well-matched circulating and vaccine strains, IIV3 was moderately effective against laboratory-confirmed influenza among older adults in Thailand. [ABSTRACT FROM AUTHOR]

Background In 2009, Thailand recommended pregnant women be prioritized for influenza vaccination. Vaccine uptake among Thai pregnant women is lower than other high-risk groups. Methods During December 2012–April 2013, we conducted a cross-sectional survey of a convenience sample of Thai pregnant women aged ≥15 years attending antenatal clinics at public hospitals in 8 of 77 provinces. A self-administered questionnaire covered knowledge, attitudes, and beliefs related to influenza vaccination using the Health Belief Model. We examined factors associated with willingness to be vaccinated using log-binomial regression models. Results The survey was completed by 1031 (96%) of 1072 pregnant women approached. A total of 627 (61%) women had heard about influenza vaccine and were included in the analysis, of whom 262 (42%) were willing to be vaccinated, 155 (25%) had received a healthcare provider recommendation for influenza vaccination and 25 (4%) had received the influenza vaccine during the current pregnancy. In unadjusted models, high levels of perceptions of susceptibility (prevalence ratio [PR] 1.5, 95% CI 1.2–2.0), high levels of belief in the benefits of vaccination (PR 2.3, 95% CI 1.7–3.1), moderate (PR 1.7, 95% CI 1.2–2.3) and high (PR 3.4, 95% CI 2.6–4.5) levels of encouragement by others to be vaccinated (i.e., cues to action) were positively associated with willingness to be vaccinated. Moderate (PR 0.5, 95% CI 0.4–0.7) and high levels of (PR 0.5, 95% CI 0.4–0.8) perceived barriers were negatively associated with willingness to be vaccinated. In the final adjusted model, only moderate (PR 1.5, 95% CI 1.1–2.0) and high levels of cues to action (PR 2.7, 95% CI 2.0–3.6) were statistically associated with willingness to be vaccinated. Conclusion Cues to action were associated with willingness to be vaccinated and can be used to inform communication strategies during the vaccine campaign to increase influenza vaccination among Thai pregnant women. [ABSTRACT FROM AUTHOR]