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Fluarix tetra

Manufactured by GlaxoSmithKline
Sourced in United Kingdom

Fluarix Tetra is a quadrivalent influenza vaccine produced by GlaxoSmithKline. It is designed to protect against four different strains of the influenza virus.

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7 protocols using fluarix tetra

1

Influenza and BCG Vaccine Administration

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All participants received a single intramuscular dose (0.5 ml, pre-filled syringe) in the upper arm, of a quadrivalent inactivated influenza vaccine (FluQuadri, Sanofi-Aventis Australia; Fluarix Tetra, GSK Australia; or Afluria Quad, Seqirus Australia). Participant 65 years and older received adjuvanted quadrivalent influenza vaccine (Fluad Quad, Seqirus Australia). Participants randomised to the Influenza+BCG group were vaccinated within the same hour by trained BRACE trial staff with a single dose of BCG-Denmark (AJ Vaccines, Copenhagen), 0.1 ml (corresponding to 2–8 x105 colony forming units of Mycobacterium bovis, Danish strain 1331) given intradermally in the contralateral upper arm, using a short (10 mm) bevel needle (25G to 30G). All vaccinators were trained in intradermal delivery of BCG vaccine.
Participants were informed about the normal expected local reaction to influenza vaccination and BCG vaccination, and were instructed to contact study staff if they had any concerns.
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2

Adverse Events Comparison of Influenza Vaccines

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Rates of adverse events were summarized by brand and type for HD-IIV3 (Fluzone High-Dose [Sanofi-Aventis]), aIIV3 (FLUAD [Seqirus]), and all standard nonadjuvanted QIIV brands in use (ie, Fluarix Tetra [GlaxoSmithKline], FluQuadri [Sanofi-Aventis], Afluria Quad [Seqirus], and Influvac Tetra [Mylan Health]) (Table 1), although these were not preferentially recommended in the study age group. Rates were compared using Pearson χ2 test. Characteristics of respondents who received HD-IIV3 and aIIV3 alone or with a concomitant vaccine were compared using Pearson χ2 test. P values were 2-sided, and statistical significance was set at P < .05.
Univariate analysis identified variables (chosen a priori) associated with adverse events and medical attention. Variables were included in a multivariable general linear model with Poisson distribution if they had a P < .25. Variables were retained in the multivariable model if they had a P < .05. All analysis was conducted in Stata statistical software version 14.2 (StataCorp). Analyses were conducted from September 1, 2018, to June 30, 2019.
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3

Influenza Vaccination and Pneumococcal Colonization

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Healthy adult volunteers were 1:1 randomized to receive either intranasally LAIV (2015/2016 Fluenz Tetra or FluMist Tetra, AstraZeneca, UK) or intramuscular Quadrivalent Inactivated Influenza Vaccination (Fluarix Tetra, GlaxoSmithKline, UK) as described previously 14 (link). The control group also received a nasal saline spray, while the LAIV group also received a intramuscular saline injection. Three days post vaccination all subjects were inoculated with 80,000 CFU per nostril of 6B type Spn as described 6 (link),51 (link). Nasal microbiopsies (ASL Rhino-Pro©, Arlington Scientific) and nasal lining fluid (Nasosorption™, Hunt Developments) samples were collected and stored at -80C as previously described 52 (link).
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4

Intranasal LAIV vs Quadrivalent Influenza Vaccination

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Healthy adult volunteers were 1:1 randomized to receive either intranasal LAIV (2015/2016 Fluenz Tetra or FluMist Tetra, AstraZeneca) or intramuscular quadrivalent inactivated influenza vaccination (Fluarix Tetra, GlaxoSmithKline), as described previously14 . The control group also received a nasal saline spray, while the LAIV group also received an intramuscular saline injection. Three days post-vaccination, all subjects were inoculated with 80,000 colony-forming units (CFU) per nostril of S. pneumoniae 6B type as described previously6 (link),51 . Nasal microbiopsies (ASL Rhino-Pro, Arlington Scientific) and nasal lining fluid samples (Nasosorption, Hunt Developments) were collected and stored at −80 °C as previously described52 (link).
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5

Pediatric Influenza Vaccine Effectiveness

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All the patients were enrolled at the Children’s Hospital Bambino Gesù in Rome between October 2015 and October 2016. It was a prospective observational study involving pediatric patients aged 3 to 15 years scheduled for elective tonsillectomy. Apart from fulfilling the criteria for tonsillectomy, our patients are otherwise healthy, showing no sign of immune compromise. They had not been vaccinated against influenza during the previous years. Children in the vaccine arm had been immunized with the quadrivalent vaccine (Fluarix Tetra; GlaxoSmithKline Biologicals) consisting of 60 micrograms (mcg) hemagglutinin (HA) per 0.5 ml dose, in the recommended ratio of 15 mcg of HA each of the following virus strains: A/California/7/2009 (H1N1), A/Switzerland/9715293/2013 (H3N2), B/Phuket/3073/2013 and B/Brisbane/60/2008.
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6

Randomized Nasal Flu Vaccine Study

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The study was conducted as previously described [18] (link). Briefly, participants were randomised to receive either nasal LAIV (Fluenz Tetra or FluMist Tetra, AstraZeneca, UK; used interchangeably due to procurement shortages; both are pharmaceutically identical but have different packaging and labelling) with an intramuscular placebo (0.5 mL normal saline), or a nasal placebo (0.2 mL normal saline) with an intramuscular Tetravalent Inactivated Influenza Vaccination (TIV) (Fluarix Tetra, GlaxoSmithKline, UK). Participants were blindfolded during administration, with blinding maintained until completion of primary analysis. Experimental pneumococcal challenge comprised 80,000 colony forming-units (CFU) of penicillin-susceptible, mid-log phase grown Streptococcus pneumoniae serotype 6B (strain BHN418) in 0.1 mL saline instilled by laboratory pipette into each nostril [22] .
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7

Influenza and Pneumococcal Vaccination Trends

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A total of 105,386 adults (age ≥ 17 years-old), who visited the Chang Gung Memorial Hospital (CGHM) institutions and received an influenza or pneumococcal vaccine between January 2018 and December 2021, were enrolled in the study.
In Taiwan, government-funded annual influenza vaccines are provided to individuals aged >50 years, healthcare workers, and people with risk factors for severe influenza development. Government-funded pneumococcal vaccines include pneumococcal polysaccharide vaccine (PPSV23, Pneumovax® NP Merck & Co., Inc., Kenilworth, NJ, USA) and are provided to senior citizens, as defined by the local government. Adults may choose PCV13 (Prevenar13® Pfizer Inc., New York, NY, USA) at their own expense. Influenza vaccine included Vaxigrip Tetra® (Sanofi Pasteur, Val de reuil Cedex, France), Fluarix Tetra® (GlaxoSmithKline Biologicals, Dresden, Germany), AdimFlu-S (QIS)® (Adimmune Inc., Taichung, Taiwan) and FLUCELVAX QUAD® (CSL Behring GmBH, Marburg, Germany). These vaccines were provided randomly to public in Taiwan according to the purchase amount by government since October every year.
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