Licensed seasonal quadrivalent (FluQuadri®, Sanofi, New York, PA, USA) influenza vaccines were administered to all enrolled participants. Vaccine composition for both 2019 and 2020 contained antigens from the four recommended influenza strains: A/H3N2, A/H1N1, B/(Victoria), and B/(Yamagata). For A/H3N2, the FluQuadri®, vaccine composition included antigens from A/Switzerland/8060/2017 (H3N2)-like virus in 2019 and A/South Australia/34/2019 (H3N2)-like virus in 2020. For A/H1N1, the FluQuadri®, vaccine composition included antigens from A/Michigan/45/2015 (H1N1)pdm09-like virus (2019) and A/Brisbane/02/2018 (H1N1)pdm09-like virus (2020). For B/(Victoria) lineage strains, antigens from a B/Colorado/06/2017-like virus (B/Victoria lineage) were used in the 2019 formulation and B/Washington/02/2019-like virus antigens were included in the 2020 vaccine. For B/(Yamagata), antigens from a B/Phuket/3073/2013-like virus (B/Yamagata lineage) were used for both the 2019 and 2020 formulation Vaccines were administered according to the Australian Immunisation handbook recommendations by trained immunisation nurses or study doctors [8 ].
Fluquadri
Manufactured by Sanofi
Sourced in Australia
FluQuadri is a quadrivalent influenza vaccine developed by Sanofi. It is designed to protect against four different strains of the influenza virus. The core function of FluQuadri is to provide protection against seasonal influenza.
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6 protocols using fluquadri
1
Seasonal Quadrivalent Influenza Vaccine Composition
2
Comparison of 2018 Southern Hemisphere IIV
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All participants received the 2018 southern hemisphere IIV appropriate for their age group and provided by their workplace or residence. Participants aged 18–50 years received standard dose QIV containing 15 μg of each HA (Afluria®Quad, Seqirus, Australia, or FluQuadri™, Sanofi, France). Participants aged ≥65 years received either Fluzone® High‐Dose (Sanofi) TIV containing 60 μg of each HA, or FLUAD® (Seqirus) adjuvanted TIV with 15 μg of each HA and formulated with MF59C.1. The vaccine compositions included A/Michigan/45/2015 (H1N1)pdm09‐like, A/Singapore/INFIMH‐16‐0019/2016 (H3N2)‐like and B/Phuket/3073/2013‐like viruses for TIV, and B/Brisbane/60/2008‐like virus included for QIV.
3
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.
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.
4
Seasonal Influenza Vaccine Assessment
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Recruitment occurred between February and May each study year, prior to the southern-hemisphere winter. Clinical assessment questionnaire, blood collection and spirometry were performed at the first clinic visit (day 0), prior to intramuscular administration of a single standard dose of the seasonal inactivated, trivalent or quadrivalent, split-virion influenza vaccine (FluQuadri™, Sanofi Pasteur). The vaccine consisted of 15 μg HA of each strain without adjuvant: Table 1 lists the vaccine composition in each year. Study participants returned for further blood collection 28 days p.i. to determine serum antibody levels. Further information regarding study design can be found in the Supplementary Methods.
5
IIV3 and IIV4 Immunization Trials
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The 2015 IIV3 immunisation trial is fully described elsewhere29 (link) and registered as NCT02632578 . Briefly, 30 healthy Australian adults (mean age 40.4 years) were vaccinated with the 2015 IIV3 (bioCSL Fluvax®) containing 15 μg of hemagglutinin from A/California/7/2009-like (pdmH1N1), A/Switzerland/9715293/2013 (H3N2)-like and B/Phuket/3073/2013-like strains. Blood samples were taken at baseline (d0) and d28 post-immunisation and sera, plasma and PBMCs were cryopreserved prior to use. For the 2016 IIV4 trial, 20 healthy adults were administered Sanofi FluQuadri® vaccine containing A/California/07/2009-like virus (pdmH1N1), A/Hong Kong/4801/2014-like virus (H3N2), B/Phuket/3073/2013-like virus and B/Brisbane/60/2008-like virus components. Sera, plasma and PBMCs were collected and cryopreserved from d0 and day 28. Participant information is summarised in Supplementary Figure 14 .
6
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.
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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