This is a medical study where participants will be randomly assigned to receive either a new combination vaccine that protects against both COVID-19 and the flu, or a standard flu vaccine. The researchers conducting the study won't know which vaccine each participant receives, ensuring their observations are unbiased. This study compares the new combination vaccine to an already available flu vaccine to see how well it works. It's a large-scale, final-stage study designed to thoroughly check how well the vaccines trigger an immune response (immunogenicity) and how safe they are.
The study will enroll up to approximately 7,022,000 medically stable (based on history and physical examination) adult male and female participants ≥ 65 65 years of age in Part 1 and up to approximately 2,300 medically stable (based on history and physical examination) adult male and female participants ≥ 65 years of age in Part 2. In Part 1, pParticipants will be randomly assigned to receive either CIC, Novavax COVID-19 Vaccine, tNIV, or Fluzone High-Dose in a 3:2:1:3 ratio, respectively. All participants will receive a single intramuscular (IM) injection on Day 0, will remain on study for immunogenicity data collection through Day 182 and safety data collection through Day 364 (End of Study \[EoS\]).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
9,320
CIC will contain SARs-CoV-2 antigen (35 μg), tNIV antigens (2 influenza A \[H1N1 and H3N2\] and 1 influenza B-Victoria lineage strains; 60 μg/strain
Each 0.5 mL dose comprises 5 µg SARS-CoV-2 S protein and 50 µg Matrix-M adjuvant
2 influenza A \[H1N1 and H3N2\] and 1 influenza B-Victoria lineage strains (60 μg/strain), and Matrix-M adjuvant (75 μg)
Fluzone High-Dose is supplied as a suspension for IM injection 0.5 mL with 60 µg per strain
Paratus Clinical Research - Canberra - PPDS
Bruce, Australian Capital Territory, Australia
Momentum Wellers
Wellers Hill, Brisbane, Australia
Paratus Clinical Research - Western Sydney - PPDS
Blacktown, New South Wales, Australia
Key Health- Bondi Junction
Bondi Junction, New South Wales, Australia
Emeritus Research - Sydney - PPDS
Botany, New South Wales, Australia
Numbers of participants with solicited local and systemic adverse events (AEs)
Numbers of participants with solicited local and systemic AEs over the 7 days post-vaccination.
Time frame: 7 days post-vaccination
Numbers of participants reporting unsolicited AEs and medically attended adverse events (MAAEs).
Numbers of participants reporting unsolicited AEs and MAAEs over 21 days post-vaccination.
Time frame: 28 days post-vaccination
Treatment-related MAAEs, serious adverse events (SAEs), and adverse events of special interest (AESIs) (including potential immune-mediated medical conditions [PIMMCs] and myocarditis and/or pericarditis)
Numbers of participants with treatment-related MAAEs, AESIs (including PIMMC and myocarditis and/or pericarditis), and SAEs will be collected for 12 months (approximately 364 days) post-vaccination.
Time frame: Day 0 to Day 364
Hemagglutination Inhibition (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMT
Hemagglutination Inhibition (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose of homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Days 0 and 28
Time frame: Days 0 and 28
Hemagglutination Inhibition (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMTR
Hemagglutination Inhibition (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose of homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Days 28
Time frame: Days 28
Percentage of Participants With a (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose for 3 vaccine-homologous influenza strains Expressed as SCR
Percentage of Participants With a (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose for 3 vaccine-homologous influenza strain on Days 28
Time frame: Days 28
Neutralizing Antibody (NAb) Responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMT
Neutralizing Antibody (NAb) Responses Assessed against three homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Day 28
Time frame: Days 28
Neutralizing Antibody (NAb) Responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMTR
Neutralizing Antibody (NAb) Responses Assessed against three homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Day 28
Time frame: Days 28
Percentage of Participants With a (NAb) Responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as SCR
Neutralizing Antibody (NAb) Responses Assessed against three homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Day 28
Time frame: Days 28
Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of (tNIV) comparable to Fluzone High-Dose of homologous influenza A and B strains expressed as GMT
Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of (tNIV) comparable to Fluzone High-Dose of 2 influenza A strains and an influenza B-Victoria lineage strain) on Day 28
Time frame: Day 28
Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of (tNIV) comparable to Fluzone High-Dose of homologous influenza A and B strains expressed as GMTR
Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of (tNIV) comparable to Fluzone High-Dose of 2 influenza A strains and an influenza B-Victoria lineage strain) on Day 28
Time frame: Day 28
Percentage of Participants with (HAI) antibody titers specific to HA receptor-binding domains of (tNIV) comparable to Fluzone High-Dose of homologous influenza A and B strains expressed as SCR
Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of (tNIV) comparable to Fluzone High-Dose of 2 influenza A strains and an influenza B-Victoria lineage strain) on Day 28
Time frame: Day 28
Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as Geometric Mean Titers (GMT)
HAI antibody titers specific for the HA receptor binding domains of vaccine response CIC vaccine compared to Fluzone High-Dose on Day 28
Time frame: Days 28
Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMFR
HAI antibody titers specific for the HA receptor binding domains of vaccine response CIC vaccine compared to Fluzone High-Dose on Day 28
Time frame: Days 28
Percentage of Participants with HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as SCR
HAI antibody titers specific for the HA receptor binding domains of vaccine response CIC vaccine compared to Fluzone High-Dose on Day 28
Time frame: Days 28
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMTR
HAI antibody titers specific for the HA receptor binding domains of vaccine response CIC vaccine compared to Fluzone High-Dose on Day 28
Time frame: Days 28
Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMT
Neutralizing antibody titers specific to vaccine homologous influenza strains (ie, 2 influenza A strains and an influenza B-Victoria lineage strain) as measured by a neutralization assay, CIC and Fluzone High Dose on Day 28
Time frame: Days 28
Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMFR
Neutralizing antibody titers specific to vaccine homologous influenza strains (ie, 2 influenza A strains and an influenza B-Victoria lineage strain) as measured by a neutralization assay, CIC and Fluzone High Dose on Day 28
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Genesis Research Services
Broadmeadow, New South Wales, Australia
Northern Beaches Clinical Research - PPDS
Brookvale, New South Wales, Australia
Northside Health
Coffs Harbour, New South Wales, Australia
East Sydney Doctors
Darlinghurst, New South Wales, Australia
Momentum Darlinghurst
Darlinghurst, New South Wales, Australia
...and 48 more locations
Time frame: Days 28
Percentage of Participants with a NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as SCR
Neutralizing antibody titers specific to vaccine homologous influenza strains (ie, 2 influenza A strains and an influenza B-Victoria lineage strain) as measured by a neutralization assay, CIC and Fluzone High Dose on Day 28
Time frame: Days 28
Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMTR
Neutralizing antibody titers specific to vaccine homologous influenza strains (ie, 2 influenza A strains and an influenza B-Victoria lineage strain) as measured by a neutralization assay, CIC and Fluzone High Dose on Day 28
Time frame: Days 28
Hemagglutination Inhibition (HAI) antibody titers to tNIV and Fluzone High-Dose Expressed as GMT
Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of vaccine-homologous influenza A and B strains on Day 28
Time frame: Day 28
Hemagglutination Inhibition (HAI) antibody titers to tNIV and Fluzone High-Dose Expressed as GMFR
Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of vaccine-homologous influenza A and B strains on Day 28 homologous SARS-CoV-2 strain CIC, Fluarix or Fluzone HD, and Novavax COVID-19 Vaccine expressed as SCR
Time frame: Day 28
Percentage of Participants with (HAI) antibody titers to tNIV and Fluzone High-Dose Expressed as SCR
Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of vaccine-homologous influenza A and B strains on Day 28
Time frame: Day 28
Influenza neutralizing antibody (NAb) responses of trivalent nanoparticle influenza vaccine (tNIV) comparable to Fluzone High-Dose Expressed as GMT
Influenza neutralizing antibody (NAb) responses of trivalent nanoparticle influenza vaccine (tNIV) comparable to Fluzone High-Dose against three influenza strains (two A strains and one B-Victoria strain) on Day 28.
Time frame: Day 28
Influenza neutralizing antibody (NAb) responses of trivalent nanoparticle influenza vaccine (tNIV) comparable to Fluzone High-Dose Expressed as GMFR
Influenza neutralizing antibody (NAb) responses of trivalent nanoparticle influenza vaccine (tNIV) comparable to Fluzone High-Dose against three influenza strains (two A strains and one B-Victoria strain) on Day 28.
Time frame: Day 28
Influenza neutralizing antibody (NAb) responses of trivalent nanoparticle influenza vaccine (tNIV) comparable to Fluzone High-Dose Expressed as GMTR
Influenza neutralizing antibody (NAb) responses of trivalent nanoparticle influenza vaccine (tNIV) comparable to Fluzone High-Dose against three influenza strains (two A strains and one B-Victoria strain) on Day 28.
Time frame: Day 28
Percentage of Participants with (NAb) responses of trivalent nanoparticle influenza vaccine (tNIV) comparable to Fluzone High-Dose Expressed as SCR
Influenza neutralizing antibody (NAb) responses of trivalent nanoparticle influenza vaccine (tNIV) comparable to Fluzone High-Dose against three influenza strains (two A strains and one B-Victoria strain) on Day 28.
Time frame: Day 28