The goal of Phase 3 Study is Comparing the Safety and Immune Response of Three Batches of a COVID-19 and Flu Combination Vaccine in Seniors Aged 65+
This is a randomized, Phase 3 study comparing the safety and immunogenicity of 3 different lots of Novavax coronavirus disease 2019 (COVID-19) and influenza combination (CIC) vaccine in terms of wild-type influenza hemagglutinin inhibition (HAI) antibody responses to 3 vaccine-homologous influenza strains (i.e., 2 influenza A strains and an influenza B-Victoria lineage strain) and 1 IM dose of Fluzone HD in terms of the neutralizing antibody (NAb) responses to the homologous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
SARS-CoV-2 rS (35 µg) + trivalent hemagglutinin nanoparticle influenza (tNIV) antigen (180 µg; 60 µg per strain) + Matrix-M adjuvant (75 µg)
60 µg per strain of 3 strains (sodium phosphate buffered isotonic sodium chloride solution + formaldehyde and octyl phenol ethoxylate)
Numbers of participants with solicited local and systemic 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 medically attended adverse events (MAAEs) over 28 days post-vaccination.
Time frame: 28 days post-vaccination.
Number of participants with MAAEs, SAEs, AESIs (including [PIMMCs] and myocarditis and/or pericarditis).
Numbers of participants with Medical Attended Adverse Events (MAAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) (including potential immune-mediated medical conditions \[PIMMCs\] and myocarditis and/or pericarditis).
Time frame: 6 months (approximately 182 days) post-vaccination.
Hemagglutination-inhibition (HAI) antibody titers specific for the Hemagglutinin (HA) receptor binding domains of vaccine homologous Influenza A and B strains expressed as Geometric Mean Titer (GMT)
HAI antibody titers specific for the Hemagglutinin (HA) receptor binding domains of vaccine response to immunization of 3 lots of CIC vaccine to 3 vaccine-homologous influenza strains at Days 0 and 28 Expressed as GMT
Time frame: Day 0 to Day 28
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A and B strains expressed as Geometric Mean Fold Rise (GMFR)
HAI antibody titers specific for the HA receptor binding domains of vaccine response to immunization of 3 lots of CIC vaccine to 3 vaccine-homologous influenza strains at Days 0 and 28 Expressed as GMFR.
Time frame: Day 0 to Day 28
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HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A and B strains expressed as Geometric Mean Titer Ratio (GMTR)
HAI antibody titers specific for the HA receptor binding domains of vaccine response to immunization of 3 lots of CIC vaccine to 3 vaccine-homologous influenza strains at Days 0 and 28 Expressed as GMTR
Time frame: Day 0 to Day 28
HAI antibody Titers specific for the Hemagglutinin (HA) receptor binding domains of vaccine- homologous influenza strains A and B Expressed as Seroconversion Rate (SCR)
HAI antibody titers specific for the HA receptor binding domains of vaccine response to immunization of 3 lots of CIC vaccine to 3 vaccine-homologous influenza strains at Days 0 and 28 Expressed as SCR.
Time frame: Day 0 to Day 28
Neutralizing Antibody (NAb)specific to vaccine homologous wild-type influenza strains A and B Expressed as GMT.
Neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, as measured by a neutralization assay CIC vaccine Expressed as GMT
Time frame: Day- 0 to 28
Neutralizing Antibody (NAb)specific to vaccine homologous wild-type influenza strains A and B Expressed as GMFR.
Neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, as measured by a neutralization assay CIC vaccine Expressed as GMFR.
Time frame: Day- 0 to 28
Number of participants of Neutralizing antibody titers specific to vaccine-matched wild-type A and B influenza strains expressed as GMTR.
Neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, as measured by a neutralization assay CIC vaccine Expressed as GMTR
Time frame: Day- 0 to 28
Percentage of Participants with a Neutralizing Antibody (NAb)specific to vaccine homologous wild-type influenza strains A and B expressed as SCR.
Neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, as measured by a neutralization assay CIC vaccine Expressed as SCR
Time frame: Day- 0 to 28