Phase 3 Study Comparing Safety and Immune Response of Three Batches of Novavax Flu Vaccine in older adult participants
This is a randomized, Phase 3 study comparing the safety and immunogenicity of 3 different lots of Novavax trivalent hemagglutinin (HA) nanoparticle influenza vaccine (NIV) with Matrix-M (tNIV) in terms of wild-type influenza hemagglutinin inhibition (HAI) antibody responses to 3 vaccine-homologous influenza strains (ie, 2 influenza A strains and an influenza B-Victoria lineage strain).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
tNIV will be administered as a single 0.5 mL IM injection Day 0
Safety- Solicited AEs over 7 days post-vaccination
Numbers and proportions of participants with solicited local and systemic AEs over the 7 days post-vaccination.
Time frame: 7 days post-vaccination
Safety- Unsolicited AEs and MAAEs over 28 days post-vaccination
Numbers and proportions of participants reporting unsolicited AEs and MAAEs over 28 days post-vaccination.
Time frame: Day 0 to 28
Safety-Treatment-related MAAEs, SAEs, and AESIs (including PIMMC)
Numbers and proportions of participants with treatment-related MAAEs, AESIs (including PIMMCs), and SAEs over 6 months (approximately 182 days) post-vaccination.
Time frame: Day-0 to 182
Immunogenicity-HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMT
HAI antibody titers specific for the HA receptor binding domains of vaccine response to 3 vaccine-homologous influenza strains (ie, 2 influenza A strains and an influenza B-Victoria lineage strain) at Day 28.
Time frame: Day-0 to 28
Immunogenicity-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 to 3 vaccine-homologous influenza strains (ie, 2 influenza A strains and an influenza B-Victoria lineage strain) at Day 28.
Time frame: Day-0 to 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 wild-type A and B influenza strains, as measured by a neutralization assay of vaccine response to 3 vaccine-homologous influenza strains (ie, 2 influenza A strains and an influenza B-Victoria lineage strain) at Day 28.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 0 to Day 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 wild-type A and B influenza strains, as measured by a neutralization assay of vaccine response to 3 vaccine-homologous influenza strains (ie, 2 influenza A strains and an influenza B-Victoria lineage strain) at Day 28 \[Post vaccination\].
Time frame: Day 28 [Post vaccination]
Influenza 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 wild-type A and B influenza strains, as measured by a neutralization assay of vaccine response to 3 vaccine-homologous influenza strains (ie, 2 influenza A strains and an influenza B-Victoria lineage strain) at Day 28 \[Post vaccination\].
Time frame: Day 28 [Post vaccination]