Lot Consistency Study of COVID-19 and Influenza Combination Vaccine
NCT Number: NCT06482359
Acronym: CIC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: COVID-19|Influenza
Interventions: BIOLOGICAL: coformulated CIC Vaccine|BIOLOGICAL: Fluzone HD trivalent
Sponsor: Novavax
Sex: ALL
Age: OLDER_ADULT
Enrollment: 1925
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-11-01
Completion Date: 2025-05-17

Summary:
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+

Primary Outcome Measures: Numbers of participants with solicited local and systemic AEs., Numbers of participants with solicited local and systemic AEs over the 7 days post-vaccination., 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., 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)., 6 months (approximately 182 days) post-vaccination.
Secondary Outcome Measures: 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, 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., 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 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, 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., 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, 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., 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, 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, Day- 0 to 28