A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine
- Conditions
- COVID-19
- Interventions
- Biological: CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M AdjuvantBiological: tNIV VaccineBiological: Fluzone High Dose
- Registration Number
- NCT06291857
- Lead Sponsor
- Novavax
- Brief Summary
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.
- Detailed Description
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 \[EoS\]).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 9320
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description CIC Vaccine CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant A single 0.5 mL IM injection on Day 0 Novavax COVID-19 Vaccine Novavax COVID-19 Vaccine A single 0.5 mL IM injection on Day 0 tNIV Vaccine tNIV Vaccine A single 0.5 mL IM injection on Day 0 Fluzone High-Dose Fluzone High Dose A single 0.5 mL IM injection on Day 0
- Primary Outcome Measures
Name Time Method Numbers of participants with solicited local and systemic adverse events (AEs) 7 days post-vaccination Numbers of participants with solicited local and systemic AEs over the 7 days post-vaccination.
Numbers of participants reporting unsolicited AEs and medically attended adverse events (MAAEs). 28 days post-vaccination Numbers of participants reporting unsolicited AEs and MAAEs over 21 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) Day 0 to Day 364 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.
Hemagglutination Inhibition (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMT Days 0 and 28 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
Hemagglutination Inhibition (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMTR Days 28 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
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 Days 28 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
Neutralizing Antibody (NAb) Responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMT Days 28 Neutralizing Antibody (NAb) Responses Assessed against three homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Day 28
Neutralizing Antibody (NAb) Responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMTR Days 28 Neutralizing Antibody (NAb) Responses Assessed against three homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Day 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 Days 28 Neutralizing Antibody (NAb) Responses Assessed against three homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on 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 GMT Day 28 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
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 Day 28 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
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 Day 28 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
- Secondary Outcome Measures
Name Time Method 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) Days 28 HAI antibody titers specific for the HA receptor binding domains of vaccine response CIC vaccine compared to Fluzone High-Dose on Day 28
Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMFR Days 28 HAI antibody titers specific for the HA receptor binding domains of vaccine response CIC vaccine compared to Fluzone High-Dose on Day 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 Days 28 HAI antibody titers specific for the HA receptor binding domains of vaccine response CIC vaccine compared to Fluzone High-Dose on Day 28
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMTR Days 28 HAI antibody titers specific for the HA receptor binding domains of vaccine response CIC vaccine compared to Fluzone High-Dose on Day 28
Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMT Days 28 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
Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMFR Days 28 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
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 Days 28 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
Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMTR Days 28 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
Hemagglutination Inhibition (HAI) antibody titers to tNIV and Fluzone High-Dose Expressed as GMT Day 28 Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of vaccine-homologous influenza A and B strains on Day 28
Hemagglutination Inhibition (HAI) antibody titers to tNIV and Fluzone High-Dose Expressed as GMFR Day 28 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
Percentage of Participants with (HAI) antibody titers to tNIV and Fluzone High-Dose Expressed as SCR Day 28 Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of vaccine-homologous influenza A and B strains on Day 28
Influenza neutralizing antibody (NAb) responses of trivalent nanoparticle influenza vaccine (tNIV) comparable to Fluzone High-Dose Expressed as GMT Day 28 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.
Influenza neutralizing antibody (NAb) responses of trivalent nanoparticle influenza vaccine (tNIV) comparable to Fluzone High-Dose Expressed as GMFR Day 28 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.
Influenza neutralizing antibody (NAb) responses of trivalent nanoparticle influenza vaccine (tNIV) comparable to Fluzone High-Dose Expressed as GMTR Day 28 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.
Percentage of Participants with (NAb) responses of trivalent nanoparticle influenza vaccine (tNIV) comparable to Fluzone High-Dose Expressed as SCR Day 28 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.
Trial Locations
- Locations (58)
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
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
Oztrials Clinical Research
🇦🇺Drummoyne, New South Wales, Australia
Paratus Clinical Research - Central Coast - PPDS
🇦🇺Kanwal, New South Wales, Australia
Novatrials
🇦🇺Kotara, New South Wales, Australia
Australian Clinical Research Network
🇦🇺Maroubra, New South Wales, Australia
Hunter Diabetes Centre
🇦🇺Merewether, New South Wales, Australia
Sutherland Shire Clinical Research - PPDS
🇦🇺Miranda, New South Wales, Australia
Pioneer Clinical Research - North Sydney
🇦🇺North Sydney, New South Wales, Australia
Momentum St Leonards
🇦🇺Sydney, New South Wales, Australia
Taylor Square Private Clinic
🇦🇺Surry Hills, New South Wales, Australia
Innovate Clinical Research Pty Ltd
🇦🇺Sydney, New South Wales, Australia
Wollongong Clinical Research - PPDS
🇦🇺Wollongong, New South Wales, Australia
Menzies School of Health Research
🇦🇺Casuarina, Northern Territory, Australia
University of the Sunshine Coast, Vitality Village - UniSC Clinical Trials - PPDS
🇦🇺Birtinya, Queensland, Australia
Momentum Taringa
🇦🇺Brisbane, Queensland, Australia
Griffith University Clinical Trials Unit
🇦🇺Griffith, Queensland, Australia
Nucleus Network Pty Ltd
🇦🇺Herston, Queensland, Australia
Paratus Clinical Research - Brisbane Clinic - PPDS
🇦🇺Herston, Queensland, Australia
Veritus Research - Emeritus - PPDS
🇦🇺Bayswater, Victoria, Australia
Emeritus Research -PPDS
🇦🇺Camberwell, Victoria, Australia
Mater Hospital Brisbane
🇦🇺South Brisbane, Queensland, Australia
Cmax - Ppds
🇦🇺Adelaide, South Australia, Australia
Ryrie St, Geelong, VIC 3220, Australia
🇦🇺Geelong, Victoria, Australia
University of Melbourne - Melbourne
🇦🇺Melbourne N., Victoria, Australia
Doherty Clinical Trials Limited
🇦🇺Melbourne, Victoria, Australia
Nucleus Network Limited
🇦🇺Melbourne, Victoria, Australia
Momentum Sunshine
🇦🇺Melbourne, Victoria, Australia
Institute for Respiratory Health - Midland
🇦🇺Midland, Western Australia, Australia
Telethon Kids Institute
🇦🇺Nedlands, Western Australia, Australia
CliniTrials
🇦🇺Perth, Western Australia, Australia
Momentum Tauranga - PPDS
🇳🇿Tauranga, Bay Of Plenty, New Zealand
Momentum Hawke's Bay - PPDS
🇳🇿Hastings, Hawke's Bay, New Zealand
Momentum Dunedin - PPDS
🇳🇿Dunedin, Otago, New Zealand
Southern Clinical Trials - Totara - PCRN - PPDS
🇳🇿Auckland, New Zealand
Pacific Clinical Research Network - Auckland - PCRN - PPDS
🇳🇿Auckland, New Zealand
Optimal Clinical Trials Ltd - North Shore - PPDS
🇳🇿Auckland, New Zealand
Pacific Clinic Research Network - Rotorua - PCRN - PPDS
🇳🇿Rotorua, New Zealand
Momentum Kapiti - PPDS
🇳🇿Waikanae, New Zealand
Lakeland Clinical Trials - Wellington - PCRN - PPDS
🇳🇿Wellington, New Zealand
Momentum Wellington - PPDS
🇳🇿Wellington, New Zealand
Aotearoa Clinical Trials Trust
🇳🇿Wellington, New Zealand
Optimal Clinical Trials Ltd - PPDS
🇳🇿Auckland, New Zealand
Momentum Pukekohe - PPDS
🇳🇿Auckland, New Zealand
New Zealand Clinical Research - Christchurch - PPDS
🇳🇿Christchurch, New Zealand
Pacific Clinical Research Network - Christchurch - PCRN - PPDS
🇳🇿Christchurch, New Zealand
Lakeland Clinical Trials - Waikato - PCRN-PPDS
🇳🇿Hamilton, New Zealand
Momentum Lower Hutt - PPDS
🇳🇿Lower Hutt, New Zealand
Southern Clinical Trials - Tasman - PCRN - PPDS
🇳🇿Nelson, New Zealand
Momentum Palmerston North - PPDS
🇳🇿Palmerston North, New Zealand