A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine

Phase 3

Not yet recruiting

• Conditions: COVID-19
• Interventions: Biological: CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant; Biological: Novavax COVID-19 Vaccine; Biological: tNIV Vaccine; Biological: Fluzone High Dose

• Registration Number: NCT06291857
• Lead Sponsor: Novavax

Brief Summary

The goal of this Phase 3 study is to compare the effectiveness, safety, and side effects of the CIC vaccine with approved flu vaccines and the Novavax COVID-19 Vaccine with adjuvant.

Detailed Description

This is a large study to test how well a new combination vaccine for COVID-19 and influenza (the CIC vaccine) works in adults 65 and older compared to other vaccines. The study will check if the CIC vaccine triggers a similar or better immune response (measured by antibody levels) than the Fluzone High-Dose influenza vaccine and the Novavax COVID-19 vaccine. It will also test a new, standalone flu vaccine (tNIV) to see if it works as well as Fluzone High-Dose.

The study has two parts:

Part 1 will include up to 7,020 adults and will test how well both CIC and tNIV vaccines trigger an immune response and track side effects.

Part 2 will include up to 2,300 adults to further monitor the safety of both vaccines.

Study Timeline

• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-01
• Study First Posted: 2024-03-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22
• Study Start: 2024-12-09
• Primary Completion: 2025-02-25
• Study Completion: 2026-02-24

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 9320

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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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
Part 1 and Part 2 Safety- Numbers of participants with solicited local and systemic AEs	7 days post-vaccination	Numbers of participants with solicited local and systemic AEs over the 7 days post-vaccination.
Part 1 and Part 2 Safety-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.
Part 1 and Part 2 Safety-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) over 6 months	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.
Part-1 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
Part-1 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
Part-1 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
Part-1 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
Part-1 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
Part-1 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
Part-1 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
Part-1 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
Part-1 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
Part-1 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
Part-1 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
Part-1 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
Part-1 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
Part-1 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
Part-1 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
Part-1 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
Part-1 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
Part-1 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
Part-1 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
Part-1 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
Part-1 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.
Part-1 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.
Part-1 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.
Part-1 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

Taylor Square Private Clinic; 🇦🇺 Surry Hills, New South Wales, Australia

Momentum St Leonards; 🇦🇺 Sydney, 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

Mater Hospital Brisbane; 🇦🇺 South Brisbane, Queensland, Australia

Cmax - Ppds; 🇦🇺 Adelaide, South Australia, Australia

Veritus Research - Emeritus - PPDS; 🇦🇺 Bayswater, Victoria, Australia

Emeritus Research -PPDS; 🇦🇺 Camberwell, Victoria, 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

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

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