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

NCT06291857 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CIC-E-301
• Study Type: interventional
• Target: 9,320
• Locations: 2 countries
• Sites: 58

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.

Conditions

COVID-19

Keywords

CIC (Coronavirus Disease 2019 Influenza Combination); Influenza; Fluzone High-Dose

Outcome Measures

Primary Outcomes (12)

• Numbers of participants with solicited local and systemic adverse events (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 MAAEs over 21 days post-vaccination.

  28 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)

  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.

  Day 0 to Day 364

• Hemagglutination Inhibition (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMT

  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

  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

  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

  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

  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

  Days 28

• Neutralizing Antibody (NAb) Responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMT

  Neutralizing Antibody (NAb) Responses Assessed against three homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Day 28

  Days 28

• Neutralizing Antibody (NAb) Responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMTR

  Neutralizing Antibody (NAb) Responses Assessed against three homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Day 28

  Days 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

  Neutralizing Antibody (NAb) Responses Assessed against three homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Day 28

  Days 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

  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

  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

  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

  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

  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

  Day 28

Secondary Outcomes (15)

• 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

• Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMFR

  Days 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 homologous A and B influenza strains Expressed as GMTR

  Days 28

• Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMT

  Days 28

Study Arms (4)

CIC Vaccine

EXPERIMENTAL

A single 0.5 mL IM injection on Day 0

Biological: CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant

Novavax COVID-19 Vaccine

EXPERIMENTAL

A single 0.5 mL IM injection on Day 0

Biological: Novavax COVID-19 Vaccine

tNIV Vaccine

EXPERIMENTAL

A single 0.5 mL IM injection on Day 0

Biological: tNIV Vaccine

Fluzone High-Dose

EXPERIMENTAL

A single 0.5 mL IM injection on Day 0

Biological: Fluzone High Dose

Interventions

CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant BIOLOGICAL

CIC will contain SARs-CoV-2 antigen (35 μg), tNIV antigens (2 influenza A \[H1N1 and H3N2\] and 1 influenza B-Victoria lineage strains; 60 μg/strain

Also known as: COVID-19 and influenza combination

CIC Vaccine

Novavax COVID-19 Vaccine BIOLOGICAL

Each 0.5 mL dose comprises 5 µg SARS-CoV-2 S protein and 50 µg Matrix-M adjuvant

Also known as: Novavax SARS-CoV-2 rS vaccine

Novavax COVID-19 Vaccine

tNIV Vaccine BIOLOGICAL

2 influenza A \[H1N1 and H3N2\] and 1 influenza B-Victoria lineage strains (60 μg/strain), and Matrix-M adjuvant (75 μg)

Also known as: Trivalent Nanoparticle Influenza Hemagglutinin Vaccine

tNIV Vaccine

Fluzone High Dose BIOLOGICAL

Fluzone High-Dose is supplied as a suspension for IM injection 0.5 mL with 60 µg per strain

Also known as: Fluzone HD

Fluzone High-Dose

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• To be included in this study, each individual must satisfy all the following criteria:
• Willing and able to give informed consent prior to study enrollment.
• Medically stable adult male or female ≥ 65 years of age at Screening.
• Participants may have 1 or more chronic medical diagnoses, but should be clinically stable as assessed by:
• Absence of changes in medical therapy in the past 2 months due to treatment failure or toxicity;
• Absence of medical events qualifying as SAEs within 3 months; and
• Absence of known, current, and life-limiting diagnoses which render survival to completion of the protocol unlikely in the opinion of the Investigator.
• The participant has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, at Screening.
• Participant must be able to receive an injection in the deltoid of at least 1 arm.
• Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AEs.
• Participants must have completed a primary vaccination series/booster against SARS CoV-2 with an authorized/approved COVID-19 vaccine, with receipt of last dose of authorized/approved vaccine (with or without boosters\[s\]) ≥ 8 weeks prior to vaccination.
• Female participants must be surgically sterile (ie, have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or postmenopausal (defined as amenorrhea at least 12 consecutive months)
• Participants must agree to not participate in any other SARS-CoV-2 or influenza prevention or treatment studies for the duration of the study. Note: For participants who become hospitalized with COVID-19 or influenza, participation in investigational treatment studies is permitted.

You may not qualify if:

• If an individual meets any of the following criteria, he or she is ineligible for this study:
• History of laboratory-confirmed (by polymerase chain reaction \[PCR\], rapid antigen test, or rapid molecular assay) COVID-19, asymptomatic SARS-CoV-2 infection, or influenza within ≤ 8 weeks prior to Screening.
• Any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness that required substantive changes in medication in the past 2 months prior to Screening indicating that chronic illness/disease is not stable (at the discretion of the investigator). This includes any current workup of undiagnosed illness that could lead to a new condition.
• Serious chronic diseases inclusive of:
• Congestive heart failure requiring hospitalization within 3 months prior to Screening
• Hospitalization for diabetic ketoacidosis within 6 months prior to Screening
• Chronic kidney disease/renal requiring institution of substantive new therapy within 3 months prior to Screening
• Chronic neurological diseases or neurological compromise preventing access to the study clinic, compliance with protocol, or accurate reporting of safety.
• Participation in research involving an investigational product (drug/biologic/device) within 90 days before planned date of vaccination.
• Use of COVID-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to planned date of vaccination.
• History of a serious reaction to a prior influenza vaccination or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80; or any known allergies to products contained in the investigational product.
• Any history of anaphylaxis to any prior vaccine.
• History of Guillain-Barré Syndrome following a previous influenza vaccine.
• Receipt of any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within 2 months preceding the study vaccination. Note: Routine vaccinations will not be allowed until after study Day 21 and COVID-19 and influenza vaccination will not be allowed until after Day 84.
• Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccines. An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids is permitted.

Sponsors & Collaborators

• Novavax: lead

Study Sites (58)

Paratus Clinical Research - Canberra - PPDS

Bruce, Australian Capital Territory, 2617, Australia

Location

Momentum Wellers

Wellers Hill, Brisbane, 4121, Australia

Location

Paratus Clinical Research - Western Sydney - PPDS

Blacktown, New South Wales, 2148, Australia

Location

Key Health- Bondi Junction

Bondi Junction, New South Wales, 2022, Australia

Location

Emeritus Research - Sydney - PPDS

Botany, New South Wales, 2019, Australia

Location

Genesis Research Services

Broadmeadow, New South Wales, 2292, Australia

Location

Northern Beaches Clinical Research - PPDS

Brookvale, New South Wales, 2100, Australia

Location

Northside Health

Coffs Harbour, New South Wales, 2450, Australia

Location

East Sydney Doctors

Darlinghurst, New South Wales, 2010, Australia

Location

Momentum Darlinghurst

Darlinghurst, New South Wales, 2010, Australia

Location

Oztrials Clinical Research

Drummoyne, New South Wales, 2047, Australia

Location

Paratus Clinical Research - Central Coast - PPDS

Kanwal, New South Wales, 2259, Australia

Location

Novatrials

Kotara, New South Wales, 2289, Australia

Location

Australian Clinical Research Network

Maroubra, New South Wales, 2035, Australia

Location

Hunter Diabetes Centre

Merewether, New South Wales, 2291, Australia

Location

Sutherland Shire Clinical Research - PPDS

Miranda, New South Wales, 2228, Australia

Location

Pioneer Clinical Research - North Sydney

North Sydney, New South Wales, 2060, Australia

Location

Taylor Square Private Clinic

Surry Hills, New South Wales, 2010, Australia

Location

Momentum St Leonards

Sydney, New South Wales, 2065, Australia

Location

Innovate Clinical Research Pty Ltd

Sydney, New South Wales, 2077, Australia

Location

Wollongong Clinical Research - PPDS

Wollongong, New South Wales, 2500, Australia

Location

Menzies School of Health Research

Casuarina, Northern Territory, 0810, Australia

Location

University of the Sunshine Coast, Vitality Village - UniSC Clinical Trials - PPDS

Birtinya, Queensland, 4575, Australia

Location

Momentum Taringa

Brisbane, Queensland, 4068, Australia

Location

Griffith University Clinical Trials Unit

Griffith, Queensland, 4222, Australia

Location

Nucleus Network Pty Ltd

Herston, Queensland, 4006, Australia

Location

Paratus Clinical Research - Brisbane Clinic - PPDS

Herston, Queensland, 4006, Australia

Location

Mater Hospital Brisbane

South Brisbane, Queensland, 4101, Australia

Location

Cmax - Ppds

Adelaide, South Australia, 5000, Australia

Location

Veritus Research - Emeritus - PPDS

Bayswater, Victoria, 3153, Australia

Location

Emeritus Research -PPDS

Camberwell, Victoria, 3124, Australia

Location

Ryrie St, Geelong, VIC 3220, Australia

Geelong, Victoria, 3220, Australia

Location

Doherty Clinical Trials Limited

Melbourne, Victoria, 3000, Australia

Location

Nucleus Network Limited

Melbourne, Victoria, 3004, Australia

Location

Momentum Sunshine

Melbourne, Victoria, 3021, Australia

Location

University of Melbourne - Melbourne

Melbourne N., Victoria, 3051, Australia

Location

Institute for Respiratory Health - Midland

Midland, Western Australia, 6056, Australia

Location

Telethon Kids Institute

Nedlands, Western Australia, 6009, Australia

Location

CliniTrials

Perth, Western Australia, 6000, Australia

Location

Momentum Tauranga - PPDS

Tauranga, Bay of Plenty, 3110, New Zealand

Location

Momentum Hawke's Bay - PPDS

Hastings, Hawke's Bay Region, 4122, New Zealand

Location

Momentum Dunedin - PPDS

Dunedin, Otago, 9016, New Zealand

Location

Southern Clinical Trials - Totara - PCRN - PPDS

Auckland, 0600, New Zealand

Location

Pacific Clinical Research Network - Auckland - PCRN - PPDS

Auckland, 0622, New Zealand

Location

Optimal Clinical Trials Ltd - North Shore - PPDS

Auckland, 0632, New Zealand

Location

Optimal Clinical Trials Ltd - PPDS

Auckland, 1010, New Zealand

Location

Momentum Pukekohe - PPDS

Auckland, 2120, New Zealand

Location

New Zealand Clinical Research - Christchurch - PPDS

Christchurch, 8011, New Zealand

Location

Pacific Clinical Research Network - Christchurch - PCRN - PPDS

Christchurch, 8013, New Zealand

Location

Lakeland Clinical Trials - Waikato - PCRN-PPDS

Hamilton, 3243, New Zealand

Location

Momentum Lower Hutt - PPDS

Lower Hutt, New Zealand

Location

Southern Clinical Trials - Tasman - PCRN - PPDS

Nelson, 7011, New Zealand

Location

Momentum Palmerston North - PPDS

Palmerston North, 4414, New Zealand

Location

Pacific Clinic Research Network - Rotorua - PCRN - PPDS

Rotorua, 3010, New Zealand

Location

Momentum Kapiti - PPDS

Waikanae, 5036, New Zealand

Location

Lakeland Clinical Trials - Wellington - PCRN - PPDS

Wellington, 5018, New Zealand

Location

Momentum Wellington - PPDS

Wellington, 6021, New Zealand

Location

Aotearoa Clinical Trials Trust

Wellington, New Zealand

Location

MeSH Terms

Conditions

COVID-19; Influenza, Human

Interventions

NVX-CoV2373 adjuvated lipid nanoparticle; Fluzone High-Dose; Influenza Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Clinical Development

  Novavax, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 4, 2024
• Study Start: December 9, 2024
• Primary Completion (Estimated): July 26, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

AU (39); NZ (19)