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AzTrials

COVID-19Phase 3NCT06291857

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

A Phase 3 study testing CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant, Novavax COVID-19 Vaccine and tNIV Vaccine in people with COVID-19, run by Novavax at 58 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 to 75 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant, Novavax COVID-19 Vaccine and tNIV Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9,320 participants
Where
58 sitesin 2 countries
Study dates
9 Dec 2024to 9 Feb 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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:
  • Uncontrolled hypertension (NOTE: hypertension ≤ 170/100 is NOT exclusionary);
  • Congestive heart failure requiring hospitalization within 3 months prior to Screening
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  • Chronic obstructive pulmonary disease (COPD) requiring hospitalization within 3 months prior to Screening (NOTE: stable COPD is NOT exclusionary);
  • Within 3 months prior to Screening, evidence of unstable coronary artery disease as manifested by cardiac interventions (eg, cardiac stent placement, coronary artery bypass graft surgery), new cardiac medications for control of symptoms, or unstable angina (NOTE: stable coronary heart disease is NOT exclusionary);
  • 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 clinically significant gastrointestinal and hepatic diseases requiring hospitalization or institution of substantive new therapy within 3 months prior to Screening. (for example, gastroesophageal reflux disease is NOT exclusionary)
  • 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.
  • Any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination (NOTE: well-controlled hypothyroidism and mild psoriasis are not exclusionary).
  • 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.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
  • Active cancer (malignancy) therapy within 1 year prior to study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator).
  • Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the EoS.
  • Suspected or known history of alcohol abuse or drug addiction within 2 years prior to study vaccination, which in the opinion of the investigator, might interfere with protocol compliance.
  • Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature ≥ 38.0°C, on the planned day of vaccine administration).
  • History of myocarditis or pericarditis.
  • Any condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
  • Study team member or immediate family member of any study team member (inclusive of Sponsor, Contract Research Organization, and study site personnel involved in the conduct or planning of the study).
  • Known history of any prior motor neuropathy.

Trial locations and contacts

58 sites in 2 countries.

58 sites in 2 countries

Australia39 sites

  • Cmax - Ppds

    Adelaide, South Australia, 5000

  • Veritus Research - Emeritus - PPDS

    Bayswater, Victoria, 3153

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

    Birtinya, Queensland, 4575

  • Paratus Clinical Research - Western Sydney - PPDS

    Blacktown, New South Wales, 2148

  • Key Health- Bondi Junction

    Bondi Junction, New South Wales, 2022

  • Emeritus Research - Sydney - PPDS

    Botany, New South Wales, 2019

  • Momentum Taringa

    Brisbane, Queensland, 4068

  • Genesis Research Services

    Broadmeadow, New South Wales, 2292

  • Northern Beaches Clinical Research - PPDS

    Brookvale, New South Wales, 2100

  • Paratus Clinical Research - Canberra - PPDS

    Bruce, Australian Capital Territory, 2617

  • Emeritus Research -PPDS

    Camberwell, Victoria, 3124

  • Menzies School of Health Research

    Casuarina, Northern Territory, 0810

  • Northside Health

    Coffs Harbour, New South Wales, 2450

  • East Sydney Doctors

    Darlinghurst, New South Wales, 2010

  • Momentum Darlinghurst

    Darlinghurst, New South Wales, 2010

  • Oztrials Clinical Research

    Drummoyne, New South Wales, 2047

  • Ryrie St, Geelong, VIC 3220, Australia

    Geelong, Victoria, 3220

  • Griffith University Clinical Trials Unit

    Griffith, Queensland, 4222

  • Nucleus Network Pty Ltd

    Herston, Queensland, 4006

  • Paratus Clinical Research - Brisbane Clinic - PPDS

    Herston, Queensland, 4006

  • Paratus Clinical Research - Central Coast - PPDS

    Kanwal, New South Wales, 2259

  • Novatrials

    Kotara, New South Wales, 2289

  • Australian Clinical Research Network

    Maroubra, New South Wales, 2035

  • Doherty Clinical Trials Limited

    Melbourne, Victoria, 3000

  • Nucleus Network Limited

    Melbourne, Victoria, 3004

  • Momentum Sunshine

    Melbourne, Victoria, 3021

  • University of Melbourne - Melbourne

    Melbourne N., Victoria, 3051

  • Hunter Diabetes Centre

    Merewether, New South Wales, 2291

  • Institute for Respiratory Health - Midland

    Midland, Western Australia, 6056

  • Sutherland Shire Clinical Research - PPDS

    Miranda, New South Wales, 2228

  • Telethon Kids Institute

    Nedlands, Western Australia, 6009

  • Pioneer Clinical Research - North Sydney

    North Sydney, New South Wales, 2060

  • CliniTrials

    Perth, Western Australia, 6000

  • Mater Hospital Brisbane

    South Brisbane, Queensland, 4101

  • Taylor Square Private Clinic

    Surry Hills, New South Wales, 2010

  • Momentum St Leonards

    Sydney, New South Wales, 2065

  • Innovate Clinical Research Pty Ltd

    Sydney, New South Wales, 2077

  • Momentum Wellers

    Wellers Hill, Brisbane, 4121

  • Wollongong Clinical Research - PPDS

    Wollongong, New South Wales, 2500

Other trials in Australia

New Zealand19 sites

  • Southern Clinical Trials - Totara - PCRN - PPDS

    Auckland, 0600

  • Pacific Clinical Research Network - Auckland - PCRN - PPDS

    Auckland, 0622

  • Optimal Clinical Trials Ltd - North Shore - PPDS

    Auckland, 0632

  • Optimal Clinical Trials Ltd - PPDS

    Auckland, 1010

  • Momentum Pukekohe - PPDS

    Auckland, 2120

  • New Zealand Clinical Research - Christchurch - PPDS

    Christchurch, 8011

  • Pacific Clinical Research Network - Christchurch - PCRN - PPDS

    Christchurch, 8013

  • Momentum Dunedin - PPDS

    Dunedin, Otago, 9016

  • Lakeland Clinical Trials - Waikato - PCRN-PPDS

    Hamilton, 3243

  • Momentum Hawke's Bay - PPDS

    Hastings, Hawke's Bay Region, 4122

  • Momentum Lower Hutt - PPDS

    Lower Hutt

  • Southern Clinical Trials - Tasman - PCRN - PPDS

    Nelson, 7011

  • Momentum Palmerston North - PPDS

    Palmerston North, 4414

  • Pacific Clinic Research Network - Rotorua - PCRN - PPDS

    Rotorua, 3010

  • Momentum Tauranga - PPDS

    Tauranga, Bay of Plenty, 3110

  • Momentum Kapiti - PPDS

    Waikanae, 5036

  • Lakeland Clinical Trials - Wellington - PCRN - PPDS

    Wellington, 5018

  • Momentum Wellington - PPDS

    Wellington, 6021

  • Aotearoa Clinical Trials Trust

    Wellington

Other trials in New Zealand

About this study

Official title: A Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety and Immunogenicity of a COVID-19 Influenza Combination Nanoparticle Vaccine and a Standalone Trivalent Nanoparticle Influenza Hemagglutinin Vaccine in Participants ≥ 65 Years of Age.

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.

Read the detailed description

The study enrolled a total of 9,320 medically stable (based on history and physical examination) adult male and female participants ≥ 65 years of age across Part 1 and Part 2.

In Part 1, participants were randomly assigned to receive either CIC, Novavax COVID-19 Vaccine, tNIV, or Fluzone High-Dose in a 3:2:1:3 ratio, respectively. Following the completion of enrollment in Part 1, the remaining participants were enrolled into Part 2 and were randomly assigned to receive either CIC, tNIV, or Fluzone High-Dose in a 5:4:1 ratio, respectively.

All participants received a single intramuscular (IM) injection on Day 0.

Part 1: All participants remained on study for immunogenicity data collection through Day 182 and safety data collection through Day 364 (End of Study [EoS]).

Part 2: Only safety was assessed, and all participants remained on study for safety data collection through Day 364 (EoS).

Conditions
COVID-19
Being tested
CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant, Novavax COVID-19 Vaccine, tNIV Vaccine, Fluzone High Dose
Keywords
CIC (Coronavirus Disease 2019 Influenza Combination), Influenza, Fluzone High-Dose
Medical subject headings
COVID-19, Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M AdjuvantBiological

    Also called COVID-19 and influenza combination

    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

  • Novavax COVID-19 VaccineBiological

    Also called Novavax SARS-CoV-2 rS vaccine

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

  • tNIV VaccineBiological

    Also called Trivalent Nanoparticle Influenza Hemagglutinin Vaccine

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

  • Fluzone High DoseBiological

    Also called Fluzone HD

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

Study groups in NCT06291857
Study groupRoleWhat they receive
CIC VaccineExperimentalA single 0.5 mL IM injection on Day 0
Receives: Biological: CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant
Novavax COVID-19 VaccineExperimentalA single 0.5 mL IM injection on Day 0
Receives: Biological: Novavax COVID-19 Vaccine
tNIV VaccineExperimentalA single 0.5 mL IM injection on Day 0
Receives: Biological: tNIV Vaccine
Fluzone High-DoseExperimentalA single 0.5 mL IM injection on Day 0
Receives: Biological: Fluzone High Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 7

  2. 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.

    Measured: Day 28

  3. 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.

    Measured: Day 0 to Day 364

  4. 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

    Measured: Days 0 and 28

  5. 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

    Measured: Day 28

  6. 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

    Measured: Day 28

  7. 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

    Measured: Day 28

  8. 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

    Measured: Day 28

  9. 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

    Measured: Day 28

  10. 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

    Measured: Day 28

  11. 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

    Measured: Day 28

  12. 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

    Measured: Day 28

Secondary outcomes (15)

  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)

    HAI antibody titers specific for the HA receptor binding domains of vaccine response CIC vaccine compared to Fluzone High-Dose on Day 28

    Measured: Day 28

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

    HAI antibody titers specific for the HA receptor binding domains of vaccine response CIC vaccine compared to Fluzone High-Dose on Day 28

    Measured: Day 28

  3. 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

    HAI antibody titers specific for the HA receptor binding domains of vaccine response CIC vaccine compared to Fluzone High-Dose on Day 28

    Measured: Day 28

  4. 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 CIC vaccine compared to Fluzone High-Dose on Day 28

    Measured: Day 28

  5. 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 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

    Measured: Day 28

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

    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

    Measured: Day 28

  7. 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

    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

    Measured: Day 28

  8. 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 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

    Measured: Day 28

  9. Hemagglutination Inhibition (HAI) antibody titers to tNIV and Fluzone High-Dose Expressed as GMT

    Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of vaccine-homologous influenza A and B strains on Day 28

    Measured: Day 28

  10. Hemagglutination Inhibition (HAI) antibody titers to tNIV and Fluzone High-Dose Expressed as GMFR

    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

    Measured: Day 28

  11. Percentage of Participants with (HAI) antibody titers to tNIV and Fluzone High-Dose Expressed as SCR

    Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of vaccine-homologous influenza A and B strains on Day 28

    Measured: Day 28

  12. Influenza neutralizing antibody (NAb) responses of trivalent nanoparticle influenza vaccine (tNIV) comparable to Fluzone High-Dose Expressed as GMT

    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.

    Measured: Day 28

  13. Influenza neutralizing antibody (NAb) responses of trivalent nanoparticle influenza vaccine (tNIV) comparable to Fluzone High-Dose Expressed as GMFR

    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.

    Measured: Day 28

  14. Influenza neutralizing antibody (NAb) responses of trivalent nanoparticle influenza vaccine (tNIV) comparable to Fluzone High-Dose Expressed as GMTR

    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.

    Measured: Day 28

  15. Percentage of Participants with (NAb) responses of trivalent nanoparticle influenza vaccine (tNIV) comparable to Fluzone High-Dose Expressed as SCR

    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.

    Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2024
  2. Study start9 Dec 2024
  3. Primary completion24 Dec 2025
  4. Study completion9 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
9,320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06291857
Sponsor's protocol ID
CIC-E-301
Status last verified
Jun 2026
First submitted
1 Mar 2024
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant, Novavax COVID-19 Vaccine and tNIV Vaccine in people with COVID-19, run by Novavax at 58 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numbers of participants with solicited local and systemic adverse events (AEs) (time frame: Day 7). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06291857.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

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