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

PHASE3NOT_YET_RECRUITING

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.

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Study details:

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 4,950 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 3,000 adults to further monitor the safety of both vaccines.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion 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: 1. Absence of changes in medical therapy in the past 2 months due to treatment failure or toxicity; 2. Absence of medical events qualifying as SAEs within 3 months; and 3. 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.

Exclusion criteria

History of laboratory-confirmed (by polymerase chain reaction [PCR] or rapid antigen test) COVID-19 or asymptomatic SARS-CoV-2 infection; either occurring ≤ 8 weeks prior to Screening. (NOTE: Symptomatic COVID-19 or asymptomatic SARS-CoV-2 infection > 8 weeks prior to Screening is NOT exclusionary).

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: 1. Uncontrolled hypertension (NOTE: hypertension ≤ 170/100 is NOT exclusionary); 2. Congestive heart failure requiring hospitalization within 3 months prior to Screening 3. Chronic obstructive pulmonary disease (COPD) requiring hospitalization within 3 months prior to Screening (NOTE: stable COPD is NOT exclusionary); 4. 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); 5. Hospitalization for diabetic ketoacidosis within 6 months prior to Screening 6. Chronic kidney disease/renal requiring institution of substantive new therapy within 3 months prior to Screening 7. 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) 8. 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 within 6 weeks 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.

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Eligibility

Age eligible for study : 65 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-10-21

Primary completion: 2025-03-15

Study completion finish: 2025-04-09

Study type

PREVENTION

Phase

PHASE3

Trial ID

NCT06291857

Intervention or treatment

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

Conditions

• COVID-19

Condition: COVID-19
BIOLOGICAL: CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant and other drugs
South Brisbane, Queensland, Australia and more
Sponsor: Novavax

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

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Find a site

Closest Location:

Mater Hospital Brisbane

Research sites nearby

Select from list below to view details:

Mater Hospital Brisbane
South Brisbane, Queensland, Australia
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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: CIC Vaccine A single 0.5 mL IM injection on Day 0	BIOLOGICAL: CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant 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
EXPERIMENTAL: Novavax COVID-19 Vaccine A single 0.5 mL IM injection on Day 0	BIOLOGICAL: Novavax COVID-19 Vaccine Each 0.5 mL dose comprises 5 µg SARS-CoV-2 S protein and 50 µg Matrix-M adjuvant
EXPERIMENTAL: tNIV Vaccine A single 0.5 mL IM injection on Day 0	BIOLOGICAL: tNIV Vaccine 2 influenza A \[H1N1 and H3N2\] and 1 influenza B-Victoria lineage strains (60 μg/strain), and Matrix-M adjuvant (75 μg)
EXPERIMENTAL: Fluzone High-Dose A single 0.5 mL IM injection on Day 0	BIOLOGICAL: Fluzone High Dose Fluzone High-Dose is supplied as a suspension for IM injection 0.5 mL with 60 µg per strain

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Part 1 and Part 2 Safety- 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
Part 1 and Part 2 Safety-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
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	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
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	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
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	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
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	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
Part-1 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
Part-1 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
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	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
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	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
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	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
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	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 outcome

Frequently Asked Questions

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References

Clinical Trials Gov: A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine