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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06291857

Registration number

NCT06291857

Ethics application status

Date submitted

1/03/2024

Date registered

4/03/2024

Date last updated

22/11/2024

Titles & IDs

Public title

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

Scientific 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.

Secondary ID [1]

CIC-E-301

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

COVID-19

Condition category

Condition code

Infection

Other infectious diseases

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Other - CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant
Treatment: Other - Novavax COVID-19 Vaccine
Treatment: Other - tNIV Vaccine
Treatment: Other - Fluzone High Dose

Experimental: CIC Vaccine - A single 0.5 mL IM injection on Day 0

Experimental: Novavax COVID-19 Vaccine - A single 0.5 mL IM injection on Day 0

Experimental: tNIV Vaccine - A single 0.5 mL IM injection on Day 0

Experimental: Fluzone High-Dose - A single 0.5 mL IM injection on Day 0

Treatment: Other: 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

Treatment: Other: Novavax COVID-19 Vaccine
Each 0.5 mL dose comprises 5 µg SARS-CoV-2 S protein and 50 µg Matrix-M adjuvant

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

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

Intervention code [1]

Treatment: Other

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Part 1 and Part 2 Safety- Numbers of participants with solicited local and systemic AEs

Timepoint [1]

7 days post-vaccination

Primary outcome [2]

Part 1 and Part 2 Safety-Numbers of participants reporting unsolicited AEs and medically attended adverse events (MAAEs).

Timepoint [2]

28 days post-vaccination

Primary outcome [3]

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

Timepoint [3]

Day 0 to Day 364

Primary outcome [4]

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

Timepoint [4]

Days 0 and 28

Primary outcome [5]

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

Timepoint [5]

Days 28

Primary outcome [6]

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

Timepoint [6]

Days 28

Primary outcome [7]

Part-1 Neutralizing Antibody (NAb) Responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMT

Timepoint [7]

Days 28

Primary outcome [8]

Part-1 Neutralizing Antibody (NAb) Responses of the CIC vaccine compared to Fluzone High-Dose of homologous A and B strains Expressed as GMTR

Timepoint [8]

Days 28

Primary outcome [9]

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

Timepoint [9]

Days 28

Primary outcome [10]

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

Timepoint [10]

Day 28

Primary outcome [11]

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

Timepoint [11]

Day 28

Primary outcome [12]

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

Timepoint [12]

Day 28

Secondary outcome [1]

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)

Timepoint [1]

Days 28

Secondary outcome [2]

Part-1 Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMFR

Timepoint [2]

Days 28

Secondary outcome [3]

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

Timepoint [3]

Days 28

Secondary outcome [4]

Part-1 HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMTR

Timepoint [4]

Days 28

Secondary outcome [5]

Part-1 Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMT

Timepoint [5]

Days 28

Secondary outcome [6]

Part-1 Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMFR

Timepoint [6]

Days 28

Secondary outcome [7]

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

Timepoint [7]

Days 28

Secondary outcome [8]

Part-1 Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMTR

Timepoint [8]

Days 28

Secondary outcome [9]

Part-1 Hemagglutination Inhibition (HAI) antibody titers to tNIV and Fluzone High-Dose Expressed as GMT

Timepoint [9]

Day 28

Secondary outcome [10]

Part-1 Hemagglutination Inhibition (HAI) antibody titers to tNIV and Fluzone High-Dose Expressed as GMFR

Timepoint [10]

Day 28

Secondary outcome [11]

Part-1 Percentage of Participants with (HAI) antibody titers to tNIV and Fluzone High-Dose Expressed as SCR

Timepoint [11]

Day 28

Secondary outcome [12]

Part-1 Influenza neutralizing antibody (NAb) responses of trivalent nanoparticle influenza vaccine (tNIV) comparable to Fluzone High-Dose Expressed as GMT

Timepoint [12]

Day 28

Secondary outcome [13]

Part-1 Influenza neutralizing antibody (NAb) responses of trivalent nanoparticle influenza vaccine (tNIV) comparable to Fluzone High-Dose Expressed as GMFR

Timepoint [13]

Day 28

Secondary outcome [14]

Part-1 Influenza neutralizing antibody (NAb) responses of trivalent nanoparticle influenza vaccine (tNIV) comparable to Fluzone High-Dose Expressed as GMTR

Timepoint [14]

Day 28

Secondary outcome [15]

Part-1 Percentage of Participants with (NAb) responses of trivalent nanoparticle influenza vaccine (tNIV) comparable to Fluzone High-Dose Expressed as SCR

Timepoint [15]

Day 28

Eligibility

Key inclusion criteria

Inclusion Criteria

To be included in this study, each individual must satisfy all the following criteria:

1. Willing and able to give informed consent prior to study enrollment.
2. Medically stable adult male or female = 65 years of age at Screening.
3. 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.
4. The participant has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, at Screening.
5. Participant must be able to receive an injection in the deltoid of at least 1 arm.
6. Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AEs.
7. 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.
8. 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)
9. 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.

Minimum age

65 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Exclusion Criteria

If an individual meets any of the following criteria, he or she is ineligible for this study:

1. 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.
2. 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.
3. 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.
4. Participation in research involving an investigational product (drug/biologic/device) within 90 days before planned date of vaccination.
5. Use of COVID-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to planned date of vaccination.
6. 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.
7. Any history of anaphylaxis to any prior vaccine.
8. History of Guillain-Barré Syndrome following a previous influenza vaccine.
9. 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.
10. 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).
11. 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.
12. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
13. 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).
14. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the EoS.
15. 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.
16. 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).
17. History of myocarditis or pericarditis.
18. 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).
19. 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).
20. Known history of any prior motor neuropathy.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

Intervention assignment

Crossover

Other design features

Phase

Phase 3

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

9/12/2024

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

24/02/2026

Actual

Sample size

Target

9320

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,BrisbaneNSW,NT,QLD,SA,VIC,WA

Recruitment hospital [1]

Paratus Clinical Research - Canberra - PPDS - Bruce

Recruitment hospital [2]

Momentum Wellers - Wellers Hill

Recruitment hospital [3]

Paratus Clinical Research - Western Sydney - PPDS - Blacktown

Recruitment hospital [4]

Key Health- Bondi Junction - Bondi Junction

Recruitment hospital [5]

Emeritus Research - Sydney - PPDS - Botany

Recruitment hospital [6]

Genesis Research Services - Broadmeadow

Recruitment hospital [7]

Northern Beaches Clinical Research - PPDS - Brookvale

Recruitment hospital [8]

Northside Health - Coffs Harbour

Recruitment hospital [9]

East Sydney Doctors - Darlinghurst

Recruitment hospital [10]

Momentum Darlinghurst - Darlinghurst

Recruitment hospital [11]

Oztrials Clinical Research - Drummoyne

Recruitment hospital [12]

Paratus Clinical Research - Central Coast - PPDS - Kanwal

Recruitment hospital [13]

Novatrials - Kotara

Recruitment hospital [14]

Australian Clinical Research Network - Maroubra

Recruitment hospital [15]

Hunter Diabetes Centre - Merewether

Recruitment hospital [16]

Sutherland Shire Clinical Research - PPDS - Miranda

Recruitment hospital [17]

Pioneer Clinical Research - North Sydney - North Sydney

Recruitment hospital [18]

Taylor Square Private Clinic - Surry Hills

Recruitment hospital [19]

Momentum St Leonards - Sydney

Recruitment hospital [20]

Innovate Clinical Research Pty Ltd - Sydney

Recruitment hospital [21]

Wollongong Clinical Research - PPDS - Wollongong

Recruitment hospital [22]

Menzies School of Health Research - Casuarina

Recruitment hospital [23]

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

Recruitment hospital [24]

Momentum Taringa - Brisbane

Recruitment hospital [25]

Griffith University Clinical Trials Unit - Griffith

Recruitment hospital [26]

Nucleus Network Pty Ltd - Herston

Recruitment hospital [27]

Paratus Clinical Research - Brisbane Clinic - PPDS - Herston

Recruitment hospital [28]

Mater Hospital Brisbane - South Brisbane

Recruitment hospital [29]

Cmax - Ppds - Adelaide

Recruitment hospital [30]

Veritus Research - Emeritus - PPDS - Bayswater

Recruitment hospital [31]

Emeritus Research -PPDS - Camberwell

Recruitment hospital [32]

Ryrie St, Geelong, VIC 3220, Australia - Geelong

Recruitment hospital [33]

University of Melbourne - Melbourne - Melbourne N.

Recruitment hospital [34]

Doherty Clinical Trials Limited - Melbourne

Recruitment hospital [35]

Nucleus Network Limited - Melbourne

Recruitment hospital [36]

Momentum Sunshine - Melbourne

Recruitment hospital [37]

Institute for Respiratory Health - Midland - Midland

Recruitment hospital [38]

Telethon Kids Institute - Nedlands

Recruitment hospital [39]

CliniTrials - Perth

Recruitment postcode(s) [1]

2617 - Bruce

Recruitment postcode(s) [2]

4121 - Wellers Hill

Recruitment postcode(s) [3]

2148 - Blacktown

Recruitment postcode(s) [4]

2022 - Bondi Junction

Recruitment postcode(s) [5]

2019 - Botany

Recruitment postcode(s) [6]

2292 - Broadmeadow

Recruitment postcode(s) [7]

2100 - Brookvale

Recruitment postcode(s) [8]

2450 - Coffs Harbour

Recruitment postcode(s) [9]

2010 - Darlinghurst

Recruitment postcode(s) [10]

2047 - Drummoyne

Recruitment postcode(s) [11]

2259 - Kanwal

Recruitment postcode(s) [12]

2289 - Kotara

Recruitment postcode(s) [13]

2035 - Maroubra

Recruitment postcode(s) [14]

2291 - Merewether

Recruitment postcode(s) [15]

2228 - Miranda

Recruitment postcode(s) [16]

2060 - North Sydney

Recruitment postcode(s) [17]

2010 - Surry Hills

Recruitment postcode(s) [18]

2065 - Sydney

Recruitment postcode(s) [19]

2077 - Sydney

Recruitment postcode(s) [20]

2500 - Wollongong

Recruitment postcode(s) [21]

0810 - Casuarina

Recruitment postcode(s) [22]

4575 - Birtinya

Recruitment postcode(s) [23]

4068 - Brisbane

Recruitment postcode(s) [24]

4222 - Griffith

Recruitment postcode(s) [25]

4006 - Herston

Recruitment postcode(s) [26]

4101 - South Brisbane

Recruitment postcode(s) [27]

5000 - Adelaide

Recruitment postcode(s) [28]

3153 - Bayswater

Recruitment postcode(s) [29]

3124 - Camberwell

Recruitment postcode(s) [30]

3220 - Geelong

Recruitment postcode(s) [31]

3051 - Melbourne N.

Recruitment postcode(s) [32]

3000 - Melbourne

Recruitment postcode(s) [33]

3004 - Melbourne

Recruitment postcode(s) [34]

3021 - Melbourne

Recruitment postcode(s) [35]

6056 - Midland

Recruitment postcode(s) [36]

6009 - Nedlands

Recruitment postcode(s) [37]

6000 - Perth

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Bay Of Plenty

Country [2]

New Zealand

State/province [2]

Hawke's Bay

Country [3]

New Zealand

State/province [3]

Otago

Country [4]

New Zealand

State/province [4]

Auckland

Country [5]

New Zealand

State/province [5]

Christchurch

Country [6]

New Zealand

State/province [6]

Hamilton

Country [7]

New Zealand

State/province [7]

Lower Hutt

Country [8]

New Zealand

State/province [8]

Nelson

Country [9]

New Zealand

State/province [9]

Palmerston North

Country [10]

New Zealand

State/province [10]

Rotorua

Country [11]

New Zealand

State/province [11]

Waikanae

Country [12]

New Zealand

State/province [12]

Wellington

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Novavax

Address

Country

Ethics approval

Ethics application status

Summary

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.

Trial website

https://clinicaltrials.gov/study/NCT06291857

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06291857

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06291857