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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04961541




Registration number
NCT04961541
Ethics application status
Date submitted
9/07/2021
Date registered
14/07/2021
Date last updated
22/07/2022

Titles & IDs
Public title
Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine
Scientific title
A Phase 1/2, Randomized, Observer-Blinded Study to Evaluate the Safety and Immunogenicity of a Quadrivalent Hemagglutinin Nanoparticle Influenza and SARS-CoV-2 rS Nanoparticle Combination Vaccine With Matrix M1™ Adjuvant in Healthy Participants = 50 to = 70 Years of Age
Secondary ID [1] 0 0
2019nCoV-ICC-E-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV Infection 0 0
Covid19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - ICC Vaccine
Treatment: Other - qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant
Treatment: Other - SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant

Experimental: Group A - ICC Vaccine Formulation - 2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.

Experimental: Group B -ICC Vaccine Formulation - 2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.

Experimental: Group C - ICC Vaccine Formulation - 2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.

Experimental: Group D - ICC Vaccine Formulation - 2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.

Experimental: Group E - ICC Vaccine Formulation - 2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.

Experimental: Group F- ICC Vaccine Formulation - 2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.

Experimental: Group G- ICC Vaccine Formulation - 2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.

Experimental: Group H- ICC Vaccine Formulation - 2 doses of Formulation 7. 1 dose each on Days 0 and Day 56.

Experimental: Group I- ICC Vaccine Formulation - 2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.

Experimental: Group J -ICC Vaccine Formulation - 2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.

Experimental: Group K - ICC Vaccine Formulation - 2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.

Experimental: Group L - ICC Vaccine Formulation - 2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.

Experimental: Group M -ICC Vaccine Formulation - 2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.

Experimental: Group N- ICC Vaccine Formulation - 2 doses of Formulation 7. 1 dose each on Days 0 and Day 56.

Experimental: Group O - qNIV with Matrix-M1 adjuvant - 2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.

Experimental: Group P- SARS-CoV-2 rS with Matrix-M1 adjuvant - 2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.


Treatment: Other: ICC Vaccine
Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 µg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.

Treatment: Other: qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant
Intramuscular (deltoid) injections of 60 µg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 µg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.

Treatment: Other: SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant
Intramuscular (deltoid) injections of 5 µg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 µg Matrix-M1 Adjuvant on Days 0 and Day 56.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with solicited local and systemic AE's
Timepoint [1] 0 0
Day 0 to Day 63
Primary outcome [2] 0 0
Percentage of participants reporting all AE's
Timepoint [2] 0 0
Day 0 to Day 70
Primary outcome [3] 0 0
Percentage of participants with MAAE's, AESI's (including PIMMCs), SAEs
Timepoint [3] 0 0
Day 0 to Day 180
Secondary outcome [1] 0 0
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B strain(s) expressed as GMT
Timepoint [1] 0 0
Day 56 to Day 180
Secondary outcome [2] 0 0
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B strain(s) expressed as (GMFRPost/Pre)
Timepoint [2] 0 0
Day 56 to Day 180
Secondary outcome [3] 0 0
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B strain(s) expressed as SCR
Timepoint [3] 0 0
Day 56 to Day 180
Secondary outcome [4] 0 0
Percentage of participants with a reciprocal HAI titer = 40 expressed as SPR
Timepoint [4] 0 0
Day 56 to Day 180
Secondary outcome [5] 0 0
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B strain(s) expressed as GMTR
Timepoint [5] 0 0
Day 56 to Day 180
Secondary outcome [6] 0 0
Microneutralization (MN50) antibody responses expressed as GMT
Timepoint [6] 0 0
Day 56 to Day 180
Secondary outcome [7] 0 0
Microneutralization (MN50) antibody responses expressed as GMFR
Timepoint [7] 0 0
Day 56 to Day 180
Secondary outcome [8] 0 0
Microneutralization (MN50) antibody responses expressed as SCR
Timepoint [8] 0 0
Day 56 to Day 180
Secondary outcome [9] 0 0
Microneutralization (MN50) antibody responses expressed as GMTR
Timepoint [9] 0 0
Day 56 to Day 180
Secondary outcome [10] 0 0
Serum IgG antibody concentrations as ELISA units to the SARS-CoV-2 spike protein expressed as GMEU
Timepoint [10] 0 0
Day 0 to Day 180
Secondary outcome [11] 0 0
Serum IgG antibody concentrations as ELISA units to the SARS-CoV-2 spike protein expressed as GMFR
Timepoint [11] 0 0
Day 0 to Day 180
Secondary outcome [12] 0 0
Serum IgG antibody concentrations as ELISA units to the SARS-CoV-2 spike protein expressed as SCR
Timepoint [12] 0 0
Day 0 to Day 180
Secondary outcome [13] 0 0
Serum IgG antibody concentrations as ELISA units to the SARS-CoV-2 spike protein expressed as GMEUR
Timepoint [13] 0 0
Day 0 to Day 180
Secondary outcome [14] 0 0
MN50 GMTs to the SARS-CoV-2 expressed as GMT
Timepoint [14] 0 0
Day 0 to Day 180
Secondary outcome [15] 0 0
MN50 GMTs to the SARS-CoV-2 expressed as GMFR
Timepoint [15] 0 0
Day 0 to Day 180
Secondary outcome [16] 0 0
MN50 GMTs to the SARS-CoV-2 expressed as SCR
Timepoint [16] 0 0
Day 0 to Day 180
Secondary outcome [17] 0 0
MN50 GMTs to the SARS-CoV-2 expressed as GMTR
Timepoint [17] 0 0
Day 0 to Day 180

Eligibility
Key inclusion criteria
1. Healthy, medically stable adult males or females = 50 to = 70 years of age at screening.
2. Willing and able to give informed consent prior to study enrollment.
3. Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AEs.
4. Participants must have been baseline seropositive to SARS-CoV-2 defined as either:

• Having completed a primary vaccination series against SARS-CoV-2 with an authorized COVID-19 vaccine with receipt of second/final dose of authorized vaccine = 8 weeks prior to enrollment (first study vaccination).

OR

• Previously infected with SARS CoV-2 = 8 weeks prior to enrollment (first study vaccination).

Note: Baseline SARS-CoV-2 serostatus determination at screening will be based on vaccination documentation (eg, vaccination card or vaccination registry) or participants' report of a previous SARS-CoV-2 infection.
5. Women of childbearing potential (defined as any female participant who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through the end of the study.

1. Condoms (male or female) with spermicide (if acceptable in-country)
2. Diaphragm with spermicide
3. Cervical cap with spermicide
4. Intrauterine device
5. Oral or patch contraceptives
6. Norplant®, Depo-Provera®, or other in-country regulatory approved contraceptive method that is designed to protect against pregnancy
7. Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle
6. Participants must be healthy and medically stable, as determined by the investigator (based on a review of health status, vital signs [to include body temperature], medical history, and targeted physical examination [to include body weight]). Participants must have a body mass index (BMI) of 17 to 34 kg/m2, inclusive, at screening. Vital signs must be within medically acceptable ranges prior to the first vaccination.
7. 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, participation in investigational treatment studies is permitted.
Minimum age
50 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any ongoing, symptomatic acute, or chronic illness requiring medical or surgical care.

* Asymptomatic chronic conditions or findings (eg, mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (ie, unlikely to result in symptomatic illness within the time-course of this study), in the opinion of the investigator.
* Acute or chronic illnesses or conditions which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable.
* Acute or chronic illnesses reasonably expected to be associated with increased risks in the event of influenza or SARS-CoV-2 infection (eg, cardio-pulmonary diseases, diabetes mellitus, renal or hepatic dysfunction, hemoglobinopathies) are exclusionary, even if stable.
2. Participation in research involving an investigational product (drug/biologic/device) within 90 days before the planned date of the first injection.
3. Use of COVID-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to the planned date of the first injection.
4. History of a serious reaction to 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.
5. Any history of anaphylaxis to any prior vaccine.
6. History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine.
7. 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 70.
8. Any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination.
9. 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 will be defined as a systemic dose = 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
10. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
11. Active cancer (malignancy) therapy within 3 years prior to first 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).
12. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the EoS.
13. Known disturbance of coagulation.
14. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to the first trial vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance.
15. 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).
16. 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).
17. 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).

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
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/04/2022
Sample size
Target
Accrual to date
Final
642
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research - Canberra - Bruce
Recruitment hospital [2] 0 0
Paratus Clinical Research - Western Sydney - Blacktown
Recruitment hospital [3] 0 0
Northern Beaches Clinical Research - Brookvale
Recruitment hospital [4] 0 0
Paratus Clinical Research - Central Coast - Kanwal
Recruitment hospital [5] 0 0
Hunter Diabetes Centre - Merewether
Recruitment hospital [6] 0 0
University of the Sunshine Coast,Southbank - Brisbane
Recruitment hospital [7] 0 0
University of the Sunshine Coast, Health Hub Morayfield - Morayfield
Recruitment hospital [8] 0 0
University of the Sunshine Coast - Sippy Downs
Recruitment hospital [9] 0 0
Austrials Pty Ltd - Taringa - Taringa
Recruitment hospital [10] 0 0
Emeritus Research - Camberwell
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2100 - Brookvale
Recruitment postcode(s) [4] 0 0
2259 - Kanwal
Recruitment postcode(s) [5] 0 0
2291 - Merewether
Recruitment postcode(s) [6] 0 0
4101 - Brisbane
Recruitment postcode(s) [7] 0 0
4506 - Morayfield
Recruitment postcode(s) [8] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [9] 0 0
4068 - Taringa
Recruitment postcode(s) [10] 0 0
3214 - Camberwell

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novavax
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Development
Address 0 0
Novavax
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04961541