AzTrials
AzTrials

SARS-CoV InfectionPhase 1/2NCT04961541

Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine

A Phase 1/2 study testing ICC Vaccine, qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant and SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant in people with SARS-CoV Infection and Covid19, run by Novavax at 10 sites in Australia.

Completed

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

Official record
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Trial summary

This is a randomized, observer-blinded, Phase 1/2 study evaluating the safety and immunogenicity of a quadrivalent HA nanoparticle influenza and SARS-CoV-2 rS nanoparticle combination vaccine with Matrix-M1 adjuvant; this combination is referred to as ICC vaccine. Read more about this study

Who is it for?
Ages 50 to 70 yearsHealthy volunteers can take part
Conditions the study is for
SARS-CoV Infection, Covid19
What is being tested?
ICC Vaccine, qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant and SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
637 participants
Where
10 sitesAustralia
Study dates
8 Sep 2021to 22 Apr 2022
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 50 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy, medically stable adult males or females ≥ 50 to ≤ 70 years of age at screening.
  • Willing and able to give informed consent prior to study enrollment.
  • Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AEs.
  • 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
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  • 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.
  • 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.
  • Condoms (male or female) with spermicide (if acceptable in-country)
  • Diaphragm with spermicide
  • Cervical cap with spermicide
  • Intrauterine device
  • Oral or patch contraceptives
  • Norplant®, Depo-Provera®, or other in-country regulatory approved contraceptive method that is designed to protect against pregnancy
  • Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle
  • 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.
  • 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.

Who cannot join

  • 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.
  • Participation in research involving an investigational product (drug/biologic/device) within 90 days before the planned date of the first injection.
  • Use of COVID-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to the planned date of the first injection.
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  • 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.
  • 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 70.
  • Any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination.
  • 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.
  • 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 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).
  • Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the EoS.
  • Known disturbance of coagulation.
  • 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.
  • 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).
  • 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).

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Australia10 sites

  • Paratus Clinical Research - Western Sydney

    Blacktown, New South Wales, 2148

  • University of the Sunshine Coast,Southbank

    Brisbane, Queensland, 4101

  • Northern Beaches Clinical Research

    Brookvale, New South Wales, 2100

  • Paratus Clinical Research - Canberra

    Bruce, Australian Capital Territory, 2617

  • Emeritus Research

    Camberwell, Victoria, 3214

  • Paratus Clinical Research - Central Coast

    Kanwal, New South Wales, 2259

  • Hunter Diabetes Centre

    Merewether, New South Wales, 2291

  • University of the Sunshine Coast, Health Hub Morayfield

    Morayfield, Queensland, 4506

  • University of the Sunshine Coast

    Sippy Downs, Queensland, 4556

  • Austrials Pty Ltd - Taringa

    Taringa, Queensland, 4068

Other trials in Australia

About this study

Official 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

This is a randomized, observer-blinded, Phase 1/2 study evaluating the safety and immunogenicity of a quadrivalent HA nanoparticle influenza and SARS-CoV-2 rS nanoparticle combination vaccine with Matrix-M1 adjuvant; this combination is referred to as ICC vaccine.

Read the detailed description

This is a randomized, observer-blinded, Phase 1/2 study evaluating the safety and immunogenicity of a quadrivalent hemagglutinin (HA) nanoparticle influenza vaccine (qNIV) and severe acute respiratory syndrome coronavirus 2 (SARSCoV2) recombinant spike (rS) nanoparticle combination vaccine with Matrix-M1™ adjuvant; this combination vaccine is referred to as Influenza COVID-19 Combination (ICC) vaccine.

The study will enroll approximately 640 healthy (based on history and physical examination) adult male and female participants 50 to 70 years of age, inclusive, targeting participants who are baseline seropositive (either previously infected with SARS-CoV-2 ≥ 8 weeks prior to enrollment, or have been previously immunized against SARS-CoV-2 with a completed regimen of an authorized vaccine at ≥ 8 weeks prior to enrollment). Randomization will be stratified on age ≥ 50 to ≤60 or

≥ 60 to ≤ 70 years to distribute the proportions of each age stratum evenly across vaccine groups.

Being tested
ICC Vaccine, qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant, SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant
Keywords
Coronavirus
Medical subject headings
Severe Acute Respiratory Syndrome, COVID-19, Coronavirus Infections

What participants receive

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

  • ICC VaccineBiological

    Intramuscular (deltoid) injections of in-clinic mix of various doses of quadrivalent hemagglutinin nanoparticle influenza vaccine(qNIV2), SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.

  • qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 AdjuvantBiological

    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.

  • SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 AdjuvantBiological

    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.

Study groups in NCT04961541
Study groupRoleWhat they receive
Group A and Group C - ICC Vaccine FormulationExperimental2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
Receives: Biological: ICC Vaccine
Group B -ICC Vaccine FormulationExperimental2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
Receives: Biological: ICC Vaccine
Group D - ICC Vaccine FormulationExperimental2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
Receives: Biological: ICC Vaccine
Group E - ICC Vaccine FormulationExperimental2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
Receives: Biological: ICC Vaccine
Group F- ICC Vaccine FormulationExperimental2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
Receives: Biological: ICC Vaccine
Group G- ICC Vaccine FormulationExperimental2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
Receives: Biological: ICC Vaccine
Group H and Group N- ICC Vaccine FormulationExperimental2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
Receives: Biological: ICC Vaccine
Group I- ICC Vaccine FormulationExperimental2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
Receives: Biological: ICC Vaccine
Group J -ICC Vaccine FormulationExperimental2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
Receives: Biological: ICC Vaccine
Group K - ICC Vaccine FormulationExperimental2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
Receives: Biological: ICC Vaccine
Group L - ICC Vaccine FormulationExperimental2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
Receives: Biological: ICC Vaccine
Group M -ICC Vaccine FormulationExperimental2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
Receives: Biological: ICC Vaccine
Group O - qNIV with Matrix-M1 adjuvantExperimental2 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.
Receives: Biological: qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant
Group P- SARS-CoV-2 rS with Matrix-M1 adjuvantExperimental2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
Receives: Biological: SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant

What is being measured

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

  1. Number of Participants With Solicited Local and Systemic Adverse Events (AE's)

    Numbers of participants with solicited local and systemic AEs over the 7 days post-injection after first and second doses.

    Measured: Day 0 to Day 63

  2. Number of Participants Reporting All AE's

    Number of participants reporting all AEs, (solicited and unsolicited), over 70 days after the first dose.

    Measured: Day 0 to Day 70

  3. Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs

    Number of participants with Medical Attended Adverse Events (MAAE's), Adverse events (AESI's), Including potential immune-mediated medical conditions (PIMMCs), Serious Adverse Events SAEs.

    Measured: Day 0 to Day 180

Secondary outcomes (88)

  1. Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs)

    Hemagglutination-inhibition (HAI) antibody titers specific for the hemagglutinin (HA) receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.

    Measured: Day 0 to Day 182

  2. Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs

    Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.

    Measured: Day 0 to Day 182

  3. Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs

    Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.

    Measured: Day 0 to Day 182

  4. Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs

    Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.

    Measured: Day 0 to Day 182

  5. Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs

    Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.

    Measured: Day 0 to Day 182

  6. Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs

    Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.

    Measured: Day 0 to Day 182

  7. Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs

    Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.

    Measured: Day 0 to Day 182

  8. Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs

    Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.

    Measured: Day 0 to Day 182

  9. Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre)

    Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  10. Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre)

    Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  11. Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre)

    Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  12. Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre)

    Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  13. Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre)

    Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  14. Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre)

    Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  15. Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre)

    Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  16. Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre)

    Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  17. Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR)

    Hemagglutination-Inhibition (HAI) Antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of < 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  18. Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR

    Hemagglutination-Inhibition (HAI) Antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of < 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  19. Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR

    Hemagglutination-Inhibition (HAI) Antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of < 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  20. HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR

    HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of < 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  21. HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR

    HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype)strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of < 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  22. HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR

    HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of < 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  23. HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR

    HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of < 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  24. HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR

    HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of < 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  25. HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR)

    GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline [pre-vaccination] titers)

    Measured: Day 28 to Day 182

  26. HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR

    GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline [pre-vaccination] titers)

    Measured: Day 28 to Day 182

  27. HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR

    GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline [pre-vaccination] titers)

    Measured: Day 28 to Day 182

  28. HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR

    GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline [pre-vaccination] titers)

    Measured: Day 28 to Day 182

  29. HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR

    GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline [pre-vaccination] titers)

    Measured: Day 28 to Day 182

  30. HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR

    GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline [pre-vaccination] titers)

    Measured: Day 28 to Day 182

  31. HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR

    GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline [pre-vaccination] titers)

    Measured: Day 28 to Day 182

  32. HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR

    GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline [pre-vaccination] titers)

    Measured: Day 28 to Day 182

  33. Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR).

    Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  34. Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR

    Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  35. Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR

    Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  36. Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR

    Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  37. Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR

    Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype)on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  38. Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR

    Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  39. Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR

    Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  40. Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR

    Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) on Days 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  41. MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT)

    MN50 GMTs to the SARS-CoV-2 Wuhan Strain from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.

    Measured: Day 0 to Day 182

  42. MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT

    MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.

    Measured: Day 0 to Day 70

  43. MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR)

    MN50 GMTs to the SARS-CoV-2 Wuhan Strain from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  44. MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR

    MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 70

  45. MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR

    MN50 GMTs to the SARS-CoV-2 Wuhan Strain from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  46. MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR

    MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  47. MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR

    MN50 GMTs to the SARS-CoV-2 Wuhan Strain from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  48. MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR

    MN50 GMTs to the SARS-CoV-2 Omicron BA.1 from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  49. Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Brisbane (H1N1 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.

    Measured: Day 0 to Day 182

  50. Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Kansas (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.

    Measured: Day 0 to Day 182

  51. Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Wisconsin (H1N1 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.

    Measured: Day 0 to Day 182

  52. Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Cambodia (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.

    Measured: Day 0 to Day 182

  53. Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Hong Kong (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.

    Measured: Day 0 to Day 182

  54. Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Phuket (Yamagata Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.

    Measured: Day 0 to Day 182

  55. Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Maryland (Victoria Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.

    Measured: Day 0 to Day 182

  56. Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Washington (Victoria Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.

    Measured: Day 0 to Day 182

  57. Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Brisbane (H1N1 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.

    Measured: Day 28 to Day 182

  58. Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Kansas (H3N2 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.

    Measured: Day 28 to Day 182

  59. Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Wisconsin (H1N1 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.

    Measured: Day 28 to Day 182

  60. Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Cambodia (H3N2 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.

    Measured: Day 28 to Day 182

  61. Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Hong Kong (H3N2 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.

    Measured: Day 28 to Day 182

  62. Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza B/Maryland (Victoria Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.

    Measured: Day 28 to Day 182

  63. Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza B/Phuket (Yamagata Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.

    Measured: Day 28 to Day 182

  64. Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza B/Washington (Victoria Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.

    Measured: Day 28 to Day 182

  65. Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.

    Measured: Day 28 to Day 182

  66. Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Kansas (H3N2 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.

    Measured: Day 28 to Day 182

  67. Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.

    Measured: Day 28 to Day 182

  68. Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.

    Measured: Day 28 to Day 182

  69. Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.

    Measured: Day 28 to Day 182

  70. Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza B/Maryland (Victoria Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.

    Measured: Day 28 to Day 182

  71. Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza B/Phuket (Yamagata Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.

    Measured: Day 28 to Day 182

  72. Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza B/Washington (Victoria Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.

    Measured: Day 28 to Day 182

  73. Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Brisbane (H1N1 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.

    Measured: Day 28 to Day 182

  74. Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Kansas (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.

    Measured: Day 28 to Day 182

  75. Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Wisconsin (H1N1 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.

    Measured: Day 28 to Day 182

  76. Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Cambodia (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.

    Measured: Day 28 to Day 182

  77. Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Hong Kong (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.

    Measured: Day 28 to Day 182

  78. Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Maryland (Victoria Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.

    Measured: Day 28 to Day 182

  79. Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Phuket (Yamagata Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.

    Measured: Day 28 to Day 182

  80. Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR

    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Washington(VictoriaSubtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.

    Measured: Day 28 to Day 182

  81. Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU)

    IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Wuhan Strain spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.

    Measured: Day 0 to Day 182

  82. Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU

    IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Omicron BA.1 spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.

    Measured: Day 0 to Day 182

  83. Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR

    IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Wuhan Strain spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  84. Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR

    IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Omicron BA.1 Variant spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  85. Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR

    IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Wuhan Strain spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  86. Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR

    IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Omicron BA.1 Variant spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  87. Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR)

    IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Omicron BA.1 Variant spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

  88. Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR

    IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 (Wuhan) spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.

    Measured: Day 28 to Day 182

Timeline

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

  1. First posted14 Jul 2021
  2. Study start8 Sep 2021
  3. Primary completion22 Dec 2021
  4. Study completion22 Apr 2022

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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
637 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04961541
Sponsor's protocol ID
2019nCoV-ICC-E-101
Status last verified
Apr 2025
First submitted
9 Jul 2021
Last updated
10 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ICC Vaccine, qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant and SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant in people with SARS-CoV Infection and Covid19, run by Novavax at 10 sites in Australia.

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 18 inclusion and 20 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 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Australia. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Solicited Local and Systemic Adverse Events (AE's) (time frame: Day 0 to Day 63). The study lists 3 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 NCT04961541.

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 10 Apr 2025.

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