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

Primary Purpose

COVID-19, Influenza

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CIC Vaccine
CIC Vaccine
qNIV Vaccine
SARS-CoV-2 rS Vaccine
Influenza Vaccine
CIC Vaccine
Sponsored by
Novavax
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring Coronavirus, Influenza

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

  1. Medically stable adult male or females ≥ 50 to ≤ 80 years of age at screening.
  2. 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.
  3. The participant has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, at screening.
  4. Willing and able to give informed consent prior to study enrollment.
  5. Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AEs.
  6. Participants must have completed a primary vaccination series against SARS-CoV-2 with an authorized COVID 19 vaccine (and fulfill national recommendations for his/her age and morbidity category) with receipt of second/last dose of authorized vaccine (with or without boosters[s]) ≥ 8 weeks prior to enrollment (first study vaccination).
  7. 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
  8. Participants must be healthy and medically stable, as determined by the investigator (based on review of health status, vital signs [to include body temperature], medical history, and targeted physical examination [to include body weight]). Vital signs must be within medically acceptable ranges prior to vaccination.
  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, participation in investigational treatment studies is permitted.

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) or rapid antigen test) COVID-19 or asymptomatic SARS-CoV-2 infection ≤ 8 weeks prior to enrollment.

    (NOTE: Symptomatic COVID-19 or asymptomatic SARS-CoV-2 infection > 8 weeks prior to enrollment is NOT exclusionary)

  2. Any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness that required changes in medication in the past 2 months 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: well controlled hypertension ≤ grade 2 in NOT exclusionary);
    2. Congestive heart failure with a history of an acute exacerbation of any severity in the prior 2 years (NOTE:

      mild well-controlled congestive heart failure is NOT exclusionary);

    3. Chronic obstructive pulmonary disease (COPD) with a history of an acute exacerbation of any severity in the prior 2 years (NOTE: mild well-controlled COPD is NOT exclusionary);
    4. In the past 3 months, evidence of unstable coronary artery disease as manifested by cardiac interventions (eg, cardiac stent placement, coronary artery bypass grafting [CABG]) surgery, new cardiac medications for control of symptoms, or unstable angina (NOTE: stable coronary heart disease is NOT exclusionary);
    5. Asthma with a history of exacerbation in the prior 2 years or worsening of asthma symptoms or requiring changes in asthma control medications in the past 2 months (NOTE: well-controlled asthma is NOT exclusionary).
    6. Type 1 or type 2 diabetes (adult onset) requiring insulin (NOTE: non-insulin dependent type 2 diabetes is NOT exclusionary);
    7. Chronic kidney disease/renal insufficiency;
    8. Chronic gastrointestinal and hepatic diseases; or
    9. Chronic neurological diseases (such as multiple sclerosis, dementia, Parkinson's disease, degenerative neurological conditions, neuropathy, or epilepsy), history of stroke within 12 months with residual symptoms, or previous neurological disorder within 12 months with residual symptoms (NOTE: history of migraine or chronic headaches or nerve root compression that have been stable on treatment for the last 4 weeks are NOT exclusionary).
  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 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 within 6 weeks following a previous influenza vaccine.
  9. Receipt of any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within 8 weeks preceding the study vaccination. Note: Routine vaccinations will not be allowed until after study Day 21 and COVID 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: mild psoriasis is 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 3 years 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 end of study (EoS).
  15. Known disturbance of coagulation.
  16. 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.
  17. 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).
  18. History of myocarditis or pericarditis.
  19. 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).
  20. 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.

Sites / Locations

  • Paratus Clinical Research - Canberra
  • Paratus Clinical Research - Western Sydney
  • Emeritus Research - Sydney
  • Genesis Central Coast
  • Northern Beaches Clinical Research
  • East Sydney Doctors
  • Holdsworth House Medical Brisbane
  • Oztrials Clinical Research
  • Paratus Clinical Research - Central Coast
  • Australian Clinical Research Network
  • Hunter Diabetes Centre
  • Sutherland Clinical Trials
  • Illawarra Health and Medical Research Institute
  • Northside Health
  • Novatrials
  • Menzies Darwin
  • Paratus Clinical Research - Brisbane Clinic
  • Mater Adult Hospital
  • Nucleus Network Pty Ltd
  • Core Research Group
  • Austrials Pty Ltd - Taringa
  • AusTrials (Wellers Hill)
  • CMAX
  • Emeritus Research
  • Nucleus Network Limited
  • P3 Reseach - Hawkes Bay
  • P3 Research - Palmerston North
  • P3 Research - Lower Hutt
  • P3 Research Kapiti
  • Middlemore Clinical Trials
  • Optimal Clinical Trials Ltd
  • New Zealand Clinical Research - Christchurch
  • P3 Research - Dunedin
  • P3 Research - Tauranga
  • P3 Research - Wellington

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm 22

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group A (Part 1)

Group B (Part 1)

Group C (Part 1)

Group D (Part 1)

Group E (Part 1)

Group F (Part 1)

Group G (Part 1)

Group H (Part 1)

Group I (Part 1)

Group J (Part 1)

Group K (Part 1)

Group L (Part 1)

Group M (Part 1)

Group N (Part 1)

Group O (Part 1)

Group P (Part 1)

Group Q (Part 1)

Group R (Part 1)

Group S (Part 1)

Group T (Part 1)

Group U (Part 2)

Group V (Part 2)

Arm Description

CIC Vaccine Formulation 1 doses of Formulation 1. 1 dose on Days 0.

CIC Vaccine Formulation 1 doses of Formulation 2. 1 dose on Days 0.

CIC Vaccine Formulation 1 doses of Formulation 3. 1 dose on Days 0.

CIC Vaccine Formulation1 doses of Formulation 4. 1 dose on Days 0.

CIC Vaccine Formulation 1 doses of Formulation 5. 1 dose on Days 0.

CIC Vaccine Formulation 1 doses of Formulation 6. 1 dose on Days 0.

CIC Vaccine Formulation 1 doses of Formulation 7. 1 dose on Days 0.

CIC Vaccine Formulation 1 doses of Formulation 8. 1 dose on Days 0.

CIC Vaccine Formulation 1 doses of Formulation 9. 1 dose on Days 0.

CIC Vaccine Formulation 1 doses of Formulation 10. 1 dose on Days 0.

CIC Vaccine Formulation 1 doses of Formulation 11. 1 dose on Days 0.

qNIV Vaccine Formulation 1 doses of Formulation 12. 1 dose on Days 0.

qNIV Vaccine Formulation 1 doses of Formulation 13. 1 dose on Days 0.

CIC Vaccine Formulation 1 doses of Formulation 14. 1 dose on Days 0.

SARS-CoV-2 rS Vaccine Formulation 1 doses of Formulation 15. 1 dose on Days 0.

Reference Vaccine Formulation 1 doses of Formulation 16. 1 dose on Days 0.

Reference Vaccine Formulation 1 doses of Formulation 17. 1 dose on Days 0.

Reference Vaccine Formulation 1 doses of Formulation 18. 1 dose on Days 0.

Comparator Influenza Vaccine Formulation 1 doses of Formulation 19. 1 dose on Days 0.

Comparator Influenza Vaccine Formulation 1 doses of Formulation 20. 1 dose on Days 0.

CIC Vaccine Formulation 1 doses of Formulation 1. 1 dose on Days 0.

CIC Vaccine Formulation 1 doses of Formulation 2. 1 dose on Days 0.

Outcomes

Primary Outcome Measures

Part 1 and Part 2 : Number of participants with solicited local and systemic Adverse Events (AEs)
Numbers of participants with solicited local and systemic AEs over the 7 days post-vaccination.
Part 1 and Part 2 : Percentage of participants with all AEs
Proportions of participants reporting all AEs, solicited and unsolicited, over 21 days post-vaccination.
Part 1 and Part 2 : Percentage of participants with Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs)
Proportions of participants with MAAEs, AESIs (including PIMMCs and myocarditis and/or pericarditis), SAEs, will be collected for 6 months (approximately 182 days) post-vaccination

Secondary Outcome Measures

Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Geometric Mean Titer (GMT)
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s), and antigenically drifted influenza strains. Derived/calculated endpoints based on GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 0, 7, 21, 84, and other follow-up time points
Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Geometric Mean Fold Rise (GMFR)
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s), and antigenically drifted influenza strains. Derived/calculated endpoints based on Geometric mean fold rise (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 7, 21, 84, and other follow-up time points.
Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Seroconversion Rate (SCR)
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s), and antigenically drifted influenza strains. Derived/calculated endpoints based on Seroconversion rate (SCR) - defined as proportion of participants in a given Vaccine 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 7, 21, 84, and other follow-up time points
Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Seroprotection Rate (SPR)
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s), and antigenically drifted influenza strains. Derived/calculated endpoints based on Seroprotection rate (SPR) - defined as the proportion of participants with a reciprocal HAI titer ≥ 40 on Days 7, 21, 84, and other follow-up time points.
Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Geometric Mean Titer Ratio (GMTR)
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s), and antigenically drifted influenza strains. Derived/calculated endpoints based on GMTR between select treatment arms at Days 7, 21, 84, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline [pre-vaccination] titers).
Part 1 and Part 2: Neutralizing Antibody Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and/or Antigenically Drifted Influenza Strains Expressed as GMTs
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B strain(s) and/or antigenically drifted influenza strains, as measured by a MN assay expressed as GMTs.
Part 1 and Part 2 : Neutralizing Antibody Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and/or Antigenically Drifted Influenza Strains Expressed as GMFR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B strain(s) and/or antigenically drifted influenza strains, as measured by a MN assay expressed as GMFR
Part 1 and Part 2: Neutralizing Antibody Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and/or Antigenically Drifted Influenza Strains Expressed as SCR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B strain(s) and/or antigenically drifted influenza strains, as measured by a MN assay expressed as SCR.
Part 1 and Part 2: Neutralizing Antibody Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and/or Antigenically Drifted Influenza Strains Expressed as GMTR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B strain(s) and/or antigenically drifted influenza strains, as measured by a MN assay expressed as GMTR.
Part 1 and Part 2: Serum Immunoglobulin G (IgG) to the SARS-CoV-2 spike protein expressed as GMEU
IgG geometric mean enzyme-linked immunosorbent assay (ELISA) unit (GMEU) concentrations (EU/mL) to the SARS-CoV-2 S protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points, expressed as GMEU.
Part 1 and Part 2: Serum IgG to the SARS-CoV-2 spike protein expressed as GMFR
IgG geometric mean enzyme-linked immunosorbent assay (ELISA) unit (GMEU) concentrations (EU/mL) to the SARS-CoV-2 S protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points, expressed as GMFR.
Part 1 and Part 2: Serum IgG to the SARS-CoV-2 spike protein expressed as SCR
IgG geometric mean enzyme-linked immunosorbent assay (ELISA) unit (GMEU) concentrations (EU/mL) to the SARS-CoV-2 S protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points expressed as SCR.
Part 1 and Part 2: Serum IgG to the SARS-CoV-2 spike protein expressed as Geometric Mean ELISA Unit Ratio (GMEUR)
IgG geometric mean enzyme-linked immunosorbent assay (ELISA) unit (GMEU) concentrations (EU/mL) to the SARS-CoV-2 S protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points, expressed as GMEUR.
Part 1 and Part 2: Microneutralization assay (MN) 50 GMTs to the SARS-CoV-2 expressed as GMTs
MN50 GMTs to the SARS-CoV-2 from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points, expressed as GMTs.
Part 1 and Part 2: MN50 GMTs to the SARS-CoV-2 expressed as GMFR
MN50 GMTs to the SARS-CoV-2 from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points expressed as GMFR.
Part 1 and Part 2: MN50 GMTs to the SARS-CoV-2 expressed as SCR
MN50 GMTs to the SARS-CoV-2 from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points expressed as SCR.
Part 1 and Part 2: MN50 GMTs to the SARS-CoV-2 expressed as GMTR
MN50 GMTs to the SARS-CoV-2 from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points expressed as GMTR

Full Information

First Posted
August 26, 2022
Last Updated
January 24, 2023
Sponsor
Novavax
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1. Study Identification

Unique Protocol Identification Number
NCT05519839
Brief Title
A Study to Evaluate the Safety and Immunogenicity of COVID-19 and Influenza Combination Vaccine
Acronym
COVID-19
Official Title
A Phase 2, Randomized, Observer-Blinded Study to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 rS Nanoparticle and Quadrivalent Hemagglutinin Nanoparticle Influenza Combination Vaccine With Matrix-M™ Adjuvant in Healthy Participants ≥ 50 to ≤ 80 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 30, 2022 (Actual)
Primary Completion Date
July 25, 2023 (Anticipated)
Study Completion Date
December 24, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novavax

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, observer-blinded, Phase 2 study evaluating the safety and immunogenicity of a severe acute respiratory syndrome coronavirus 2 (SARSCoV2) recombinant spike (rS) (SARS-CoV-2 rS) nanoparticle and quadrivalent hemagglutinin (HA) nanoparticle influenza vaccine (qNIV) combination vaccine with Matrix-M™ adjuvant; this combination vaccine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Influenza
Keywords
Coronavirus, Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1579 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (Part 1)
Arm Type
Experimental
Arm Description
CIC Vaccine Formulation 1 doses of Formulation 1. 1 dose on Days 0.
Arm Title
Group B (Part 1)
Arm Type
Experimental
Arm Description
CIC Vaccine Formulation 1 doses of Formulation 2. 1 dose on Days 0.
Arm Title
Group C (Part 1)
Arm Type
Experimental
Arm Description
CIC Vaccine Formulation 1 doses of Formulation 3. 1 dose on Days 0.
Arm Title
Group D (Part 1)
Arm Type
Experimental
Arm Description
CIC Vaccine Formulation1 doses of Formulation 4. 1 dose on Days 0.
Arm Title
Group E (Part 1)
Arm Type
Experimental
Arm Description
CIC Vaccine Formulation 1 doses of Formulation 5. 1 dose on Days 0.
Arm Title
Group F (Part 1)
Arm Type
Experimental
Arm Description
CIC Vaccine Formulation 1 doses of Formulation 6. 1 dose on Days 0.
Arm Title
Group G (Part 1)
Arm Type
Experimental
Arm Description
CIC Vaccine Formulation 1 doses of Formulation 7. 1 dose on Days 0.
Arm Title
Group H (Part 1)
Arm Type
Experimental
Arm Description
CIC Vaccine Formulation 1 doses of Formulation 8. 1 dose on Days 0.
Arm Title
Group I (Part 1)
Arm Type
Experimental
Arm Description
CIC Vaccine Formulation 1 doses of Formulation 9. 1 dose on Days 0.
Arm Title
Group J (Part 1)
Arm Type
Experimental
Arm Description
CIC Vaccine Formulation 1 doses of Formulation 10. 1 dose on Days 0.
Arm Title
Group K (Part 1)
Arm Type
Experimental
Arm Description
CIC Vaccine Formulation 1 doses of Formulation 11. 1 dose on Days 0.
Arm Title
Group L (Part 1)
Arm Type
Experimental
Arm Description
qNIV Vaccine Formulation 1 doses of Formulation 12. 1 dose on Days 0.
Arm Title
Group M (Part 1)
Arm Type
Experimental
Arm Description
qNIV Vaccine Formulation 1 doses of Formulation 13. 1 dose on Days 0.
Arm Title
Group N (Part 1)
Arm Type
Experimental
Arm Description
CIC Vaccine Formulation 1 doses of Formulation 14. 1 dose on Days 0.
Arm Title
Group O (Part 1)
Arm Type
Experimental
Arm Description
SARS-CoV-2 rS Vaccine Formulation 1 doses of Formulation 15. 1 dose on Days 0.
Arm Title
Group P (Part 1)
Arm Type
Experimental
Arm Description
Reference Vaccine Formulation 1 doses of Formulation 16. 1 dose on Days 0.
Arm Title
Group Q (Part 1)
Arm Type
Experimental
Arm Description
Reference Vaccine Formulation 1 doses of Formulation 17. 1 dose on Days 0.
Arm Title
Group R (Part 1)
Arm Type
Experimental
Arm Description
Reference Vaccine Formulation 1 doses of Formulation 18. 1 dose on Days 0.
Arm Title
Group S (Part 1)
Arm Type
Experimental
Arm Description
Comparator Influenza Vaccine Formulation 1 doses of Formulation 19. 1 dose on Days 0.
Arm Title
Group T (Part 1)
Arm Type
Experimental
Arm Description
Comparator Influenza Vaccine Formulation 1 doses of Formulation 20. 1 dose on Days 0.
Arm Title
Group U (Part 2)
Arm Type
Experimental
Arm Description
CIC Vaccine Formulation 1 doses of Formulation 1. 1 dose on Days 0.
Arm Title
Group V (Part 2)
Arm Type
Experimental
Arm Description
CIC Vaccine Formulation 1 doses of Formulation 2. 1 dose on Days 0.
Intervention Type
Drug
Intervention Name(s)
CIC Vaccine
Intervention Description
Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (CIC Vaccine) on Day 0.
Intervention Type
Drug
Intervention Name(s)
CIC Vaccine
Intervention Description
Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV, SARS-CoV-2 rS, and 75 μg Matrix-M1 Adjuvant (CIC Vaccine) on Day 0.
Intervention Type
Drug
Intervention Name(s)
qNIV Vaccine
Intervention Description
Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV and 75 μg Matrix-M1 Adjuvant (Influenza Vaccine) on Day 0.
Intervention Type
Drug
Intervention Name(s)
SARS-CoV-2 rS Vaccine
Intervention Description
Intramuscular (deltoid) injections of in-clinic mix of various doses of SARS-CoV-2 rS, Diluent, and 50 μg Matrix-M1 Adjuvant (SARS-CoV-2 rS Vaccine) on Day 0.
Intervention Type
Drug
Intervention Name(s)
Influenza Vaccine
Intervention Description
Intramuscular (deltoid) injections of Comparator influenza on Day 0.
Intervention Type
Drug
Intervention Name(s)
CIC Vaccine
Intervention Description
Intramuscular (deltoid) injections of co-formulated mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (CIC Vaccine) on Day 0.
Primary Outcome Measure Information:
Title
Part 1 and Part 2 : Number of participants with solicited local and systemic Adverse Events (AEs)
Description
Numbers of participants with solicited local and systemic AEs over the 7 days post-vaccination.
Time Frame
Day 0 to Day 7
Title
Part 1 and Part 2 : Percentage of participants with all AEs
Description
Proportions of participants reporting all AEs, solicited and unsolicited, over 21 days post-vaccination.
Time Frame
Day 0 to Day 21
Title
Part 1 and Part 2 : Percentage of participants with Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs)
Description
Proportions of participants with MAAEs, AESIs (including PIMMCs and myocarditis and/or pericarditis), SAEs, will be collected for 6 months (approximately 182 days) post-vaccination
Time Frame
Day 0 to Day 182
Secondary Outcome Measure Information:
Title
Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Geometric Mean Titer (GMT)
Description
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s), and antigenically drifted influenza strains. Derived/calculated endpoints based on GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 0, 7, 21, 84, and other follow-up time points
Time Frame
Day 0 to Day 84
Title
Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Geometric Mean Fold Rise (GMFR)
Description
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s), and antigenically drifted influenza strains. Derived/calculated endpoints based on Geometric mean fold rise (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 7, 21, 84, and other follow-up time points.
Time Frame
Day 0 to Day 84
Title
Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Seroconversion Rate (SCR)
Description
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s), and antigenically drifted influenza strains. Derived/calculated endpoints based on Seroconversion rate (SCR) - defined as proportion of participants in a given Vaccine 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 7, 21, 84, and other follow-up time points
Time Frame
Day 0 to Day 84
Title
Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Seroprotection Rate (SPR)
Description
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s), and antigenically drifted influenza strains. Derived/calculated endpoints based on Seroprotection rate (SPR) - defined as the proportion of participants with a reciprocal HAI titer ≥ 40 on Days 7, 21, 84, and other follow-up time points.
Time Frame
Day 0 to Day 84
Title
Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Geometric Mean Titer Ratio (GMTR)
Description
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s), and antigenically drifted influenza strains. Derived/calculated endpoints based on GMTR between select treatment arms at Days 7, 21, 84, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline [pre-vaccination] titers).
Time Frame
Day 0 to Day 84
Title
Part 1 and Part 2: Neutralizing Antibody Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and/or Antigenically Drifted Influenza Strains Expressed as GMTs
Description
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B strain(s) and/or antigenically drifted influenza strains, as measured by a MN assay expressed as GMTs.
Time Frame
Day 0 to Day 84
Title
Part 1 and Part 2 : Neutralizing Antibody Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and/or Antigenically Drifted Influenza Strains Expressed as GMFR
Description
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B strain(s) and/or antigenically drifted influenza strains, as measured by a MN assay expressed as GMFR
Time Frame
Day 0 to Day 84
Title
Part 1 and Part 2: Neutralizing Antibody Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and/or Antigenically Drifted Influenza Strains Expressed as SCR
Description
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B strain(s) and/or antigenically drifted influenza strains, as measured by a MN assay expressed as SCR.
Time Frame
Day 0 to Day 84
Title
Part 1 and Part 2: Neutralizing Antibody Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and/or Antigenically Drifted Influenza Strains Expressed as GMTR
Description
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B strain(s) and/or antigenically drifted influenza strains, as measured by a MN assay expressed as GMTR.
Time Frame
Day 0 to Day 84
Title
Part 1 and Part 2: Serum Immunoglobulin G (IgG) to the SARS-CoV-2 spike protein expressed as GMEU
Description
IgG geometric mean enzyme-linked immunosorbent assay (ELISA) unit (GMEU) concentrations (EU/mL) to the SARS-CoV-2 S protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points, expressed as GMEU.
Time Frame
Day 0 to Day 84
Title
Part 1 and Part 2: Serum IgG to the SARS-CoV-2 spike protein expressed as GMFR
Description
IgG geometric mean enzyme-linked immunosorbent assay (ELISA) unit (GMEU) concentrations (EU/mL) to the SARS-CoV-2 S protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points, expressed as GMFR.
Time Frame
Day 0 to Day 84
Title
Part 1 and Part 2: Serum IgG to the SARS-CoV-2 spike protein expressed as SCR
Description
IgG geometric mean enzyme-linked immunosorbent assay (ELISA) unit (GMEU) concentrations (EU/mL) to the SARS-CoV-2 S protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points expressed as SCR.
Time Frame
Day 0 to Day 84
Title
Part 1 and Part 2: Serum IgG to the SARS-CoV-2 spike protein expressed as Geometric Mean ELISA Unit Ratio (GMEUR)
Description
IgG geometric mean enzyme-linked immunosorbent assay (ELISA) unit (GMEU) concentrations (EU/mL) to the SARS-CoV-2 S protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points, expressed as GMEUR.
Time Frame
Day 0 to Day 84
Title
Part 1 and Part 2: Microneutralization assay (MN) 50 GMTs to the SARS-CoV-2 expressed as GMTs
Description
MN50 GMTs to the SARS-CoV-2 from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points, expressed as GMTs.
Time Frame
Day 0 to Day 84
Title
Part 1 and Part 2: MN50 GMTs to the SARS-CoV-2 expressed as GMFR
Description
MN50 GMTs to the SARS-CoV-2 from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points expressed as GMFR.
Time Frame
Day 0 to Day 84
Title
Part 1 and Part 2: MN50 GMTs to the SARS-CoV-2 expressed as SCR
Description
MN50 GMTs to the SARS-CoV-2 from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points expressed as SCR.
Time Frame
Day 0 to Day 84
Title
Part 1 and Part 2: MN50 GMTs to the SARS-CoV-2 expressed as GMTR
Description
MN50 GMTs to the SARS-CoV-2 from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points expressed as GMTR
Time Frame
Day 0 to Day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: To be included in this study, each individual must satisfy all the following criteria: Medically stable adult male or females ≥ 50 to ≤ 80 years of age at screening. Participants may have 1 or more chronic medical diagnoses, but should be clinically stable as assessed by: Absence of changes in medical therapy in the past 2 months due to treatment failure or toxicity; Absence of medical events qualifying as SAEs within 3 months; and Absence of known, current, and life-limiting diagnoses which render survival to completion of the protocol unlikely in the opinion of the investigator. The participant has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, at screening. 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 completed a primary vaccination series against SARS-CoV-2 with an authorized COVID 19 vaccine (and fulfill national recommendations for his/her age and morbidity category) with receipt of second/last dose of authorized vaccine (with or without boosters[s]) ≥ 8 weeks prior to enrollment (first study vaccination). 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 review of health status, vital signs [to include body temperature], medical history, and targeted physical examination [to include body weight]). Vital signs must be within medically acceptable ranges prior to 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. Exclusion Criteria: If an individual meets any of the following criteria, he or she is ineligible for this study: History of laboratory-confirmed (by Polymerase Chain Reaction (PCR) or rapid antigen test) COVID-19 or asymptomatic SARS-CoV-2 infection ≤ 8 weeks prior to enrollment. (NOTE: Symptomatic COVID-19 or asymptomatic SARS-CoV-2 infection > 8 weeks prior to enrollment is NOT exclusionary) Any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness that required changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the investigator). This includes any current workup of undiagnosed illness that could lead to a new condition. Serious chronic diseases inclusive of: Uncontrolled hypertension (NOTE: well controlled hypertension ≤ grade 2 in NOT exclusionary); Congestive heart failure with a history of an acute exacerbation of any severity in the prior 2 years (NOTE: mild well-controlled congestive heart failure is NOT exclusionary); Chronic obstructive pulmonary disease (COPD) with a history of an acute exacerbation of any severity in the prior 2 years (NOTE: mild well-controlled COPD is NOT exclusionary); In the past 3 months, evidence of unstable coronary artery disease as manifested by cardiac interventions (eg, cardiac stent placement, coronary artery bypass grafting [CABG]) surgery, new cardiac medications for control of symptoms, or unstable angina (NOTE: stable coronary heart disease is NOT exclusionary); Asthma with a history of exacerbation in the prior 2 years or worsening of asthma symptoms or requiring changes in asthma control medications in the past 2 months (NOTE: well-controlled asthma is NOT exclusionary). Type 1 or type 2 diabetes (adult onset) requiring insulin (NOTE: non-insulin dependent type 2 diabetes is NOT exclusionary); Chronic kidney disease/renal insufficiency; Chronic gastrointestinal and hepatic diseases; or Chronic neurological diseases (such as multiple sclerosis, dementia, Parkinson's disease, degenerative neurological conditions, neuropathy, or epilepsy), history of stroke within 12 months with residual symptoms, or previous neurological disorder within 12 months with residual symptoms (NOTE: history of migraine or chronic headaches or nerve root compression that have been stable on treatment for the last 4 weeks are NOT exclusionary). Participation in research involving an investigational product (drug/biologic/device) within 90 days before planned date of vaccination. Use of COVID-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to planned date of vaccination. History of a serious reaction to 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 8 weeks preceding the study vaccination. Note: Routine vaccinations will not be allowed until after study Day 21 and COVID and influenza vaccination will not be allowed until after Day 84. Any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination (NOTE: mild psoriasis is not exclusionary). Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune- modifying drugs within 6 months prior to the administration of the study vaccines. An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids is permitted. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study. Active cancer (malignancy) therapy within 3 years prior to study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator). Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study (EoS). Known disturbance of coagulation. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to study vaccination, which in the opinion of the investigator, might interfere with protocol compliance. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature > 38.0°C, on the planned day of vaccine administration). History of myocarditis or pericarditis. Any condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting). Study team member or immediate family member of any study team member (inclusive of Sponsor, Contract Research Organization, and study site personnel involved in the conduct or planning of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development
Organizational Affiliation
Novavax, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Paratus Clinical Research - Canberra
City
Bruce
State/Province
Australian Capital Territory
Country
Australia
Facility Name
Paratus Clinical Research - Western Sydney
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
Emeritus Research - Sydney
City
Botany
State/Province
New South Wales
Country
Australia
Facility Name
Genesis Central Coast
City
Broadmeadow
State/Province
New South Wales
Country
Australia
Facility Name
Northern Beaches Clinical Research
City
Brookvale
State/Province
New South Wales
Country
Australia
Facility Name
East Sydney Doctors
City
Darlinghurst
State/Province
New South Wales
Country
Australia
Facility Name
Holdsworth House Medical Brisbane
City
Darlinghurst
State/Province
New South Wales
Country
Australia
Facility Name
Oztrials Clinical Research
City
Drummoyne
State/Province
New South Wales
Country
Australia
Facility Name
Paratus Clinical Research - Central Coast
City
Kanwal
State/Province
New South Wales
Country
Australia
Facility Name
Australian Clinical Research Network
City
Maroubra
State/Province
New South Wales
Country
Australia
Facility Name
Hunter Diabetes Centre
City
Merewether
State/Province
New South Wales
Country
Australia
Facility Name
Sutherland Clinical Trials
City
Miranda
State/Province
New South Wales
Country
Australia
Facility Name
Illawarra Health and Medical Research Institute
City
Wollongong
State/Province
New South Wales
Country
Australia
Facility Name
Northside Health
City
Coffs Harbour
State/Province
New South Whales
ZIP/Postal Code
2450
Country
Australia
Facility Name
Novatrials
City
Kotara
State/Province
New South Whales
ZIP/Postal Code
2289
Country
Australia
Facility Name
Menzies Darwin
City
Tiwi
State/Province
Norther Territory
Country
Australia
Facility Name
Paratus Clinical Research - Brisbane Clinic
City
Albion
State/Province
Queensland
Country
Australia
Facility Name
Mater Adult Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Nucleus Network Pty Ltd
City
Herston
State/Province
Queensland
Country
Australia
Facility Name
Core Research Group
City
Milton
State/Province
Queensland
Country
Australia
Facility Name
Austrials Pty Ltd - Taringa
City
Taringa
State/Province
Queensland
Country
Australia
Facility Name
AusTrials (Wellers Hill)
City
Tarragindi
State/Province
Queensland
Country
Australia
Facility Name
CMAX
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Emeritus Research
City
Camberwell
State/Province
Victoria
Country
Australia
Facility Name
Nucleus Network Limited
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
P3 Reseach - Hawkes Bay
City
Havelock North
State/Province
Hawkes Bay
Country
New Zealand
Facility Name
P3 Research - Palmerston North
City
Palmerston North
State/Province
Manawatu-Wanganui
ZIP/Postal Code
4414
Country
New Zealand
Facility Name
P3 Research - Lower Hutt
City
Palmerston
State/Province
Wellington
Country
New Zealand
Facility Name
P3 Research Kapiti
City
Paraparaumu
State/Province
Wellington
Country
New Zealand
Facility Name
Middlemore Clinical Trials
City
Auckland
Country
New Zealand
Facility Name
Optimal Clinical Trials Ltd
City
Auckland
Country
New Zealand
Facility Name
New Zealand Clinical Research - Christchurch
City
Christchurch
Country
New Zealand
Facility Name
P3 Research - Dunedin
City
Dunedin
Country
New Zealand
Facility Name
P3 Research - Tauranga
City
Tauranga
Country
New Zealand
Facility Name
P3 Research - Wellington
City
Wellington
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

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

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