Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine
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
1 other identifier
interventional
637
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2021
Shorter than P25 for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2021
CompletedFirst Posted
Study publicly available on registry
July 14, 2021
CompletedStudy Start
First participant enrolled
September 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2022
CompletedResults Posted
Study results publicly available
April 10, 2025
CompletedApril 10, 2025
April 1, 2025
4 months
July 9, 2021
April 27, 2023
April 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Day 0 to Day 63
Number of Participants Reporting All AE's
Number of participants reporting all AEs, (solicited and unsolicited), over 70 days after the first dose.
Day 0 to Day 70
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.
Day 0 to Day 180
Secondary Outcomes (88)
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)
Day 0 to Day 182
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs
Day 0 to Day 182
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs
Day 0 to Day 182
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs
Day 0 to Day 182
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
Day 0 to Day 182
- +83 more secondary outcomes
Study Arms (14)
Group A and Group C - ICC Vaccine Formulation
EXPERIMENTAL2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
Group B -ICC Vaccine Formulation
EXPERIMENTAL2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
Group D - ICC Vaccine Formulation
EXPERIMENTAL2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
Group E - ICC Vaccine Formulation
EXPERIMENTAL2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
Group F- ICC Vaccine Formulation
EXPERIMENTAL2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
Group G- ICC Vaccine Formulation
EXPERIMENTAL2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
Group H and Group N- ICC Vaccine Formulation
EXPERIMENTAL2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
Group I- ICC Vaccine Formulation
EXPERIMENTAL2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
Group J -ICC Vaccine Formulation
EXPERIMENTAL2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
Group K - ICC Vaccine Formulation
EXPERIMENTAL2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
Group L - ICC Vaccine Formulation
EXPERIMENTAL2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
Group M -ICC Vaccine Formulation
EXPERIMENTAL2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
Group O - qNIV with Matrix-M1 adjuvant
EXPERIMENTAL2 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.
Group P- SARS-CoV-2 rS with Matrix-M1 adjuvant
EXPERIMENTAL2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
- 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
- +2 more criteria
You may not qualify if:
- Any ongoing, symptomatic acute, or chronic illness requiring medical or surgical care.
- 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.
- 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).
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novavaxlead
Study Sites (10)
Paratus Clinical Research - Canberra
Bruce, Australian Capital Territory, 2617, Australia
Paratus Clinical Research - Western Sydney
Blacktown, New South Wales, 2148, Australia
Northern Beaches Clinical Research
Brookvale, New South Wales, 2100, Australia
Paratus Clinical Research - Central Coast
Kanwal, New South Wales, 2259, Australia
Hunter Diabetes Centre
Merewether, New South Wales, 2291, Australia
University of the Sunshine Coast,Southbank
Brisbane, Queensland, 4101, Australia
University of the Sunshine Coast, Health Hub Morayfield
Morayfield, Queensland, 4506, Australia
University of the Sunshine Coast
Sippy Downs, Queensland, 4556, Australia
Austrials Pty Ltd - Taringa
Taringa, Queensland, 4068, Australia
Emeritus Research
Camberwell, Victoria, 3214, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Novavax Customer Service Center
- Organization
- Novavax Inc.
Study Officials
- STUDY DIRECTOR
Clinical Development
Novavax
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2021
First Posted
July 14, 2021
Study Start
September 8, 2021
Primary Completion
December 22, 2021
Study Completion
April 22, 2022
Last Updated
April 10, 2025
Results First Posted
April 10, 2025
Record last verified: 2025-04