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COVID-19Phase 2/3NCT06485752

Phase 3 Lot Consistency Study of Trivalent Hemagglutinin Nanoparticle Influenza Vaccine

A Phase 2/3 study testing tNIV 1 and Matrix-M Adjuvant in people with COVID-19, run by Novavax.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Phase 3 Study Comparing Safety and Immune Response of Three Batches of Novavax Flu Vaccine in older adult participants Read more about this study

Who is it for?
Ages 60 to 75 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
tNIV 1 and Matrix-M Adjuvant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Nov 2024to 4 Feb 2025
Phase
Phase 2/3
Are there results?
None posted in the registry

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 60 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • To be included in this study, each individual must satisfy all of the following criteria:
  • Willing and able to give informed consent prior to study enrollment.
  • Medically stable adult male or female ≥ 60 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
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  • 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.
  • Participant must be able to receive an injection in the deltoid of at least one arm.
  • Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AEs.
  • 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 agree to not participate in any other severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or influenza prevention or treatment studies for the duration of the study. Note: For participants who become hospitalized with COVID-19 or influenza, participation in investigational treatment studies is permitted.

Who cannot join

  • If an individual meets any of the following criteria, he or she is ineligible for this study:
  • Any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness that required substantive changes in medication in the past 2 months prior to Screening indicating that chronic illness/disease is not stable (at the discretion of the Investigator). This includes any current workup of undiagnosed illness that could lead to a new condition.
  • Serious chronic diseases inclusive of:
  • Uncontrolled hypertension (NOTE: hypertension ≤ 170/100 is NOT exclusionary);
  • Congestive heart failure requiring hospitalization within 3 months prior to Screening (NOTE: stable congestive heart failure is NOT exclusionary);
  • Chronic obstructive pulmonary disease (COPD) requiring hospitalization within 3 months prior to Screening (NOTE: stable COPD is NOT exclusionary);
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  • Within 3 months prior to Screening, evidence of unstable coronary artery disease as manifested by cardiac interventions (eg, cardiac stent placement, coronary artery bypass graft surgery), new cardiac medications for control of symptoms, or unstable angina (NOTE: stable coronary heart disease is NOT exclusionary);
  • Hospitalization for diabetic ketoacidosis within 6 months prior to Screening
  • Chronic kidney disease/renal requiring institution of substantive new therapy within 3 months prior to Screening
  • Chronic clinically significant gastrointestinal and hepatic diseases requiring hospitalization or institution of substantive new therapy within 3 months prior to Screening. (f or example, gastroesophageal reflux disease is NOT exclusionary)
  • Chronic neurological diseases or neurological compromise preventing access to the study clinic, compliance with protocol, or accurate reporting of safety.
  • 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 a prior influenza vaccination or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80; or any known allergies to products contained in the investigational product.
  • 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 28 and COVID-19 and influenza vaccination will not be allowed until after Day 28.
  • Any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination (NOTE: well-controlled hypothyroidism and mild psoriasis are not exclusionary).
  • 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 1 year prior to study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the Investigator).
  • Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the EoS.
  • 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).
  • 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).

About this study

Official title: A Phase 3, Randomized, Observer-Blinded, Study to Compare the Safety and Immunogenicity of 3 Lots of Trivalent Hemagglutinin Nanoparticle Influenza Vaccine With Matrix M™ Adjuvant in Participants ≥ 60 Years of Age

Phase 3 Study Comparing Safety and Immune Response of Three Batches of Novavax Flu Vaccine in older adult participants

Read the detailed description

This is a randomized, Phase 3 study comparing the safety and immunogenicity of 3 different lots of Novavax trivalent hemagglutinin (HA) nanoparticle influenza vaccine (NIV) with Matrix-M (tNIV) in terms of wild-type influenza hemagglutinin inhibition (HAI) antibody responses to 3 vaccine-homologous influenza strains (ie, 2 influenza A strains and an influenza B-Victoria lineage strain).

Conditions
COVID-19
Being tested
tNIV 1 and Matrix-M Adjuvant
Keywords
COVID-19, influenza Vaccine
Medical subject headings
COVID-19, Influenza, Human

What participants receive

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

  • tNIV 1 and Matrix-M AdjuvantBiological

    Also called Influenza vaccine

    tNIV will be administered as a single 0.5 mL IM injection Day 0

Study groups in NCT06485752
Study groupRoleWhat they receive
Lot 1 (Group 1)Active comparatorinfluenza A [H1N1]
Receives: Biological: tNIV 1 and Matrix-M Adjuvant
Lot 2 (Group 2)Active comparatorinfluenza A [H3N2]
Receives: Biological: tNIV 1 and Matrix-M Adjuvant
Lot 3 (Group 3)Active comparatorinfluenza B-Victoria lineage strains
Receives: Biological: tNIV 1 and Matrix-M Adjuvant

What is being measured

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

  1. Safety- Solicited AEs over 7 days post-vaccination

    Numbers and proportions of participants with solicited local and systemic AEs over the 7 days post-vaccination.

    Measured: 7 days post-vaccination

  2. Safety- Unsolicited AEs and MAAEs over 28 days post-vaccination

    Numbers and proportions of participants reporting unsolicited AEs and MAAEs over 28 days post-vaccination.

    Measured: Day 0 to 28

  3. Safety-Treatment-related MAAEs, SAEs, and AESIs (including PIMMC)

    Numbers and proportions of participants with treatment-related MAAEs, AESIs (including PIMMCs), and SAEs over 6 months (approximately 182 days) post-vaccination.

    Measured: Day-0 to 182

  4. Immunogenicity-HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMT

    HAI antibody titers specific for the HA receptor binding domains of vaccine response to 3 vaccine-homologous influenza strains (ie, 2 influenza A strains and an influenza B-Victoria lineage strain) at Day 28.

    Measured: Day-0 to 28

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

    HAI antibody titers specific for the HA receptor binding domains of vaccine response to 3 vaccine-homologous influenza strains (ie, 2 influenza A strains and an influenza B-Victoria lineage strain) at Day 28.

    Measured: Day-0 to 28

Secondary outcomes (3)

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

    Neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, as measured by a neutralization assay of vaccine response to 3 vaccine-homologous influenza strains (ie, 2 influenza A strains and an influenza B-Victoria lineage strain) at Day 28.

    Measured: Day 0 to Day 28

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

    Neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, as measured by a neutralization assay of vaccine response to 3 vaccine-homologous influenza strains (ie, 2 influenza A strains and an influenza B-Victoria lineage strain) at Day 28 [Post vaccination].

    Measured: Day 28 [Post vaccination]

  3. Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as SCR

    Neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, as measured by a neutralization assay of vaccine response to 3 vaccine-homologous influenza strains (ie, 2 influenza A strains and an influenza B-Victoria lineage strain) at Day 28 [Post vaccination].

    Measured: Day 28 [Post vaccination]

Timeline

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

  1. First posted3 Jul 2024
  2. Study startNov 2024 (estimated)
  3. Primary completion4 Feb 2025
  4. Study completion4 Feb 2025

Why it stopped: Decided to not move forward with the study

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 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06485752
Sponsor's protocol ID
tNIV-E-316
Status last verified
Mar 2025
First submitted
27 Jun 2024
Last updated
11 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing tNIV 1 and Matrix-M Adjuvant in people with COVID-19, run by Novavax.

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 19 inclusion and 26 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: withdrawn, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

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

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Safety- Solicited AEs over 7 days post-vaccination (time frame: 7 days post-vaccination). The study lists 5 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 NCT06485752.

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 11 Mar 2025.

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