Phase 3 Lot Consistency Study of Trivalent Hemagglutinin Nanoparticle Influenza Vaccine

NCT06485752 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: tNIV-E-316
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

COVID-19

Keywords

COVID-19, influenza Vaccine

Outcome Measures

Primary Outcomes (5)

• 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.

  7 days post-vaccination

• 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.

  Day 0 to 28

• 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.

  Day-0 to 182

• 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.

  Day-0 to 28

• 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.

  Day-0 to 28

Secondary Outcomes (3)

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

  Day 0 to Day 28

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

  Day 28 [Post vaccination]

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

  Day 28 [Post vaccination]

Study Arms (3)

Lot 1 (Group 1)

ACTIVE COMPARATOR

influenza A \[H1N1\]

Biological: tNIV 1 and Matrix-M Adjuvant

Lot 2 (Group 2)

ACTIVE COMPARATOR

influenza A \[H3N2\]

Biological: tNIV 1 and Matrix-M Adjuvant

Lot 3 (Group 3)

ACTIVE COMPARATOR

influenza B-Victoria lineage strains

Biological: tNIV 1 and Matrix-M Adjuvant

Interventions

tNIV 1 and Matrix-M Adjuvant BIOLOGICAL

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

Also known as: Influenza vaccine

Lot 1 (Group 1); Lot 2 (Group 2); Lot 3 (Group 3)

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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:
• 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 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.
• 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).

Sponsors & Collaborators

• Novavax: lead

MeSH Terms

Conditions

COVID-19; Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 3, 2024
• Study Start: November 1, 2024
• Primary Completion: February 4, 2025
• Study Completion: February 4, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03