Influenza, Human Clinical Trial
Official title:
Phase 2 Clinical Trial to Confirm the Dose and Formulation of a Recombinant Quadrivalent Nanoparticle Influenza Vaccine (Quad-NIV) With or Without Matrix-M1™ Adjuvant in Healthy Adults ≥ 65 Years of Age
Verified date | November 2022 |
Source | Novavax |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A Phase 2 trial to confirm the dose and formulation, demonstrate adjuvant effect, and evaluate the safety and tolerability of a single intramuscular injection of Quad-NIV with or without Matrix-M1 adjuvant in healthy adults ≥ 65 years of age. A total of approximately 1375 subjects were to be randomized to seven treatment groups to receive Quad-NIV or an active comparator.
Status | Terminated |
Enrollment | 1375 |
Est. completion date | April 26, 2019 |
Est. primary completion date | April 26, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: 1. Clinically-stable adult male or female, = 65 years of age. Subjects may have 1 or more chronic medical diagnoses, but should be clinically stable as assessed by: - Absence of changes in medical therapy within 1 month due to treatment failure or toxicity, - Absence of medical events qualifying as serious adverse events within 2 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. 2. Willing and able to give informed consent prior to trial enrollment, and 3. Living in the community and able to attend trial visits, comply with trial requirements, and provide timely, reliable, and complete reports of adverse events. Exclusion Criteria: 1. Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first injection. 2. Participation in any previous Novavax's influenza vaccine clinical trial(s). 3. History of a serious reaction to prior influenza vaccination, known allergy to constituents of licensed comparator vaccines or polysorbate 80. 4. History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine. 5. Received any vaccine in the 4 weeks preceding the trial vaccination and any influenza vaccine within 6 months preceding the trial vaccination. 6. Any known or suspected immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination. 7. 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 trial vaccine. 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. 8. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the trial vaccine or during the trial. 9. 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). 10. Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of trial results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting). 11. Known disturbance of coagulation. 12. Suspicion or recent history (within 1 year of planned vaccination) of alcohol or other substance abuse. |
Country | Name | City | State |
---|---|---|---|
United States | US078 | Cary | North Carolina |
United States | US050 | Dakota Dunes | South Dakota |
United States | US135 | Hollywood | Florida |
United States | US056 | Moncks Corner | South Carolina |
United States | US025 | Norfolk | Nebraska |
United States | US018 | Omaha | Nebraska |
United States | US108 | Raleigh | North Carolina |
United States | US138 | Rockville | Maryland |
United States | US137 | Salisbury | North Carolina |
United States | US045 | Savannah | Georgia |
United States | US132 | Statesville | North Carolina |
United States | US013 | Stockbridge | Georgia |
United States | US071 | Wilmington | North Carolina |
United States | US063 | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Novavax |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects With Adverse Events (AEs) | Adverse Events over the 7 days post-injection; all adverse events (including adverse changes in clinical laboratory parameters) through 21 days post-injection; and Medically Attended Adverse Events (MAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs) through 6 months post-injection. | Day 0 - Day 182 | |
Primary | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B strain(s) at Days 0 and Day 28 post-vaccination expressed as geometric man titer (GMT). | Day 0 - Day 28 | |
Primary | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | HAI antibody titers specific for at least 2 antigenically-drifted influenza strains, at Days 0 and 28 post-vaccination expressed as geometric man titer (GMT). | Day 0 - Day 28 | |
Secondary | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as GMT on Day 0,28,56 and 182. | Day 0 - Day 182 | |
Secondary | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as GMFR on Day 28,56 and 182. | Day 28 - Day 182 | |
Secondary | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as SCR on Day 28,56 and 182. | Day 28 - Day 182 | |
Secondary | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as SPR on Day 28,56 and 182. | Day 28 - Day 182 | |
Secondary | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | HAI antibody titers specific for antigenically-drifted influenza strains, at Days 0,28, 56 and 182 expressed as geometric man titer (GMT). | Day 0 - Day 182 | |
Secondary | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | HAI antibody titer responses specific for antigenically-drifted influenza strains, at Days 28, 56, and 182 expressed as Geometric Fold Ratio. | Day 28 - Day 182 | |
Secondary | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | HAI antibody titers specific for antigenically-drifted influenza strains, at Days 28, 56 and 182 expressed as SCR. | Day 28 - Day 182 | |
Secondary | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | HAI antibody titers specific for antigenically-drifted influenza strains, at Days 28, 56 and 182 expressed as SPR. | Day 28 - Day 182 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03442582 -
Afluria Pregnancy Registry
|
||
Completed |
NCT03275389 -
A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years
|
Phase 1 | |
Completed |
NCT05981846 -
A Phase II Trial to Evaluate the Safety and Immunogenicity of BIMERVAX® When Coadministered With Seasonal Influenza Vaccine (SIIV) in Adults Older Than 65 Years of Age Fully Vaccinated Against COVID-19
|
Phase 2 | |
Completed |
NCT05044195 -
A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age
|
Phase 3 | |
Completed |
NCT02914275 -
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.
|
Phase 3 | |
Completed |
NCT04590066 -
Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates at a Large Retail Pharmacy
|
N/A | |
Recruiting |
NCT03778203 -
Development of Childhood Anti-influenza Immunity
|
Phase 4 | |
Completed |
NCT04527614 -
Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection
|
N/A | |
Completed |
NCT05269290 -
Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute Respiratory Viral Infections
|
Phase 3 | |
Completed |
NCT06385821 -
A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus
|
Phase 3 | |
Completed |
NCT02998996 -
Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU
|
Phase 1/Phase 2 | |
Completed |
NCT02984280 -
Specific Respiratory Infections as Triggers of Acute Medical Events
|
N/A | |
Completed |
NCT02867358 -
A Clinical Trial of KT07 Capsule in the U.S.A
|
Phase 2 | |
Withdrawn |
NCT02883972 -
Childhood Influenza Immunisation Invitation Trial in Schools
|
N/A | |
Completed |
NCT02545543 -
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age
|
Phase 3 | |
Completed |
NCT02621164 -
Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents
|
Phase 3 | |
Completed |
NCT02212106 -
A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years
|
Phase 4 | |
Completed |
NCT02243774 -
Mail Outreach To Increase Vaccination Acceptance Through Engagement
|
N/A | |
Completed |
NCT02344134 -
Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects
|
Phase 3 | |
Completed |
NCT01674205 -
Study of Immune Responses in Healthy Adults Receiving Live Influenza Virus Vaccines
|
Phase 1 |