Phase 3 Pivotal Trial of NanoFlu™ in Older Adults
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|ClinicalTrials.gov Identifier: NCT04120194|
Recruitment Status : Unknown
Verified April 2020 by Novavax.
Recruitment status was: Active, not recruiting
First Posted : October 9, 2019
Last Update Posted : April 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Influenza, Human||Biological: NanoFlu Biological: Fluzone Quadrivalent||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2650 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Randomized, Observer-blinded, Active-controlled Trial to Evaluate Immunogenicity & Safety of a Recombinant Quadrivalent Nanoparticle Influenza Vaccine (Quad-NIV) With Matrix-M1™ Adjuvant Against Fluzone® Quadrivalent in Clinically Stable Adults ≥ 65 Years of Age|
|Actual Study Start Date :||October 14, 2019|
|Actual Primary Completion Date :||March 16, 2020|
|Estimated Study Completion Date :||November 2020|
NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
Other Name: Quad-NIV
Active Comparator: Fluzone Quadrivalent
Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
Biological: Fluzone Quadrivalent
Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
- Hemagglutination inhibition (HAI) titers of vaccine homologous influenza strains [ Time Frame: Day 0 - Day 28 ]Comparative HAI responses by ratio of geometric mean titers (GMTs) and seroconversion rate (SCR) difference
- Number of adverse events (AEs) [ Time Frame: Day 0 - Day 364 ]Solicited local and systemic AEs over 7 days post-injection; all AEs through 28 days post-injection; and medically-attended events (MAEs), serious adverse events (SAEs), and significant new medical conditions (SNMCs) though 1 year post-injection
- HAI titers to all vaccine homologous influenza strains and at least 1 antigenically drifted strain [ Time Frame: Day 0 - Day 28 ]GMT, geometric mean ratio (GMR), SCR, seroprotection rate (SPR)
- Cell-mediated immune (CMI) responses [ Time Frame: Day 0 - Day 28 ]Counts of peripheral blood effector memory T-cell populations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04120194
|Study Director:||Vivek Shinde, MD||Novavax, Inc.|