Fluzone High-Dose Quadrivalent (influenza vaccine) / Evotec, Sanofi - LARVOL DELTA

Immunogenicity and safety of high-dose versus standard-dose quadrivalent inactivated influenza vaccine in patients living with HIV: a randomized controlled trial. (PubMed, Vaccine) - "To address this gap, we conducted a randomized, single-blinded, controlled trial to compare the immunogenicity and safety of the high-dose (HD) IIV4 (60 μg, Efluelda, Sanofi) with the SD IIV4 (15 μg, Vaxigrip Tetra, Sanofi)...In conclusion, HD IIV4 enhanced immunogenicity against the vaccine A/H3N2 strain compared with SD IIV4, without increasing the risk of adverse events compared to SD IIV4. These findings suggest that HD IIV4 may enhance immunogenicity in PLWH and warrant further investigation in studies evaluating clinical effectiveness (TCTR20230501002)."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease • Influenza • Respiratory Diseases • CD4

mFLUSIVA - an mRNA-based influenza vaccine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients (clinicaltrials.gov) - P2 | N=270 | Active, not recruiting | Sponsor: Vanderbilt University Medical Center | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases • Transplantation

DAN-COMBO: Effectiveness of An Influenza/COVID-19 Vaccine (mCombriax [mRNA-1083]) in Adults ? 65 Years (clinicaltrials.gov) - P4 | N=410000 | Not yet recruiting | Sponsor: Tor Biering-Srensen

New P4 trial • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Fluad vs. Fluzone High-Dose Vaccine Effectiveness Among Adults ?65 Years (clinicaltrials.gov) - P=N/A | N=1500000 | Recruiting | Sponsor: Kaiser Permanente | N=960000 ➔ 1500000 | Trial completion date: May 2026 ➔ May 2028 | Trial primary completion date: May 2025 ➔ May 2027

Enrollment change • Trial completion date • Trial primary completion date • Cardiovascular • Infectious Disease • Influenza • Pneumonia • Respiratory Diseases

Tfh Dysfunction in HIV and Aging (clinicaltrials.gov) - P4 | N=400 | Active, not recruiting | Sponsor: University of Miami | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Jun 2026 ➔ Apr 2027

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Influenza • Respiratory Diseases • CD4

A Study on the Safety and Immunogenicity of Hexavalent Influenza mRNA Vaccine in Adult Participants 50 Years of Age and Older (clinicaltrials.gov) - P1/2 | N=1162 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine (clinicaltrials.gov) - P3 | N=9320 | Completed | Sponsor: Novavax | Trial completion date: Sep 2026 ➔ Feb 2026 | Trial primary completion date: Jul 2026 ➔ Dec 2025 | Active, not recruiting ➔ Completed

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Tfh Dysfunction in HIV and Aging (clinicaltrials.gov) - P4 | N=400 | Active, not recruiting | Sponsor: University of Miami | Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease • Influenza • Respiratory Diseases • CD4

PIVOT: Immunogenicity of Alternative Annual Influenza Vaccination Strategies in Older Adults in Hong Kong (clinicaltrials.gov) - P4 | N=1861 | Completed | Sponsor: The University of Hong Kong | Active, not recruiting ➔ Completed | Trial completion date: Dec 2026 ➔ Dec 2025

Trial completion • Trial completion date • Infectious Disease • Influenza • Respiratory Diseases

B Cell and Antibody Response to Seasonal Influenza Vaccines in Younger and Older Adults (clinicaltrials.gov) - P4 | N=50 | Active, not recruiting | Sponsor: University of Alabama at Birmingham | Recruiting ➔ Active, not recruiting | Trial completion date: May 2026 ➔ May 2027

Enrollment closed • Trial completion date • Infectious Disease • Influenza • Respiratory Diseases

FluVax3: A Deep Longitudinal Analysis of Next Generation Influenza Vaccines in Older Adults (clinicaltrials.gov) - P4 | N=75 | Active, not recruiting | Sponsor: The Jackson Laboratory | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

Assessment of hemagglutinin-inhibition activity following influenza vaccination during the 2022-2023, 2023-2024, and 2024-2025 seasons. (PubMed, PLoS One) - "In this three-season (2022-2023-2024-2025) study, 1,328 participants aged 9-89 years received one of six vaccine types (Fluzone standard dose (SD) or high dose (HD), Fluad, Flucelvax, Flublok, Flumist). Participants vaccinated with Flumist had low or no measurable serum HAI activity. Overall, the elicitation of vaccine induced immune responses is strongly influenced by vaccine formulation, age and immune history of the participant."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Activation of cDC2 and monoDCs on Day 1 is Associated with Stronger Responses to the Fluzone High-Dose in older adults. (IMMUNOLOGY 2026) - "These findings identify Day1 immune remodeling of cDC2 and monoDCs as a factor for effective influenza vaccine responses among older adults, offering mechanistic insights for precision influenza vaccine strategies."

Clinical • Infectious Disease • Influenza • Respiratory Diseases • CD40 • CDK1 • GBP5 • IRF1

Th10 and activated Tfh1 expansion correlate with strong, while Tfr expansion correlate with poor responses to Fluzone High Dose in older adults (IMMUNOLOGY 2026) - "Together, these data highlight Th10 and Tfh1 cells as positive immunological correlates of robust antibody responses to high-dose influenza vaccine in older adults, while Tfr expansion emerges as a negative correlate. These findings provide mechanistic insight into the T cell determinants of vaccine responsiveness in aging and may inform future strategies to enhance immunogenicity among older populations."

Clinical • IO biomarker • Infectious Disease • Influenza • Respiratory Diseases • FOXP3 • ICOS

Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe (clinicaltrials.gov) - P=N/A | N=670 | Not yet recruiting | Sponsor: Sanofi | Initiation date: Mar 2026 ➔ Oct 2026

Trial initiation date • Infectious Disease • Influenza • Respiratory Diseases

A Trial to Evaluate the Effect of CD388 on the Immunogenicity of Fluzone® HD Vaccine (clinicaltrials.gov) - P1 | N=100 | Active, not recruiting | Sponsor: Cidara Therapeutics Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: May 2026 ➔ Dec 2026 | Trial primary completion date: May 2026 ➔ Dec 2026

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases

A Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Rush University Medical Center | N=18 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Infectious Disease • Influenza • Oncology • Respiratory Diseases • Solid Tumor • Triple Negative Breast Cancer • HER-2

Comparative evaluation of 5 combination adjuvants on immunogenicity and efficacy of approved seasonal influenza vaccines. (PubMed, NPJ Vaccines) - "To address this, we have performed a side-by-side comparison of 5 novel combination adjuvants (Alhydroxyquim-II, T-VANT, TRAC-478, IVAX-1 and IVAX-3) by formulating each with two approved seasonal influenza vaccines, Flublok® and Fluzone HD®, and assessing immunogenicity and efficacy in female and male C57Bl/6 mice. Greater morbidity after challenge was also detected in males compared to females. Side-by-side comparisons of existing and novel adjuvants with the same antigen and model system will help inform rational adjuvant selection and guide vaccine development for influenza and other infectious diseases."

Journal • Infectious Disease • Influenza • Respiratory Diseases

High vs. Standard Dose Influenza Vaccine in Adult SOT Recipients (clinicaltrials.gov) - P2 | N=396 | Active, not recruiting | Sponsor: Vanderbilt University Medical Center | Trial completion date: Apr 2026 ➔ Dec 2026 | Trial primary completion date: Jan 2026 ➔ Jul 2026

Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases • Solid Organ Transplantation • Transplantation

A Trial to Evaluate the Effect of CD388 on the Immunogenicity of Fluzone® HD Vaccine (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Cidara Therapeutics Inc.

New P1 trial • Infectious Disease • Influenza • Respiratory Diseases

Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. (clinicaltrials.gov) - P=N/A | N=670 | Not yet recruiting | Sponsor: Sanofi | Trial completion date: Dec 2030 ➔ Jan 2028 | Trial primary completion date: Dec 2030 ➔ Dec 2027

Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases

Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe (clinicaltrials.gov) - P=N/A | N=670 | Not yet recruiting | Sponsor: Sanofi

New trial • Infectious Disease • Influenza • Respiratory Diseases

A Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Rush University Medical Center | Trial completion date: Sep 2027 ➔ Dec 2027 | Trial primary completion date: Sep 2026 ➔ Jun 2027

Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Infectious Disease • Influenza • Oncology • Respiratory Diseases • Solid Tumor • Triple Negative Breast Cancer

Brand-specific influenza vaccine effectiveness in three Nordic countries during the 2024-2025 season: a target trial emulation study based on registry data. (PubMed, Lancet Reg Health Eur) - "Brand-specific VE was 63.4% (38.1-88.7) for Efluelda Tetra (split virion-high dose), 48.2% (40.8-55.6) for Fluad Tetra (subunit standard-dose adjuvanted), 43.6% (23.7-63.6) for Vaxigrip Tetra (split virion standard-dose), and 30.6% (-7.8 to 69.1) for Influvac Tetra (subunit standard-dose)...Annual monitoring using Nordic registries is crucial for informing evidence-based vaccination strategies and regulatory decisions. European Medicines Agency."

Journal • Infectious Disease • Influenza • Respiratory Diseases