FluMist Quadrivalent (live attenuated influenza vaccine nasal spray) / AstraZeneca, Daiichi Sankyo - LARVOL DELTA

SmokeyFlu: Woodsmoke Exposure, Influenza Infection, and Nasal Immunity (clinicaltrials.gov) - P4 | N=112 | Suspended | Sponsor: University of North Carolina, Chapel Hill | Trial completion date: Dec 2027 ➔ Dec 2028 | Initiation date: Mar 2025 ➔ Oct 2026 | Not yet recruiting ➔ Suspended | Trial primary completion date: Dec 2027 ➔ Dec 2028

Trial completion date • Trial initiation date • Trial primary completion date • Trial suspension • Infectious Disease • Influenza • Otorhinolaryngology • Respiratory Diseases

Functional Consequences of T-bet Expression in Flu-specific Memory B Cells After Live Attenuated Influenza Vaccine (LAIV) (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: University of Alabama at Birmingham | Recruiting ➔ Completed | N=18 ➔ 10 | Trial completion date: Dec 2025 ➔ Jun 2025

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

Exploring nurses' experiences with a school-located influenza vaccination program: A qualitative study in the region of Murcia, Spain. (PubMed, Hum Vaccin Immunother) - "Nursing professionals should be fully involved in providing information to parents about the main aspects of influenza infection and benefits of having their children vaccinated against seasonal influenza. Nurses also advocated that the flu vaccination for children should begin at the same time as vaccination for adults, with vaccination planning completely integrated into the school schedule.Practice implications: The study results could guide healthcare authorities in facilitating the implementation of school-located influenza vaccination programs and increase immunization of preschool children against flu."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Disruption of the commensal microbiota impairs the maintenance of antigen specific memory T cells. (IMMUNOLOGY 2025) - "We also found that AB-treated mice failed to maintain lung tissue-resident CD4+ and CD8+ memory T cells generated by immunization with a live-attenuated influenza vaccine (FluMist). Collectively, these finds support the requirement of an intact commensal microbiota for the maintenance of CD4+ memory T cells generated upon infection and vaccination. The mechanisms mediating this effect of the commensal microbiota in memory T cell maintenance are currently under active investigation.Keywords: Cells T Cells; Infections Viral; Processes Memory; Tissues Lung Mucosa"

Clinical • Infectious Disease • Influenza • Respiratory Diseases • CD4 • CD8

Broadly active intranasal influenza vaccine with a nanocomplex particulate adjuvant targeting mast cells and toll-like receptor 9. (PubMed, J Control Release) - "Flumist is the only FDA-approved intranasal influenza vaccine. MP12W-CpG NPs provided similar protection in an influenza challenge model. This study demonstrates the potential of this novel intranasal nanocomplex for vaccination."

Journal • Immunology • Infectious Disease • Inflammation • Influenza • Respiratory Diseases • TLR9

ICICLE: A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age (clinicaltrials.gov) - P=N/A | N=4121 | Terminated | Sponsor: MedImmune LLC | N=8760 ➔ 4121 | Suspended ➔ Terminated; FDA did not require the fourth season of recruitment as planned originally. Study closed.

Enrollment change • Trial termination • Infectious Disease • Influenza • Respiratory Diseases

SmokeyFlu: Woodsmoke Exposure, Influenza Infection, and Nasal Immunity (clinicaltrials.gov) - P4 | N=112 | Not yet recruiting | Sponsor: University of North Carolina, Chapel Hill

New P4 trial • Infectious Disease • Influenza • Otorhinolaryngology • Respiratory Diseases

Addressing Unfunded Vaccines Through a Co-payment Mechanism in Pharmacies (clinicaltrials.gov) - P=N/A | N=600 | Not yet recruiting | Sponsor: Canadian Immunization Research Network | Initiation date: Sep 2024 ➔ Apr 2025 | Trial primary completion date: Mar 2025 ➔ Mar 2026

Trial initiation date • Trial primary completion date

Live Attenuated Influenza Vaccine As a Nasal Model for Influenza Infection (clinicaltrials.gov) - P4 | N=25 | Recruiting | Sponsor: University of Alabama at Birmingham | Suspended ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases • CFTR

In brief: FluMist influenza vaccine for self-administration. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Infectious Disease • Influenza • Respiratory Diseases

PRISM: Revealing Protective Immunity to Influenza Using Systems Immunology (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: Emory University | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases

An Open Label Study of IgG Fc Glycan Composition in Human Immunity (clinicaltrials.gov) - P1 | N=129 | Terminated | Sponsor: Rockefeller University | Phase classification: P=N/A ➔ P1 | Active, not recruiting ➔ Terminated; Inadequate enrollment

Phase classification • Trial termination

Influenza vaccine for 2024-2025. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Infectious Disease • Influenza • Respiratory Diseases • Respiratory Syncytial Virus Infections

Live Attenuated Influenza Vaccine as a Nasal Model for Influenza Infection (clinicaltrials.gov) - P4 | N=20 | Suspended | Sponsor: University of Alabama at Birmingham | Trial completion date: Dec 2024 ➔ Dec 2025 | Active, not recruiting ➔ Suspended | Trial primary completion date: Dec 2024 ➔ Dec 2025

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

PRISM: Revealing Protective Immunity to Influenza Using Systems Immunology (clinicaltrials.gov) - P4 | N=50 | Not yet recruiting | Sponsor: Emory University

New P4 trial • Infectious Disease • Influenza • Respiratory Diseases

The efficacy and safety of a quadrivalent live attenuated influenza nasal vaccine in Japanese children: a phase 3, randomized, placebo-controlled study. (PubMed, J Infect Chemother) - "MEDI3250 had a greater preventive effect against influenza onset in Japanese children than placebo; no new safety signals were observed relative to previous clinical and post-marketing studies of MEDI3250."

Clinical • Journal • P3 data • Infectious Disease • Influenza • Pediatrics • Respiratory Diseases

Addressing Unfunded Vaccines Through a Co-payment Mechanism in Pharmacies (clinicaltrials.gov) - P=N/A | N=600 | Not yet recruiting | Sponsor: Canadian Immunization Research Network

New trial

Sequential Infection with Influenza A Virus Followed by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Leads to More Severe Disease and Encephalitis in a Mouse Model of COVID-19. (PubMed, Viruses) - "Conversely, prior infection with a commercially available, multivalent live-attenuated influenza vaccine (Fluenz Tetra) elicited the same reduction in SARS-CoV-2 RNA synthesis, albeit without the associated increase in disease severity...Interestingly, infection with an attenuated, apathogenic influenza vaccine does not result in an aberrant immune response and enhanced disease severity. Taken together, the data suggest coinfection ('twinfection') is deleterious and mitigation steps should be instituted as part of the comprehensive public health and management strategy of COVID-19."

Journal • Preclinical • CNS Disorders • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • ACE2

Budget impact of introducing live attenuated influenza vaccine for intranasal self- or caregiver administration in the United States (AMCP 2024) - "BACKGROUND: A supplemental Biologics License Applica- tion for live attenuated influenza vaccine (LAIV; FluMist Quadrivalent [Influenza Vaccine Live, Intranasal] Intranasal spray) self or caregiver administration for individuals aged 18-49 and 2-17 years, respectively, has been accepted for re- view by the US Food and Drug Administration; a regulatory decision is anticipated in 2024... Preliminary results suggest that, if approved, the introduction of the first influenza vaccine for self/care- giver administration would not impact the overall budget in the United States and would provide an additional acces- sible option for influenza vaccination."

HEOR • Infectious Disease • Influenza • Respiratory Diseases

VAXXAIR: Vaccine Pandemic Preparedness Through Airway Immunology Characterization (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark | Trial completion date: Dec 2025 ➔ Apr 2026 | Initiation date: Jan 2024 ➔ May 2024 | Trial primary completion date: Dec 2025 ➔ Apr 2026

Trial completion date • Trial initiation date • Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases • CD4 • CD8

FLU-TW: The Effects of Attenuated Versus Inactivated Flu Vaccine in Twin Sets (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Stanford University | Recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

FLU-TW: The Effects of Attenuated Versus Inactivated Flu Vaccine in Twin Sets (clinicaltrials.gov) - P4 | N=40 | Recruiting | Sponsor: Stanford University

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

Immune Response To Intranasal Influenza Vaccination (clinicaltrials.gov) - P=N/A | N=300 | Active, not recruiting | Sponsor: University of Bergen | Trial completion date: Dec 2022 ➔ Dec 2030 | Trial primary completion date: Dec 2022 ➔ Dec 2025

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

FDA Will Evaluate First Self-Administered FluMist Vaccine. (PubMed, JAMA) - No abstract available

Journal

LAIV-TTB: Response to Live Attenuated Influenza Vaccine in Tonsillar Tissues and Blood (clinicaltrials.gov) - P4 | N=0 | Withdrawn | Sponsor: Stanford University | N=50 ➔ 0 | Trial completion date: Dec 2024 ➔ Nov 2023 | Recruiting ➔ Withdrawn | Trial primary completion date: Dec 2024 ➔ Nov 2023

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