Fluarix Quadrivalent (influenza vaccine) / GSK - 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

Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactived Split Influenza Vaccine in Healthy Infants (clinicaltrials.gov) - P3 | N=260 | Completed | Sponsor: Il-Yang Pharm. Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: May 2026 ➔ Oct 2025

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

Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactived Split Influenza Vaccine in Healthy Korea Infants (clinicaltrials.gov) - P3 | N=245 | Active, not recruiting | Sponsor: Il-Yang Pharm. Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2025 ➔ May 2026

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

Anti-neuraminidase antibody responses in older adults after consecutive vaccinations with enhanced influenza vaccines: a randomized controlled trial. (PubMed, J Infect Dis) - "MF-59 adjuvanted aIIV3 induced superior NAI antibody response in older adults than SD-IIV4 in a 2-year randomized trial."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 Vaccine (SARS-CoV-2 [COVID-19] and Influenza) in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=2457 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

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

Reactogenicity, safety, and immunogenicity of a quadrivalent seasonal influenza vaccine in adults aged 65 years and older: Phase 4 study results from India during December 2023-February 2024. (PubMed, Hum Vaccin Immunother) - P4 | "The hemagglutination inhibition titers increased from Day 1 to Day 22 against all the four influenza strains, A/(H1N1), A/(H3N2), B/Yamagata, and B/Victoria, with SPRs > 80% and SCRs > 75% at Day 22. Fluarix Tetra was well tolerated and immunogenic in adults aged ≥65 years in India.Trial registration: NCT05648357."

Journal • P4 data • Infectious Disease • Influenza • Pain • Respiratory Diseases

Absolute and Relative Effectiveness of Cell- and Egg-based Quadrivalent Inactivated Influenza Vaccine Products from 2014-2015 to 2018-2019 seasons, U.S. Flu VE Network. (PubMed, Clin Infect Dis) - "Comparisons of influenza vaccine products over multiple seasons showed benefit against symptomatic laboratory-confirmed outpatient influenza of both egg- and cell culture-based quadrivalent inactivated influenza vaccines, with similar absolute and relative levels of protection provided by each product."

Journal • Infectious Disease • Influenza • Respiratory Diseases

A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=40817 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Jun 2026 ➔ Aug 2025 | Trial primary completion date: Jun 2026 ➔ Aug 2025

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

Immunogenicity and safety of quadrivalent recombinant influenza vaccine in Korean adults: Phase III, randomized study. (PubMed, Vaccine) - P3 | "This Phase III, parallel, randomized, modified double-blind, active controlled, multi-center study was designed to compare the immunogenicity and safety of single dose intramuscular RIV4 with a locally-licensed quadrivalent-inactivated influenza vaccine (IIV4, Fluarix® quadrivalent) in participants aged ≥18 years during 2021-22 Northern Hemisphere influenza season at three tertiary care centers in South Korea...Neither immediate unsolicited AEs were reported within 30 min of vaccination nor SAEs, AESIs nor deaths were reported during the 6-month follow-up. Clinical Trial Registration:ClinicalTrials.gov number - NCT05144945."

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

Safety and Immunogenicity of OVX836, a Nucleoprotein-Based Universal Influenza Vaccine, Co-Administered with Fluarix® Tetra, a Seasonal Hemagglutinin-Based Vaccine. (PubMed, Vaccines (Basel)) - P2 | "The humoral anti-NP IgG and NP-specific CMI responses to OVX836 were strong in the two OVX836 groups, and no major interference of IIV was observed. This study supports further clinical development of OVX836 as a combined IIV/OVX836 seasonal vaccine capable of inducing robust and complementary HAI and CMI NP-specific responses."

Clinical • Journal • Infectious Disease • Influenza • Respiratory Diseases

Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 Vaccine (SARS-CoV-2 [COVID-19] and Influenza) in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=2457 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Mind The Gap: Delays Between Vaccine Licensure And NITAG Recommendation In The US Versus Europe (ISPOR 2025) - "The vaccines included in the review were a pneumococcal vaccine (Prevnar13), a human papillomavirus (HPV) vaccine (Gardasil-9), and a quadrivalent influenza vaccine (Fluarix Quadrivalent). The time between vaccine licensure and NITAG recommendation is substantially shorter in the US than in almost all European countries. Our research demonstrates there is potential to improve vaccine market access in Europe."

Infectious Disease • Influenza • Oncology • Pneumococcal Infections • Respiratory Diseases

A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=56000 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

Immunogenicity and Safety of Influenza and COVID-19 Multicomponent Vaccine in Adults ≥50 Years: A Randomized Clinical Trial. (PubMed, JAMA) - P3 | "Participants in 2 age cohorts (≥65 years and 50-64 years) were randomly assigned (1:1) to receive mRNA-1083 plus placebo or coadministered licensed quadrivalent seasonal influenza (≥65 years: high-dose quadrivalent inactivated influenza vaccine [HD-IIV4]; 50-64 years: standard-dose IIV4 [SD-IIV4]) and COVID-19 (all ages: mRNA-1273) vaccines. In this study, mRNA-1083 met noninferiority criteria and induced higher immune responses than recommended standard care influenza (standard and high dose) and COVID-19 vaccines against all 4 influenza strains (among those ages 50-64 y), the 3 clinically relevant influenza strains (among those aged ≥65 y), and SARS-CoV-2 (all ages), with an acceptable tolerability and safety profile. ClinicalTrials.gov Identifier: NCT06097273."

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

Does Repeat Influenza Vaccination Constrain Influenza Immune Responses and Protection (clinicaltrials.gov) - P=N/A | N=1500 | Active, not recruiting | Sponsor: University of Melbourne | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2023 ➔ Jun 2025 | Trial primary completion date: Nov 2023 ➔ Jun 2025

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

A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=56000 | Recruiting | Sponsor: ModernaTX, Inc. | Trial primary completion date: Dec 2025 ➔ Jun 2026

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

Enhanced passive safety surveillance of standard-dose and high-dose influenza vaccines in Finland and Germany 2023-24 season. (PubMed, Hum Vaccin Immunother) - "No safety signal was detected during this surveillance. The 2023-24 season surveillance did not suggest any clinically significant changes in safety profile compared with previously reported safety data for SD-IIV4 and HD-IIV4."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 Vaccine (SARS-CoV-2 [COVID-19] and Influenza) in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=2450 | Recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Aug 2026 ➔ Dec 2025 | Trial primary completion date: Aug 2026 ➔ Dec 2025

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

Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 Vaccine (SARS-CoV-2 [COVID-19] and Influenza) in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=2450 | Recruiting | Sponsor: ModernaTX, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 Vaccine (SARS-CoV-2 [COVID-19] and Influenza) in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=2450 | Not yet recruiting | Sponsor: ModernaTX, Inc.

New P3 trial • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Safety of quadrivalent recombinant influenza vaccine in pregnant persons and their infants. (PubMed, AJOG Glob Rep) - P=N/A | "Compared with receipt of a SD-IIV4 during pregnancy, this large study did not identify any pregnancy, birth, or neonatal/infant safety concerns following receipt of a RIV4 during pregnancy and demonstrates that the safety of RIV4 in pregnancy was similar to SD-IIV4. This study provides additional evidence regarding the safety of influenza vaccination in pregnant persons and further supports ACIP and ACOG recommendations that all pregnant persons receive an inactivated or recombinant influenza vaccine."

Journal • Gynecology • Infectious Disease • Influenza • Obstetrics • Respiratory Diseases • Small for Gestational Age

Immunogenicity and Safety of the Concomitant Administration of OVX836 and Quadrivalent Influenza Vaccine in Healthy Volunteers. (clinicaltrials.gov) - P2 | N=180 | Completed | Sponsor: Osivax | Phase classification: P2a ➔ P2

Phase classification • Infectious Disease • Influenza • Respiratory Diseases

Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactived Split Influenza Vaccine in Healthy Korea Infants (clinicaltrials.gov) - P3 | N=245 | Recruiting | Sponsor: Il-Yang Pharm. Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases

A prospective, randomized, parallel, active controlled, phase III Indian study of immunogenicity and safety of two inactivated influenza vaccines - Vaxiflu-4 and Fluarix tetra in children aged 6 months to 35 months. (PubMed, Hum Vaccin Immunother) - "Adverse events (AEs) were similar for both vaccines, including pain at the injection site, erythema, swelling, and pyrexia. The test vaccine, Vaxiflu-4, showed non-inferiority in terms of immunogenicity and safety when compared with reference vaccine, Fluarix Tetra (Clinical trial registry number: CTRI/2022/05/042514)."

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

Immunogenicity Trial of 3 Influenza Vaccines (clinicaltrials.gov) - P3 | N=366 | Completed | Sponsor: Tan Tock Seng Hospital | Recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases