Fluarix Quadrivalent (influenza vaccine) / GSK - LARVOL DELTA

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

IGNITE P303: Study of mRNA-1010 Seasonal Influenza Vaccine in Adults (clinicaltrials.gov) - P3 | N=8422 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Cost-effectiveness of recombinant influenza vaccine compared with standard dose influenza vaccine in adults 18-64 years of age. (PubMed, Vaccine) - "While RIV4 was effective and cost-effective relative to SD-IIV4 for both 50-64-year-old and 18-64-year-old adults, cost-effectiveness was sensitive to small changes in parameters among 18-64-year-olds. Because substantial public health benefits occur with enhanced vaccines, health systems and policy makers may opt for preferential product use in select age/risk groups (e.g., 50-64 year olds) to maximize their cost-benefit ratios."

Cost effectiveness • HEOR • Journal • Infectious Disease • Influenza • Respiratory Diseases

A Study to Assess the Safety and Immune Response of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India (clinicaltrials.gov) - P4 | N=250 | Completed | Sponsor: GlaxoSmithKline | Recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Enhanced passive safety surveillance of high-dose and standard-dose quadrivalent inactivated split-virion influenza vaccines in Germany and Finland during the 2022/23 influenza season. (PubMed, Hum Vaccin Immunother) - "Of 133 AEFI (48 vaccinees) with time of onset reported, all occurred ≤7 days post-vaccination (RR 4.80%, 95% CI: 3.56, 6.31), which was similar to the 2021/22 season (RR 4.90%, 95% CI: 3.65, 6.43). The EPSS for HD-IIV4 and for SD-IIV4 in the 2022/23 influenza season did not suggest any clinically relevant changes in safety beyond what is known/expected for IIV4s."

Journal • Infectious Disease • Influenza • Respiratory Diseases

An 8-Year Prospective, Observational, Multi-centre Post-Marketing Safety Surveillance Study Conducted in South Korea (2014-2022) Following the Introduction of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) for Subjects Aged 6 Months and Older. (PubMed, Drug Saf) - "No safety concerns were found during this surveillance study of IIV4 in subjects aged ≥ 6 months in Korea. The findings of this study suggest IIV4 is safe and well tolerated for use in all age groups with a vaccine indication."

Journal • Observational data • P4 data • 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 | Not yet recruiting | Sponsor: Il-Yang Pharm. Co., Ltd. | Trial primary completion date: Apr 2024 ➔ Feb 2025

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

IGNITE P303: Study of mRNA-1010 Seasonal Influenza Vaccine in Adults (clinicaltrials.gov) - P3 | N=8400 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults 50 Years Old and Older (clinicaltrials.gov) - P3 | N=22510 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

A Study to Assess the Safety and Immune Response of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India (clinicaltrials.gov) - P4 | N=250 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases

Immunogenicity and Safety of the Concomitant Administration of OVX836 Influenza Vaccine, Quadrivalent Inactivated Influenza Vaccines and Placebo in Healthy Subjects. (clinicaltrials.gov) - P2 | N=478 | Completed | Sponsor: Osivax | Active, not recruiting ➔ Completed | Phase classification: P2a ➔ P2

Phase classification • Trial completion • Infectious Disease • Influenza • Respiratory Diseases