quadrivalent influenza modRNA vaccine (PF-07252220) / Pfizer, BioNTech - LARVOL DELTA

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza (clinicaltrials.gov) - P2 | N=1019 | Completed | Sponsor: BioNTech SE | Phase classification: P1/2 ➔ P2

Phase classification • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

A Phase 1/2 Randomized Study to Evaluate the Safety, Tolerability, and Immunogenicity of Nucleoside-Modified Messenger RNA Influenza Vaccines in Healthy Adults. (PubMed, Vaccines (Basel)) - P1/2 | "Based on safety and immunogenicity for different IRV doses, schedules, and valencies versus the quadrivalent influenza vaccine (QIV; Fluzone High-Dose Quadrivalent, Sanofi Pasteur) in phase 1 (65-85-year-olds), quadrivalent IRV (qIRV) was further evaluated in 65- through 85-year-olds and 18- through 64-year-olds in phase 2, leading to phase 3 dose selection. Antibody and cell-mediated immune responses showed comparable trends across qIRV doses in 18- through 85-year-olds; a dose-related pattern was observed in 65- through 85-year-olds (60 μg > 30 μg). Phase 3 investigations of qIRV 60 µg in older adults and qIRV 30 µg in younger adults are warranted (ClinicalTrials.gov Identifier: NCT05052697)."

Journal • P1/2 data • Infectious Disease • Influenza • Pain • Respiratory Diseases

Efficacy and Immunogenicity Results of Messenger RNA Influenza Vaccine in Adults 18−64 Years of Age (WVCE 2024) - "Lack of influenza B cases limits confirmation of efficacy against both influenza A and B strains. qIRV has an acceptable safety profile."

Clinical • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • CD4 • CD8 • IFNG

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza (clinicaltrials.gov) - P1/2 | N=1019 | Completed | Sponsor: BioNTech SE | Phase classification: P2 ➔ P1/2

Phase classification • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older (clinicaltrials.gov) - P3 | N=46169 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza (clinicaltrials.gov) - P2 | N=1018 | Completed | Sponsor: BioNTech SE | Active, not recruiting ➔ Completed

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

A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older (clinicaltrials.gov) - P3 | N=46180 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza (clinicaltrials.gov) - P2 | N=1018 | Active, not recruiting | Sponsor: BioNTech SE | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Dec 2023 | Trial primary completion date: Dec 2024 ➔ Dec 2023

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

A Study to Examine Respiratory Combination Vaccines Against Respiratory Syncytial Virus (RSV) and Flu in Older Adults (clinicaltrials.gov) - P1 | N=455 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Examine Respiratory Combination Vaccines Against Respiratory Syncytial Virus (RSV) and Flu in Older Adults (clinicaltrials.gov) - P1 | N=455 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

Enrollment closed • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza (clinicaltrials.gov) - P2 | N=990 | Recruiting | Sponsor: BioNTech SE | Phase classification: P1 ➔ P2 | N=180 ➔ 990

Enrollment change • Phase classification • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older (clinicaltrials.gov) - P3 | N=53200 | Recruiting | Sponsor: Pfizer | N=36200 ➔ 53200

Enrollment change • Infectious Disease • Influenza • Respiratory Diseases

A Study to Examine Respiratory Combination Vaccines Against Respiratory Syncytial Virus (RSV) and Flu in Older Adults (clinicaltrials.gov) - P1 | N=450 | Recruiting | Sponsor: Pfizer | N=250 ➔ 450

Enrollment change • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Examine Respiratory Combination Vaccines Against Respiratory Syncytial Virus (RSV) and Flu in Older Adults (clinicaltrials.gov) - P1 | N=250 | Recruiting | Sponsor: Pfizer | Active, not recruiting ➔ Recruiting

Enrollment open • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older (clinicaltrials.gov) - P3 | N=36200 | Recruiting | Sponsor: Pfizer | Active, not recruiting ➔ Recruiting | Trial completion date: Aug 2023 ➔ Mar 2024 | Trial primary completion date: Aug 2023 ➔ Mar 2024

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

A Study to Learn Whether Respiratory Syncytial Virus (RSV) and Flu Vaccines Given Together as a Single Shot Work as Well as When Given Separately (clinicaltrials.gov) - P1 | N=251 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

Enrollment closed • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza (clinicaltrials.gov) - P1 | N=180 | Recruiting | Sponsor: BioNTech SE | N=360 ➔ 180 | Trial completion date: Jun 2024 ➔ Dec 2024 | Trial primary completion date: Jun 2024 ➔ Dec 2024

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

A Study to Learn Whether Respiratory Syncytial Virus (RSV) and Flu Vaccines Given Together as a Single Shot Work as Well as When Given Separately (clinicaltrials.gov) - P1 | N=250 | Recruiting | Sponsor: Pfizer

New P1 trial • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Modified RNA Vaccine Against Influenza (clinicaltrials.gov) - P1/2 | N=1168 | Completed | Sponsor: Pfizer | Recruiting ➔ Completed | N=1980 ➔ 1168 | Trial completion date: Jul 2023 ➔ Jan 2023 | Trial primary completion date: Jul 2023 ➔ Jan 2023

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

A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older (clinicaltrials.gov) - P3 | N=36454 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza (clinicaltrials.gov) - P1 | N=360 | Recruiting | Sponsor: BioNTech SE | N=180 ➔ 360

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

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza (clinicaltrials.gov) - P1 | N=180 | Recruiting | Sponsor: BioNTech SE | Not yet recruiting ➔ Recruiting | Trial completion date: May 2023 ➔ Jun 2024 | Trial primary completion date: May 2023 ➔ Jun 2024

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

A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older (clinicaltrials.gov) - P3 | N=46200 | Recruiting | Sponsor: Pfizer | N=25000 ➔ 46200

Enrollment change • Infectious Disease • Influenza • Respiratory Diseases

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza (clinicaltrials.gov) - P1 | N=180 | Not yet recruiting | Sponsor: BioNTech SE

New P1 trial • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Modified RNA Vaccine Against Influenza (clinicaltrials.gov) - P1/2 | N=1980 | Recruiting | Sponsor: Pfizer | N=615 ➔ 1980

Enrollment change • Infectious Disease • Influenza • Respiratory Diseases