Flucelvax Quadrivalent (influenza vaccine) / CSL Behring - LARVOL DELTA

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

Efficacy Study With QIVc in Pediatric Subjects (clinicaltrials.gov) - P3 | N=5723 | Completed | Sponsor: Seqirus | Active, not recruiting ➔ Completed | N=3830 ➔ 5723 | Trial primary completion date: Mar 2024 ➔ Nov 2023

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

Efficacy Study With QIVc in Pediatric Subjects (clinicaltrials.gov) - P3 | N=3830 | Recruiting | Sponsor: Seqirus | Trial completion date: Sep 2023 ➔ Mar 2024 | Trial primary completion date: Sep 2023 ➔ Mar 2024

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

RIVER: Randomized Influenza Vaccine Evaluation of Immune Response (clinicaltrials.gov) - P4 | N=366 | Active, not recruiting | Sponsor: Marshfield Clinic Research Foundation | Trial completion date: Sep 2022 ➔ Dec 2023

Trial completion date • Infectious Disease • Influenza • Respiratory Diseases

Cell-Based Manufacturing Technology Increases Antigenic Match of Influenza Vaccine and Results in Improved Effectiveness. (PubMed, Vaccines (Basel)) - "The first mammalian cell-only strain was included in Flucelvax Quadrivalent in 2017. The inclusion of both proteins in a vaccine may provide an advantage over recombinant vaccines containing hemagglutinin alone. Findings from real world effectiveness studies support the use of cell-based influenza vaccines."

Journal • Review • Infectious Disease • Influenza • Respiratory Diseases

Immunogenicity Trial of 3 Influenza Vaccines (clinicaltrials.gov) - P3 | N=360 | Recruiting | Sponsor: Tan Tock Seng Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases

Absolute and Relative Effectiveness of Cell Culture-Based Inactivated Influenza Vaccine against Medically-Attended, Laboratory-Confirmed Influenza in Northcentral Wisconsin, US, 2019-20 (OPTIONS XI 2022) - "We assessed absolute vaccine effectiveness (aVE) of cell culture-based inactivated influenza vaccine (ccIIV4) (Flucelvax Quadrivalent, Seqirus Inc.), aVE of standard egg-based IIV (IIV4), and the relative VE (rVE) of ccIIV4 vs IIV4 during the 2019-20 influenza season...There was no difference in VE between ccIIV4 and IIV4, although some CIs were wide. Differences between ccIIV4 and IIV4 VE were not expected since egg-adapted changes have been rarely observed for A/H1N1pdm09 and B/Victoria."

Preclinical • Cough • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Effect of Repeat Vaccination on Immunogenicity of Quadrivalent Cell-Culture and Recombinant Influenza Vaccines Among Healthcare Personnel Aged 18-64 Years: A Randomized, Open-Label Trial. (PubMed, Clin Infect Dis) - "In adult HCPs, receipt of RIV two consecutive seasons or the second season was more immunogenic than consecutive egg-based IIV for three of the four components of quadrivalent vaccine. Immunogenicity of ccIIV/ccIIV was similar to that of IIV/IIV. Differences in hemagglutinin antigen content may play a role in immunogenicity of influenza vaccination in consecutive seasons."

Journal • Preclinical • Infectious Disease • Respiratory Diseases

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2022-23 Influenza Season. (PubMed, MMWR Recomm Rep) - "SECOND, THE APPROVED AGE INDICATION FOR THE CELL CULTURE-BASED INACTIVATED INFLUENZA VACCINE, FLUCELVAX QUADRIVALENT (CCIIV4), WAS CHANGED IN OCTOBER 2021 FROM ≥2 YEARS TO ≥6 MONTHS...Updates and other information are available from CDC's influenza website (https://www.cdc.gov/flu). Vaccination and health care providers should check this site periodically for additional information."

Journal • Infectious Disease • Respiratory Diseases

Immunogenicity Trial of 3 Influenza Vaccines (clinicaltrials.gov) - P3 | N=360 | Not yet recruiting | Sponsor: Tan Tock Seng Hospital

New P3 trial • Infectious Disease • Respiratory Diseases

B Cell and Antibody Response to Seasonal Influenza Vaccines in Younger and Older Adults (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: University of Alabama at Birmingham | Trial completion date: May 2023 ➔ May 2024 | Trial primary completion date: May 2022 ➔ May 2023

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

RIVER: Randomized Influenza Vaccine Evaluation of Immune Response (clinicaltrials.gov) - P4 | N=366 | Active, not recruiting | Sponsor: Marshfield Clinic Research Foundation | Trial completion date: Jan 2022 ➔ Sep 2022

Trial completion date • Infectious Disease • Respiratory Diseases

Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial. (PubMed, Lancet Respir Med) - P3 | "To our knowledge, this substudy is the first to show the safety, immunogenicity, and efficacy profile of a COVID-19 vaccine when co-administered with seasonal influenza vaccines. Our results suggest concomitant vaccination might be a viable immunisation strategy."

Clinical • Journal • P3 data • Fatigue • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Respiratory Diseases

RIVER: Randomized Influenza Vaccine Evaluation of Immune Response (clinicaltrials.gov) - P4; N=366; Active, not recruiting; Sponsor: Marshfield Clinic Research Foundation; Trial completion date: Sep 2020 ➔ Jan 2022

Clinical • Trial completion date • Infectious Disease • Respiratory Diseases

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices, United States, 2021-22 Influenza Season. (PubMed, MMWR Recomm Rep) - "Third, the approved age indication for the cell culture-based inactivated influenza vaccine, Flucelvax Quadrivalent (ccIIV4), has been expanded from ages ≥4 years to ages ≥2 years...These recommendations apply to U.S.-licensed influenza vaccines used according to Food and Drug Administration-licensed indications. Updates and other information are available from CDC's influenza website (https://www.cdc.gov/flu); vaccination and health care providers should check this site periodically for additional information."

Journal • Allergy • Critical care • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Flucelvax (TIVc or QIVc) Pregnancy Registry (clinicaltrials.gov) - P=N/A; N=692; Completed; Sponsor: Seqirus; Active, not recruiting ➔ Completed

Preclinical • Trial completion • Infectious Disease • Respiratory Diseases

Efficacy Study With QIVc in Pediatric Subjects (clinicaltrials.gov) - P3; N=3830; Recruiting; Sponsor: Seqirus; Trial completion date: Mar 2022 ➔ Sep 2023; Trial primary completion date: Mar 2022 ➔ Sep 2023

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Pediatrics • Respiratory Diseases

A Phase 3 Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects (clinicaltrialsregister.eu) - P3; N=2414; Sponsor: Seqirus Inc.

Clinical • Head-to-Head • New P3 trial • Infectious Disease • Pediatrics • Respiratory Diseases

Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of QIVc in Subjects ≥2 to <18 Years of Age (clinicaltrials.gov) - P3; N=4514; Completed; Sponsor: Seqirus; Phase classification: P4 ➔ P3

Clinical • Phase classification • Infectious Disease

Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects (clinicaltrials.gov) - P3; N=2414; Completed; Sponsor: Seqirus; Active, not recruiting ➔ Completed

Clinical • Head-to-Head • Trial completion • Infectious Disease • Pediatrics

Efficacy Study With QIVc in Pediatric Subjects (clinicaltrials.gov) - P3; N=3830; Recruiting; Sponsor: Seqirus; Trial completion date: Jul 2021 ➔ Mar 2022

Trial completion date • Infectious Disease • Pediatrics

Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects (clinicaltrials.gov) - P3; N=2502; Active, not recruiting; Sponsor: Seqirus; Trial completion date: May 2020 ➔ Aug 2020; Trial primary completion date: May 2020 ➔ Aug 2020

Clinical • Head-to-Head • Trial completion date • Trial primary completion date • Infectious Disease • Pediatrics