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- ||||||| Trial completion: Immunogenicity Trial of 3 Influenza Vaccines (clinicaltrials.gov) - Oct 15, 2024
P3, N=366, Completed, Sponsor: Tan Tock Seng Hospital
Recruiting --> Completed
- ||| Enrollment closed: A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above (clinicaltrials.gov) - Jun 26, 2024
P1/2, N=1002, Active, not recruiting, Sponsor: Sanofi Pasteur, a Sanofi Company
Recruiting --> Completed Recruiting --> Active, not recruiting
- | Fluzone Quadrivalent (influenza vaccine) / Sanofi, Flublok Quadrivalent (influenza vaccine) / Sanofi
Trial termination, IO biomarker: Comparison of Recombinant Influenza Vaccine Versus Standard Egg-Based Inactivated Influenza Vaccine in Adults 18-64 Years (clinicaltrials.gov) - May 13, 2024
P4, N=3988, Terminated, Sponsor: Fatimah Dawood
Recruiting --> Active, not recruiting Active, not recruiting --> Terminated; Insufficient funding.
- |||| Fluzone High-Dose Quadrivalent (influenza vaccine) / Evotec, Sanofi, quadrivalent influenza mRNA vaccine (MRT5413) / Sanofi
Trial completion: Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants18 Years of Age and Older (clinicaltrials.gov) - May 9, 2024
P1/2, N=682, Completed, Sponsor: Sanofi Pasteur, a Sanofi Company
Active, not recruiting --> Terminated; Insufficient funding. Active, not recruiting --> Completed
- ||| Flublok Quadrivalent (influenza vaccine) / Sanofi
Trial completion: Substudy 01 - Safety and Immunogenicity of One Monovalent Modified mRNA Vaccine Encoding Influenza Hemagglutinin With LNP, in Adult Participants Aged 18 to 49 Years and 60 Years and Above (clinicaltrials.gov) - May 8, 2024
P1, N=159, Completed, Sponsor: Sanofi Pasteur, a Sanofi Company
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||| Fluzone High-Dose Quadrivalent (influenza vaccine) / Evotec, Sanofi, MRT5410 / Sanofi
Trial completion: Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adult Participants 18 Years of Age and Older (clinicaltrials.gov) - Apr 22, 2024
P1/2, N=682, Completed, Sponsor: Sanofi Pasteur, a Sanofi Company
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ||||| New P1/2 trial: A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above (clinicaltrials.gov) - Apr 12, 2024
P1/2, N=1002, Recruiting, Sponsor: Sanofi Pasteur, a Sanofi Company
- |||| Fluzone High-Dose Quadrivalent (influenza vaccine) / Evotec, Sanofi, quadrivalent influenza mRNA vaccine (MRT5407) / Sanofi
Trial completion: Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adult Participants18 Years of Age and Older (clinicaltrials.gov) - Apr 3, 2024
P1/2, N=560, Completed, Sponsor: Sanofi Pasteur, a Sanofi Company
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | Flublok Quadrivalent (influenza vaccine) / Sanofi, Flublok (influenza vaccine) / Sanofi, Ildong, Shionogi
Journal: Flublok Quadrivalent Vaccine Adjuvanted with R-DOTAP Elicits a Robust and Multifunctional CD4 T Cell Response That Is of Greater Magnitude and Functional Diversity Than Conventional Adjuvant Systems. (Pubmed Central) - Mar 28, 2024
The elicited CD4+ T cells specific for HA-derived epitopes produce IL-2, IFN-?, IL-4/5, and granzyme B and have multifunctional potential. Hence, R-DOTAP, which has been verified safe by human studies, can offer exciting opportunities as an immune stimulant for next-generation prophylactic recombinant protein-based vaccines.
- ||||||| Flublok Quadrivalent (influenza vaccine) / Sanofi, VaxiGrip QIV IM (quadrivalent inactivated influenza vaccine) / Sanofi
Trial completion: FLUO: Trial Assessing the Immunogenicity and Safety of Two Influenza Vaccine Strategies Among Severe Obese Adult Patients (clinicaltrials.gov) - Feb 26, 2024
P3, N=206, Completed, Sponsor: Assistance Publique - H
Hence, R-DOTAP, which has been verified safe by human studies, can offer exciting opportunities as an immune stimulant for next-generation prophylactic recombinant protein-based vaccines. Active, not recruiting --> Completed
- ||||||| Flublok Quadrivalent (influenza vaccine) / Sanofi
Trial completion: Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age. (clinicaltrials.gov) - Jan 17, 2024
P3, N=1323, Completed, Sponsor: Sanofi Pasteur, a Sanofi Company
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | Flublok Quadrivalent (influenza vaccine) / Sanofi
Enrollment change, Trial termination: Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years (clinicaltrials.gov) - Jan 11, 2024
P3, N=366, Terminated, Sponsor: Sanofi Pasteur, a Sanofi Company
N=1412 --> 366 | Recruiting --> Terminated; Sponsor decision to prematurely stop the study. This decision was made without any safety concerns.
- | Flublok Quadrivalent (influenza vaccine) / Sanofi
Journal: Recombinant or Standard-Dose Influenza Vaccine in Adults under 65 Years of Age. (Pubmed Central) - Dec 17, 2023
P=N/A
The high-dose recombinant vaccine conferred more protection against PCR-confirmed influenza than an egg-based standard-dose vaccine among adults between the ages of 50 and 64 years. (Funded by Sanofi; ClinicalTrials.gov number, NCT03694392.).
- || Flublok Quadrivalent (influenza vaccine) / Sanofi
Enrollment closed: Substudy 01 - Safety and Immunogenicity of One Monovalent Modified mRNA Vaccine Encoding Influenza Hemagglutinin With LNP, in Adult Participants Aged 18 to 49 Years and 60 Years and Above (clinicaltrials.gov) - Dec 13, 2023
P1, N=159, Active, not recruiting, Sponsor: Sanofi Pasteur, a Sanofi Company
(Funded by Sanofi; ClinicalTrials.gov number, NCT03694392.). Recruiting --> Active, not recruiting
- ||| Flublok Quadrivalent (influenza vaccine) / Sanofi
New P1 trial: Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and Older (clinicaltrials.gov) - Nov 7, 2023
P1, N=388, Completed, Sponsor: Sanofi Pasteur, a Sanofi Company
- |||| Flublok Quadrivalent (influenza vaccine) / Sanofi, VaxiGrip QIV IM (quadrivalent inactivated influenza vaccine) / Sanofi
Trial primary completion date: FLUO: Trial Assessing the Immunogenicity and Safety of Two Influenza Vaccine Strategies Among Severe Obese Adult Patients (clinicaltrials.gov) - Sep 21, 2023
P3, N=206, Active, not recruiting, Sponsor: Assistance Publique - H
Recruiting --> Active, not recruiting Trial primary completion date: Oct 2023 --> Apr 2023
- ||| Fluzone High-Dose Quadrivalent (influenza vaccine) / Evotec, Sanofi, quadrivalent influenza mRNA vaccine (MRT5413) / Sanofi
Enrollment closed: Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants18 Years of Age and Older (clinicaltrials.gov) - Jun 6, 2023
P1/2, N=684, Active, not recruiting, Sponsor: Sanofi Pasteur, a Sanofi Company
Trial primary completion date: Oct 2023 --> Apr 2023 Recruiting --> Active, not recruiting
- ||| Fluzone High-Dose Quadrivalent (influenza vaccine) / Evotec, Sanofi, quadrivalent influenza mRNA vaccine (MRT5407) / Sanofi
Enrollment closed: Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adult Participants18 Years of Age and Older (clinicaltrials.gov) - Jun 2, 2023
P1/2, N=560, Active, not recruiting, Sponsor: Sanofi Pasteur, a Sanofi Company
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- | Fluzone Quadrivalent (influenza vaccine) / Sanofi, Flublok Quadrivalent (influenza vaccine) / Sanofi
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, IO biomarker: Comparison of Recombinant Influenza Vaccine Versus Standard Egg-Based Inactivated Influenza Vaccine in Adults 18-64 Years (clinicaltrials.gov) - May 12, 2023
P4, N=3988, Active, not recruiting, Sponsor: Fatimah Dawood
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | N=16247 --> 3988 | Trial completion date: Sep 2024 --> Dec 2023 | Trial primary completion date: Jun 2024 --> Dec 2023
- ||||| Flublok Quadrivalent (influenza vaccine) / Sanofi
Enrollment closed: Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age. (clinicaltrials.gov) - May 11, 2023
P3, N=1323, Active, not recruiting, Sponsor: Sanofi Pasteur, a Sanofi Company
Recruiting --> Active, not recruiting | N=16247 --> 3988 | Trial completion date: Sep 2024 --> Dec 2023 | Trial primary completion date: Jun 2024 --> Dec 2023 Recruiting --> Active, not recruiting
- ||| Flublok Quadrivalent (influenza vaccine) / Sanofi
New P1 trial: Substudy 01 - Safety and Immunogenicity of One Monovalent Modified mRNA Vaccine Encoding Influenza Hemagglutinin With LNP, in Adult Participants Aged 18 to 49 Years and 60 Years and Above (clinicaltrials.gov) - Apr 25, 2023
P1, N=225, Recruiting, Sponsor: Sanofi Pasteur, a Sanofi Company
- | Trial completion date: RIVER: Randomized Influenza Vaccine Evaluation of Immune Response (clinicaltrials.gov) - Apr 24, 2023
P4, N=366, Active, not recruiting, Sponsor: Marshfield Clinic Research Foundation
Recruiting --> Active, not recruiting Trial completion date: Sep 2022 --> Dec 2023
- ||| Fluzone High-Dose Quadrivalent (influenza vaccine) / Evotec, Sanofi, MRT5410 / Sanofi
Enrollment closed: Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adult Participants 18 Years of Age and Older (clinicaltrials.gov) - Apr 3, 2023
P1/2, N=683, Active, not recruiting, Sponsor: Sanofi Pasteur, a Sanofi Company
Trial completion date: Sep 2022 --> Dec 2023 Recruiting --> Active, not recruiting
- ||||| Flublok Quadrivalent (influenza vaccine) / Sanofi, VaxiGrip QIV IM (quadrivalent inactivated influenza vaccine) / Sanofi
Enrollment closed: FLUO: Trial Assessing the Immunogenicity and Safety of Two Influenza Vaccine Strategies Among Severe Obese Adult Patients (clinicaltrials.gov) - Mar 29, 2023
P3, N=206, Active, not recruiting, Sponsor: Assistance Publique - H
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- ||| Flublok Quadrivalent (influenza vaccine) / Sanofi
Trial completion: Flublok v. Standard Dose Vaccine Effectiveness Among Kaiser Permanente Northern California Adults 18-64 Years (clinicaltrials.gov) - Mar 1, 2023
P=N/A, N=2776278, Completed, Sponsor: Kaiser Permanente
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- ||||| Fluzone High-Dose Quadrivalent (influenza vaccine) / Evotec, Sanofi, quadrivalent influenza mRNA vaccine (MRT5413) / Sanofi
New P1/2 trial: Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants18 Years of Age and Older (clinicaltrials.gov) - Dec 14, 2022
P1/2, N=682, Recruiting, Sponsor: Sanofi Pasteur, a Sanofi Company
- |||| Fluzone High-Dose Quadrivalent (influenza vaccine) / Evotec, Sanofi, MRT5410 / Sanofi
Enrollment open: Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adult Participants 18 Years of Age and Older (clinicaltrials.gov) - Dec 1, 2022
P1/2, N=690, Recruiting, Sponsor: Sanofi Pasteur, a Sanofi Company
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- ||||| Fluzone High-Dose Quadrivalent (influenza vaccine) / Evotec, Sanofi, MRT5410 / Sanofi
New P1/2 trial: Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adult Participants 18 Years of Age and Older (clinicaltrials.gov) - Nov 22, 2022
P1/2, N=690, Not yet recruiting, Sponsor: Sanofi Pasteur, a Sanofi Company
- |||||| Flublok Quadrivalent (influenza vaccine) / Sanofi
Enrollment open: Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years (clinicaltrials.gov) - Nov 17, 2022
P3, N=1412, Recruiting, Sponsor: Sanofi Pasteur, a Sanofi Company
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||| Flublok Quadrivalent (influenza vaccine) / Sanofi, VaxiGrip QIV IM (quadrivalent inactivated influenza vaccine) / Sanofi
Enrollment open, Trial completion date, Trial primary completion date: FLUO: Trial Assessing the Immunogenicity and Safety of Two Influenza Vaccine Strategies Among Severe Obese Adult Patients (clinicaltrials.gov) - Nov 8, 2022
P3, N=206, Recruiting, Sponsor: Assistance Publique - H
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Trial completion date: Apr 2023 --> Aug 2023 | Trial primary completion date: Mar 2023 --> Aug 2023
- |||||| NanoFlu (recombinant hemagglutinin protein nanoparticle) / Novavax
Trial termination: Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults (clinicaltrials.gov) - Nov 4, 2022
P2, N=1375, Terminated, Sponsor: Novavax
Not yet recruiting --> Recruiting | Trial completion date: Apr 2023 --> Aug 2023 | Trial primary completion date: Mar 2023 --> Aug 2023 Completed --> Terminated; This study was terminated 182 days after initial dosing.
- |||||| Flublok Quadrivalent (influenza vaccine) / Sanofi
Enrollment open: Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age. (clinicaltrials.gov) - Nov 3, 2022
P3, N=1334, Recruiting, Sponsor: Sanofi Pasteur, a Sanofi Company
Completed --> Terminated; This study was terminated 182 days after initial dosing. Not yet recruiting --> Recruiting
- ||||||| Flublok Quadrivalent (influenza vaccine) / Sanofi
Trial completion: Study Describing the Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine (RIV4) Versus a Licensed Quadrivalent-inactivated Influenza Vaccine (IIV4) (Fluarix (clinicaltrials.gov) - Nov 1, 2022
P3, N=300, Completed, Sponsor: Sanofi Pasteur, a Sanofi Company
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- |||||| Enrollment open: Immunogenicity Trial of 3 Influenza Vaccines (clinicaltrials.gov) - Oct 27, 2022
P3, N=360, Recruiting, Sponsor: Tan Tock Seng Hospital
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- || Review, Journal: Genetic engineering of baculovirus-insect cell system to improve protein production. (Pubmed Central) - Oct 8, 2022
As the demand for biotechnology increases, there has been a concomitant effort into optimizing yield, stability and protein glycosylation through genetic engineering and the manipulation of baculovirus vector and host cells. In this review, we summarize the strategies and technological advances of BEVS in recent years and explore how this will be used to inform the further development and application of this system.
- |||| Fluzone High-Dose Quadrivalent (influenza vaccine) / Evotec, Sanofi, quadrivalent influenza mRNA vaccine (MRT5407) / Sanofi
Enrollment open: Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adult Participants18 Years of Age and Older (clinicaltrials.gov) - Oct 7, 2022
P1/2, N=560, Recruiting, Sponsor: Sanofi Pasteur, a Sanofi Company
In this review, we summarize the strategies and technological advances of BEVS in recent years and explore how this will be used to inform the further development and application of this system. Not yet recruiting --> Recruiting
- |||| Flublok Quadrivalent (influenza vaccine) / Sanofi, VaxiGrip QIV IM (quadrivalent inactivated influenza vaccine) / Sanofi
Trial completion: Immunogenicity Trial of Recombinant Influenza Vaccine Among HCP in Israel (clinicaltrials.gov) - Oct 7, 2022
P4, N=572, Completed, Sponsor: Centers for Disease Control and Prevention
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- ||||| Fluzone High-Dose Quadrivalent (influenza vaccine) / Evotec, Sanofi, quadrivalent influenza mRNA vaccine (MRT5407) / Sanofi
New P1/2 trial: Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adult Participants18 Years of Age and Older (clinicaltrials.gov) - Sep 23, 2022
P1/2, N=560, Not yet recruiting, Sponsor: Sanofi Pasteur, a Sanofi Company
- | Trial completion date, Trial primary completion date: FluVax3: A Deep Longitudinal Analysis of Next Generation Influenza Vaccines in Older Adults (clinicaltrials.gov) - Sep 16, 2022
P4, N=66, Recruiting, Sponsor: The Jackson Laboratory
Active, not recruiting --> Completed Trial completion date: Aug 2025 --> Dec 2026 | Trial primary completion date: Aug 2025 --> Dec 2026
- | Fluzone Quadrivalent (influenza vaccine) / Sanofi, Flublok Quadrivalent (influenza vaccine) / Sanofi
Enrollment open, IO biomarker: Comparison of Recombinant Influenza Vaccine Versus Standard Egg-Based Inactivated Influenza Vaccine in Adults 18-64 Years (clinicaltrials.gov) - Sep 16, 2022
P4, N=16247, Recruiting, Sponsor: Fatimah Dawood
Trial completion date: Aug 2025 --> Dec 2026 | Trial primary completion date: Aug 2025 --> Dec 2026 Not yet recruiting --> Recruiting
- Effectiveness of Recombinant Influenza Vaccine vs. Standard Dose Inactivated Influenza Vaccines Against Hospitalized Influenza-Related Outcomes in Adults: A Cluster Randomized Trial (144 ABC) - Sep 8, 2022 - Abstract #IDWeek2022IDWEEK_2661;
- | Flucelvax Quadrivalent (influenza vaccine) / CSL Behring, Flublok quadrivalent vaccine (RIV4) / Sanofi
Preclinical, Journal: 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 Central) - Aug 30, 2022
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.
- | New P4 trial: FluVax3: A Deep Longitudinal Analysis of Next Generation Influenza Vaccines in Older Adults (clinicaltrials.gov) - Aug 26, 2022
P4, N=66, Recruiting, Sponsor: The Jackson Laboratory
- | Fluzone Quadrivalent (influenza vaccine) / Sanofi, Flublok Quadrivalent (influenza vaccine) / Sanofi
New P4 trial, IO biomarker: Comparison of Recombinant Influenza Vaccine Versus Standard Egg-Based Inactivated Influenza Vaccine in Adults 18-64 Years (clinicaltrials.gov) - Aug 24, 2022
P4, N=16247, Not yet recruiting, Sponsor: Fatimah Dawood
- |||||||||| Flublok Quadrivalent (influenza vaccine) / Sanofi
New P3 trial: Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years (clinicaltrials.gov) - Aug 24, 2022
P3, N=1412, Not yet recruiting, Sponsor: Sanofi Pasteur, a Sanofi Company
- |||||||||| Flublok Quadrivalent (influenza vaccine) / Sanofi
New P3 trial: Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age. (clinicaltrials.gov) - Aug 23, 2022
P3, N=1334, Not yet recruiting, Sponsor: Sanofi Pasteur, a Sanofi Company
- |||||||||| Flublok Quadrivalent (influenza vaccine) / Sanofi
New P3 trial: Study with Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 through 49 Years of Age. Estudio con la vacuna antigripal tetravalente recombinante (RIV4) en participantes de 9 a 49 años. (EUDRACT) - Aug 2, 2022
P3, N=1334, Ongoing, Sponsor: Sanofi Pasteur Inc
- |||||||||| Flublok Quadrivalent (influenza vaccine) / Sanofi
New P3 trial: Study with Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared with Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years Estudio con la vacuna antigripal tetravalente recombinante (RIV4) en comparación con la vacuna antigripal tetravalente a base de huevo (IIV4) en participantes de 3 a 8 años. (EUDRACT) - Aug 2, 2022
P3, N=1412, Ongoing, Sponsor: Sanofi Pasteur Inc
- |||||||||| New P3 trial: Immunogenicity Trial of 3 Influenza Vaccines (clinicaltrials.gov) - Jul 29, 2022
P3, N=360, Not yet recruiting, Sponsor: Tan Tock Seng Hospital
- ||||| Flublok Quadrivalent (influenza vaccine) / Sanofi
Enrollment closed: Study Describing the Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine (RIV4) Versus a Licensed Quadrivalent-inactivated Influenza Vaccine (IIV4) (Fluarix (clinicaltrials.gov) - Jul 5, 2022
P3, N=301, Active, not recruiting, Sponsor: Sanofi Pasteur, a Sanofi Company
Differences in hemagglutinin antigen content may play a role in immunogenicity of influenza vaccination in consecutive seasons. Recruiting --> Active, not recruiting