Clinical trials: Influenza in Humans
Influenza Immunization, Healthy Volunteers
Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Japanese Adults 60 Years of Age and Older
Primary Objective: To demonstrate that QIV-HD induced an immune response (as assessed by hemagglutination inhibition [HAI] geometric mean titers [GMTs] and seroconversion rates) that was superior to responses induced by QIV-SD…
- Trial name
- NCT04498832
- Testing
- High-Dose Quadrivalent Influenza Vaccine, (Zonal Purified, Split Virus) 2020-2021 Strains (QIV-HD), Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains (QIV-SD)
- Where
- 10 sites in Japan
- Volunteers
- 2,100 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza
Immunogenicity and Safety Study of Inactivated Subunit H5N1 Influenza Vaccine in Prior Recipients of Live Attenuated H2N2, H6N1 and H9N2 Influenza Vaccines and in H5N1 and Live Attenuated Vaccine Naïve Individuals
The purpose of this study is to evaluate the immunogenicity and safety of inactivated subunit H5N1 influenza vaccine in individuals who have previously received live attenuated H2N2, H6N1, or H9N2 influenza vaccine, as well as in…
- Trial name
- NCT03816878
- Testing
- H5N1 pISV
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Influenza (Healthy Volunteers)
Study to Evaluate the Effectiveness of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Adults 65 Years of Age and Older
Primary Objective: To demonstrate the superior relative effectiveness of QIV-HD as compared to QIV-SD among persons 65 years of age and older for the prevention of cardiovascular and/or respiratory hospitalizations.
- Trial name
- NCT04137887
- Testing
- Quadrivalent Influenza Vaccine (split virion, inactivated) High-Dose (QIV-HD), Standard-Dose Inactivated Influenza Vaccine Quadrivalent, Northern Hemisphere strains (QIV-SD)
- Where
- Finland
- Volunteers
- 33,096 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza Immunization, Healthy Volunteers
Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Europeans Adults 60 Years of Age and Older
Primary Objective: To demonstrate that high-dose quadrivalent influenza vaccine (QIV-HD) induces an immune response that is superior to the responses induced by standard-dose quadrivalent influenza vaccine (QIV-SD) for all 4…
- Trial name
- NCT04024228
- Testing
- Standard-Dose influenza virus surface antigens (haemagglutinin and neuraminidase), Inactivated, Influenza Vaccine Quadrivalent, 2019-2020 Northern Hemisphere Strains (QIV-SD), High-Dose Influenza Vaccine (split virion, inactivated), Quadrivalent (QIV-HD) 2019-2020 Northern Hemisphere formulation
- Where
- 17 sites in Belgium, France and 4 more
- Volunteers
- 1,539 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza
Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
The primary objective of the study was to provide sera (collected from participants before vaccination [Blood Sample 1] and after final vaccination [Blood Sample 2]) to the Center for Biologics Evaluation and Research (CBER) for…
- Trial name
- GRC00097 (NCT04109222)
- Testing
- Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation, Fluzone High-Dose vaccine, 2019-2020 formulation
- Where
- 2 sites in United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza Immunization, Healthy Volunteers
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2020-2021 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
Primary Objective: To provide serum samples (collected from participants before vaccination [Blood Sample 1] and after final vaccination [Blood Sample 2]) to Center for Biologics Evaluation and Research (CBER) for further…
- Trial name
- NCT04551677
- Testing
- Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2020-2021 formulation, Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2020-2021 formulation
- Where
- 2 sites in United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza Immunization, Healthy Volunteers
Study of a Quadrivalent High-Dose Influenza Vaccine and a Moderna COVID-19 Vaccine Administered Either Concomitantly or Singly in Participants 65 Years of Age and Older Previously Vaccinated With a 2-dose Schedule of Moderna COVID-19 Vaccine
The main purpose of this Phase II study was to assess the safety and immunogenicity of a dose of Fluzone High-Dose (HD) Quadrivalent vaccine and a third dose or booster dose of Moderna coronavirus disease 19 (COVID-19) vaccine…
- Trial name
- NCT04969276
- Testing
- Quadrivalent Inactivated Influenza High Dose, COVID-19 mRNA Vaccine (nucleoside modified)
- Where
- 6 sites in United States
- Volunteers
- 306 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza Immunization, Healthy Volunteers
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
This was a phase IV, multi-center, open-label study. The study collected serum samples from children 6 months to less than (<) 9 years of age who received Fluzone Quadrivalent vaccine and adults greater than or equal to (>=) 65…
- Trial name
- NCT05050318
- Testing
- Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation, Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation
- Where
- 2 sites in United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza
Inactivated Split Virus Seasonal Influenza Vaccine (Vero Cell-Derived)
The purpose of this study is to determine if a Vero cell-derived trivalent seasonal influenza vaccine produced by the modified manufacturing process: 1.
- Trial name
- NCT01773928
- Testing
- Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified), VCIV manufactured with the current manufacturing process (VCIV current), Fluzone®, licensed trivalent influenza vaccine (TIV)
- Where
- 20 sites in United States
- Volunteers
- 1,928 people, healthy volunteers welcome
- Sponsor
- Alachua Government Services, Inc.
Influenza (Healthy Volunteers)
Study Describing the Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine (RIV4) Versus a Licensed Quadrivalent-inactivated Influenza Vaccine (IIV4) (Fluarix® Quadrivalent) in Participants 18 Years of Age and Older in South Korea
To describe the immune response induced by quadrivalent recombinant influenza vaccine (RIV4) and Quadrivalent-inactivated Influenza Vaccine (IIV4) in 18-49 and greater than or equal to (>=) 50 years of age participants by…
- Trial name
- NCT05144945
- Testing
- Quadrivalent Recombinant Influenza Vaccine (RIV4), Quadrivalent inactivated influenza vaccine (IIV4)
- Where
- 3 sites in South Korea
- Volunteers
- 301 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza Immunization
Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age.
The purpose of this study was to demonstrate the non-inferiority (NI) of the HAI immune response of RIV4 in participants aged 9 to 17 years vs participants aged 18 to 49 years and to describe the immunogenicity and safety profile…
- Trial name
- NCT05513053
- Testing
- Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH
- Where
- 35 sites in United States, Czechia and 2 more
- Volunteers
- 1,308 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza Immunization
Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years
The purpose of this study was to demonstrate the non-inferior HAI immune response of quadrivalent recombinant influenza vaccine (RIV4) vs licensed Egg-Based Quadrivalent Influenza Vaccine (IIV4) for the 4 strains based on the…
- Trial name
- NCT05513391
- Testing
- Recombinant influenza vaccine (RIV4), Quadrivalent influenza vaccine (IIV4)
- Where
- 31 sites in United States, Poland and 1 more
- Volunteers
- 366 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza
Influenza Challenge Study to Determine the Optimal Infection Dose and Safety of a Recombinant H3N2 (A/Texas/71/2017 (H3N2, Clade 3C3a) Influenza Strain
An open-label, dose-ranging influenza challenge study in healthy adult volunteers to determine the optimal infection dose and safety of a recombinant H3N2 (A/Texas/ A/Texas/71/2017 (H3N2, clade 3C3a) influenza strain.
- Trial name
- NCT04978454
- Testing
- Influenza RG-A/Texas/71/2017 (H3N2) Challenge
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Influenza
DMID 21-0041; Influenza CVD 59000
The primary objective of EMIT-2 is to use a randomized controlled trial (RCT) design to implement interventions which are known to reduce inhalation (airborne) transmission, so that the contribution of transmission by route of…
- Trial name
- EMIT-2 (NCT05666245)
- Testing
- Personal Protective Equipment (PPE) - Under High Air Hygiene, No Intervention - Under High Air Hygiene, Personal Protective Equipment (PPE) - Under Low Air Hygiene
- Where
- 2 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Influenza, Human
Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Astrakhan/3212/2020 Like (H5N8) Virus Vaccine With AS03 Adjuvant System in Medically Stable Adults
The purpose of this study is to assess the safety and immunogenicity of different formulations of monovalent Influenza A/Astrakhan/3212/2020-like virus vaccine with AS03 adjuvant system in adults greater than or equal to (>=)18…
- Trial name
- NCT05975840
- Testing
- FLU Q-PAN H5N8 375_B, FLU Q-PAN H5N8 375_A, FLU Q-PAN H5N8 750_B
- Where
- 20 sites in United States
- Volunteers
- 518 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
H3N2 Influenza
Assess the Safety and Immunogenicity of One or Two Doses of Sing2016 M2SR H3N2 Influenza Vaccine
This is a Phase 1b, randomized, double-blind, dose-escalating, age de-escalating, placebo-controlled study of 200 children, ages 6 months to 17 years.
- Trial name
- NCT04960397
- Testing
- Sing2016 M2SR H3N2
- Where
- 4 sites in United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pregnancy
Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women
This is a pilot, prospective, randomized, open-label clinical trial. During the study, pregnant women will be randomized (1:1) to receive co-administration of a single intramuscular (IM) 0.5 mL dose of US-licensed inactivated…
- Trial name
- Tdap/IIV (NCT02783170)
- Testing
- Tetanus, Diphtheria, and Pertussis Vaccine, 2016-2017 Quadrivalent Inactivated Influenza Vaccine, 2017-2018 Quadrivalent Inactivated Influenza Vaccine
- Where
- 3 sites in United States
- Volunteers
- 81 people
- Sponsor
- Duke University
Influenza, Human, COVID-19
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza
Substudy A: This is a Phase 1 randomized, open-label study to describe the safety and immunogenicity of up to 3 dose- level combinations of modRNA quadrivalent influenza vaccine (qIRV (22/23)) and bivalent BNT162b2 (original/Omi…
- Trial name
- NCT05596734
- Testing
- bivalent BNT162b2 (original/Omi BA.4/BA.5), qIRV (22/23), QIV
- Where
- 59 sites in United States
- Volunteers
- 1,019 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Influenza, Human
A Study to Assess the Safety and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults
The purpose of this study is to find and confirm the dose and asses the reactogenicity, safety and immune response of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine (GSK4382276A)…
- Trial name
- NCT05823974
- Testing
- F2C22C/DL001Z, F2B22A/DL001Z, F2B22B/DL001Z
- Where
- 41 sites in United States, Belgium and 2 more
- Volunteers
- 1,275 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Seasonal Influenza
Study of mRNA-1010 Seasonal Influenza Vaccine in Adults
This study includes 3 parts: Parts A, B, and C. The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1010 seasonal influenza vaccine in adults.
- Trial name
- IGNITE P303 (NCT05827978)
- Testing
- mRNA-1010, Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine
- Where
- 103 sites in United States
- Volunteers
- 8,411 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.