New H7 flu vaccine shows promise in early trial
NCT ID NCT05608005
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two different doses of an experimental H7 flu vaccine with an added booster (adjuvant) against a version without the booster. About 581 healthy adults aged 18 and older took part. The goal was to see which dose produced the strongest immune response and was safest, to pick the best one for future studies.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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581 people
The number who actually took part.
- Started
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Nov 2022
- Finished
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Feb 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged 18 years or older on the day of inclusion * Participants who are healthy as determined by medical evaluation including medical history and physical examination * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile. OR Is of childbearing potential and agrees to use a highly effective contraceptive method or abstinence from at least 4 weeks prior to each study intervention administration until at least 12 weeks after the last study intervention administration. * A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 24 hours before the first dose of study intervention * Informed consent form has been signed and dated Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances * Thrombocytopenia or bleeding disorder contraindicating intramuscular injection based on investigator's judgement * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion (1) (1) Chronic illness may include, but is not limited to, cardiac disorders, renal disorders, auto-immune disorders, diabetes, psychiatric disorders, or chronic infection * Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of study intervention administration in the absence of therapy, and participants who have a history of neoplastic disease and who have been disease-free for ≥ 5 years) * Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 100.4°F) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided * Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion * Receipt of any vaccine in the 14 days preceding Visit 1 or planned receipt of any vaccine prior to Visit 3, except for seasonal flu vaccine, which may be received at least 2 weeks after Visit 2 * Previous vaccination against H7N9 with an investigational vaccine * Receipt of immune globulins, blood or blood-derived products in the past 3 months * Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study * Personal or family history of Guillain-Barré syndrome * Self-reported seropositivity for Hepatitis B antigen or Hepatitis C "The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial."
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CenExel ACMR (Atlanta Center for Medical Research) Site Number : 8400022
Atlanta, Georgia, 30331, United States
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Centricity Research-Mesa Site Number : 8400006
Mesa, Arizona, 85206, United States
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Foothill Family Research-South Site Number : 8400009
Salt Lake City, Utah, 84121, United States
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JBR Clinical Research Site Number : 8400005
Salt Lake City, Utah, 84107, United States
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M3 Wake Research Inc Site Number : 8400010
Raleigh, North Carolina, 27612, United States
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Preferred Primary Care Physicians Site Number : 8400015
Pittsburgh, Pennsylvania, 15236, United States
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Preferred Primary Care Physicians, Inc. Site Number : 8400002
Pittsburgh, Pennsylvania, 15243, United States
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Research Centers of America Site Number : 8400024
Hollywood, Florida, 33024, United States
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St Johns Center for Clinical Research Site Number : 8400021
Saint Augustine, Florida, 32086, United States
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Suncoast Research Associates, LLC Site Number : 8400008
Miami, Florida, 33173, United States
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Velocity Clinical Research Anderson Site Number : 8400016
Anderson, South Carolina, 29621, United States
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Velocity Clinical Research Site Number : 8400019
Austin, Texas, 78759, United States
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Velocity Clinical Research Site Number : 8400027
Metairie, Louisiana, 70006, United States
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Velocity Clinical Research Valparaiso Site Number : 8400007
Valparaiso, Indiana, 46383, United States
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Velocity Clinical Research-Hallandale Beach Site Number : 8400026
Hallandale, Florida, 33009, United States
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WR-ClinSearch, LLC Site Number : 8400003
Chattanooga, Tennessee, 37421, United States
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