InfluenzaPhase 1NCT06460064

First-in-human Study to Assess the Safety, Tolerability and Immunogenicity of the Adjuvanted Universal Influenza Vaccine fH1/DSP-0546LP

A Phase 1 study testing fH1 2 ug, fH1 8 ug and DSP-0546LP 2.5 ug in people with Influenza, run by Sumitomo Pharma Co., Ltd. at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a single center, randomized, double-blind, placebo-controlled, dose-finding, FIH, Phase 1 study to assess the safety, tolerability, and immunogenicity of the adjuvanted Universal Influenza Vaccine (fH1/DSP-0546LP) after IM administrations in healthy adults. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: fH1 2 ug, fH1 8 ug and DSP-0546LP 2.5 ug
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 144 participants
Where: 1 siteBelgium
Study dates: 26 Jun 2024to 31 Mar 2026
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult male or female subject between 18 and 40 years of age at the time of informed consent.
Subject who is fully informed of and understands the objectives, procedures, anticipated side effects of the vaccine and risks of the study and who voluntarily provides written consent to participate in the study.
Subject's body weight is equal to or more than 50 kg, and body mass index is at least 18 kg/m2 but no more than 30 kg/m2 at screening.
Subject willing and able to comply with the study requirements, including laboratory tests and reporting symptoms.
A male subject with a female partner of childbearing potential must agree to use adequate and reliable contraception (e.g., using condom or have had vasectomy with proven sterility for male and using contraceptive agents, diaphragm, intrauterine devices (IUDs), or bilateral tubal ligation for female partner) from informed consent until at least 30 days after last administration of the study vaccine.
A female subject is eligible for this study if she is neither pregnant nor breastfeeding and 1 of the following:

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Of non childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year).
Of childbearing potential but has been and agrees to continue practicing highly effective contraception from informed consent until at least 30 days after the last administration. Highly effective methods of contraception include 1 or more of the following:
a female subject who is abstinent or have a sexual relationship with sole female partner;
male partner who is sterile (vasectomized) prior to the female subject's entry into the study and is the sole sexual partner for the female subject;
hormonal (oral, intravaginal, transdermal, implantable or injectable), which is associated with inhibition of ovulation;
an intrauterine hormone-releasing system;
an intrauterine device with a documented failure rate of < 1%;
bilateral tubal occlusion.
A female subject who is premenopausal and of childbearing potential must have a negative urine pregnancy-test result at screening, on Days 1 and 22.
Subject must agree not to donate sperm or eggs from informed consent until at least 30 days after last administration of the study vaccine.

Who cannot join

Subject with a history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, hematological, respiratory, psychiatric or neurologic disease, and who is considered ineligible for the study by the Principal Investigator (PI) or sub Investigator.
Subject with other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior that may increase the risk of study participation or, in the Investigator's judgement, make the subject inappropriate for the study.
Subject immunocompromised with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
Subject with a history or evidence of autoimmune disease or known immunodeficiency of any cause or severe allergy.
Subject who receives chronic treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g., for cancer or an autoimmune disease, within 60 days before the Screening Visit or planned receipt throughout the study. If systemic corticosteroids have been administered short term (< 14 days) for treatment of an acute illness, subjects should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before first administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
Subject with a history of severe adverse reaction associated with a vaccine and/or a known or suspected allergic reaction (e.g., anaphylaxis) or hypersensitivity to any component of the investigational product including egg protein.

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Subject with a history of substance abuse or drug abuse. If there is any doubt about the correctness of the information provided by the subject (history) or observation of a behavior that raises concerns about drug use, drug screening will be conducted at the Screening Visit or prior to first administration.
Subject with a positive serology (hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antigen/antibody) at screening.
Subject with any clinically significant abnormal clinical laboratory value (hematology, serum chemistry, urinalysis, coagulation) determined by the PI or sub-Investigator at screening.
Subject with a history of excessive alcohol consumption (defined as drinking at least 21 units of alcohol beverage per week for a man and 14 units of alcohol beverage per week for a woman) within 6 months of the Screening Visit. Following common drinks contain 1 unit of alcohol: 300 ml beer [4% alcohol by volume (ABV)], 100 ml of wine (12% ABV), 30 ml of spirits (40% ABV).
Subject who drinks large quantities of caffeinated beverages (coffee, tea, green tea, cola, tonic drink, etc) (approximately 1.8 L daily or more).
Subject with a history of tobacco (including electronic cigarette) dependency or subject who smokes ≥ 20 cigarettes daily (excluding subject who stopped smoking more than 2 years ago).
Subject who has received seasonal flu vaccine within a year prior to the Screening Visit.
Subject who has experienced significant blood loss or donated blood (≥ 400 mL) within 90 days prior to the first administration or donated 200 mL of blood or more within 30 days prior to the first administration; has donated blood components within 14 days prior to the first administration.
Subject who has received blood/plasma products or immunoglobulins within 6 months prior to the Screening Visit.
Subject who has received any investigational drug or who is currently participating or has participated in a clinical study within 90 days prior to the Screening Visit.
Subject who has participated in a clinical study of any influenza vaccine, or any investigational vaccine or experimental influenza viral challenge delivered directly to the respiratory tract within a year prior to the first administration.
Subject with a history of hospitalization (excluding hospitalization for medical checkup) for at least one night within 45 days prior to the Screening Visit.
Subject who has used prescription or over-the-counter medications except chronic medication and contraceptives for female subjects within 7 days or 5 half-lives prior to the first administration.
In the Investigator's judgement, the subject has current symptoms suggestive of an acute infection, or presence of long-term medical, neurologic, or psychiatric sequalae of prior COVID-19.
Subject who has received any other licensed vaccine within 28 days prior to screening or who is planning to receive any vaccine up to 28 days after the last vaccine administration.
Subject who is a staff member of the clinical site/Sponsor/Contract research organization (CRO) or the relative of a staff member.
Subject who is in the opinion of the PI or sub-Investigator, unsuitable in any other way to participate in this study.
Subject with bleeding disorder that would, in the opinion of the Investigator, contraindicate IM injection.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Center for Vaccinology
Ghent, Corneel Heymanslaan 10, 9000

Other trials in Belgium

About this study

Official title: A Single Center, Randomized, Double-blind, Placebo-controlled, First-in-human Phase 1 Study to Assess the Safety, Tolerability and Immunogenicity of the Adjuvanted Universal Influenza Vaccine "fH1/DSP-0546LP" After Intramuscular (IM) Administrations in Healthy Adults

Read the detailed description

This will be a single center, randomized, placebo-controlled, double-blind study. In this study, safety, tolerability, and immunogenicity of fH1 formulated with DSP-0546LP will be assessed after IM administration in healthy adults aged 18 to 40 years.

This study includes 6 cohorts, with a combination of 2 dose levels of fH1 (2 and 8 μg), 3 dose levels of DSP-0546LP (2.5, 5, and 10 μg), and placebo. Each dose level of fH1 will be combined with the low, medium, and high dose level of DSP-0546LP. Subjects will receive 2 administrations at 3-week intervals.

Randomized subjects will undergo 11 visits including screening, 2 administration visits (Day 1 and Day 22 [± 2]), and follow-up visits on Day 4 (+1) (telephone contact), Day 8 (± 1), Day 25 (+1) (telephone contact), Day 29 (± 1), Day 36 (± 2), Day 50 (± 4), Day 204 (± 7), and Day 386 (± 10).

Conditions: Influenza
Being tested: fH1 2 ug, fH1 8 ug, DSP-0546LP 2.5 ug, DSP-0546LP 5 ug, DSP-0546LP 10 ug
Keywords: Influenza, universal, vaccine, adjuvant, TLR7
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fH1 2 ugBiological
2 administrations at 3-week intervals.
fH1 8 ugBiological
2 administrations at 3-week intervals.
DSP-0546LP 2.5 ugBiological
2 administrations at 3-week intervals.
DSP-0546LP 5 ugBiological
2 administrations at 3-week intervals.
DSP-0546LP 10 ugBiological
2 administrations at 3-week intervals.
PlaceboBiological
2 administrations at 3-week intervals.

Study groups in NCT06460064
Study group	Role	What they receive
combination of fH1 2 ug and DSP-0546LP 2.5 ug	Experimental	The study vaccine (fH1 2 ug and DSP-0546LP 2.5 ug) will be administered IM into the deltoid muscle of the non-dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals. Receives: Biological: fH1 2 ug; Biological: DSP-0546LP 2.5 ug
combination of fH1 8 ug and DSP-0546LP 2.5 ug	Experimental	The study vaccine (fH1 8 ug and DSP-0546LP 2.5 ug) will be administered IM into the deltoid muscle of the non-dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals. Receives: Biological: fH1 8 ug; Biological: DSP-0546LP 2.5 ug
combination of fH1 2 ug and DSP-0546LP 5 ug	Experimental	The study vaccine (fH1 2 ug and DSP-0546LP 5 ug) will be administered IM into the deltoid muscle of the non-dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals. Receives: Biological: fH1 2 ug; Biological: DSP-0546LP 5 ug
combination of fH1 8 ug and DSP-0546LP 5 ug	Experimental	The study vaccine (fH1 8 ug and DSP-0546LP 5 ug) will be administered IM into the deltoid muscle of the non-dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals. Receives: Biological: fH1 8 ug; Biological: DSP-0546LP 5 ug
combination of fH1 2 ug and DSP-0546LP 10 ug	Experimental	The study vaccine (fH1 2 ug and DSP-0546LP 10 ug) will be administered IM into the deltoid muscle of the non-dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals. Receives: Biological: fH1 2 ug; Biological: DSP-0546LP 10 ug
combination of fH1 8 ug and DSP-0546LP 10 ug	Experimental	The study vaccine (fH1 8 ug and DSP-0546LP 10 ug) will be administered IM into the deltoid muscle of the non- dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals. Receives: Biological: fH1 8 ug; Biological: DSP-0546LP 10 ug
fH1 2 ug	Experimental	The study vaccine (fH1 2 ug) will be administered IM into the deltoid muscle of the non- dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals. Receives: Biological: fH1 2 ug
fH1 8 ug	Experimental	The study vaccine (fH1 8 ug) will be administered IM into the deltoid muscle of the non-dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals. Receives: Biological: fH1 8 ug
DSP-0546LP 2.5 ug	Experimental	The study vaccine (DSP-0546LP 2.5 ug) will be administered IM into the deltoid muscle of the non-dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals. Receives: Biological: DSP-0546LP 2.5 ug
DSP-0546LP 5 ug	Experimental	The study vaccine (DSP-0546LP 5 ug) will be administered IM into the deltoid muscle of the non- dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals. Receives: Biological: DSP-0546LP 5 ug
DSP-0546LP 10 ug	Experimental	The study vaccine (DSP-0546LP 10 ug) will be administered IM into the deltoid muscle of the non- dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals. Receives: Biological: DSP-0546LP 10 ug
Placebo	Placebo comparator	The study vaccine (placebo) will be administered IM into the deltoid muscle of the non- dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals. Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of solicited local adverse events (AEs) during a 7-day follow-up period after each administration.
Solicited local AEs: pain, redness, swelling, induration, warmth, and pruritus at injection site
Measured: 7 days after each administration
Incidence of solicited systemic AEs during a 7-day follow-up period after each administration.
Solicited systemic AEs: feverishness, chills, myalgia, fatigue, headache, nausea, arthralgia, malaise, and body temperature (measured axillary)
Measured: 7 days after each administration
Incidence of unsolicited AEs from the first administration to 4 weeks after the second administration.
Clinical observations, clinical laboratory values and vital signs
Measured: From the first administration to 4 weeks after the second administration.
Incidence of serious adverse events (SAEs), AEs leading to study discontinuation, and adverse events of special interest throughout the study period.
Measured: From the first administration to 52-week follow-up after the second administration

Secondary outcomes (3)

Percentage of subjects with increased immunoglobulin (Ig) G response to long alpha helix (LAH) after administration of fH1/DSP-0546LP.
Measured: From the day of the first administration to 52-week follow-up after the second administration
Percentage of subjects with increased neuraminidase inhibition antibody titer after administration of fH1/DSP-0546LP.
Measured: From the day of the first administration to 1 week after the second administration.
Seroconversion rate (SCR) of hemagglutination inhibition (HAI) antibody titers after administration of fH1/DSP-0546LP.
SCR is defined as the percentage of subjects with either a baseline (Day 1) HAI titer < 1:10 and post-administration titer ≥ 1:40, or baseline titer ≥ 1:10 and ≥ 4-fold increase in post-administration titer.
Measured: From the day of the first administration to 1 week after the second administration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 202431 Mar 2026

First posted14 Jun 2024
Study start26 Jun 2024
Primary completion31 Mar 2026
Study completion31 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for InfluenzaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06460064
Sponsor's protocol ID: R2411201
Other IDs: JP19pc0101043, 2023-504378-39-00, 2023
Status last verified: Apr 2026
First submitted: 29 Apr 2024
Last updated: 17 Apr 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Center, Randomized, Double-blind, Placebo-controlled, First-in-human Phase 1 Study to Assess the Safety, Tolerability and Immunogenicity of the Adjuvanted Universal Influenza Vaccine "fH1/DSP-0546LP" After Intramuscular (IM) Administrations in Healthy Adults
ClinicalTrials.gov ID: NCT06460064
Acronym / sponsor ID: R2411201
Conditions: Influenza
Keywords: Influenza, universal, vaccine, adjuvant, TLR7
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 144 participants (actual)
Lead sponsor: Sumitomo Pharma Co., Ltd.Industry (pharma, biotech, devices)
Study start: 26 Jun 2024 (actual)
Primary completion: 31 Mar 2026 (actual)
Study completion: 31 Mar 2026 (actual)
First posted: 14 Jun 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 12

Arm	Type	Receives
combination of fH1 2 ug and DSP-0546LP 2.5 ug	Experimental	Biological: fH1 2 ug, Biological: DSP-0546LP 2.5 ugThe study vaccine (fH1 2 ug and DSP-0546LP 2.5 ug) will be administered IM into the deltoid muscle of the non-dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
combination of fH1 8 ug and DSP-0546LP 2.5 ug	Experimental	Biological: fH1 8 ug, Biological: DSP-0546LP 2.5 ugThe study vaccine (fH1 8 ug and DSP-0546LP 2.5 ug) will be administered IM into the deltoid muscle of the non-dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
combination of fH1 2 ug and DSP-0546LP 5 ug	Experimental	Biological: fH1 2 ug, Biological: DSP-0546LP 5 ugThe study vaccine (fH1 2 ug and DSP-0546LP 5 ug) will be administered IM into the deltoid muscle of the non-dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
combination of fH1 8 ug and DSP-0546LP 5 ug	Experimental	Biological: fH1 8 ug, Biological: DSP-0546LP 5 ugThe study vaccine (fH1 8 ug and DSP-0546LP 5 ug) will be administered IM into the deltoid muscle of the non-dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
combination of fH1 2 ug and DSP-0546LP 10 ug	Experimental	Biological: fH1 2 ug, Biological: DSP-0546LP 10 ugThe study vaccine (fH1 2 ug and DSP-0546LP 10 ug) will be administered IM into the deltoid muscle of the non-dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
combination of fH1 8 ug and DSP-0546LP 10 ug	Experimental	Biological: fH1 8 ug, Biological: DSP-0546LP 10 ugThe study vaccine (fH1 8 ug and DSP-0546LP 10 ug) will be administered IM into the deltoid muscle of the non- dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
fH1 2 ug	Experimental	Biological: fH1 2 ugThe study vaccine (fH1 2 ug) will be administered IM into the deltoid muscle of the non- dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
fH1 8 ug	Experimental	Biological: fH1 8 ugThe study vaccine (fH1 8 ug) will be administered IM into the deltoid muscle of the non-dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
DSP-0546LP 2.5 ug	Experimental	Biological: DSP-0546LP 2.5 ugThe study vaccine (DSP-0546LP 2.5 ug) will be administered IM into the deltoid muscle of the non-dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
DSP-0546LP 5 ug	Experimental	Biological: DSP-0546LP 5 ugThe study vaccine (DSP-0546LP 5 ug) will be administered IM into the deltoid muscle of the non- dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
DSP-0546LP 10 ug	Experimental	Biological: DSP-0546LP 10 ugThe study vaccine (DSP-0546LP 10 ug) will be administered IM into the deltoid muscle of the non- dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
Placebo	Placebo comparator	Biological: PlaceboThe study vaccine (placebo) will be administered IM into the deltoid muscle of the non- dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (16 listed)

Healthy adult male or female subject between 18 and 40 years of age at the time of informed consent.
Subject who is fully informed of and understands the objectives, procedures, anticipated side effects of the vaccine and risks of the study and who voluntarily provides written consent to participate in the study.
Subject's body weight is equal to or more than 50 kg, and body mass index is at least 18 kg/m2 but no more than 30 kg/m2 at screening.
Subject willing and able to comply with the study requirements, including laboratory tests and reporting symptoms.
A male subject with a female partner of childbearing potential must agree to use adequate and reliable contraception (e.g., using condom or have had vasectomy with proven sterility for male and using contraceptive agents, diaphragm, intrauterine devices (IUDs), or bilateral tubal ligation for female partner) from informed consent until at least 30 days after last administration of the study vaccine.

Key exclusion criteria (24 listed)

Subject with a history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, hematological, respiratory, psychiatric or neurologic disease, and who is considered ineligible for the study by the Principal Investigator (PI) or sub Investigator.
Subject with other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior that may increase the risk of study participation or, in the Investigator's judgement, make the subject inappropriate for the study.
Subject immunocompromised with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
Subject with a history or evidence of autoimmune disease or known immunodeficiency of any cause or severe allergy.
Subject who receives chronic treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g., for cancer or an autoimmune disease, within 60 days before the Screening Visit or planned receipt throughout the study. If systemic corticosteroids have been administered short term (< 14 days) for treatment of an acute illness, subjects should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before first administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
fH1 2 ug2 administrations at 3-week intervals.	Biological	combination of fH1 2 ug and DSP-0546LP 10 ug, combination of fH1 2 ug and DSP-0546LP 2.5 ug, combination of fH1 2 ug and DSP-0546LP 5 ug, fH1 2 ug
fH1 8 ug2 administrations at 3-week intervals.	Biological	combination of fH1 8 ug and DSP-0546LP 10 ug, combination of fH1 8 ug and DSP-0546LP 2.5 ug, combination of fH1 8 ug and DSP-0546LP 5 ug, fH1 8 ug
DSP-0546LP 2.5 ug2 administrations at 3-week intervals.	Biological	DSP-0546LP 2.5 ug, combination of fH1 2 ug and DSP-0546LP 2.5 ug, combination of fH1 8 ug and DSP-0546LP 2.5 ug
DSP-0546LP 5 ug2 administrations at 3-week intervals.	Biological	DSP-0546LP 5 ug, combination of fH1 2 ug and DSP-0546LP 5 ug, combination of fH1 8 ug and DSP-0546LP 5 ug
DSP-0546LP 10 ug2 administrations at 3-week intervals.	Biological	DSP-0546LP 10 ug, combination of fH1 2 ug and DSP-0546LP 10 ug, combination of fH1 8 ug and DSP-0546LP 10 ug
Placebo2 administrations at 3-week intervals.	Biological	Placebo

Primary outcome

Incidence of solicited local adverse events (AEs) during a 7-day follow-up period after each administration.
Time frame: 7 days after each administration
Solicited local AEs: pain, redness, swelling, induration, warmth, and pruritus at injection site
Incidence of solicited systemic AEs during a 7-day follow-up period after each administration.
Time frame: 7 days after each administration
Solicited systemic AEs: feverishness, chills, myalgia, fatigue, headache, nausea, arthralgia, malaise, and body temperature (measured axillary)
Incidence of unsolicited AEs from the first administration to 4 weeks after the second administration.
Time frame: From the first administration to 4 weeks after the second administration.
Clinical observations, clinical laboratory values and vital signs
Incidence of serious adverse events (SAEs), AEs leading to study discontinuation, and adverse events of special interest throughout the study period.
Time frame: From the first administration to 52-week follow-up after the second administration

3 secondary outcomes

Percentage of subjects with increased immunoglobulin (Ig) G response to long alpha helix (LAH) after administration of fH1/DSP-0546LP.
Time frame: From the day of the first administration to 52-week follow-up after the second administration
Percentage of subjects with increased neuraminidase inhibition antibody titer after administration of fH1/DSP-0546LP.
Time frame: From the day of the first administration to 1 week after the second administration.
Seroconversion rate (SCR) of hemagglutination inhibition (HAI) antibody titers after administration of fH1/DSP-0546LP.
Time frame: From the day of the first administration to 1 week after the second administration.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing fH1 2 ug, fH1 8 ug and DSP-0546LP 2.5 ug in people with Influenza, run by Sumitomo Pharma Co., Ltd. at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of solicited local adverse events (AEs) during a 7-day follow-up period after each administration. (time frame: 7 days after each administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06460064.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.