InfluenzaPhase 1/2NCT05608005
Study on Two Adjuvanted Dose Levels of Panblok H7+MF59 Compared for Immunogenicity and Safety With an Unadjuvanted Dose of Panblok H7 in Participants 18 Years of Age and Older
A Phase 1/2 study testing Panblok + MF59 Dose 1, Panblok + MF59 Dose 2 and Unadjuvanted Panblok Dose 3 in people with Influenza and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 16 sites in United States.
Trial summary
VAM00001 is a Phase I/II, randomized, modified double-blind, multi-center study. The purpose of this study is to compare 2 dose levels of Panblok H7 (dose 1 and dose 2 of rHA) with a standard squalene dose of adjuvant MF59 to Panblok H7 (dose 3) unadjuvanted in approximately 700 adult participants in order to select… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Healthy Volunteers
- What is being tested?
- Panblok + MF59 Dose 1, Panblok + MF59 Dose 2 and Unadjuvanted Panblok Dose 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 581 participants
- Where
- 16 sitesUnited States
- Study dates
- 3 Nov 2022to 13 Feb 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
- Chronic illness may include, but is not limited to, cardiac disorders, renal disorders, auto-immune disorders, diabetes, psychiatric disorders, or chronic infection
Show all 18Show fewer
- 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."
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Velocity Clinical Research Anderson Site Number : 8400016
Anderson, South Carolina, 29621
CenExel ACMR (Atlanta Center for Medical Research) Site Number : 8400022
Atlanta, Georgia, 30331
Velocity Clinical Research Site Number : 8400019
Austin, Texas, 78759
WR-ClinSearch, LLC Site Number : 8400003
Chattanooga, Tennessee, 37421
Velocity Clinical Research-Hallandale Beach Site Number : 8400026
Hallandale, Florida, 33009
Research Centers of America Site Number : 8400024
Hollywood, Florida, 33024
Centricity Research-Mesa Site Number : 8400006
Mesa, Arizona, 85206
Velocity Clinical Research Site Number : 8400027
Metairie, Louisiana, 70006
Suncoast Research Associates, LLC Site Number : 8400008
Miami, Florida, 33173
Preferred Primary Care Physicians Site Number : 8400015
Pittsburgh, Pennsylvania, 15236
Preferred Primary Care Physicians, Inc. Site Number : 8400002
Pittsburgh, Pennsylvania, 15243
M3 Wake Research Inc Site Number : 8400010
Raleigh, North Carolina, 27612
St Johns Center for Clinical Research Site Number : 8400021
Saint Augustine, Florida, 32086
JBR Clinical Research Site Number : 8400005
Salt Lake City, Utah, 84107
Foothill Family Research-South Site Number : 8400009
Salt Lake City, Utah, 84121
Velocity Clinical Research Valparaiso Site Number : 8400007
Valparaiso, Indiana, 46383
About this study
Official title: A Parallel-group, Phase I/II, Randomized, Modified Double-blind, 3-arm, Active Comparator, Multi-center, Prevention Study to Evaluate the Immunogenicity and Safety of Two Adjuvanted Dose Levels of Panblok H7+MF59 Influenza Vaccine Compared With an Unadjuvanted Dose of Panblok H7 in Participants 18 Years of Age and Older
VAM00001 is a Phase I/II, randomized, modified double-blind, multi-center study.
The purpose of this study is to compare 2 dose levels of Panblok H7 (dose 1 and dose 2 of rHA) with a standard squalene dose of adjuvant MF59 to Panblok H7 (dose 3) unadjuvanted in approximately 700 adult participants in order to select one dose formulation to be used for further clinical development. The randomization ratio will be 3:3:1 for Panblok H7 (dose 1) + MF59, Panblok H7 (dose 2) + MF59, and Panblok H7 (dose 3) unadjuvanted, respectively. Each study group will be stratified into the age groups 18-64 years and ≥ 65 years of age.
The study duration for each participant will be approximately 13 months.
Read the detailed description
The study duration for each participant will be approximately 13 months.
- Conditions
- Influenza, Healthy Volunteers
- Being tested
- Panblok + MF59 Dose 1, Panblok + MF59 Dose 2, Unadjuvanted Panblok Dose 3
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panblok + MF59 Dose 1Biological
Pharmaceutical form: suspension for injection Route of administration: intramuscular
Panblok + MF59 Dose 2Biological
Pharmaceutical form: suspension for injection Route of administration: intramuscular
Unadjuvanted Panblok Dose 3Biological
Pharmaceutical form: liquid for injection Route of administration: intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 2 doses, 21 days apart, of Panblok H7 dose 1 + MF59 Receives: Biological: Panblok + MF59 Dose 1 |
| Group 2 | Experimental | 2 doses, 21 days apart, of Panblok H7 dose 2 + MF59 Receives: Biological: Panblok + MF59 Dose 2 |
| Group 3 | Active comparator | 2 doses, 21 days apart, of Panblok H7 dose 3 unadjuvanted Receives: Biological: Unadjuvanted Panblok Dose 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 22
The HAI antibody was measured by hemagglutination inhibition using horse red blood cells (HIH) measurement method. The 95% confidence interval (CI) was based on the Student t-distribution of log10-transformed values.
Measured: Day 22
Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 43
The HAI antibody was measured by HIH measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.
Measured: Day 43
Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 22
The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Measured: Days 1 and 22
Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 43
The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Measured: Days 1 and 43
Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 202
The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Measured: Days 1 and 202
Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 387
The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Measured: Days 1 and 387
Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 22
The seroconversion was defined as titer <10 on Day 1 and post-injection titer >=40 on Day 22 or Day 43; or defined as titer >=10 on Day 1 and a >=4-fold increase in titer on Day 22 or Day 43. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Measured: Day 22
Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 43
The seroconversion was defined as titer <10 on Day 1 and post-injection titer >=40 on Day 22 or Day 43; or defined as titer >=10 on Day 1 and a >=4-fold increase in titer on Day 22 or Day 43. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Measured: Day 43
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 1
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Measured: Day 1
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 22
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Measured: Day 22
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 43
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Measured: Day 43
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 202
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Measured: Day 202
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 387
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Measured: Day 387
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 1
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Measured: Day 1
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 22
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Measured: Day 22
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 43
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Measured: Day 43
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 202
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Measured: Day 202
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 387
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Measured: Day 387
Geometric Mean of Neutralization Test (NT) Antibody Titer at Day 22
The NT antibody was measured by seroneutralization (SN) measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.
Measured: Day 22
Geometric Mean of Neutralization Test Antibody Titer at Day 43
The NT antibody was measured by SN measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.
Measured: Day 43
Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 22
The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Measured: Days 1 and 22
Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 43
The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Measured: Days 1 and 43
Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 202
The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Measured: Days 1 and 202
Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 387
The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Measured: Days 1 and 387
Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Measured: Day 22
Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Measured: Day 43
Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 22
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Measured: Day 22
Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 43
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Measured: Day 43
Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 1
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Measured: Day 1
Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 22
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Measured: Day 22
Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 43
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Measured: Day 43
Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 202
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Measured: Day 202
Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 387
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Measured: Day 387
Secondary outcomes (4)
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination. Systemic AEs are all AEs that were not injection or administration site reactions. Immediate events are recorded to capture medically relevant unsolicited systemic AEs which occur within the first 30 minutes after vaccination.
Measured: Up to 30 minutes after each vaccination
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
An adverse reaction (AR) is any noxious and unintended response to a study vaccine related to any dose. A solicited reaction is an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form. An injection/administration site reaction is an AR at and around the injection/administration site of the investigational medical product. Systemic ARs are all ARs that are not injection or administration site reactions.
Measured: Up to 7 days after each vaccination
Number of Participants With Unsolicited AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination.
Measured: Up to 21 days after each vaccination
Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)
An SAE is any untoward medical occurrence that at any dose results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event. An AESI (serious or non-serious) is one of scientific and medical concern specific to the Sponsor's study vaccine or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor can be appropriate. An MAAE is a new onset or a worsening of a condition that prompts the participant to seek unplanned medical advice at a physician's office or Emergency Department.
Measured: From first dose vaccine administration (Day 1) until 12 months after the last dose administration, 387 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start3 Nov 2022
- Primary completion18 Feb 2023
- Study completion13 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants (18-64 years of age and ≥65 years of age) will be randomized in a 3:3:1 ratio to receive 2 doses, 21 days apart, by intramuscular (IM) route of either Panblok H7+MF59 (dose 1), Panblok H7+MF59 (dose 2), or unadjuvanted Panblok H7 (dose 3) at D01.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 581 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, MCM Vaccines B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608005
- Sponsor's protocol ID
- VAM00001
- Other IDs
- U1111-1256-9115
- Status last verified
- Sep 2025
- First submitted
- 20 Oct 2022
- Last updated
- 24 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel-group, Phase I/II, Randomized, Modified Double-blind, 3-arm, Active Comparator, Multi-center, Prevention Study to Evaluate the Immunogenicity and Safety of Two Adjuvanted Dose Levels of Panblok H7+MF59 Influenza Vaccine Compared With an Unadjuvanted Dose of Panblok H7 in Participants 18 Years of Age and Older
- ClinicalTrials.gov ID
- NCT05608005
- Acronym / sponsor ID
- VAM00001
- Conditions
- Influenza, Healthy Volunteers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 581 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 18 Feb 2023 (actual)
- Study completion
- 13 Feb 2024 (actual)
- First posted
- 7 Nov 2022 (actual)
- Results
- Posted 20 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
VAM00001 is a Phase I/II, randomized, modified double-blind, multi-center study.
The purpose of this study is to compare 2 dose levels of Panblok H7 (dose 1 and dose 2 of rHA) with a standard squalene dose of adjuvant MF59 to Panblok H7 (dose 3) unadjuvanted in approximately 700 adult participants in order to select one dose formulation to be used for further clinical development. The randomization ratio will be 3:3:1 for Panblok H7 (dose 1) + MF59, Panblok H7 (dose 2) + MF59, and Panblok H7 (dose 3) unadjuvanted, respectively. Each study group will be stratified into the age groups 18-64 years and ≥ 65 years of age.
The study duration for each participant will be approximately 13 months.
Detailed description
The study duration for each participant will be approximately 13 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Eligible participants (18-64 years of age and ≥65 years of age) will be randomized in a 3:3:1 ratio to receive 2 doses, 21 days apart, by intramuscular (IM) route of either Panblok H7+MF59 (dose 1), Panblok H7+MF59 (dose 2), or unadjuvanted Panblok H7 (dose 3) at D01.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Panblok + MF59 Dose 12 doses, 21 days apart, of Panblok H7 dose 1 + MF59 |
| Group 2 | Experimental | Biological: Panblok + MF59 Dose 22 doses, 21 days apart, of Panblok H7 dose 2 + MF59 |
| Group 3 | Active comparator | Biological: Unadjuvanted Panblok Dose 32 doses, 21 days apart, of Panblok H7 dose 3 unadjuvanted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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)
- 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)
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 |
|---|---|---|
| Panblok + MF59 Dose 1Pharmaceutical form: suspension for injection Route of administration: intramuscular | Biological | Group 1 |
| Panblok + MF59 Dose 2Pharmaceutical form: suspension for injection Route of administration: intramuscular | Biological | Group 2 |
| Unadjuvanted Panblok Dose 3Pharmaceutical form: liquid for injection Route of administration: intramuscular | Biological | Group 3 |
Primary outcome
Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 22
Time frame: Day 22
The HAI antibody was measured by hemagglutination inhibition using horse red blood cells (HIH) measurement method. The 95% confidence interval (CI) was based on the Student t-distribution of log10-transformed values.
Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 43
Time frame: Day 43
The HAI antibody was measured by HIH measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.
Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 22
Time frame: Days 1 and 22
The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 43
Time frame: Days 1 and 43
The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 202
Time frame: Days 1 and 202
The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 387
Time frame: Days 1 and 387
The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 22
Time frame: Day 22
The seroconversion was defined as titer <10 on Day 1 and post-injection titer >=40 on Day 22 or Day 43; or defined as titer >=10 on Day 1 and a >=4-fold increase in titer on Day 22 or Day 43. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 43
Time frame: Day 43
The seroconversion was defined as titer <10 on Day 1 and post-injection titer >=40 on Day 22 or Day 43; or defined as titer >=10 on Day 1 and a >=4-fold increase in titer on Day 22 or Day 43. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 1
Time frame: Day 1
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 22
Time frame: Day 22
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 43
Time frame: Day 43
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 202
Time frame: Day 202
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 387
Time frame: Day 387
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 1
Time frame: Day 1
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 22
Time frame: Day 22
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 43
Time frame: Day 43
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 202
Time frame: Day 202
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 387
Time frame: Day 387
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Geometric Mean of Neutralization Test (NT) Antibody Titer at Day 22
Time frame: Day 22
The NT antibody was measured by seroneutralization (SN) measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.
Geometric Mean of Neutralization Test Antibody Titer at Day 43
Time frame: Day 43
The NT antibody was measured by SN measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.
Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 22
Time frame: Days 1 and 22
The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 43
Time frame: Days 1 and 43
The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 202
Time frame: Days 1 and 202
The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 387
Time frame: Days 1 and 387
The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22
Time frame: Day 22
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43
Time frame: Day 43
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 22
Time frame: Day 22
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 43
Time frame: Day 43
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 1
Time frame: Day 1
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 22
Time frame: Day 22
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 43
Time frame: Day 43
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 202
Time frame: Day 202
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 387
Time frame: Day 387
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
4 secondary outcomes
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
Time frame: Up to 30 minutes after each vaccination
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
Time frame: Up to 7 days after each vaccination
Number of Participants With Unsolicited AEs
Time frame: Up to 21 days after each vaccination
Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)
Time frame: From first dose vaccine administration (Day 1) until 12 months after the last dose administration, 387 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- VAM00001 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
Clinical Sciences & Operations study director
MCM Vaccines B.V.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Panblok + MF59 Dose 1, Panblok + MF59 Dose 2 and Unadjuvanted Panblok Dose 3 in people with Influenza and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 16 sites in United States.
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 7 inclusion and 18 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 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 22 (time frame: Day 22). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2025.