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

NCT05608005
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Phase
Phase 1/Phase 2
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Recruitment status
Completed
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Participants
581
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Lead sponsor
Sanofi Pasteur, a Sanofi Company
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Start date
2022-11-03
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Number of sites
16
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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 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.
clinicaltrials.gov
Short title
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
clinicaltrials.gov
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
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Control arm
Active comparator
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2024-02-13
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First posted
2022-11-07
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Registry last updated
2025-09-24
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Primary completion date
2023-02-18
clinicaltrials.gov
Start date
2022-11-03
clinicaltrials.gov

Actual participants
581
clinicaltrials.gov
Participants
581
clinicaltrials.gov
Participant count basis
Actual
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Protocol amendments
5
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Randomisation ratio
3:3:1
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Number of sites
16
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Registry sponsor category
Industry
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Lead sponsor
Sanofi Pasteur, a Sanofi Company
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Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05608005
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05608005
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masking description
Modified double-blind: * Investigators and study staff who conduct the safety assessment, laboratory personnel who analyze the blood samples, Sponsor's personnel and study Team members, and the participant will not know which study dose is administered * Only the study staff who prepare and administer the study intervention and are not involved with the safety evaluation will know which study dose is administered
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 22

    Timeframe: 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.

  2. Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 43

    Timeframe: 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.

  3. Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 22

    Timeframe: 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.

  4. Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 43

    Timeframe: 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.

  5. Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 202

    Timeframe: 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.

  6. Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 387

    Timeframe: 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.

  7. Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 22

    Timeframe: 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.

  8. Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 43

    Timeframe: 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.

  9. Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 1

    Timeframe: 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.

  10. Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 22

    Timeframe: 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.

  11. Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 43

    Timeframe: 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.

  12. Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 202

    Timeframe: 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.

  13. Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 387

    Timeframe: 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.

  14. Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 1

    Timeframe: 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.

  15. Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 22

    Timeframe: 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.

  16. Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 43

    Timeframe: 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.

  17. Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 202

    Timeframe: 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.

  18. Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 387

    Timeframe: 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.

  19. Geometric Mean of Neutralization Test (NT) Antibody Titer at Day 22

    Timeframe: 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.

  20. Geometric Mean of Neutralization Test Antibody Titer at Day 43

    Timeframe: 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.

  21. Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 22

    Timeframe: 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.

  22. Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 43

    Timeframe: 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.

  23. Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 202

    Timeframe: 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.

  24. Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 387

    Timeframe: 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.

  25. Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22

    Timeframe: 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.

And 8 more, listed on the interactive page.

  1. Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)

    Timeframe: Up to 30 minutes after each vaccination

    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.

  2. Number of Participants With Solicited Injection Site Reactions and Systemic Reactions

    Timeframe: Up to 7 days after each vaccination

    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.

  3. Number of Participants With Unsolicited AEs

    Timeframe: Up to 21 days after each vaccination

    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.

  4. Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)

    Timeframe: From first dose vaccine administration (Day 1) until 12 months after the last dose administration, 387 days

    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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

  • 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

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."

Sources for eligibility
clinicaltrials.gov

  • Centricity Research-Mesa Site Number : 8400006Mesa, United States
  • Velocity Clinical Research-Hallandale Beach Site Number : 8400026Hallandale, United States
  • Research Centers of America Site Number : 8400024Hollywood, United States
  • Suncoast Research Associates, LLC Site Number : 8400008Miami, United States
  • St Johns Center for Clinical Research Site Number : 8400021Saint Augustine, United States
  • CenExel ACMR (Atlanta Center for Medical Research) Site Number : 8400022Atlanta, United States
  • Velocity Clinical Research Valparaiso Site Number : 8400007Valparaiso, United States
  • Velocity Clinical Research Site Number : 8400027Metairie, United States
  • M3 Wake Research Inc Site Number : 8400010Raleigh, United States
  • Preferred Primary Care Physicians Site Number : 8400015Pittsburgh, United States
  • Preferred Primary Care Physicians, Inc. Site Number : 8400002Pittsburgh, United States
  • Velocity Clinical Research Anderson Site Number : 8400016Anderson, United States
  • WR-ClinSearch, LLC Site Number : 8400003Chattanooga, United States
  • Velocity Clinical Research Site Number : 8400019Austin, United States
  • JBR Clinical Research Site Number : 8400005Salt Lake City, United States
  • Foothill Family Research-South Site Number : 8400009Salt Lake City, United States
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • U1111-1256-9115
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)