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
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 22 |
5.74; 5.61; 5.28 | — |
| PRIMARY Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 43 |
12.6; 13.4; 5.80 | — |
| PRIMARY Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 22 |
1.09; 1.05; 1.03 | — |
| PRIMARY Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 43 |
2.39; 2.52; 1.13 | — |
| PRIMARY Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 202 |
1.01; 0.966; 0.990 | — |
| PRIMARY Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 387 |
0.998; 0.976; 0.978 | — |
| PRIMARY Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 22 |
2.2; 0.4; 0.0 | — |
| PRIMARY Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 43 |
22.9; 22.9; 1.4 | — |
| PRIMARY Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 1 |
0.0; 0.9; 0.0 | — |
| PRIMARY Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 22 |
2.2; 0.9; 0.0 | — |
| PRIMARY Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 43 |
23.2; 23.4; 1.4 | — |
| PRIMARY Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 202 |
0.5; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 387 |
0.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 1 |
3.4; 3.4; 1.3 | — |
| PRIMARY Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 22 |
6.9; 6.5; 2.6 | — |
| PRIMARY Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 43 |
46.9; 52.4; 9.7 | — |
| PRIMARY Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 202 |
3.3; 2.4; 1.5 | — |
| PRIMARY Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 387 |
3.0; 2.5; 0.0 | — |
| PRIMARY Geometric Mean of Neutralization Test (NT) Antibody Titer at Day 22 |
7.23; 6.85; 6.88 | — |
| PRIMARY Geometric Mean of Neutralization Test Antibody Titer at Day 43 |
26.8; 25.8; 11.5 | — |
| PRIMARY Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 22 |
1.21; 1.14; 1.09 | — |
| PRIMARY Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 43 |
4.51; 4.29; 1.86 | — |
| PRIMARY Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 202 |
1.20; 1.17; 0.856 | — |
| PRIMARY Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 387 |
1.20; 1.18; 0.909 | — |
| PRIMARY Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22 |
10.0; 7.3; 7.9; 2.2; 2.2; 0.0 | — |
| PRIMARY Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43 |
54.9; 55.8; 29.2; 35.7; 35.1; 11.1 | — |
| PRIMARY Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 22 |
22.2; 17.2; 18.4; 7.8; 6.0; 5.3 | — |
| PRIMARY Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 43 |
64.6; 71.4; 48.6; 51.1; 51.9; 26.4 | — |
| PRIMARY Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 1 |
14.2; 15.5; 18.4 | — |
| PRIMARY Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 22 |
26.8; 24.1; 26.3 | — |
| PRIMARY Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 43 |
69.6; 76.2; 54.2 | — |
| PRIMARY Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 202 |
25.7; 25.0; 6.1 | — |
| PRIMARY Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 387 |
24.1; 26.3; 8.2 | — |
| SECONDARY Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) |
1; 0; 0 | — |
| SECONDARY Number of Participants With Solicited Injection Site Reactions and Systemic Reactions |
53; 57; 8; 57; 56; 20 | — |
| SECONDARY Number of Participants With Unsolicited AEs |
32; 39; 9 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) |
11; 12; 6; 1; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Aged 18 years or older on the day of inclusion
- Participants who are healthy as determined by medical evaluation including medical history and physical examination
- A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile.
OR Is of childbearing potential and agrees to use a highly effective contraceptive method or abstinence from at least 4 weeks prior to each study intervention administration until at least 12 weeks after the last study intervention administration.
- A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 24 hours before the first dose of study intervention
- Informed consent form has been signed and dated
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
- Thrombocytopenia or bleeding disorder contraindicating intramuscular injection based on investigator's judgement
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion (1)
(1) Chronic illness may include, but is not limited to, cardiac disorders, renal disorders, auto-immune disorders, diabetes, psychiatric disorders, or chronic infection
- Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of study intervention administration in the absence of therapy, and participants who have a history of neoplastic disease and who have been disease-free for ≥ 5 years)
- Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 100.4°F) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
- Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion
- Receipt of any vaccine in the 14 days preceding Visit 1 or planned receipt of any vaccine prior to Visit 3, except for seasonal flu vaccine, which may be received at least 2 weeks after Visit 2
- Previous vaccination against H7N9 with an investigational vaccine
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
- Personal or family history of Guillain-Barré syndrome
- Self-reported seropositivity for Hepatitis B antigen or Hepatitis C
"The above information is not intended to con
Data sourced from ClinicalTrials.gov (NCT05608005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.