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

Sanofi Pasteur, a Sanofi Company581 enrolled

Overview

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.

The study duration for each participant will be approximately 13 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

581

Conditions

Influenza Healthy Volunteers

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 18 years or older on the day of inclusion * Participants who are healthy as determined by medical evaluation including medical history and physical examination * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile. OR Is of childbearing potential and agrees to use a highly effective contraceptive method or abstinence from at least 4 weeks prior to each study intervention administration until at least 12 weeks after the last study intervention administration. * A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 24 hours before the first dose of study intervention * Informed consent form has been signed and dated Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances * Thrombocytopenia or bleeding disorder contraindicating intramuscular injection based on investigator's judgement * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion (1) (1) Chronic illness may include, but is not limited to, cardiac disorders, renal disorders, auto-immune disorders, diabetes, psychiatric disorders, or chronic infection * Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of study intervention administration in the absence of therapy, and participants who have a history of neoplastic disease and who have been disease-free for ≥ 5 years) * Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 100.4°F) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided * Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion * Receipt of any vaccine in the 14 days preceding Visit 1 or planned receipt of any vaccine prior to Visit 3, except for seasonal flu vaccine, which may be received at least 2 weeks after Visit 2 * Previous vaccination against H7N9 with an investigational vaccine * Receipt of immune globulins, blood or blood-derived products in the past 3 months * Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study * Personal or family history of Guillain-Barré syndrome * Self-reported seropositivity for Hepatitis B antigen or Hepatitis C "The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial."

Locations (16)

Centricity Research-Mesa Site Number : 8400006

Mesa, Arizona, United States

Velocity Clinical Research-Hallandale Beach Site Number : 8400026

Hallandale, Florida, United States

Research Centers of America Site Number : 8400024

Hollywood, Florida, United States

Suncoast Research Associates, LLC Site Number : 8400008

Miami, Florida, United States

St Johns Center for Clinical Research Site Number : 8400021

Saint Augustine, Florida, United States

CenExel ACMR (Atlanta Center for Medical Research) Site Number : 8400022

Atlanta, Georgia, United States

Velocity Clinical Research Valparaiso Site Number : 8400007

Valparaiso, Indiana, United States

Velocity Clinical Research Site Number : 8400027

Metairie, Louisiana, United States

M3 Wake Research Inc Site Number : 8400010

Raleigh, North Carolina, United States

Preferred Primary Care Physicians Site Number : 8400015

Pittsburgh, Pennsylvania, United States

...and 6 more locations

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Days 1 and 22

Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 43

Time frame: Days 1 and 43

Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 202

Time frame: Days 1 and 202

Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 387

Time frame: 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.

Time frame: Day 22

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

Time frame: Day 43

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