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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

Primary Purpose

Influenza Immunization, Healthy Volunteers

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Panblok + MF59 Dose 1
Panblok + MF59 Dose 2
Unadjuvanted Panblok Dose 3
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza Immunization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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."

Sites / Locations

  • Aventiv Research Mesa-Site Number:8400006
  • Velocity Clinical Research-Hallandale Beach-Site Number:8400026
  • Research Centers of America-Site Number:8400024
  • Suncoast Research Associates, LLC-Site Number:8400008
  • Headlands Research Orlando-Site Number:8400014
  • St Johns Center for Clinical Research-Site Number:8400021
  • CenExel ACMR (Atlanta Center for Medical Research)-Site Number:8400022
  • CRA Headlands Stockbridge-Site Number:8400020
  • Velocity Clinical Research Valparaiso-Site Number:8400007
  • MedPharmics-Site Number:8400027
  • M3 Wake Research Inc-Site Number:8400010
  • Wrightsville Family Practice Pa-Site Number:8400025
  • Preferred Primary Care Physicians-Site Number:8400015
  • Preferred Primary Care Physicians, Inc.-Site Number:8400002
  • Velocity Clinical Research Anderson-Site Number:8400016
  • WR-ClinSearch, LLC-Site Number:8400003
  • Velocity Clinical Research Cedar Park-Site Number:8400019
  • JBR Clinical Research-Site Number:8400005
  • Foothill Family Research-South-Site Number:8400009

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

2 doses, 21 days apart, of Panblok H7 dose 1 + MF59

2 doses, 21 days apart, of Panblok H7 dose 2 + MF59

2 doses, 21 days apart, of Panblok H7 dose 3 unadjuvanted

Outcomes

Primary Outcome Measures

Geometric Mean Titers of Hemagglutination inhibition (HAI) Antibody (Ab) titers in participants
HAI Ab titers obtained on Day 22 for comparison with Day 01, Day 202 and Day 387 by HIH measurement method
Geometric Mean Titers of Hemagglutination inhibition (HAI) Antibody (Ab) titers in participants
HAI Ab titers obtained on Day 43 for comparison with Day 01, Day 202 and Day 387 by HIH measurement method
Geometric Mean of individual Ratio (GMR) of HAI Ab titers in participants
Individual HAI Ab titers ratio Day 22/Day 01 (baseline) by HIH measurement method
Geometric Mean of individual Ratio (GMR) of HAI Ab titers in participants
Individual HAI Ab titers ratio Day 43/Day 01 (baseline) by HIH measurement method
Geometric Mean of individual Ratio (GMR) of HAI Ab titers in participants
Individual HAI Ab titers ratio Day 202/Day 01 (baseline) by HIH measurement method
Geometric Mean of individual Ratio (GMR) of HAI Ab titers in participants
Individual HAI Ab titers ratio Day 387/ Day 01 (baseline) by HIH measurement method
Percentage of participants with seroconversion
Seroconversion: defined as titer < 10 (1/dilution [1/dil]) on Day 01 and post-vaccination titer ≥ 40 (1/dil) on Day 22 or Day 43; or titer ≥ 10 (1/dil) on Day 01 and a ≥ 4-fold increase in titer (1/dil) on Day 22 or Day 43 Vaccination taking place on Day 01 and Day 22 by HIH measurement method
Percentage of participants with HAI titer above predefined threshold
Participants with HAI Ab titers ≥ 40 (1/dil) by HIH measurement method
Percentage of participants with HAI titer above predefined threshold
Participants with HAI Ab titers ≥ 40 (1/dil) by HIH measurement method
Percentage of participants with HAI titer above predefined threshold
Participants with HAI Ab titers ≥ 40 (1/dil) by HIH measurement method
Percentage of participants with HAI titer above predefined threshold
Participants with HAI Ab titers ≥ 40 (1/dil) by HIH measurement method
Percentage of participants with HAI titer above predefined threshold
Participants with HAI Ab titers ≥ 40 (1/dil) by HIH measurement method
Percentage of participants with detectable HAI Ab titer
Detectable HAI Ab titer, ie, with a titer ≥ 10 (1/dil) by HIH measurement method
Percentage of participants with detectable HAI Ab titer
Detectable HAI Ab titer, ie, with a titer ≥ 10 (1/dil) by HIH measurement method
Percentage of participants with detectable HAI Ab titer
Detectable HAI Ab titer, ie, with a titer ≥ 10 (1/dil) by HIH measurement method
Percentage of participants with detectable HAI Ab titer
Detectable HAI Ab titer, ie, with a titer ≥ 10 (1/dil) by HIH measurement method
Percentage of participants with detectable HAI Ab titer
Detectable HAI Ab titer, ie, with a titer ≥ 10 (1/dil) by HIH measurement method
Geometric Mean Titers Ratio (GMTR) for Group1/Group3, Group2/Group3, and Group2/Group1
Ratio of GMTs for Group1/Group3, Group2/Group3, and Group2/Group1 Vaccination taking place on Day 01 and Day 22 by HIH measurement method
Geometric Mean Titers of Neutralization (NT) Ab titer in participants
Neutralization (NT) Ab titer obtained on Day 22 for comparison with D01, D202, and D387 by SN measurement method
Geometric Mean Titers of Neutralization (NT) Ab titer in participants
Neutralization (NT) Ab titer obtained on Day 43 for comparison with D01, D202, and D387 by SN measurement method
Geometric Mean of individual Ratio (GMR) of NT Ab titers in participants
Individual NT Ab titer ratio Day 22/Day 01 (baseline) by SN measurement method
Geometric Mean of individual Ratio (GMR) of NT Ab titers in participants
Individual NT Ab titer ratio Day 43/Day 01 (baseline) by SN measurement method
Geometric Mean of individual Ratio (GMR) of NT Ab titers in participants
Individual NT Ab titer ratio Day 202/Day 01 (baseline) by SN measurement method
Geometric Mean of individual Ratio (GMR) of NT Ab titers in participants
Individual NT Ab titer ratio Day 387/Day 01 (baseline) by SN measurement method
Percentage of participants with NT Ab titer above predefined threshold
Participants with NT Ab titers ≥ 20 (1/dil), ≥ 40 (1/dil), ≥ 80 (1/dil) on Day 22; compared to Day 01, Day 202, and Day 387 by SN measurement method
Percentage of participants with NT Ab titer above predefined threshold
Participants with NT Ab titers ≥ 20 (1/dil), ≥ 40 (1/dil), ≥ 80 (1/dil) on Day 43; compared to Day 01, Day 202, and Day 387 by SN measurement method
Percentage of participants with fold-increase in NT Ab titer
Fold-increase in NT Ab titer [post/pre] ≥ 2 and ≥ 4 on Day 22 and Day 43, as compared to D01 Vaccination taking place on Day 01 and Day 22 by SN measurement method
Percentage of participants with detectable NT Ab titer
Detectable NT Ab titer, ie, with a titer ≥ 10 (1/dil) by SN measurement method
Percentage of participants with detectable NT Ab titer
Detectable NT Ab titer, ie, with a titer ≥ 10 (1/dil) by SN measurement method
Percentage of participants with detectable NT Ab titer
Detectable NT Ab titer, ie, with a titer ≥ 10 (1/dil) by SN measurement method
Percentage of participants with detectable NT Ab titer
Detectable NT Ab titer, ie, with a titer ≥ 10 (1/dil) by SN measurement method
Percentage of participants with detectable NT Ab titer
Detectable NT Ab titer, ie, with a titer ≥ 10 (1/dil) by SN measurement method
GMR for Group1/Group3, Group2/Group3, and Group2/Group1
Ratio of GMs for Group1/Group3, Group2/Group3, and Group2/Group1 Vaccination taking place on Day 01 and Day 22 by SN measurement method

Secondary Outcome Measures

Number of participants with immediate adverse events (AEs)
Immediate adverse events are any unsolicited systemic adverse events
Number of participants with solicited injection site and systemic reactions
Solicited injection site reactions include injection site pain, erythema, swelling, induration, ecchymosis Solicited systemic reactions include fever, headache, malaise, myalgia
Number of participants with unsolicited AEs
Unsolicited (spontaneously reported) AEs, not fulfilling criteria for solicited adverse reactions
Number of participants with medically adverse events (MAAEs)
MAAEs
Number of participants with adverse events of special interest (AESIs)
AESIs
Number of participants with serious adverse events (SAEs) (including AESIs)
SAEs (including AESIs)

Full Information

First Posted
October 20, 2022
Last Updated
October 18, 2023
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT05608005
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 3, 2022 (Actual)
Primary Completion Date
February 18, 2023 (Actual)
Study Completion Date
January 26, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Immunization, Healthy Volunteers

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
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
Allocation
Randomized
Enrollment
582 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
2 doses, 21 days apart, of Panblok H7 dose 1 + MF59
Arm Title
Group 2
Arm Type
Experimental
Arm Description
2 doses, 21 days apart, of Panblok H7 dose 2 + MF59
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
2 doses, 21 days apart, of Panblok H7 dose 3 unadjuvanted
Intervention Type
Biological
Intervention Name(s)
Panblok + MF59 Dose 1
Intervention Description
Pharmaceutical form: suspension for injection Route of administration: intramuscular
Intervention Type
Biological
Intervention Name(s)
Panblok + MF59 Dose 2
Intervention Description
Pharmaceutical form: suspension for injection Route of administration: intramuscular
Intervention Type
Biological
Intervention Name(s)
Unadjuvanted Panblok Dose 3
Intervention Description
Pharmaceutical form: liquid for injection Route of administration: intramuscular
Primary Outcome Measure Information:
Title
Geometric Mean Titers of Hemagglutination inhibition (HAI) Antibody (Ab) titers in participants
Description
HAI Ab titers obtained on Day 22 for comparison with Day 01, Day 202 and Day 387 by HIH measurement method
Time Frame
At Day 22
Title
Geometric Mean Titers of Hemagglutination inhibition (HAI) Antibody (Ab) titers in participants
Description
HAI Ab titers obtained on Day 43 for comparison with Day 01, Day 202 and Day 387 by HIH measurement method
Time Frame
At Day 43
Title
Geometric Mean of individual Ratio (GMR) of HAI Ab titers in participants
Description
Individual HAI Ab titers ratio Day 22/Day 01 (baseline) by HIH measurement method
Time Frame
At Day 22
Title
Geometric Mean of individual Ratio (GMR) of HAI Ab titers in participants
Description
Individual HAI Ab titers ratio Day 43/Day 01 (baseline) by HIH measurement method
Time Frame
At Day 43
Title
Geometric Mean of individual Ratio (GMR) of HAI Ab titers in participants
Description
Individual HAI Ab titers ratio Day 202/Day 01 (baseline) by HIH measurement method
Time Frame
At Day 202
Title
Geometric Mean of individual Ratio (GMR) of HAI Ab titers in participants
Description
Individual HAI Ab titers ratio Day 387/ Day 01 (baseline) by HIH measurement method
Time Frame
At Day 387
Title
Percentage of participants with seroconversion
Description
Seroconversion: defined as titer < 10 (1/dilution [1/dil]) on Day 01 and post-vaccination titer ≥ 40 (1/dil) on Day 22 or Day 43; or titer ≥ 10 (1/dil) on Day 01 and a ≥ 4-fold increase in titer (1/dil) on Day 22 or Day 43 Vaccination taking place on Day 01 and Day 22 by HIH measurement method
Time Frame
At 21 days after each vaccination
Title
Percentage of participants with HAI titer above predefined threshold
Description
Participants with HAI Ab titers ≥ 40 (1/dil) by HIH measurement method
Time Frame
At Day 01
Title
Percentage of participants with HAI titer above predefined threshold
Description
Participants with HAI Ab titers ≥ 40 (1/dil) by HIH measurement method
Time Frame
At Day 22
Title
Percentage of participants with HAI titer above predefined threshold
Description
Participants with HAI Ab titers ≥ 40 (1/dil) by HIH measurement method
Time Frame
At Day 43
Title
Percentage of participants with HAI titer above predefined threshold
Description
Participants with HAI Ab titers ≥ 40 (1/dil) by HIH measurement method
Time Frame
At Day 202
Title
Percentage of participants with HAI titer above predefined threshold
Description
Participants with HAI Ab titers ≥ 40 (1/dil) by HIH measurement method
Time Frame
At Day 387
Title
Percentage of participants with detectable HAI Ab titer
Description
Detectable HAI Ab titer, ie, with a titer ≥ 10 (1/dil) by HIH measurement method
Time Frame
At Day 01
Title
Percentage of participants with detectable HAI Ab titer
Description
Detectable HAI Ab titer, ie, with a titer ≥ 10 (1/dil) by HIH measurement method
Time Frame
At Day 22
Title
Percentage of participants with detectable HAI Ab titer
Description
Detectable HAI Ab titer, ie, with a titer ≥ 10 (1/dil) by HIH measurement method
Time Frame
At Day 43
Title
Percentage of participants with detectable HAI Ab titer
Description
Detectable HAI Ab titer, ie, with a titer ≥ 10 (1/dil) by HIH measurement method
Time Frame
At Day 202
Title
Percentage of participants with detectable HAI Ab titer
Description
Detectable HAI Ab titer, ie, with a titer ≥ 10 (1/dil) by HIH measurement method
Time Frame
At Day 387
Title
Geometric Mean Titers Ratio (GMTR) for Group1/Group3, Group2/Group3, and Group2/Group1
Description
Ratio of GMTs for Group1/Group3, Group2/Group3, and Group2/Group1 Vaccination taking place on Day 01 and Day 22 by HIH measurement method
Time Frame
At 21 days after each vaccination
Title
Geometric Mean Titers of Neutralization (NT) Ab titer in participants
Description
Neutralization (NT) Ab titer obtained on Day 22 for comparison with D01, D202, and D387 by SN measurement method
Time Frame
At Day 22
Title
Geometric Mean Titers of Neutralization (NT) Ab titer in participants
Description
Neutralization (NT) Ab titer obtained on Day 43 for comparison with D01, D202, and D387 by SN measurement method
Time Frame
At Day 43
Title
Geometric Mean of individual Ratio (GMR) of NT Ab titers in participants
Description
Individual NT Ab titer ratio Day 22/Day 01 (baseline) by SN measurement method
Time Frame
At Day 22
Title
Geometric Mean of individual Ratio (GMR) of NT Ab titers in participants
Description
Individual NT Ab titer ratio Day 43/Day 01 (baseline) by SN measurement method
Time Frame
At Day 43
Title
Geometric Mean of individual Ratio (GMR) of NT Ab titers in participants
Description
Individual NT Ab titer ratio Day 202/Day 01 (baseline) by SN measurement method
Time Frame
At Day 202
Title
Geometric Mean of individual Ratio (GMR) of NT Ab titers in participants
Description
Individual NT Ab titer ratio Day 387/Day 01 (baseline) by SN measurement method
Time Frame
At Day 387
Title
Percentage of participants with NT Ab titer above predefined threshold
Description
Participants with NT Ab titers ≥ 20 (1/dil), ≥ 40 (1/dil), ≥ 80 (1/dil) on Day 22; compared to Day 01, Day 202, and Day 387 by SN measurement method
Time Frame
At Day 22
Title
Percentage of participants with NT Ab titer above predefined threshold
Description
Participants with NT Ab titers ≥ 20 (1/dil), ≥ 40 (1/dil), ≥ 80 (1/dil) on Day 43; compared to Day 01, Day 202, and Day 387 by SN measurement method
Time Frame
At Day 43
Title
Percentage of participants with fold-increase in NT Ab titer
Description
Fold-increase in NT Ab titer [post/pre] ≥ 2 and ≥ 4 on Day 22 and Day 43, as compared to D01 Vaccination taking place on Day 01 and Day 22 by SN measurement method
Time Frame
At 21 days after each vaccination
Title
Percentage of participants with detectable NT Ab titer
Description
Detectable NT Ab titer, ie, with a titer ≥ 10 (1/dil) by SN measurement method
Time Frame
At Day 01
Title
Percentage of participants with detectable NT Ab titer
Description
Detectable NT Ab titer, ie, with a titer ≥ 10 (1/dil) by SN measurement method
Time Frame
At Day 22
Title
Percentage of participants with detectable NT Ab titer
Description
Detectable NT Ab titer, ie, with a titer ≥ 10 (1/dil) by SN measurement method
Time Frame
At Day 43
Title
Percentage of participants with detectable NT Ab titer
Description
Detectable NT Ab titer, ie, with a titer ≥ 10 (1/dil) by SN measurement method
Time Frame
At Day 202
Title
Percentage of participants with detectable NT Ab titer
Description
Detectable NT Ab titer, ie, with a titer ≥ 10 (1/dil) by SN measurement method
Time Frame
At Day 387
Title
GMR for Group1/Group3, Group2/Group3, and Group2/Group1
Description
Ratio of GMs for Group1/Group3, Group2/Group3, and Group2/Group1 Vaccination taking place on Day 01 and Day 22 by SN measurement method
Time Frame
At 21 days after each vaccination
Secondary Outcome Measure Information:
Title
Number of participants with immediate adverse events (AEs)
Description
Immediate adverse events are any unsolicited systemic adverse events
Time Frame
Within 30 minutes after each vaccination
Title
Number of participants with solicited injection site and systemic reactions
Description
Solicited injection site reactions include injection site pain, erythema, swelling, induration, ecchymosis Solicited systemic reactions include fever, headache, malaise, myalgia
Time Frame
Up to 7 days after each/any vaccination
Title
Number of participants with unsolicited AEs
Description
Unsolicited (spontaneously reported) AEs, not fulfilling criteria for solicited adverse reactions
Time Frame
Up to 21 days after each/any vaccination
Title
Number of participants with medically adverse events (MAAEs)
Description
MAAEs
Time Frame
From Day 01 up to Day 387
Title
Number of participants with adverse events of special interest (AESIs)
Description
AESIs
Time Frame
From Day 01 up to Day 387
Title
Number of participants with serious adverse events (SAEs) (including AESIs)
Description
SAEs (including AESIs)
Time Frame
From Day 01 up to Day 387

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 contain all considerations relevant to a potential participation in a clinical trial."
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
MCM Vaccines B.V.
Official's Role
Study Director
Facility Information:
Facility Name
Aventiv Research Mesa-Site Number:8400006
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
Velocity Clinical Research-Hallandale Beach-Site Number:8400026
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Research Centers of America-Site Number:8400024
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Suncoast Research Associates, LLC-Site Number:8400008
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Headlands Research Orlando-Site Number:8400014
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
St Johns Center for Clinical Research-Site Number:8400021
City
Saint Augustine
State/Province
Florida
ZIP/Postal Code
32086
Country
United States
Facility Name
CenExel ACMR (Atlanta Center for Medical Research)-Site Number:8400022
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
CRA Headlands Stockbridge-Site Number:8400020
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Velocity Clinical Research Valparaiso-Site Number:8400007
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
MedPharmics-Site Number:8400027
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
M3 Wake Research Inc-Site Number:8400010
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Wrightsville Family Practice Pa-Site Number:8400025
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
Preferred Primary Care Physicians-Site Number:8400015
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Preferred Primary Care Physicians, Inc.-Site Number:8400002
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Velocity Clinical Research Anderson-Site Number:8400016
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
WR-ClinSearch, LLC-Site Number:8400003
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Velocity Clinical Research Cedar Park-Site Number:8400019
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
JBR Clinical Research-Site Number:8400005
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Foothill Family Research-South-Site Number:8400009
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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

Learn more about this trial

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

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