The study aims to evaluate an egg-based H5N8 influenza vaccine up to 3 dose levels (low, medium, and high dose) given with or without adjuvant to see if the adjuvant improves vaccine effectiveness. The study will enroll healthy adults aged 18 years and over. Participants will receive 2 injections in their arm of either one of the 3 dose levels of the study vaccine (low, medium, or high dose) with the adjuvant or the unadjuvanted vaccine (high dose). Study duration per participant: approximately 14 months (including screening visit).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
640
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
AMR Clinical Phoenix, Arizona- Site Number : 8400004
Tempe, Arizona, United States
RECRUITINGPeninsula Research Associates- Site Number : 8400011
Rolling Hills Estates, California, United States
RECRUITINGCalifornia Research Foundation- Site Number : 8400007
San Diego, California, United States
RECRUITINGAlliance for Multispeciality Research - Coral Gables- Site Number : 8400003
Coral Gables, Florida, United States
RECRUITINGAccel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400017
DeLand, Florida, United States
RECRUITINGAlliance for Multispeciality Research - Fort Myers- Site Number : 8400001
Fort Myers, Florida, United States
RECRUITINGIndago Research & Health Center- Site Number : 8400010
Miami Lakes, Florida, United States
RECRUITINGAccel Research Sites - NeuroStudies- Site Number : 8400014
Decatur, Georgia, United States
RECRUITINGiResearch Atlanta- Site Number : 8400008
Decatur, Georgia, United States
RECRUITINGAMR Chicago- Site Number : 8400005
Oak Brook, Illinois, United States
RECRUITING...and 6 more locations
Number of participants with immediate Adverse Events (AEs)
Immediate adverse events are medically relevant unsolicited systemic adverse events reported in the 30 minutes after vaccination
Time frame: Within 30 minutes after each vaccination
Number of participants experiencing solicited administration site reactions (pre-listed in the participant diary and case report form [CRF])
A solicited reaction is an adverse reaction (sign or symptom) observed and reported under the conditions pre-listed (for example: injection site pain or headache). Solicited administration site reactions are reactions at and around the injection/administration site
Time frame: Within 8 days of each vaccination, including the day of vaccination
Number of participants experiencing solicited systemic reactions (pre-listed in the participant diary and CRF)
All solicited reactions that are not solicited injection or administration site reactions
Time frame: Within 8 days of each vaccination, including the day of vaccination
Number of participants experiencing unsolicited AEs
Unsolicited AE: an observed AE that does not fulfill the conditions of solicited reactions
Time frame: Within 21 days after the first vaccination, including the day of the first vaccination, and within 28 days after the second vaccination, including the day of the second vaccination
Number of participants experiencing Medically Attended Adverse Events (MAAEs)
MAAEs are collected throughout the study
Time frame: From Day 01 until the end of the study, approximately 14 months
Number of participants experiencing Adverse Events of Special Interest (AESIs)
AESIs are collected throughout the study
Time frame: From Day 01 until the end of the study, approximately 14 months
Number of participants experiencing Serious Adverse Events (SAEs)
SAEs are collected throughout the study
Time frame: From Day 01 until the end of the study, approximately 14 months
Number of participants experiencing out-of-range biological test results (including shift from baseline values)
Safety laboratory assessments will include clinical chemistry and hematology
Time frame: Up to 8 days after each vaccination
Number of participants experiencing AEs leading to discontinuation
AEs leading to discontinuation are collected throughout the study
Time frame: From Day 01 until the end of the study, approximately 14 months
Geometric mean titer of hemagglutination inhibition (HAI) assay antibody (Ab) titer
Influenza vaccine antibody titers are measured by HAI assay
Time frame: Day 01 and Day 43
Number of participants with HAI Ab titer ≥ 40 (1 dilution [dil]; ie, seroprotection)
Influenza vaccine antibody titers are measured by HAI assay
Time frame: Day 43
Number of participants with seroconversion
Seroconversion is defined as HAI Ab titer \< 10 (1/dil) on Day 01 and post-injection titer ≥ 40 (1/dil) on Day 43; or defined as HAI Ab titer ≥ 10 (1/dil) on Day 01 and a ≥ 4-fold increase in titer (1/dil) on Day 43
Time frame: Day 01 and Day 43
Geometric mean titer ratio of individual HAI Ab titer ratio Day 43/Day 01
Influenza vaccine antibody titers are measured by HAI assay
Time frame: Day 01 and Day 43
Geometric mean titer of hemagglutination inhibition (HAI) assay antibody (Ab) titer obtained on Day 01, Day 22, Day 43, Day 202
Influenza vaccine antibody titers are measured by HAI assay
Time frame: Day 01, Day 22, Day 43, Day 202
Geometric mean titer ratio of individual HAI Ab titer ratios Day 22/Day 01, Day 43/Day 01, Day 202/Day 43
Individual HAI Ab titer ratios are calculated for the following time points: Day 22/Day 01, Day 43/Day 01 and Day 202/Day 43
Time frame: Day 01, Day 22, Day 43, Day 202
Number of participants with individual HAI Ab titer ≥ 40 (1/dil) on Day 01, Day 22, Day 43, Day 202
Influenza vaccine antibody titers are measured by HAI assay
Time frame: Day 01, Day 22, Day 43, Day 202
Number of participants with seroconversion on Day 22 compared to Day 01 (baseline)
Seroconversion is defined as titer \< 10 (1/dil) on Day 01 and post-injection titer ≥ 40 (1/dil) on Day 22; or defined as titer ≥ 10 (1/dil) on Day 01 and a ≥ 4 fold increase in titer (1/dil) on Day 22
Time frame: Day 01, Day 22
Number of participants with detectable HAI Ab titer
Detectable HAI Ab titer: a titer ≥ 10 (1/dil)
Time frame: Day 01, Day 22, Day 43, Day 202
Geometric mean titer of neutralization (NT) Ab titer
Influenza vaccine antibody titers are measured by serum neutralization (SN) assay
Time frame: Day 01, Day 22, Day 43, Day 202
Geometric mean titer ratio of individual NT Ab titer ratio
Individual NT Ab titer ratios are calculated for the following time points: Day 22/Day 01, Day 43/Day 01 and Day 202/Day 43
Time frame: Day 01, Day 22, Day 43, Day 202
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Number of participants with NT Ab titer ≥ 20 (1/dil)
NT Ab titer ≥ 20 (1/dil) on Day 43; compared to Day 01 and Day 202
Time frame: Day 01, Day 43, Day 202
Number of participants with NT Ab titer ≥ 40 (1/dil)
NT Ab titer ≥ 40 (1/dil) on Day 43; compared to Day 01 and Day 202
Time frame: Day 01, Day 43, Day 202
Number of participants with NT Ab titer ≥ 80 (1/dil)
NT Ab titer ≥ 80 (1/dil) on Day 43; compared to Day 01 and Day 202
Time frame: Day 01, Day 43, Day 202
Geometric mean fold-rise of fold increase in NT Ab titer [post/pre] ≥ 2 and ≥ 4
Influenza vaccine antibody titers are measured by serum neutralization (SN) assay
Time frame: Day 43
Number of participants with detectable NT Ab titer
Detectable NT Ab titer: a titer ≥ 10 (1/dil) on Day 01, Day 22, Day 43, Day 202
Time frame: Day 01, Day 22, Day 43, Day 202