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FluBlok

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Apr 6, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment4,648
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00539981Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlokPHASE3 COMPLETED 4,648Sep 15, 2007May 28, 2008Apr 6, 202224 United States
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Study Endpoints
Primary Endpoints
Number of Participants Reporting Solicited Injection Site (Local) Reactions
Within 7 days post vaccination

Solicited reaction (reactogenicity event) was an adverse event (AE) that was pre-listed in electronic case report form(eCRF), considered to be related to vaccination and recorded by participant by means of memory aid. Injection sites reaction included pain,bruising,redness,swelling. Pain and bruising:Grade0: didn't have it at all; Grade1: noticed it, but it didn't interfere with usual activities at all; Grade2: had it, and it was bad enough to prevent a significant part of usual activities; Grade3: had it, and it prevented most or all of normal activities, or had to see a doctor for prescription medicine, Redness and swelling: participants measured largest diameter of any injection site reaction and grade them from 0 to 3, where Grade0: measured less than(\<)10 milliliters(mm); Grade1: larger than or equal to(\>=) 10mm and \<20mm; Grade 2: \>=20mm and \<50mm; Grade3: \>=50mm. Participants with multiple symptoms in same category were counted once per category using symptom with maximum grade

Number of Participants Reporting Solicited Systemic Reactions
Within 7 days post vaccination

Solicited reaction (reactogenicity event) was an AE that was pre-listed in eCRF, considered to be related to vaccination recorded by the participant by means of a memory aid between the day of vaccination (Day 0) and Day 7 post vaccination. Systemic events included fever, fatigue, shivering, joint pain, muscle pain, headache, and nausea. Fever: \>=100.4 degree Fahrenheit (ºF) to \<101.1ºF; \>=101.2ºF to \<102.2ºF; \>=102.2ºF; Fatigue, shivering, joint pain, muscle pain, headache and nausea: Grade 0: didn't have it at all; Grade 1: noticed it, but it didn't interfere with usual activities at all; Grade 2: had it, and it was bad enough to prevent a significant part of usual activities; and Grade 3: had it, and it prevented most or all of normal activities, or had to see a doctor for prescription medicine. Participants with multiple symptoms in the same category were counted once per category using the symptom with the maximum grade.

Number of Participants Reporting Unsolicited Adverse Events
From Day 0 (post-vaccination) through Day 28 post vaccination

An AE was defined as any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a study vaccine, whether or not considered to be related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination, ascertained during follow-up visit or telephone contact up to (and including) the Day 28 contact, whether reported spontaneously by the participant or in response to general questions about current or interim health status.

Lot Consistency: Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies Following FluBlok Vaccination
Day 28 post vaccination

GMTs of anti-influenza antibodies were measured using a single radial immunodiffusion (SRID) assay for 3 strains: A/Solomon Islands \[H1N1\], A/Wisconsin \[H3N2\], and B/Malaysia. Titers were expressed in terms of 1/dilution.

Percentage of Participants With Positive Cell Culture/Culture-Confirmed Influenza Like Illness as Defined by Centers for Disease Control and Prevention (CDC-ILI)
14 days post vaccination through and up to 6 months

CDC-defined ILI was defined as fever (body temperature \>=100ºF oral accompanied by cough and/or sore throat, on the same day or on consecutive days) due to strains represented in the vaccine.

Secondary Endpoints
Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With FluBlok
28 days post vaccination
Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With FluBlok
28 days post vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
FluBlok (Lots A, B, C)EXPERIMENTALParticipants received a single 0.5 milliliters (mL) dose of FluBlok vaccine from any of the Lots A, B, or C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
PlaceboPLACEBO_COMPARATORParticipants received a single dose of placebo matched to FluBlok, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
Interventions
NameTypeDescription
FluBlok®BIOLOGICALDose: 0.5 mL, single dose; Route of administration: intramuscular. Recombinant Trivalent Hemagglutinin Influenza Vaccine containing 45 microgram (mcg) of each hemagglutinin derived from A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
PlaceboBIOLOGICALDose: 0.5 mL normal saline for injection, single dose; Route of administration: intramuscular
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Eligibility Criteria
Age Range18 Years — 49 Years
SexALL
Healthy VolunteersYes
Study Sites24

Inclusion Criteria: * Healthy adult aged 18-49 years. * Provided informed consent prior to any study procedures. * Able to comply with all study procedures. * Available for follow-up for the duration of the influenza season. * Women of child-bearing potential must have had a negative urine pregnanc...

Countries:United States
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