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CVSQIV

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |BioNTech SE|Last Updated: Jun 6, 2023

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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment240
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05252338A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVSQIV in Healthy AdultsPHASE1 COMPLETED 240 — — Feb 7, 2022Sep 27, 2022Jun 6, 20233 Panama
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Study Endpoints
Primary Endpoints
The frequencies of Grade 3 ARs and any SAR within at least 20 hours after the trial vaccine administration by dose level, for decisions on subsequent vaccination of additional sentinel subjects with the same dose level.
up to day 2
The frequencies of Grade 3 ARs and any SAR within at least 60 hours after the trial vaccine administration by dose level, for decisions on dose escalation as well as continuation of enrollment at the same dose level.
up to day 3
The frequencies, intensities and duration of solicited local ARs on the day of vaccination and the following 7 days by dose level, for the characterization of the safety and reactogenicity profile.
up to day 8
The frequencies, intensities, duration and relationship to trial vaccination of solicited systemic AEs on the day of vaccination and the following 7 days by dose level, for the characterization of the safety and reactogenicity profile.
up to day 8
The occurrence, intensities and relationship to trial vaccination of unsolicited AEs on the day of vaccination and the following 28 days by dose level, for the characterization of the safety and reactogenicity profile.
up to day 29
The occurrence and relationship to trial vaccination of SAEs and AESIs throughout the trial, for the characterization of the safety and reactogenicity profile.
through study completion, an average of 6 months
Secondary Endpoints
For each antigen, the proportion of subjects with antigen-specific serum HAI assay titers.
On Day 22 and Day 183
For each antigen, geometric mean titers (GMTs) of antigen-specific HAI antibody titers.
On Day 22 and Day 183
For each antigen, the proportion of subjects with antigen-specific seroconversion measured by HAI assay.
On Day 22 and Day 183
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Younger Adults group aged 18-55 yearsEXPERIMENTALSubjects will be enrolled in a staggered manner in up to 5 dose levels (provisional dose levels of 3, 6, 12, 20 and 28µg). All subjects will receive a single dose of CVSQIV on Day 1.
Adults group aged ≥65 yearsEXPERIMENTALSubjects will be enrolled in a staggered manner in up to 5 dose levels (provisional dose levels of 3, 6, 12, 20 and 28µg). All subjects will receive a single dose of CVSQIV on Day 1.
Interventions
NameTypeDescription
CVSQIVBIOLOGICALParticipants will receive an intramuscular injection by needle in the deltoid area.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Healthy male or female subjects between the ages of 18 and 55 years, inclusive, at enrollment (Younger Adults groups) or aged ≥65 years at enrollment (Older Adults groups). A healthy subject is defined as an individual who is in good general health, according to the Investigat...

Countries:Panama
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Competitive Landscape -Influenza 16 trials
CompanyTickerTrialsLead PhaseDrugs
Sinovac Biotech Ltd.SVA1PHASE3Participants will receive one dose of vaccine of Sinovac QIV, Vaxigrip QIV
GSK plc Sponsored ADRGSK3PHASE2Flu mRNA, Comparator 1, Comparator 2, Comparator 3, Zanamivir
Moderna, Inc.MRNA1PHASE3mRNA-1018-H5
Traws Pharma, Inc.TRAW2PHASE2TRX-100, Influenza A/France/759/2021 virus
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Sanofi SA Sponsored ADRSNY3PHASE1Trivalent messenger ribonucleic acid hemagglutinin Vaccine 1, TIV mRNA-neuraminidase, TIV mRNA-HA Vaccine 2, Quadrivalent Influenza Standard Dose Vaccine, Efluelda Tetra Pre-filled syringe
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Unity Health TorontoUBX1PHASE3Baloxavir
Pfizer Inc.PFE1 — COVID-19 Vaccine
Abbott LaboratoriesABT1NAUndisclosed
Grace Therapeutics, Inc.GRCE1NAUndisclosed
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