Recent Updates
Recently added Catalysts

Cell-Derived Trivalent Subunit Influenza Vaccine

Phase 2

Influenza | Monoclonal antibody | Infectious Disease |Abbott Laboratories|Last Updated: Oct 25, 2013

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment1,270

FDA Designations

No designations recorded

Clinical trial landscape

Cell-Derived Trivalent Subunit Influenza Vaccine · 1 trial · 1 indication

Phase 2 1
NCT00889889Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Adults Aged >= 18 and <= 64, Plus RevaccinationInfluenza
COMPLETED1,270 Analytics
PHASE2COMPLETED
Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Adults Aged >= 18 and <= 64, Plus Revaccination
Influenza
NCT008898891,270
Unlock trial analytics

Study Endpoints

Primary Endpoints

To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the FDA requirement for influenza vaccines.
3 weeks
To assess after the first vaccination the safety and tolerability of the cell-derived subunit vaccine compared to placebo.
6 months

Secondary Endpoints

To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.
6 months
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination.
3 weeks
To assess after the second vaccination the safety and tolerability of the cell-derived subunit vaccine.
6 months
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Cell-Derived Trivalent Subunit Influenza VaccineBIOLOGICALsurface antigen, inactivated, prepared in cell cultures
PlaceboBIOLOGICALPlacebo
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites15

Inclusion Criteria 1. Willing and able to give informed consent and able to adhere to all protocol required study procedures. 2. Men and women aged \>= 18 and \<= 64 years. 3. Being in good health as judged by medical history, physical examination and clinical judgment of the investigator. Exclusi...

Countries:United States
Unlock Eligibility Criteria

Competitive Landscape -Influenza 14 trials

CompanyTickerTrialsLead PhaseDrugs
Sinovac Biotech Ltd.SVA1PHASE3Participants will receive one dose of vaccine of Sinovac QIV, Vaxigrip QIV
GSK plc Sponsored ADRGSK2PHASE2Flu mRNA, Comparator 1, Comparator 2, Comparator 3
Moderna, Inc.MRNA1PHASE3mRNA-1018-H5
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Traws Pharma, Inc.TRAW2PHASE2TRX-100
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Sanofi SA Sponsored ADRSNY2 - Efluelda Tetra Pre-filled syringe
Pfizer Inc.PFE1 - COVID-19 Vaccine
Abbott LaboratoriesABT1N/AUndisclosed
Grace Therapeutics, Inc.GRCE1N/AUndisclosed
Unlock Competitive Intelligence

Frequently asked questions about Cell-Derived Trivalent Subunit Influenza Vaccine

What is Cell-Derived Trivalent Subunit Influenza Vaccine used for?

Cell-Derived Trivalent Subunit Influenza Vaccine is an investigational vaccine being developed for the prevention of influenza. It is designed to provide immunity against seasonal flu strains. The vaccine is currently in clinical development and has not been approved by regulatory authorities.

Who makes Cell-Derived Trivalent Subunit Influenza Vaccine?

Cell-Derived Trivalent Subunit Influenza Vaccine is being developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker symbol ABT. The vaccine is currently in Phase 2 clinical development for the prevention of influenza.

What phase is Cell-Derived Trivalent Subunit Influenza Vaccine in?

Cell-Derived Trivalent Subunit Influenza Vaccine is in Phase 2 clinical development. It is an investigational vaccine for influenza and has not yet received regulatory approval. The vaccine is being studied for its immunogenicity and safety in adult populations.

What clinical trials is Cell-Derived Trivalent Subunit Influenza Vaccine in?

Cell-Derived Trivalent Subunit Influenza Vaccine has one completed clinical trial, NCT00889889, which was a Phase 2 study titled 'Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Adults Aged >= 18 and <= 64, Plus Revaccination.' The trial enrolled 1,270 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is Cell-Derived Trivalent Subunit Influenza Vaccine FDA approved?

Cell-Derived Trivalent Subunit Influenza Vaccine is not FDA approved. It is an investigational vaccine currently in Phase 2 clinical development for influenza. The vaccine has completed one clinical trial, but it remains under investigation and has not been authorized for use by regulatory agencies.