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Influenza Vaccine

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |Abbott Laboratories|Last Updated: Oct 27, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment3,138

FDA Designations

No designations recorded

Clinical trial landscape

Influenza Vaccine · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT00999206Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza VaccineInfluenza
COMPLETED3,138 Analytics
PHASE3COMPLETED
Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Anti-HA antibody titers and derived parameters seroprotection, seroconversion and fold increase
3 weeks
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the CHMP criteria for immunogenicity.
3 weeks
To assess the safety and tolerability of the cell-derived vaccine and compare to an egg-derived influenza vaccine.
6 months
To assess the safety and tolerability of the cell-derived vaccine following revaccination.
6 months

Secondary Endpoints

To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination, by applying the CHMP criteria for immunogenicity.
3 weeks
To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.
6 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Influenza VaccineBIOLOGICALsurface antigen, inactivated, prepared in cell cultures
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites19

Inclusion Criteria 1. Female or male subjects \>= 18 years of age (adults \>= 18 to \< =60 years of age or elderly \>= 61 years of age). 2. Willing and able to give informed consent before any protocol procedures are performed. 3. Able to adhere to visit schedules and all protocol required study pr...

Countries:AustraliaNew ZealandCzechiaEstoniaLithuania
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Frequently asked questions about Influenza Vaccine

What is Influenza Vaccine used for?

Influenza Vaccine is used for the prevention of influenza, commonly known as the flu. It is being developed as a vaccine to protect against seasonal influenza infection. The vaccine is intended for use in adults, including elderly populations, to reduce the risk of influenza and its complications.

Who makes Influenza Vaccine?

Influenza Vaccine is being developed by Abbott Laboratories, a company traded on the stock exchange under the ticker symbol ABT. Abbott Laboratories is conducting clinical trials to evaluate the safety and immunogenicity of this vaccine for the prevention of influenza.

What phase is Influenza Vaccine in?

Influenza Vaccine is currently in Phase 3 clinical development. This phase involves large-scale studies to confirm the vaccine's efficacy and monitor adverse reactions. The most advanced trial, NCT00999206, is a Phase 3 study that has been completed, evaluating the safety, immunogenicity, and lot consistency of the cell-derived influenza vaccine.

What clinical trials is Influenza Vaccine in?

Influenza Vaccine has been studied in two clinical trials. The first, NCT00999206, is a Phase 3 trial that has been completed, enrolling 3,138 participants in Australia and New Zealand to measure safety, immunogenicity, and lot consistency. The second, NCT01013675, is a Phase 2 trial completed with 622 elderly participants in Czechia, Estonia, and Lithuania, assessing immunogenicity and safety.

Is Influenza Vaccine the same as a cell-derived influenza vaccine?

Yes, Influenza Vaccine is a cell-derived influenza vaccine. The clinical trials for this vaccine, including NCT00999206 and NCT01013675, specifically evaluate a cell-derived formulation. This means the vaccine is produced using cell culture technology rather than traditional egg-based methods, which may offer advantages in manufacturing speed and flexibility.