Recent Updates
Recently added Catalysts

Influenza

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Mar 23, 2017

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials3
Total Enrollment8,720

FDA Designations

No designations recorded

Clinical trial landscape

Influenza · 3 trials · 1 indication

Phase 3 3
NCT00380211Safety and Immunogenicity of FluLaval™ TR and Fluarix® (Influenza Vaccines) in Young and Older AdultsInfluenza
COMPLETED660 Analytics
NCT00197288Study Comparing the Immune Response of Fluarix and Fluzone Influenza VaccinesInfluenza
COMPLETED1,847 Analytics
NCT00197223Post-marketing Study to Evaluate the Efficacy of Influenza VaccineInfluenza
COMPLETED6,213 Analytics
PHASE3COMPLETED
Safety and Immunogenicity of FluLaval™ TR and Fluarix® (Influenza Vaccines) in Young and Older Adults
InfluenzaUnlock trial analytics
PHASE3COMPLETED
Study Comparing the Immune Response of Fluarix and Fluzone Influenza Vaccines
InfluenzaUnlock trial analytics
PHASE3COMPLETED
Post-marketing Study to Evaluate the Efficacy of Influenza Vaccine
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

21 days after vaccination: seroconversion rate, seroprotection rate,
geometric mean titer fold increase
Immunological non-inferiority (GMT & seroconversion rates) of Fluarix vs Fluzone 21 days post-vaccination in adults (18 yrs)
Incidence of culture confirmed influenza A and/or B during the surveillance period

Secondary Endpoints

Immediate AEs; solicited and spontaneous AEs within 42 days of vaccination;
SAEs over the whole study period
Non-inferiority of Fluarix vs Fluzone 21 days post-vacc in elderly (>65 yrs)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Influenza vaccine (A/H3N2, A/H1N1, and B strains)BIOLOGICAL -
FluarixBIOLOGICAL -
InfluenzaBIOLOGICAL -
Influenza vaccineBIOLOGICAL -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: * Male or female adults (≥18 yrs) * Stable health status * Provide informed consent * Access to direct phone service (NOT a pay phone or a common-use phone service) * Eligible females must have a negative pregnancy test Exclusion Criteria: * Febrile illness (\>38.0°C oral temp...

Countries:United StatesCzechia
Unlock Eligibility Criteria

Frequently asked questions about Influenza

What is Influenza vaccine used for?

Influenza vaccine is used for the prevention of influenza, commonly known as the flu. It is an investigational vaccine being developed by GSK plc (GSK) for use in adults aged 18 years and older. The vaccine is intended to stimulate the immune system to protect against influenza infection.

Who makes the Influenza vaccine?

The Influenza vaccine is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in adult populations.

What phase is the Influenza vaccine in?

The Influenza vaccine is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. Phase 3 trials are designed to confirm its efficacy and monitor adverse reactions in larger populations.

What clinical trials is the Influenza vaccine in?

The Influenza vaccine has been studied in three completed Phase 3 clinical trials. These include NCT00197223, a post-marketing study in Czechia with 6,213 participants; NCT00197288, a comparison of immune responses in the United States with 1,847 participants; and NCT00380211, a safety and immunogenicity study in the United States with 660 participants.

Is the Influenza vaccine the same as Fluarix or Fluzone?

The Influenza vaccine is compared against Fluarix and Fluzone in clinical trials. In NCT00197288, the immune response of the Influenza vaccine was compared with Fluarix and Fluzone. In NCT00380211, the safety and immunogenicity of FluLaval TR and Fluarix were evaluated. These are separate vaccines used as comparators.

How does the Influenza vaccine work?

The Influenza vaccine is a monoclonal antibody modality, designed to target influenza. It works by providing passive immunity through antibodies that neutralize the influenza virus, potentially offering protection against infection. The vaccine is administered to healthy adults to stimulate an immune response.