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4 adjuvanted pandemic influenza candidate vaccines

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: May 10, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment400

FDA Designations

No designations recorded

Clinical trial landscape

4 adjuvanted pandemic influenza candidate vaccines · 1 trial · 1 indication

Phase 1 1
NCT00309634Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged Between 18 and 60 YearsInfluenza
COMPLETED400 Analytics
PHASE1COMPLETED
Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged Between 18 and 60 Years
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the humoral immune response induced by the study vaccines in term of anti-haemagglutinin antibody titers.
To evaluate the safety and reactogenicity of the study vaccines in term of solicited local and general adverse events, unsolicited adverse events and serious adverse events"

Secondary Endpoints

To evaluate the humoral immune response induced by the study vaccines in term of serum neutralizing antibody titers
To evaluate the cell-mediated immune response induced by the study vaccines in term of frequency of influenza-specific CD4/CD8 T lymphocytes
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Study Design & Arms

AllocationRANDOMIZED
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
4 adjuvanted pandemic influenza candidate vaccinesBIOLOGICAL -
4 non-adjuvanted pandemic influenza candidate vaccinesBIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: * A male or female between, and including, 18 and 60 years of age at the time of the first vaccination. * Healthy subjects as established by medical history and clinical examination before entering into the study. * If the subject is female, she must be of non-childbearing poten...

Countries:Belgium
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Frequently asked questions about 4 adjuvanted pandemic influenza candidate vaccines

What is 4 adjuvanted pandemic influenza candidate vaccines used for?

4 adjuvanted pandemic influenza candidate vaccines are investigational vaccines being studied for use in influenza. They are designed to be given to adults aged between 18 and 60 years to evaluate their safety and immunogenicity as a pandemic influenza vaccine.

Who makes 4 adjuvanted pandemic influenza candidate vaccines?

4 adjuvanted pandemic influenza candidate vaccines are being developed by GSK plc, a biopharma company listed on the stock exchange under the ticker GSK.

What phase is 4 adjuvanted pandemic influenza candidate vaccines in?

4 adjuvanted pandemic influenza candidate vaccines are in Phase 1 clinical development. They are investigational and have not been approved by regulatory authorities. One Phase 1 trial has been completed.

What clinical trials is 4 adjuvanted pandemic influenza candidate vaccines in?

4 adjuvanted pandemic influenza candidate vaccines have one completed clinical trial, NCT00309634, titled 'Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged Between 18 and 60 Years'. This Phase 1 study enrolled 400 participants in Belgium.

Is 4 adjuvanted pandemic influenza candidate vaccines the same as a pandemic influenza vaccine?

4 adjuvanted pandemic influenza candidate vaccines are pandemic influenza vaccine candidates. The clinical trial NCT00309634 evaluates the safety and immunogenicity of a pandemic influenza vaccine, which refers to these candidate vaccines.