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4 adjuvanted pandemic influenza candidate vaccines

Phase 1

Influenza | Vaccine | Infectious Disease |GSK plc|Trials Updated: May 10, 2017

4 adjuvanted pandemic influenza candidate vaccines development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2006

4 adjuvanted pandemic influenza candidate vaccines target and mechanism

ModalityVaccine

Also known as 4 non-adjuvanted pandemic influenza candidate vaccines

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment400

FDA Designations

No designations recorded

4 adjuvanted pandemic influenza candidate vaccines clinical trials

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?

It is a group of four adjuvanted pandemic influenza vaccine candidates developed by GSK plc. These vaccine candidates are designed for use against pandemic influenza and were evaluated together in a Phase 1 clinical study in adults aged 18 to 60 years. The program is in early clinical development.

What is 4 adjuvanted pandemic influenza candidate vaccines used for?

The four adjuvanted pandemic influenza candidate vaccines are intended for immunization against pandemic influenza. They were studied in healthy adult volunteers aged 18 to 60 years to assess safety and immune response. The candidates target influenza, an infectious disease, and remain investigational.

Who makes 4 adjuvanted pandemic influenza candidate vaccines?

GSK plc, which trades under the ticker GSK, is the developer of the four adjuvanted pandemic influenza candidate vaccines. GSK sponsored the Phase 1 clinical trial evaluating these candidates in Belgium. The company is the sole developer named for this vaccine program.

What phase is 4 adjuvanted pandemic influenza candidate vaccines in?

The four adjuvanted pandemic influenza candidate vaccines are in Phase 1 clinical development. The program has completed one Phase 1 trial with 400 participants. These vaccine candidates are investigational and have not been approved for use.

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

The four adjuvanted pandemic influenza candidate vaccines were evaluated in one completed Phase 1 trial, NCT00309634, titled a study to evaluate the safety and immunogenicity of a pandemic influenza vaccine in adults aged between 18 and 60 years. The trial enrolled 400 participants in Belgium and was randomized but uncontrolled.