Recent Updates
Recently added Catalysts

Influenza Vaccine, Formulation 2008-2009

Phase 2

Seasonal Influenza | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Dec 1, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment133

FDA Designations

No designations recorded

Clinical trial landscape

Influenza Vaccine, Formulation 2008-2009 · 1 trial · 1 indication

Phase 2 1
NCT00748813Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine Using the Strain Composition 2008/2009Seasonal Influenza
COMPLETED133 Analytics
PHASE2COMPLETED
Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine Using the Strain Composition 2008/2009
Seasonal InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluation of antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) test on Day 0 and on Day 21
21 days (-1/+5)

Secondary Endpoints

Evaluation of safety
21 days (-1/+5)
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1OTHER -

Interventions

NameTypeDescription
Influenza Vaccine, Formulation 2008-2009BIOLOGICAL1 dose of Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2008-2009
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Subjects eligible for enrollment into this study are male and female adults who are: 1. ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry 2. able to comply with all study requirements 3. in good health as determined by...

Countries:Italy
Unlock Eligibility Criteria

Frequently asked questions about Influenza Vaccine, Formulation 2008-2009

What is Influenza Vaccine, Formulation 2008-2009 used for?

Influenza Vaccine, Formulation 2008-2009 is an investigational vaccine being developed for the prevention of influenza, including seasonal influenza. It is designed to elicit an immune response against the influenza virus strains included in the 2008-2009 formulation. The vaccine is intended for use in various age groups, including children, adults, and the elderly.

Who makes Influenza Vaccine, Formulation 2008-2009?

Influenza Vaccine, Formulation 2008-2009 is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is publicly traded on the New York Stock Exchange under the ticker symbol NVS. The company has conducted clinical trials to evaluate the safety and immunogenicity of this seasonal influenza vaccine formulation.

What phase is Influenza Vaccine, Formulation 2008-2009 in?

Influenza Vaccine, Formulation 2008-2009 is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The development program includes completed Phase 2 and Phase 3 trials, but the overall program is currently categorized as Phase 2, with no active trials ongoing.

What clinical trials is Influenza Vaccine, Formulation 2008-2009 in?

Influenza Vaccine, Formulation 2008-2009 has been studied in three completed clinical trials. These include NCT00310648, a Phase 3 trial in elderly subjects in China; NCT00316628, a Phase 2 trial in adults aged 65 and over in Italy; and NCT00408395, a Phase 2 trial in children in Finland. A fourth trial, NCT00748813, evaluated the 2008/2009 strain composition in healthy adults.

How does Influenza Vaccine, Formulation 2008-2009 work?

Influenza Vaccine, Formulation 2008-2009 works by presenting inactivated influenza virus surface antigens to the immune system. This exposure triggers the production of antibodies that recognize and neutralize the specific influenza virus strains included in the vaccine formulation. The vaccine is designed to provide protection against seasonal influenza infection by priming the immune system to respond rapidly upon exposure.