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Influenza Trivalent Inactivated Vaccines

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment89

FDA Designations

No designations recorded

Clinical trial landscape

Influenza Trivalent Inactivated Vaccines · 1 trial · 1 indication

Phase 2 1
NCT00644540Immunogenicity and Safety Following a Single Dose of Influenza Vaccines in Healthy Children Who Received Either One or the Other Vaccine (an Adjuvanted Sub-unit Influenza Vaccine and a Non-adjuvanted Split Virion Influenza Vaccine) in the Previous V70P2 StudyFLU
COMPLETED89 Analytics
PHASE2COMPLETED
Immunogenicity and Safety Following a Single Dose of Influenza Vaccines in Healthy Children Who Received Either One or the Other Vaccine (an Adjuvanted Sub-unit Influenza Vaccine and a Non-adjuvanted Split Virion Influenza Vaccine) in the Previous V70P2 Study
FLU
NCT0064454089
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Study Endpoints

Primary Endpoints

To evaluate the immunogenicity of a single 0.25mL or 0.5mL IM injection of two different influenza vaccines, in terms of post-immunization geometric mean titers (GMTs), as measured by HI test, in healthy children aged up to 48 months.
181 days

Secondary Endpoints

Immunogenicity of a single 0.25 or 0.5mL IM injection of two different influenza vaccines in terms of seroprotection, and seroconversion or significant increase, as measured by HI test in healthy children aged up to 48 months.
181 days
To evaluate the safety and tolerability of a single 0.25 or 0.5 mL IM injection of two different influenza vaccines in healthy children aged up to 48 months
181 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Influenza Trivalent Inactivated VaccinesBIOLOGICALThis phase II, observer-blind, parallel groups, single center, extension study will be performed over a period of approximately 6 months in a study population of healthy children up to 48 months of age. Up to two hundred and forty-four children (244) having previously participated in Novartis Vaccines Study V70P2 will be vaccinated with the same influenza vaccines received in the previous trial. Each subject will receive a single vaccine dose of 0.25mL, or of 0.5mL, if aged respectively up to 35 months or 36 up to 48 months, administered intramuscularly (IM) in the deltoid muscle, preferably of the non-dominant arm.
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Eligibility Criteria

Age Range16 Months to 48 Months
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * children up to 48 months of age, who received both doses of one of the two study vaccines in the previous V70P2 trial, whose parents/legal guardians have given written informed consent prior to study entry, * in good health as determined by:medical history, physical examinatio...

Countries:Finland
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Frequently asked questions about Influenza Trivalent Inactivated Vaccines

What is Influenza Trivalent Inactivated Vaccines used for?

Influenza Trivalent Inactivated Vaccines are used for the prevention of influenza, commonly known as the flu. The vaccine is designed to induce an immune response against influenza virus strains. It is being studied for use in children, with clinical trials evaluating its immunogenicity and safety in this population.

Who makes Influenza Trivalent Inactivated Vaccines?

Influenza Trivalent Inactivated Vaccines are being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate the vaccine's safety and immunogenicity in pediatric populations.

What phase is Influenza Trivalent Inactivated Vaccines in?

Influenza Trivalent Inactivated Vaccines are in Phase 2 clinical development. The vaccine is investigational and has not yet been approved for commercial use. It is being evaluated in a completed Phase 2 trial that assessed its immunogenicity and safety following a single dose in healthy children.

What clinical trials is Influenza Trivalent Inactivated Vaccines in?

Influenza Trivalent Inactivated Vaccines have one completed clinical trial registered under NCT00644540. This Phase 2 study evaluated the immunogenicity and safety of a single dose of influenza vaccines in healthy children aged 16 months and older in Finland. The trial enrolled 89 participants and was active-controlled.

How does Influenza Trivalent Inactivated Vaccines work?

Influenza Trivalent Inactivated Vaccines work by exposing the immune system to inactivated influenza virus components, prompting the body to produce antibodies against the virus. This prepares the immune system to recognize and fight off the actual influenza virus if the person is later exposed, reducing the risk of infection.