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Influenza Trivalent Inactivated vaccines Novartis

Phase 2

Influenza | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Apr 7, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment360

FDA Designations

No designations recorded

Clinical trial landscape

Influenza Trivalent Inactivated vaccines Novartis · 1 trial · 1 indication

Phase 2 1
NCT00649883Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Two Different Influenza Vaccines in Healthy Children Aged 6 to <60 MonthsInfluenza
COMPLETED360 Analytics
PHASE2COMPLETED
Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Two Different Influenza Vaccines in Healthy Children Aged 6 to <60 Months
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the safety and tolerability of one and two doses of investigational vaccines or active control influenza vaccine in unprimed healthy children aged 6 months to <36 months.
211 days

Secondary Endpoints

To evaluate the immunogenicity of two doses of investigational influenza vaccine or active control influenza vaccines, as measured by HI assay in children aged 36 to <60 months.
211 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Influenza Trivalent Inactivated vaccines NovartisBIOLOGICALChildren 6 to \<36 months of age will receive two 0.25 mL doses, and children 36 to \<60 months of age will receive two 0.5 mL doses of investigational influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.
Influenza Trivalent Inactivated vaccinesBIOLOGICALChildren 6 to \<36 months of age will receive two 0.25 mL doses, and children 36 to \<60 months of age will receive two 0.5 mL doses of active control influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.
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Eligibility Criteria

Age Range6 Months to 59 Months
SexALL
Healthy VolunteersYes
Study Sites5

Inclusion Criteria: * Children of 6 to \<60 months of age, whose parents/legal guardians have given written informed consent prior to study entry. * In good health as determined by: medical history, physical examination, clinical judgment of the investigator. * Able to comply with all study procedu...

Countries:Guatemala
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Frequently asked questions about Influenza Trivalent Inactivated vaccines Novartis

What is Influenza Trivalent Inactivated vaccines Novartis used for?

Influenza Trivalent Inactivated vaccines Novartis is an investigational vaccine being developed for the prevention of influenza. It is designed to provide immunity against three strains of the influenza virus. The vaccine is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Influenza Trivalent Inactivated vaccines Novartis?

Influenza Trivalent Inactivated vaccines Novartis is being developed by Novartis AG, a multinational pharmaceutical company headquartered in Switzerland. Novartis is listed on the New York Stock Exchange under the ticker symbol NVS. The vaccine is in Phase 2 clinical trials for influenza.

What phase is Influenza Trivalent Inactivated vaccines Novartis in?

Influenza Trivalent Inactivated vaccines Novartis is in Phase 2 clinical development. It is an investigational vaccine and has not yet received regulatory approval. The vaccine is being studied for its safety and immunogenicity in healthy children aged 6 to less than 60 months.

What clinical trials is Influenza Trivalent Inactivated vaccines Novartis in?

Influenza Trivalent Inactivated vaccines Novartis has one completed Phase 2 clinical trial, identified by the National Clinical Trial number NCT00649883. This trial evaluated the safety and immunogenicity of two different doses of the vaccine in healthy children aged 6 to less than 60 months in Guatemala. The trial enrolled 360 participants.

How does Influenza Trivalent Inactivated vaccines Novartis work?

Influenza Trivalent Inactivated vaccines Novartis is a trivalent inactivated vaccine, meaning it contains killed influenza viruses from three strains. When administered, it stimulates the immune system to produce antibodies against these strains, providing protection against seasonal influenza. The vaccine is being developed as a preventive measure for influenza.