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Flu-ID 15μg

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Mar 16, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment795

FDA Designations

No designations recorded

Clinical trial landscape

Flu-ID 15μg · 1 trial · 1 indication

Phase 3 1
NCT00554333Comparative Study of Immunogenicity and Safety of Flu-ID Vaccine Versus Flu-IM VaccineInfluenza
COMPLETED795 Analytics
PHASE3COMPLETED
Comparative Study of Immunogenicity and Safety of Flu-ID Vaccine Versus Flu-IM Vaccine
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Immunogenicity Anti-Haemagglutinin (Anti-HA) antibody titres (1/dil) for the three strains obtained on Day 21 after vaccination.
21 days

Secondary Endpoints

Immunogenicity The derived endpoints will be: - Anti-HA individual titre ratios [Day 21 / Day 0]
21 days
Immunogenicity The derived endpoints will be: - Seroprotection status [anti-HA individual titre ≥40 (1/dil)] on Day 21
21 days
Seroconversion or significant increase status at Day 21:anti-HA individual post-vaccination titre ≥40 (1/dil) on D21 for subjects with a pre-vaccination anti-HA individual titre <10 (1/dil) on D0
21 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTALInactivated Split-Virion Influenza Vaccine for Intradermal Route
2ACTIVE_COMPARATORInactivated adjuvanted Influenza Vaccine for Intramuscular Route

Interventions

NameTypeDescription
Flu-ID 15μgBIOLOGICALInactivated Split-Virion Influenza Vaccine for Intradermal Route
Inactivated adjuvanted Influenza VaccineBIOLOGICALInactivated adjuvanted Influenza Vaccine for Intramuscular Route
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Eligibility Criteria

Age Range65 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites8

Inclusion Criteria: * Aged 65 years or older on the day of inclusion Exclusion Criteria: * Febrile illness (oral temperature ≥37.5°C) on the day of inclusion * Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination * Unstable chronic illness * Congenital or acquired immu...

Countries:BelgiumFrance
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Frequently asked questions about Flu-ID 15μg

What is Flu-ID 15μg used for?

Flu-ID 15μg is an investigational vaccine being developed for the prevention of influenza. It is a monoclonal antibody-based product intended to provide immunity against the flu virus. The vaccine is currently in clinical development and has not been approved by regulatory authorities.

Who makes Flu-ID 15μg?

Flu-ID 15μg is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the safety and immunogenicity of this influenza vaccine candidate.

What phase is Flu-ID 15μg in?

Flu-ID 15μg is in Phase 3 clinical development. It is an investigational vaccine and has not yet received regulatory approval. The Phase 3 trial has been completed, and the results will inform potential future regulatory submissions.

What clinical trials is Flu-ID 15μg in?

Flu-ID 15μg has been studied in one completed Phase 3 clinical trial with the identifier NCT00554333. This trial compared the immunogenicity and safety of Flu-ID 15μg against a Flu-IM vaccine in 795 participants aged 65 years and older in Belgium and France.

Is Flu-ID 15μg the same as Flu-IM?

No, Flu-ID 15μg is not the same as Flu-IM. Flu-ID 15μg is an investigational vaccine being developed by Sanofi, while Flu-IM is a comparator vaccine used in the clinical trial. The trial was designed to compare the immune response and safety of the two vaccines.