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H5N1 pandemic Influenza vaccine 3.75µg

Phase 2

Pandemic H5N1 Influenza | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Oct 12, 2015

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment722

FDA Designations

No designations recorded

Clinical trial landscape

H5N1 pandemic Influenza vaccine 3.75µg · 1 trial · 1 indication

Phase 2 1
NCT00914771Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two Monovalent H5N1 Influenza Vaccines Containing 2 Doses of H5N1 Influenza Antigen, in Non-elderly Adult and Elderly SubjectsPandemic H5N1 Influenza
COMPLETED722 Analytics
PHASE2COMPLETED
Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two Monovalent H5N1 Influenza Vaccines Containing 2 Doses of H5N1 Influenza Antigen, in Non-elderly Adult and Elderly Subjects
Pandemic H5N1 Influenza
NCT00914771722
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Study Endpoints

Primary Endpoints

Day 43 post vaccination ratio of GMTs for the 2 different vaccine groups (3.75µ / 7.5µg) including two-sided 95% confidence intervals as measured by HI and SRH in the adult and elderly population combined.
43 days
Solicited local reactions: ecchymosis, erythema, induration, swelling and pain at injection site.
6 weeks
Solicited systemic reactions: headache, arthralgia, chills, fatigue, malaise, myalgia, nausea, sweating and fever as measured by axillary temperature for Day 1 through 7 and Day 22 to 28 of the study.
6 weeks

Secondary Endpoints

Geometric mean titers/area (GMTs/GMAs) on each blood sampling days as determined by HI and SRH, and the applicable geometric mean ratios.
6 weeks
Percentage of subjects achieving seroconversion or significant increase in antibody titer on each post-vaccination blood sampling days, as measured by HI and SRH.
6 weeks
Percentage of subjects achieving an HI titer ≥40/ SRH area ≥25mm² on each blood sampling days.
6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposePREVENTION

Treatment Arms

ArmTypeDescription
H5N1 pandemic Influenza vaccine 3.75µgACTIVE_COMPARATOR -
H5N1 pandemic Influenza vaccine 7.5µgACTIVE_COMPARATOR -

Interventions

NameTypeDescription
H5N1 pandemic Influenza vaccine 3.75µgBIOLOGICAL2 doses of monovalent MF59-adjuvanted H5N1 pandemic vaccine containing 3.75µg H5N1 antigen
H5N1 pandemic Influenza vaccine 7.5µgBIOLOGICAL2 doses of monovalent MF59-adjuvanted H5N1 pandemic vaccine containing 7.5µg H5N1 antigen
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites12

Inclusion Criteria: * Males and females 18 yrs of age and above on the day of enrollment. * Individuals in good health as determined by medical history, physical examination and clinical judgment of the investigator * Documented consent obtained after the nature of the study has been explained acco...

Countries:PolandTurkey (Türkiye)
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Frequently asked questions about H5N1 pandemic Influenza vaccine 3.75µg

What is H5N1 pandemic Influenza vaccine 3.75µg used for?

H5N1 pandemic Influenza vaccine 3.75µg is an investigational vaccine being developed for the prevention of pandemic H5N1 influenza. It is intended for use in non-elderly adults and elderly subjects to generate an immune response against the H5N1 influenza virus strain.

Who makes H5N1 pandemic Influenza vaccine 3.75µg?

H5N1 pandemic Influenza vaccine 3.75µg is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The vaccine is currently in clinical development for pandemic H5N1 influenza.

What phase is H5N1 pandemic Influenza vaccine 3.75µg in?

H5N1 pandemic Influenza vaccine 3.75µg is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the vaccine remains under investigation for pandemic H5N1 influenza.

What clinical trials is H5N1 pandemic Influenza vaccine 3.75µg in?

H5N1 pandemic Influenza vaccine 3.75µg has been studied in one completed Phase 2 clinical trial, registered as NCT00914771. This randomized, double-blind, active-controlled study evaluated the safety and immunogenicity of two doses administered three weeks apart in 722 non-elderly adult and elderly subjects in Poland and Turkey.

How does H5N1 pandemic Influenza vaccine 3.75µg work?

H5N1 pandemic Influenza vaccine 3.75µg is a monovalent vaccine containing 3.75 micrograms of H5N1 influenza antigen. It is designed to stimulate the immune system to produce antibodies against the H5N1 influenza virus, potentially providing protection against pandemic influenza caused by this strain.