Recent Updates
Recently added Catalysts

Pandemic Influenza Vaccine

Phase 1

Influenza A Subtype H5N1 Infection | Monoclonal antibody | Infectious Disease |Altimmune, Inc.|Last Updated: May 29, 2025

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

Pandemic Influenza Vaccine · 1 trial · 1 indication

Phase 1 1
NCT00755703Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine.Influenza A Subtype H5N1 Infection
COMPLETED48 Analytics
PHASE1COMPLETED
Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine.
Influenza A Subtype H5N1 Infection
NCT0075570348
Unlock trial analytics

Study Endpoints

Primary Endpoints

To assess the safety of a nasally administered adenovirus-vectored pandemic influenza vaccine in healthy human adults.
56 day observations with 2 year follow-up

Secondary Endpoints

Determination of immunogenicity and correlates of protection based on HI titers in vaccinates
28 days and 56 days post vaccination
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelFACTORIAL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALThere will be 12 subjects in Group 1 that will receive 10e8 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d).
Group 2EXPERIMENTALThere will be 12 subjects in Group 2 that will receive 10e9 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d).
Group 3EXPERIMENTALThere will be 12 subjects in Group 3 that will receive 10e10 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d).
Experimental: Group 4PLACEBO_COMPARATORThere will be 12 subjects in Group 4 that will receive a placebo consisting of buffer administered via intranasal spray on day 0 and day 28 (+/- 4d).

Interventions

NameTypeDescription
Pandemic Influenza VaccineBIOLOGICALUndetermined
PlaceboBIOLOGICAL -
Unlock Study Design Details

Eligibility Criteria

Age Range19 Years to 49 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males and females in good general health, 19-49 years of age * Subjects must provide written consent * Willing to participate through study completion * Willing to undergo nasal washes and swabs and provide urine and blood samples per protocol for safety and immunogeni...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Pandemic Influenza Vaccine

What is Pandemic Influenza Vaccine used for?

Pandemic Influenza Vaccine is an investigational vaccine being developed for the prevention of Influenza A Subtype H5N1 Infection, commonly known as avian or bird flu. It is designed to be administered intranasally and is currently in Phase 1 clinical development.

Who makes Pandemic Influenza Vaccine?

Pandemic Influenza Vaccine is being developed by Altimmune, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALT. The company is conducting clinical trials to evaluate the safety and immunogenicity of this intranasal vaccine candidate.

What phase is Pandemic Influenza Vaccine in?

Pandemic Influenza Vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. A Phase 1 clinical trial has been completed to assess its safety and immunogenicity in healthy volunteers.

What clinical trials is Pandemic Influenza Vaccine in?

Pandemic Influenza Vaccine has one completed Phase 1 clinical trial registered as NCT00755703, titled 'Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine.' This randomized, double-blind, placebo-controlled trial enrolled 48 participants in the United States.

How is Pandemic Influenza Vaccine administered?

Pandemic Influenza Vaccine is administered intranasally, meaning it is given through the nose. This route of administration is designed to mimic the natural route of influenza infection and potentially induce mucosal immunity in the respiratory tract.