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Influenza Monovalent Whole virus adjuvanted vaccine

Phase 1

Influenza | Vaccine | Infectious Disease |GSK plc|Trials Updated: May 8, 2017

Influenza Monovalent Whole virus adjuvanted vaccine target and mechanism

ModalityVaccine

Also known as Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment400

FDA Designations

No designations recorded

Influenza Monovalent Whole virus adjuvanted vaccine clinical trials

Influenza Monovalent Whole virus adjuvanted vaccine · 1 trial · 1 indication

Phase 1 1
NCT00309647Study to Evaluate the Safety and Immunogenicity of Pandemic Monovalent (H5N1) Influenza Vaccines (Whole Virus Formulation) in Adults 18 and 60 Years of AgeInfluenza
COMPLETED400 Analytics
PHASE1COMPLETED
Study to Evaluate the Safety and Immunogenicity of Pandemic Monovalent (H5N1) Influenza Vaccines (Whole Virus Formulation) in Adults 18 and 60 Years of Age
Influenza
NCT00309647400
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Study Endpoints

Primary Endpoints

To evaluate the humoral immune response induced by the study vaccines in term of anti-haemagglutinin antibody titers
At Days 0, 21, 42 and 180

Geometric mean titers (GMTs) of serum antibodies

To evaluate the humoral immune response induced by the study vaccines in terms of seroconversion rates (SCRs), Conversion factors and protection rates to H5N1 virus
At days 21, 42 and 180
Occurrence of solicited local and general adverse events
During a 7 day follow-up period (i.e. day of vaccination and 6 subsequent days) after each dose of vaccine and overall
Occurrence of unsolicited adverse events
During a 21 day follow-up period after the first vaccination and 30 day follow-up period after the second vaccination
Occurrence of serious adverse events
During the entire study (Days 0 to 180)

Secondary Endpoints

To evaluate the humoral immune response induced by the study vaccines in term of serum neutralizing antibody titers
At Days 0, 21, 42 and 180
To evaluate the cell-mediated immune response induced by the study vaccines in term of frequency of influenza-specific CD4/CD8 T lymphocytes
At days 0, 21, 42 and 180
To evaluate the humoral immune response induced by the study vaccines in terms of SCR for serum neutralizing antibody titers
At Days 21, 42 and 180
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
H5N1 Formulation 1 GroupEXPERIMENTALSubjects in this group received 2 doses of H5N1 adjuvanted formulation 1 vaccine at a 21-day interval
H5N1 Formulation 2 GroupEXPERIMENTALSubjects in this group received 2 doses of H5N1 adjuvanted formulation 2 vaccine at a 21-day interval
H5N1 Formulation 3 GroupEXPERIMENTALSubjects in this group received 2 doses of H5N1 adjuvanted formulation 3 vaccine at a 21-day interval
H5N1 Formulation 4 GroupEXPERIMENTALSubjects in this group received 2 doses of H5N1 adjuvanted formulation 4 vaccine at a 21-day interval
H5N1 Formulation 5 GroupACTIVE_COMPARATORSubjects in this group received 2 doses of H5N1 formulation 5 vaccine at a 21-day interval
H5N1 Formulation 6 GroupACTIVE_COMPARATORSubjects in this group received 2 doses of H5N1 formulation 6 vaccine at a 21-day interval
H5N1 Formulation 7 GroupACTIVE_COMPARATORSubjects in this group received 2 doses of H5N1 formulation 7 vaccine at a 21-day interval
H5N1 Formulation 8 GroupACTIVE_COMPARATORSubjects in this group received 2 doses of H5N1 formulation 8 vaccine at a 21-day interval

Interventions

NameTypeDescription
Influenza Monovalent Whole virus (H5N1) adjuvanted vaccineBIOLOGICAL2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
Influenza Monovalent Whole virus (H5N1)BIOLOGICAL2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites9

Inclusion criteria: * A male or female between, and including, 18 and 60 years of age at the time of the first vaccination. * Healthy subjects as established by medical history and clinical examination before entering into the study. * If the subject is female, she must be of non-childbearing poten...

Countries:Germany
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Competitive Landscape -Influenza 35 trials

Top 8 of 11 competitors

CompanyTickerTrialsLead PhaseDrugs
GSK plc Sponsored ADRGSK3PHASE3mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine
Moderna, Inc.MRNA2PHASE3mRNA-1018-H5, mRNA-1010, Fluarix Trivalent
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Traws Pharma, Inc.TRAW2PHASE2TRX-100
Sanofi SA Sponsored ADRSNY4PHASE1H5N8 pandemic influenza vaccine (adjuvanted)
Hoffmann-La RocheRHHBY2PHASE3Baloxavir Marboxil
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Sinovac Biotech Ltd.SVA1PHASE1Cell-based Trivalent Split Influenza Virus Vaccine, Egg-based Trivalent Split Influenza Virus Vaccine
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Frequently asked questions about Influenza Monovalent Whole virus adjuvanted vaccine

What is the Influenza Monovalent Whole virus adjuvanted vaccine?

It is an investigational vaccine developed by GSK plc for influenza, specifically a pandemic monovalent H5N1 whole virus formulation that includes an adjuvant. It is designed to stimulate an immune response against a single influenza virus strain rather than multiple seasonal strains.

What is the Influenza Monovalent Whole virus adjuvanted vaccine used for?

It is being developed for the prevention of influenza, specifically pandemic H5N1 influenza. The vaccine uses a whole virus formulation with an adjuvant and targets a single monovalent strain. It is intended for adults, including those 18 years of age and older.

Who makes the Influenza Monovalent Whole virus adjuvanted vaccine?

GSK plc, which trades under the ticker GSK, is the developer of the Influenza Monovalent Whole virus adjuvanted vaccine. The company conducted the clinical development of this pandemic H5N1 whole virus formulation for influenza prevention.

What phase is the Influenza Monovalent Whole virus adjuvanted vaccine in?

The Influenza Monovalent Whole virus adjuvanted vaccine is in Phase 1 development. It is an investigational vaccine and has not been approved. One Phase 1 trial has been completed, and no active trials are currently listed for this asset.

What clinical trials is the Influenza Monovalent Whole virus adjuvanted vaccine in?

The vaccine was evaluated in a completed Phase 1 trial, NCT00309647, titled a study to evaluate the safety and immunogenicity of pandemic monovalent H5N1 influenza vaccines in adults 18 and 60 years of age. The trial enrolled 400 participants in Germany and was active controlled and randomized.

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