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Trivalent influenza subunit vaccine Influvac

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |Abbott Laboratories|Last Updated: Dec 22, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials3
Total Enrollment361

FDA Designations

No designations recorded

Clinical trial landscape

Trivalent influenza subunit vaccine Influvac · 4 trials · 2 indications

Phase 3 4
NCT02381418Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the Southern Hemisphere 2015 SeasonInfluenza
COMPLETED120 Analytics
NCT01633749Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2012/2013 SeasonProphylaxis of Influenza
COMPLETED120 Analytics
NCT01146015Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2010/2011 SeasonInfluenza
COMPLETED121 Analytics
NCT00881842Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 09/10 SeasonInfluenza
COMPLETED120 Analytics
PHASE3COMPLETED
Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the Southern Hemisphere 2015 Season
InfluenzaUnlock trial analytics
PHASE3COMPLETED
Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2012/2013 Season
Prophylaxis of InfluenzaUnlock trial analytics
PHASE3COMPLETED
Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2010/2011 Season
InfluenzaUnlock trial analytics
PHASE3COMPLETED
Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 09/10 Season
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.
3 weeks post vaccination

Seroprotection and Seroconversion Rate for A/H1N1, A/H3N2, and B Strains 3 weeks After Vaccination in non-elderly adults and elderly adults.

Antihemagglutinin antibody titers and the derived parameters seroprotection, seroconversion and mean fold increase
3 weeks

Standard parameters to quantify antibody levels. Recommended in the CHMP guideline.

Solicited local and systemic reactions, overall inconvenience
3 days

Reactogenicity and inconvenience

Unsolicited adverse events
3 weeks

Other adverse events

HI titers and its derived parameters after 2 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2010/2011 as defined by the CHMP guideline for influenza vaccines
2 weeks
HI titers and its derived parameters after 3 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2010/2011 as defined by the CHMP guideline for influenza vaccines
3 weeks
HI titers and its derived parameters after 2 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2008/2009 as defined by the CHMP guideline for influenza vaccines.
2 weeks
HI titers and its derived parameters after 3 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2008/2009 as defined by the CHMP guideline for influenza vaccines.
3 weeks

Secondary Endpoints

Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
up to 3 weeks post vaccination
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTALTrivalent influenza subunit vaccine Influvac. "3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 "
Trivalent influenza subunit vaccine InfluvacEXPERIMENTAL3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1

Interventions

NameTypeDescription
Trivalent influenza subunit vaccine InfluvacBIOLOGICAL"3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Willing and able to give informed consent and able to adhere to all protocol required study procedures. * Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination. * Being in good health as judged by medical history, physical examination (if ...

Countries:AustraliaGermanyBelgium
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Frequently asked questions about Trivalent influenza subunit vaccine Influvac

What is Trivalent influenza subunit vaccine Influvac used for?

Trivalent influenza subunit vaccine Influvac is used for the prophylaxis of influenza, a seasonal viral infection. It is an inactivated subunit vaccine designed to protect against three influenza virus strains. The vaccine is intended for adults aged 18 years and older, as studied in clinical trials.

Who makes Trivalent influenza subunit vaccine Influvac?

Trivalent influenza subunit vaccine Influvac is developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker ABT. The vaccine is being investigated for the prevention of influenza and has undergone clinical trials in multiple countries.

What phase is Trivalent influenza subunit vaccine Influvac in?

Trivalent influenza subunit vaccine Influvac is in Phase 3 clinical development. It is an investigational vaccine for the prophylaxis of influenza. All completed trials have been Phase 3 studies, and the vaccine is not yet approved for use.

What clinical trials is Trivalent influenza subunit vaccine Influvac in?

Trivalent influenza subunit vaccine Influvac has been studied in several completed Phase 3 trials, including NCT00881842, NCT01146015, NCT01633749, and NCT02381418. These trials evaluated the vaccine's immunogenicity and safety against seasonal influenza strains in healthy adults aged 18 years and older.

Is Trivalent influenza subunit vaccine Influvac the same as Influvac?

Trivalent influenza subunit vaccine Influvac is commonly referred to as Influvac. The drug name includes the brand identifier Influvac, and it is a trivalent formulation containing three influenza virus strains. It is an inactivated subunit vaccine for influenza prophylaxis.