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Standard-Dose influenza virus surface antigens, Inactivated, Influenza Vaccine Quadrivalent, 2019-2020 Northern Hemisphere Strains

Phase 3

Influenza Immunization | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Sep 12, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment1,539

FDA Designations

No designations recorded

Clinical trial landscape

Standard-Dose influenza virus surface antigens, Inactivated, Influenza Vaccine Quadrivalent, 2019-2020 Northern Hemisphere Strains · 1 trial · 2 indications

Phase 3 1
NCT04024228Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Europeans Adults 60 Years of Age and OlderInfluenza Immunization
COMPLETED1,539 Analytics
PHASE3COMPLETED
Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Europeans Adults 60 Years of Age and Older
Influenza Immunization
NCT040242281,539
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Study Endpoints

Primary Endpoints

Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years
Day 28 post-vaccination

GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).Titers were expressed in terms of 1/dilution.

Secondary Endpoints

Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants
Day 0 (pre-vaccination), Day 28 (post-vaccination)
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years
Day 0 (pre-vaccination), Day 28 (post-vaccination)
Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants
Day 0 (pre-vaccination), Day 28 (post-vaccination)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1: QIV-HDEXPERIMENTALParticipants received a single injection of 0.7 milliliters (mL) QIV-HD, intramuscularly (IM) at Day 0.
Group 2: QIV-SDACTIVE_COMPARATORParticipants received a single injection of 0.5 mL QIV-SD, IM at Day 0.

Interventions

NameTypeDescription
Standard-Dose influenza virus surface antigens (haemagglutinin and neuraminidase), Inactivated, Influenza Vaccine Quadrivalent, 2019-2020 Northern Hemisphere Strains (QIV-SD)BIOLOGICALPharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
High-Dose Influenza Vaccine (split virion, inactivated), Quadrivalent (QIV-HD) 2019-2020 Northern Hemisphere formulationBIOLOGICALPharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
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Eligibility Criteria

Age Range60 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites17

Inclusion criteria : * Sixty years of age and older on the day of inclusion. * Able to attend all scheduled visits and complied with all trial procedures. Exclusion criteria: * Participant was pregnant, or lactating, or of childbearing potential and did not used an effective method of contracepti...

Countries:BelgiumFranceGermanyItalyNetherlandsPoland
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