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Valneva SE (VALN)

Valneva SE operates as a specialized biopharmaceutical company, concentrating its efforts on developing and bringing to market preventative vaccines for infectious diseases where current medical options are insufficient. Its portfolio of commercial travel vaccines includes IXIARO, an inactivated vaccine derived from Vero cell culture, which provides active immunity against Japanese encephalitis. Another offering is DUKORAL, an oral vaccine designed to guard against diarrhea induced by Vibrio cholerae or enterotoxigenic Escherichia coli (ETEC) bacteria. The company's development pipeline features VLA2001, a candidate vaccine targeting SARS-CoV-2. Additionally, Valneva is progressing with VLA15, a Lyme disease vaccine candidate that has successfully concluded Phase II clinical trials and is being co-developed and commercialized with Pfizer, Inc. They are also advancing VLA1553, a chikungunya virus vaccine candidate currently undergoing Phase III clinical evaluation, in partnership with Instituto Butantan for its development, production, and marketing as a single-shot vaccine. Valneva's products are sold across a wide geographical area, including the United States, Canada, Germany, Austria, the Nordic countries, the United Kingdom, various other European nations, and internationally. Founded in 1998, the company maintains its headquarters in Saint-Herblain, France.

Sector: Biological Products, (No Diagnostic Substances)

Industry: Biotechnology

Valneva SE logo

Valneva SE

NASDAQ:VALNHealthcare
-4.55%$5.45
AH$5.45+0.00%vs close
Mkt Cap$516.79M
Float36.7M
O/S94.82M
Vol
$ Vol
RVOL
Inst Own4.0%
SI0.5%
Earnings
Dilution
Valneva SE logoNASDAQ:VALN$5.45-4.55%
Phase Distribution
44 lead-sponsored trials·5 active·35 completed
Phase 17
Phase 1/21
Phase 26
Phase 2/33
Phase 320
Phase 41
Not applicable6
(7 more as collaborator)
Status Overview
Recruiting2
Active, not recruiting3
Completed35
Stopped4

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 4
    Completed

    This is a Study to Assess the Safety and Immunogenicity of Ixiaro® (IC51) in an Elderly Population

    IXIARO®

    Japanese Encephalitis

    Enrollment
    200
    Start
    Jun 2010
    Primary Completion
    Jun 2011
    Completion
    Oct 2011
    NCT01158599
  • Phase 3
    Completed

    Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

    IC51

    Japanese Encephalitis

    Enrollment
    639
    Start
    Sep 2006
    Primary Completion
    Apr 2007
    Completion
    Sep 2007
    NCT00594958
  • Phase 3
    Completed

    Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51

    IC51

    Japanese Encephalitis

    Enrollment
    349
    Start
    Oct 2005
    Primary Completion
    Sep 2007
    Completion
    Apr 2009
    NCT00595270
  • Phase 3
    Completed

    Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51

    IC51

    Japanese Encephalitis

    Enrollment
    198
    Start
    Dec 2007
    Primary Completion
    Oct 2009
    Completion
    Oct 2009
    NCT00595309
  • Phase 3
    Completed

    Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51

    Japanese Encephalitis purified inactivated vaccine

    Japanese Encephalitis

    Enrollment
    389
    Start
    Dec 2007
    Primary Completion
    Feb 2008
    Completion
    Jun 2008
    NCT00595465
  • Phase 3
    Completed

    Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51

    IC51

    Japanese Encephalitis

    Enrollment
    374
    Start
    Sep 2005
    Primary Completion
    Feb 2006
    Completion
    Nov 2007
    NCT00595790
  • Phase 3
    Completed

    Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440

    IC51, HAVRIX

    Japanese Encephalitis

    Enrollment
    192
    Start
    Sep 2005
    Primary Completion
    Jul 2006
    Completion
    Aug 2008
    NCT00596271
  • Phase 3
    Completed

    Immunogenicity Study of the Japanese Encephalitis Vaccine IC51

    IC51, JE-VAX

    Japanese Encephalitis

    Enrollment
    867
    Start
    Sep 2005
    Primary Completion
    Sep 2006
    Completion
    Sep 2006
    NCT00604708
  • Phase 3
    Completed

    Safety and Tolerability of the Japanese Encephalitis Vaccine IC51

    Japanese Encephalitis purified inactivated vaccine (IC51), Placebo

    Japanese Encephalitis

    Enrollment
    2,675
    Start
    Oct 2005
    Primary Completion
    -
    Completion
    Nov 2006
    NCT00605085
  • Phase 3
    Completed

    Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling

    IC51

    Japanese Encephalitis

    Enrollment
    304
    Start
    Sep 2008
    Primary Completion
    Jun 2010
    Completion
    Jun 2010
    NCT00776230
  • Phase 3
    Completed

    Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population

    IC51 Japanese Encephalitis, Havrix®720

    Encephalitis

    Enrollment
    1,869
    Start
    Mar 2010
    Primary Completion
    Feb 2011
    Completion
    Jul 2011
    NCT01041573
  • Phase 3
    Completed

    Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries

    IC51, IC51

    Encephalitis

    Enrollment
    100
    Start
    Jan 2010
    Primary Completion
    Aug 2013
    Completion
    Aug 2013
    NCT01047839
  • Phase 3
    Completed

    Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study

    IC51 has given in the parent study IC51-322

    Japanese Encephalitis

    Enrollment
    23
    Start
    Oct 2010
    Primary Completion
    Oct 2012
    Completion
    Sep 2014
    NCT01246479
  • Phase 3
    Completed

    Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic Country

    IXIARO, IXIARO

    Japanese Encephalitis

    Enrollment
    300
    Start
    Dec 2010
    Primary Completion
    Nov 2011
    Completion
    Oct 2013
    NCT01296360
  • Phase 3
    Completed

    Pivotal Study to Evaluate Safety and Immunogenicity of a Live-Attenuated Chikungunya Virus Vaccine Candidate in Adults

    VLA1553, Placebo

    Chikungunya Virus Infection

    Enrollment
    4,128
    Start
    Sep 2020
    Primary Completion
    May 2021
    Completion
    Oct 2021
    NCT04546724
  • Phase 3
    Completed

    Study to Demonstrate Consistency of Three Lots of a Live-attenuated Chikungunya Virus Vaccine Candidate in Healthy Adults

    Biological Vaccine VLA1553

    Chikungunya Virus Infection

    Enrollment
    409
    Start
    Feb 2021
    Primary Completion
    Jul 2021
    Completion
    Jan 2022
    NCT04786444
  • Phase 3
    Active, not recruiting

    Antibody Persistence And Long Term Safety Of A Chikungunya Virus Vaccine (VLA1553)

    VLA1553

    Chikungunya Virus Infection

    Enrollment
    363
    Start
    Apr 2021
    Primary Completion
    Mar 2023
    Completion
    May 2031est.
    NCT04838444
  • Phase 3
    Completed

    COV-COMPARE Immunogenicity of Vaccine VLA2001 Compared to AZD1222

    VLA2001, AZD1222

    SARS-CoV-2 Virus Infection

    Enrollment
    4,034
    Start
    Apr 2021
    Primary Completion
    Jul 2021
    Completion
    Mar 2023
    NCT04864561
  • Phase 3
    Completed

    Safety and Immunogenicity of VLA2001 Adults Aged ≥56 Years

    VLA2001

    SARS-CoV-2 Virus Infection

    Enrollment
    306
    Start
    Aug 2021
    Primary Completion
    Nov 2021
    Completion
    Nov 2022
    NCT04956224
  • Phase 3
    Withdrawn

    A Clinical Phase 3 Trial of VLA1553 in Adult Participants with Human Immunodeficiency Virus (HIV)

    VLA1553

    Chikungunya Virus Infection

    Enrollment
    0
    Start
    Apr 2024
    Primary Completion
    Aug 2024
    Completion
    Aug 2024
    NCT06028841
  • Phase 3
    Withdrawn

    A Trial to Evaluate the Safety and Immunogenicity of VLA1553 in Healthy Children

    VLA1553, Control

    Chikungunya Virus Infection

    Enrollment
    0
    Start
    Feb 2026est.
    Primary Completion
    Dec 2026est.
    Completion
    Nov 2027est.
    NCT07133178
  • Phase 2/3
    Completed

    Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43

    IC43, Placebo

    Pseudomonas Aeruginosa Infection

    Enrollment
    803
    Start
    Mar 2012
    Primary Completion
    Aug 2015
    Completion
    Dec 2015
    NCT01563263
  • Phase 2/3
    Withdrawn

    COVID-19 Paediatric VLA2001-321 Study

    VLA2001, Active Comparator

    SARS-CoV-2 Infection

    Enrollment
    0
    Start
    Oct 2022est.
    Primary Completion
    Jul 2023est.
    Completion
    Aug 2025est.
    NCT05298644
  • Phase 2/3
    Completed

    VLA2001 Booster in Adult Participants After Priming With mRNA COVID-19 Vaccine and/or Natural SARS-CoV-2 Infection

    VLA2001

    SARS-CoV-2 Infection

    Enrollment
    178
    Start
    May 2022
    Primary Completion
    Sep 2022
    Completion
    May 2023
    NCT05364242
  • Phase 2
    Completed

    Virological Response Study of the HCV Vaccine IC41

    IC41

    Chronic Hepatitis C

    Enrollment
    71
    Start
    Feb 2006
    Primary Completion
    Jul 2008
    Completion
    Jul 2008
    NCT00601770

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