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Human Papillomavirus 9-valent Vaccine

Phase 3

Meningococcal Immunisation | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Sep 12, 2025

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment463

FDA Designations

No designations recorded

Clinical trial landscape

Human Papillomavirus 9-valent Vaccine · 1 trial · 2 indications

Phase 3 1
NCT04490018Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or With Two Other Vaccines in Healthy AdolescentsMeningococcal Immunisation
COMPLETED463 Analytics
PHASE3COMPLETED
Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or With Two Other Vaccines in Healthy Adolescents
Meningococcal ImmunisationUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® Vaccine (Non-inferiority Analysis): Groups 1 and 2
Day 31 (post-vaccination)

Antibody titers against meningococcal serogroups A, C, W, and Y were measured by serum bactericidal assay using human complement (hSBA). Non-inferiority data analysis for this outcome measure was planned to be conducted only for Groups 1 and 2, not for Group 3. Group 3 data is reported separately.

Secondary Endpoints

Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W
Day 01 (pre-vaccination) and Day 31 (post-vaccination)
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W
Day 01 (pre-vaccination) and Day 31 (post-vaccination)
Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W
From Baseline (Day 01) to Day 31 (post-vaccination)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)EXPERIMENTALParticipants received 0.5-milliliter (mL) intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)ACTIVE_COMPARATORParticipants received 0.5-mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)EXPERIMENTALParticipants received 0.5-mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.

Interventions

NameTypeDescription
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine)BIOLOGICALPharmaceutical form: Liquid solution for injection Route of administration: Intramuscular
Meningococcal group A, C, W-135, and Y conjugate vaccineBIOLOGICALPharmaceutical form: Powder and solvent for solution for injection Route of administration: Intramuscular
Human Papillomavirus 9-valent Vaccine (9vHPV)BIOLOGICALPharmaceutical form: Suspension for injection Route of administration: Intramuscular
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV)BIOLOGICALPharmaceutical form: Suspension for injection Route of administration: Intramuscular
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Eligibility Criteria

Age Range10 Years to 17 Years
SexALL
Healthy VolunteersYes
Study Sites23

Inclusion Criteria: * Aged 10 to 17 years on the day of inclusion ('10 to 17 years' means from the day of the 10th birthday to the day before the 18th birthday). * Meningococcal serogroup C Conjugate vaccine (MenC) naïve participants or participants having received monovalent MenC priming in infanc...

Countries:HungaryItalySingaporeSpain
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Frequently asked questions about Human Papillomavirus 9-valent Vaccine

What is Human Papillomavirus 9-valent Vaccine used for?

Human Papillomavirus 9-valent Vaccine is being studied for meningococcal immunisation in healthy adolescents. It is an investigational monoclonal antibody in Phase 3 clinical development, evaluated for its ability to provide protection against meningococcal disease.

Who makes Human Papillomavirus 9-valent Vaccine?

Sanofi (ticker: SNY) is developing Human Papillomavirus 9-valent Vaccine. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy for meningococcal immunisation in adolescent populations.

What phase is Human Papillomavirus 9-valent Vaccine in?

Human Papillomavirus 9-valent Vaccine is in Phase 3 clinical development. It is an investigational product, not yet approved, and is being studied for meningococcal immunisation in healthy adolescents.

What clinical trials is Human Papillomavirus 9-valent Vaccine in?

Human Papillomavirus 9-valent Vaccine is associated with clinical trial NCT04490018, a Phase 3 study comparing a quadrivalent meningococcal conjugate vaccine to a reference vaccine in healthy adolescents. The trial enrolled 463 participants across Hungary, Italy, Singapore, and Spain.

How does Human Papillomavirus 9-valent Vaccine work?

Human Papillomavirus 9-valent Vaccine is a monoclonal antibody designed to target meningococcal bacteria. It is being evaluated for its ability to stimulate an immune response that provides protection against meningococcal disease in healthy adolescents.