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9vHPV Vaccine

Phase 3

Dengue Fever | Monoclonal antibody | Infectious Disease |Takeda Pharmaceutical Company Limited|Last Updated: Feb 7, 2024

Success Probability

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment614

FDA Designations

No designations recorded

Clinical trial landscape

9vHPV Vaccine · 1 trial · 1 indication

Phase 3 1
NCT04313244Immunogenicity and Safety of Dengue Tetravalent Vaccine (TDV) and Recombinant 9-valent Human Papillomavirus Vaccine (9vHPV) in Participants Aged ≥9 to <15 YearsDengue Fever
COMPLETED614 Analytics
PHASE3COMPLETED
Immunogenicity and Safety of Dengue Tetravalent Vaccine (TDV) and Recombinant 9-valent Human Papillomavirus Vaccine (9vHPV) in Participants Aged ≥9 to <15 Years
Dengue FeverUnlock trial analytics

Study Endpoints

Primary Endpoints

Geometric Mean Titers (GMTs) for Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, 58
Day 210 (Month 7)

GMTs for HPV were measured by immunoglobulin G binding assay (IgGBA) assay. HPV-6, HPV-11, HPV-16, HPV-18, HPV-31, HPV-33, HPV-45, HPV-52 and HPV-58 were the types of HPV analyzed.

Secondary Endpoints

Percentage of Participants With Seropositivity for HPV Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 as Measured by Immunoglobulin G Binding Assay (IgGBA)
Day 210 (Month 7)
GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes
Day 120 (Month 4)
Percentage of Participants With Seropositivity for Each of the 4 Dengue Serotypes
Day 120 (Month 4)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
9vHPV+TDVEXPERIMENTALParticipants will receive 0.5 mL 9vHPV intramuscularly (IM) with 0.5 mL TDV subcutaneously (SC) once on Day 1 (Month 0) followed by 0.5 mL TDV SC once on Day 90 (Month 3) and 0.5 mL 9vHPV IM once on Day 180 (Month 6).
9vHPVEXPERIMENTALParticipants will receive 0.5 mL 9vHPV vaccine IM once on Day 1 (Month 0) followed by 0.5 mL 9vHPV vaccine IM once on Day 180 (Month 6).

Interventions

NameTypeDescription
9vHPV VaccineBIOLOGICAL9vHPV intramuscular injection
Dengue Tetravalent Vaccine (TDV)BIOLOGICALTDV subcutaneous injection
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Eligibility Criteria

Age Range9 Years to 14 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: 1. Participants who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and the clinical judgment of the investigator. 2. Participants who can comply with trial procedures and are available for th...

Countries:Thailand
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Frequently asked questions about 9vHPV Vaccine

What is 9vHPV Vaccine used for?

9vHPV Vaccine is a recombinant 9-valent human papillomavirus vaccine being studied in participants aged 9 to under 15 years. It is being evaluated in a Phase 3 clinical trial for its immunogenicity and safety, with the trial also assessing a dengue tetravalent vaccine. The vaccine is intended for use in infectious disease prevention.

Who makes 9vHPV Vaccine?

9vHPV Vaccine is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting a Phase 3 clinical trial to evaluate the vaccine's immunogenicity and safety in participants aged 9 to under 15 years.

What phase is 9vHPV Vaccine in?

9vHPV Vaccine is in Phase 3 clinical development. It is an investigational vaccine, not yet approved, and is being studied in a completed Phase 3 trial (NCT04313244) that evaluated its immunogenicity and safety in 614 participants aged 9 to under 15 years.

What clinical trials is 9vHPV Vaccine in?

9vHPV Vaccine is associated with one completed Phase 3 clinical trial, NCT04313244, titled 'Immunogenicity and Safety of Dengue Tetravalent Vaccine (TDV) and Recombinant 9-valent Human Papillomavirus Vaccine (9vHPV) in Participants Aged ≥9 to <15 Years'. The trial enrolled 614 participants in Thailand and was controlled but not double-blind.

Is 9vHPV Vaccine the same as a dengue vaccine?

No, 9vHPV Vaccine is a recombinant 9-valent human papillomavirus vaccine, not a dengue vaccine. It was studied alongside a dengue tetravalent vaccine in the same clinical trial, NCT04313244, which evaluated both vaccines' immunogenicity and safety in participants aged 9 to under 15 years.