CLINICAL TRIALS PROFILE FOR GARDASIL 9

All Clinical Trials for GARDASIL 9

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00520598 ↗	Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)	Completed	Merck Sharp & Dohme Corp.	Phase 2	2007-10-01	The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)
NCT00806676 ↗	Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease	Completed	Merck Sharp & Dohme Corp.	N/A	2008-12-01	People with chronic kidney disease are known to have immune response abnormalities, including a diminished response to some vaccinations. Those with chronic kidney disease have a disproportionate burden of HPV 6-, 11-, 16- and/or 18-related genital tract disease. Due to immune response abnormalities, the CKD population may or may not respond to the recommended three-dose regimen of Gardasil®, a vaccine intended to protect against HPV 6-, 11-, 16-, and 18-related genital tract disease. The objective of this study is to measure the antibody response to Gardasil® in female patients 9-21 years of age with chronic kidney disease (CKD) (Stage 1-4), end-stage kidney disease (Stage 5 CKD), and status-post kidney transplant. Gardasil® vaccine will be administered according to the FDA-approved schedule. Blood samples to measure antibody levels to vaccine strains of human papillomavirus (HPV) will be obtained at months 0, 7 and 24.
NCT00806676 ↗	Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease	Completed	Johns Hopkins University	N/A	2008-12-01	People with chronic kidney disease are known to have immune response abnormalities, including a diminished response to some vaccinations. Those with chronic kidney disease have a disproportionate burden of HPV 6-, 11-, 16- and/or 18-related genital tract disease. Due to immune response abnormalities, the CKD population may or may not respond to the recommended three-dose regimen of Gardasil®, a vaccine intended to protect against HPV 6-, 11-, 16-, and 18-related genital tract disease. The objective of this study is to measure the antibody response to Gardasil® in female patients 9-21 years of age with chronic kidney disease (CKD) (Stage 1-4), end-stage kidney disease (Stage 5 CKD), and status-post kidney transplant. Gardasil® vaccine will be administered according to the FDA-approved schedule. Blood samples to measure antibody levels to vaccine strains of human papillomavirus (HPV) will be obtained at months 0, 7 and 24.
NCT00911521 ↗	Immunogenicity and Safety of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With SLE: a Controlled Study	Completed	Tuen Mun Hospital	Phase 4	2009-10-01	The purpose of this trial is to study the effect of Human Papillomavirus (HPV) vaccination on the elevation of antibody titer to 4 serotypes of HPV in patients with systemic lupus erythematous and compare the antibody response with an equal number of age-matched healthy women.
NCT00941889 ↗	The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata	Completed	Washington University School of Medicine	N/A	2007-07-01	The primary objective of this pilot study is to evaluate the effect of the HPV vaccine Gardasil on anal condylomata recurrence and persistence rates in HIV positive patients.
NCT01133509 ↗	A Model for Implementation of Cervical Cancer Screening and HPV Vaccination the Emergency Department: a Pilot Study	Unknown status	Merck Sharp & Dohme Corp.	N/A	2009-09-01	In this pilot study, we intend to demonstrate that a great portion of women at high risk (inadequate screening, HPV 16/18 and/or cytology) are presenting to the ED, cytology/ HPV testing via ThinPrep®Pap testTM and surveillance. We intend to provide improved access to healthcare and monitoring through administration of vaccine to eligible patients and 1 year follow up for patients involved in this study. Females meeting inclusion/exclusion criteria participating in the study (n=100) that have not had a cytology test in 2 or more years will be offered the Thin Prep® cytology test. This study will allow surveillance of disease through cytology and HPV DNA testing via collection of data using Thin Prep® cytology with reflex HPV DNA testing according to established guidelines as described below. Provide improved access to healthcare and monitoring through administration of vaccine for eligible females as established by guidelines. Patients will receive first vaccine in the ED and will have arranged follow up for administration of the 2 month and 6 month series of the HPV vaccination. Through data collection, we intend to determine if there is a need for vaccination and determine if patients are likely to follow up..
NCT01133509 ↗	A Model for Implementation of Cervical Cancer Screening and HPV Vaccination the Emergency Department: a Pilot Study	Unknown status	Eastern Virginia Medical School	N/A	2009-09-01	In this pilot study, we intend to demonstrate that a great portion of women at high risk (inadequate screening, HPV 16/18 and/or cytology) are presenting to the ED, cytology/ HPV testing via ThinPrep®Pap testTM and surveillance. We intend to provide improved access to healthcare and monitoring through administration of vaccine to eligible patients and 1 year follow up for patients involved in this study. Females meeting inclusion/exclusion criteria participating in the study (n=100) that have not had a cytology test in 2 or more years will be offered the Thin Prep® cytology test. This study will allow surveillance of disease through cytology and HPV DNA testing via collection of data using Thin Prep® cytology with reflex HPV DNA testing according to established guidelines as described below. Provide improved access to healthcare and monitoring through administration of vaccine for eligible females as established by guidelines. Patients will receive first vaccine in the ED and will have arranged follow up for administration of the 2 month and 6 month series of the HPV vaccination. Through data collection, we intend to determine if there is a need for vaccination and determine if patients are likely to follow up..

Clinical Trial Conditions for GARDASIL 9

Condition Name

Condition Name for GARDASIL 9
Intervention	Trials
HIV	2
Cervical Cancer	2
Systemic Lupus Erythematosus	2
Human Papilloma Virus	2

Condition MeSH

Condition MeSH for GARDASIL 9
Intervention	Trials
Papillomavirus Infections	6
Uterine Cervical Neoplasms	4
Papilloma	4
Neoplasms	3

Clinical Trial Locations for GARDASIL 9

Trials by Country

Trials by Country for GARDASIL 9
Location	Trials
United States	8
China	5
Canada	3
France	1
Sweden	1

Trials by US State

Trials by US State for GARDASIL 9
Location	Trials
Georgia	2
Massachusetts	1
North Carolina	1
Michigan	1
Virginia	1

Clinical Trial Progress for GARDASIL 9

Clinical Trial Phase

Clinical Trial Phase for GARDASIL 9
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	5
Phase 3	5

Clinical Trial Status

Clinical Trial Status for GARDASIL 9
Clinical Trial Phase	Trials
Completed	10
Not yet recruiting	2
Active, not recruiting	2

Clinical Trial Sponsors for GARDASIL 9

Sponsor Name

Sponsor Name for GARDASIL 9
Sponsor	Trials
Merck Sharp & Dohme Corp.	9
National Cancer Institute (NCI)	2
Zagazig University	1

Sponsor Type

Sponsor Type for GARDASIL 9
Sponsor	Trials
Other	21
Industry	13
NIH	3

GARDASIL 9 Market Analysis and Financial Projection

Last updated: February 11, 2026

What is the current status of GARDASIL 9 clinical trials?

GARDASIL 9, developed by Merck, is approved for the prevention of human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Its clinical development primarily involves post-marketing studies, with ongoing research focusing on expanding indications like therapeutic use and immunogenicity in different populations.

As of Q4 2022, no new phase 3 registration trials are active for GARDASIL 9. Merck’s focus has shifted toward real-world effectiveness studies and vaccination coverage assessments. The company maintains a portfolio of post-approval observational studies targeting long-term safety and the vaccine's protection durability. These include surveillance of adverse events following immunization (AEFIs) and efficacy in specific subpopulations such as immunocompromised individuals.

Additionally, phase 4 studies are underway in regions like Asia and Africa to evaluate vaccine performance in diverse demographic settings. Data from these studies are expected to inform future booster strategies and potential label expansions.

How does GARDASIL 9 compare to competing HPV vaccines in the market?

Vaccine	HPV Types CoveredView	Approved Age Range	Dose Schedule	Market Share (2022)	Notable Features
GARDASIL 9	6, 11, 16, 18, 31, 33, 45, 52, 58	9–45 years	2 or 3 doses (depending on age at vaccination)	65%	Broadest HPV type coverage, strong safety profile
Cervarix	16, 18	9–25 years	3 doses	20%	Focuses on high-risk HPV types 16 and 18
Gardasil (quadrivalent)	6, 11, 16, 18	9–26 years	3 doses	10%	Older formulation, largely replaced by GARDASIL 9 in many markets

GARDASIL 9 holds a dominant market position owing to its expanded HPV type coverage, which translates to broader protection compared to earlier vaccines like Cervarix and the quadrivalent Gardasil.

What are the recent market trends and projections for GARDASIL 9?

Market Trends

• The global HPV vaccine market reached approximately $4.2 billion in revenue in 2022, driven by increasing vaccination rates in developed countries and rising awareness in emerging markets.
• GARDASIL 9 accounts for roughly 65% of the market share, reflecting its superiority in range, safety, and publisher approval rates.
• Gavi and other global health agencies increasingly promote GARDASIL 9 to address HPV-related cancers and genital warts.

Market Drivers

• Increasing vaccination programs targeting adolescents and young adults.
• Government policies expanding HPV vaccination age coverage.
• Growing recognition of HPV's role in multiple cancers beyond cervical, including anal, oropharyngeal, and penile cancers.
• Patent exclusivity until 2027 in major markets, such as the US and EU, secures Merck’s market share.

Market Projections (2023-2030)

Year	Estimated Market Size	Growth Rate	Major Influencing Factors
2023	$4.4 billion	4.8%	Expansion in emerging markets, increased awareness
2025	$5.4 billion	6.2%	Implementation of school-based vaccination programs
2030	$6.8 billion	8.1%	Broader age group coverage, new policy mandates

By 2030, the market is expected to grow significantly, influenced by policy shifts and the integration of HPV vaccination into routine immunization schedules globally.

What are the regulatory and patent considerations affecting GARDASIL 9?

GARDASIL 9 received approval from the US FDA in 2014 and the European EMA in 2015. It is protected by multiple patents extending to at least 2027, covering composition, manufacturing processes, and vaccine formulations. Patent expiry opens the door for biosimilar or generic competition, but as of the latest data, no biosimilar versions have advanced beyond development phases.

Regulatory landscapes are evolving to include recommendations for males and older age groups, which could potentially expand GARDASIL 9’s authorized indications. Recent approvals in countries like India and China reflect its growing acceptance.

What is the outlook for GARDASIL 9's commercial performance?

Continuing market expansion hinges on increasing vaccination rates, especially in low- and middle-income countries (LMICs). Gavi’s support and tiered pricing programs have facilitated access, but disparities remain.

Merck’s pipeline may influence future revenue streams through even broader indications or booster formulations. The company is also developing next-generation vaccines with broader type coverage and enhanced immunogenicity, which could pressure GARDASIL 9’s market share in the long term.

Key Takeaways

• GARDASIL 9 remains the market leader, with a dominant share driven by its broad HPV coverage.
• Market growth in the next decade hinges on policy adoption, vaccination campaigns, and expanding access in LMICs.
• No new phase 3 data or approval filings are pending; current focus is on post-marketing surveillance and expanding indications.
• Patent exclusivity likely limits biosimilar entry until 2027, protecting Merck’s revenue.
• Future growth may be challenged by next-generation vaccines and aggregate immunization strategies.

5 Frequently Asked Questions

1. When is GARDASIL 9 expected to face biosimilar competition?
Patent protections extend until at least 2027. Biosimilar development is underway but faces regulatory and technical hurdles; commercial entry is unlikely before 2027.

2. Are there plans to expand GARDASIL 9 indications?
No announced regulatory filings for new indications. Ongoing studies aim to assess efficacy in males beyond age 45 and in immunocompromised populations.

3. How does GARDASIL 9 perform in real-world effectiveness studies?
Data shows sustained protection over five years post-vaccination, with reduced HPV infection rates and associated lesions in vaccinated populations.

4. What regions are prioritized for GARDASIL 9 market expansion?
Asia, Africa, and Latin America present growth opportunities through increased government funding, integrating HPV vaccines into national immunization programs.

5. What are the main safety concerns associated with GARDASIL 9?
Post-marketing data indicate a safety profile consistent with clinical trials. Common side effects include pain at injection site, headache, and fatigue. Rare adverse events are monitored continuously.

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References

[1] Merck & Co. GARDASIL 9 product monograph, 2022.
[2] MarketResearch.com. HPV Vaccines Market Analysis, 2022.
[3] WHO Strategic Advisory Group of Experts (SAGE): HPV vaccination recommendations, 2021.
[4] FDA approval letter, GARDASIL 9, 2014.
[5] European Medicines Agency (EMA): GARDASIL 9 authorisation details, 2015.