CLINICAL TRIALS PROFILE FOR GARDASIL

All Clinical Trials for GARDASIL

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

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for GARDASIL

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for GARDASIL

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for GARDASIL
Clinical Trial Phase	Trials
Completed	10
Unknown status	2
Not yet recruiting	2

Clinical Trial Sponsors for GARDASIL

Sponsor Name

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

Sponsor Type

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

Last updated: April 23, 2026

Gardasil (HPV Vaccine): Clinical Trial Update, Market Analysis, and Projection

What is Gardasil in today’s product set?

Gardasil is the brand name for human papillomavirus (HPV) vaccines marketed by Merck in multiple formulations. In the US, Gardasil is represented by Gardasil 9 (9-valent HPV vaccine, 9vHPV), covering HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Gardasil 9 is the dominant commercial product in jurisdictions using the 9-valent formulation.

Core commercial relevance:

• Gardasil 9 is used for prevention of HPV-related disease including cervical precancer, cervical cancer, anal cancer, vulvar and vaginal precancers, penile cancer, and genital warts associated with vaccine HPV types.
• The product is embedded in national immunization programs and demand is driven by routine vaccination schedules and catch-up programs.

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What is the current clinical trial status for Gardasil?

This update focuses on the clinical pipeline activity that can move near-term product economics (new indications, label expansions, schedule changes, and durability/serostatus evidence) rather than completed efficacy readouts.

2024 to 2026 signal (ongoing/active activity):

• Ongoing post-licensure and real-world evidence generation continues to support broad use in adolescents and young adults, including studies aligned with national policy schedules and immunogenicity/efficacy bridging across age cohorts.
• For Gardasil 9 specifically, the core evidence base was established prior to 2020, and current trial activity is primarily durability, immunobridging, and program optimization rather than new HPV-type coverage.

Implication for near-term market risk:

• With the 9-valent clinical efficacy framework already established, new studies tend to support retention of current use patterns rather than create new revenue pools that would materially rebase demand in the next 12 to 24 months.

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How big is the HPV vaccine market and where does Gardasil sit?

The global HPV vaccine market is forecast to remain one of the most durable vaccine categories due to:

• Large eligible populations (pre-adolescent and adolescent cohorts plus catch-up)
• Long product lifecycles tied to national vaccination program procurement
• Ongoing expansion in coverage in lower-coverage geographies

Market structure

• Category demand is split between 2-valent competitors and 4-valent legacy products (historically) and 9-valent products (current preferred option in many markets).
• Gardasil 9 competes in the 9-valent segment and benefits from payer and guideline alignment in countries adopting 9-valent schedules.

Commercial drivers

1. Routine immunization coverage: uptake determines bulk procurement volume.
2. Catch-up programs: convert previously missed cohorts into new demand.
3. Tender cycles and geography mix: can shift volumes year-to-year even when underlying incidence is stable.
4. Guideline updates: support durable claims and reduce friction in public procurement.

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Which clinical and regulatory evidence most supports continued revenue?

Gardasil 9’s current market positioning is supported by long-established evidence for:

• High immunogenicity against all included HPV types
• Protection against HPV-related precancers and cancers
• Real-world effectiveness in vaccinated cohorts
• Safety profile consistent with vaccine class expectations

What matters commercially now:

• Age-range utilization (including older adolescents and selected adult groups, where policy allows)
• Schedule adherence feasibility for public programs
• Durability evidence supporting extended intervals and minimizing booster requirements (where policy permits)

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What is the near-term market trajectory for Gardasil?

Near-term trajectory is driven by procurement volumes and tender outcomes rather than novel clinical discoveries.

2024 to 2026 demand levers

• Southern Europe, Latin America, and parts of Asia/Africa: demand is sensitive to budget cycles and procurement execution. Where supply access improves, volumes rise.
• US and other high-coverage markets: volume growth is constrained by population demographics, with growth coming from incremental coverage and catch-up implementations.
• Competition in 9-valent segment: price pressure can occur where multiple 9-valent options are offered under tenders, but Merck maintains strong share in many markets due to program fit and procurement relationships.

What could move the curve down?

• Delays in tender cycles
• Policy shifts that change target ages or schedule structures
• Competitive pricing in government contracts that compresses gross margin

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Market projection: base case through 2028

Projection framework

Because HPV vaccine sales are dominated by:

• population cohorts entering routine vaccination ages,
• plus government procurement timing, and
• plus catch-up uptake,

the most reliable projection approach is to model category growth and then apply share and pricing assumptions for the 9-valent segment.

Base case (directional)

• Expect steady category growth with low-to-mid single digit CAGR dynamics driven by expanding coverage in underpenetrated markets.
• Gardasil 9 maintains share in high-coverage countries and remains the 9-valent default in many tenders, with potential periodic price pressure from competitive bids.

Bull case (directional)

• Faster catch-up uptake in priority geographies
• Better procurement execution and reduced tender delays
• Continued label/policy alignment that supports broad use and reduces program friction

Bear case (directional)

• Tender-driven pricing compression
• Coverage plateau in mature markets outpacing growth in emerging markets
• Competitive displacement in specific national programs

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Competitive positioning: why Gardasil’s economics remain resilient

Key resilience factors:

• 9-valent clinical breadth aligned with broad HPV disease prevention needs.
• Entrenchment in immunization program procurement structures.
• Durable safety and efficacy messaging that reduces prescriber and payer uncertainty.

Key pressure points:

• Government tender pricing.
• Switching costs at national program level when new tender specifications or product preferences emerge.
• Supply chain execution and cold-chain logistics continuity.

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Key risks and diligence checklist for investors

Clinical and policy risks

• Policy changes in eligible ages and schedule structures can change unit demand.
• Evidence review cycles that lead to updated immunization guidance can alter procurement patterns.

Commercial execution risks

• Tender timing can create quarter-to-quarter volatility.
• Price compression in competitive bids can affect revenue quality even if volumes hold.

Pipeline risks

• Gardasil’s core clinical value is already proven; pipeline risk is mostly related to label expansions that affect uptake rather than fundamental efficacy.

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What should companies infer from Gardasil’s current trial profile?

• The trial landscape for Gardasil is currently more about supporting utilization than creating new product-defining evidence.
• This shifts Gardasil’s risk profile toward market access, procurement execution, and pricing rather than scientific uncertainty.

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Key Takeaways

• Gardasil’s modern commercial footprint centers on Gardasil 9 (9-valent HPV vaccine covering HPV 6, 11, 16, 18, 31, 33, 45, 52, 58).
• Active clinical activity is largely post-licensure evidence, durability, and immunobridging that supports utilization and program fit, not new type coverage.
• Market growth depends mainly on vaccination coverage expansion, catch-up uptake, and tender execution, with share and price dynamics in the 9-valent segment shaping Gardasil’s revenue trajectory.
• Near-term outcomes (2024 to 2026) are more sensitive to procurement and pricing than to breakthrough clinical events.
• Projection through 2028 is best viewed as steady category growth with periodic price-driven volatility, where Gardasil remains a high-probability incumbent in 9-valent programs.

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FAQs

1) Is Gardasil still the main HPV vaccine brand by Merck in most markets?

Yes. In markets using the 9-valent formulation, Gardasil 9 is the operative product for Merck’s HPV vaccine commercial position.

2) What clinical evidence drives Gardasil’s current demand?

High immunogenicity and efficacy evidence against HPV types included in the 9-valent formulation, supported by long-standing safety and effectiveness data used in guideline-based procurement.

3) What most affects quarterly Gardasil sales?

Government and public payer procurement cycles plus tender pricing. Catch-up program execution can also shift short-term volumes.

4) How does competition impact Gardasil?

Competition primarily affects pricing in specific tender environments. Share retention depends on product inclusion in national immunization schedules and tender specifications.

5) What type of future clinical studies matter most for sales?

Studies that inform uptake policy, schedule optimization, and label/age-range expansion that can broaden target populations.

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References

[1] Merck & Co., Inc. GARDASIL 9 (human papillomavirus 9-valent vaccine, recombinant) Prescribing Information. (US label).
[2] World Health Organization (WHO). Human papillomavirus (HPV) vaccines: position papers and immunization recommendations.
[3] FDA. Vaccines Licensed for Human Use: HPV Vaccines (Gardasil/Gardasil 9). FDA product and regulatory information.
[4] Centers for Disease Control and Prevention (CDC). HPV Vaccine Recommendations (immunization schedules and guidance).
[5] Gavi, the Vaccine Alliance. HPV vaccine introduction and country coverage resources.