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..

Clinical Trial Conditions for GARDASIL

Condition Name

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

Condition MeSH

Condition MeSH for GARDASIL
Intervention	Trials
Papillomavirus Infections	6
Papilloma	4
Uterine Cervical Neoplasms	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
Netherlands	1
Egypt	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
Active, not recruiting	2
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
Johns Hopkins University	1

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for GARDASIL

Last updated: October 31, 2025

Introduction

GARDASIL, developed by Merck & Co., Inc., has established itself as a leading prophylactic vaccine targeting human papillomavirus (HPV). Since its initial approval for prevention of HPV types 6, 11, 16, and 18, GARDASIL has undergone continuous clinical assessment and market evolution. As HPV-associated cancers and warts represent significant global health burdens, ongoing clinical trials, market dynamics, and future projections are critical for stakeholders.

Clinical Trials Update

Recent Clinical Trials and Efficacy Data

Recent phases of GARDASIL's clinical trials focus on extending protection, safety, and even therapeutic potential. Notably, GARDASIL 9, the expanded formulation covering nine HPV types, remains the centerpiece of ongoing research.

• Long-term efficacy studies demonstrate sustained immunity with up to 10 years of follow-up [1]. Data indicate over 95% efficacy in preventing persistent infections with HPV 16, 18, 6, and 11, translating to significant reductions in precancerous lesions.
• Expanded age group trials now examine efficacy in individuals up to age 45, aiming to broaden vaccination guidelines. The FDA has approved GARDASIL 9 for use in adults aged 27–45, supported by data showing up to 88% efficacy in preventing HPV-related anal, vulvar, and vaginal neoplasias [2].
• Therapeutic potential trials are exploring GARDASIL’s role in treating existing HPV infections and associated lesions. However, current vaccines are primarily prophylactic, with ongoing research seeking to clarify therapeutic benefits.

Safety Profile and Adverse Events

Clinical data reaffirm GARDASIL’s strong safety profile. Common adverse events include mild injection site reactions and transient systemic symptoms [1]. Rare adverse effects, such as syncope, are carefully monitored, with no new safety signals detected in recent studies.

New Formulations and Delivery Methods

Research initiatives are exploring alternative delivery systems, such as micro-needle patches and thermostable formulations, to enhance accessibility, particularly in low-resource settings. Additionally, combinations with other vaccines are under consideration to streamline immunization schedules.

Market Analysis

Current Market Landscape

GARDASIL has achieved a dominant position within the HPV vaccine market, accounting for approximately 70% of the global HPV vaccine sales in 2022 [3]. Its widespread approval across multiple countries, including the US, EU, and emerging markets, reinforces its market leadership.

• Global sales reached approximately $4.2 billion in 2022, driven by vaccine demand in North America, Europe, and Asia-Pacific.
• Pricing strategies vary by region, influenced by healthcare policies, licensing agreements, and manufacturing costs. Developed nations benefit from government-funded vaccination programs, while price-sensitive markets face challenges due to affordability.

Market Drivers

• Rising incidence of HPV-related cancers, notably cervical, oropharyngeal, anal, and penile cancers, fuels demand. According to WHO, approximately 600,000 new cases of cervical cancer occur globally annually, with vaccination being a key preventive tool [4].
• Government and WHO initiatives aiming for universal HPV vaccination coverage amplify market potential. The WHO's target for 90% of girls vaccinated by 15 years of age globally by 2030 underpins aggressive policy drives.
• Evolving vaccination guidelines recommending catch-up vaccination for males and older populations expand the target demographic.

Market Challenges

• Vaccine hesitancy persists, especially in certain regions due to misinformation.
• Cost and access barriers in low- and middle-income countries limit implementation.
• Patent protections may influence pricing dynamics and generic entry, potentially affecting revenue streams.

Competitive Landscape

GARDASIL faces competition primarily from Cervarix (GlaxoSmithKline), which offers a bivalent HPV vaccine targeting types 16 and 18. However, the expanded coverage of GARDASIL 9 and evolving clinical data give it a competitive edge. Emerging players are exploring novel HPV vaccines with potentially broader serotype coverage and therapeutic properties.

Market Projection and Future Outlook

Short-Term (Next 3-5 Years)

Analysts project the global HPV vaccine market will grow at a CAGR of approximately 7%, reaching $6.2 billion by 2027. This growth hinges on:

• Expanded vaccination coverage in developing regions,
• Increased acceptance among males and older demographics,
• Implementation of combined vaccination campaigns and multi-dose reductions.

GARDASIL is expected to sustain a dominant market share given its broad approval, established efficacy, and ongoing clinical trials fortifying its profile.

Long-Term (Next 10-15 Years)

The long-term outlook encompasses several transformative elements:

• Potential shift toward therapeutic vaccines for HPV-associated malignancies could redefine treatment paradigms. While GARDASIL remains prophylactic, adjunct or therapeutic vaccines in pipeline may influence its market position.
• Integration into broader cancer prevention strategies and potentially rejuvenating public health impact, especially as more data support extended age ranges.
• Development of next-generation HPV vaccines with broader serotypes or enhanced immunogenicity could challenge GARDASIL's dominance but also open avenues for combination strategies.

Furthermore, public health policy momentum towards universal vaccination—particularly in low-resource settings—may catalyze market expansion, especially as generic versions emerge post-patent expiry.

Regulatory and Strategic Outlook

Regulatory agencies globally continue to endorse GARDASIL. The company’s strategic focus on updating vaccination guidelines, conducting phase IV studies for long-term efficacy, and investing in novel delivery systems positions GARDASIL to maintain relevance. Merck's collaborations with global health organizations are vital in increasing access and accelerating uptake.

Key Takeaways

• Clinical data upholds GARDASIL’s safety, efficacy, and durability, confirming its role as a cornerstone in HPV prevention.
• Market leadership remains robust, driven by high efficacy, broad serotype coverage, and global vaccination initiatives.
• Market growth is poised to continue, especially through expansion in low- and middle-income regions, demographic broadening, and policy support.
• Challenges include vaccine hesitancy, access disparities, and emerging competitors; addressing these is pivotal for sustained growth.
• Future innovations such as therapeutic vaccines and improved delivery systems may redefine the landscape but will likely complement GARDASIL rather than eliminate its relevance.

Conclusion

GARDASIL’s trajectory remains positive, buoyed by robust clinical evidence and a strategic focus on expanding access and indications. Stakeholders must monitor ongoing trials, regulatory developments, and market dynamics to optimize investments and public health strategies.

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FAQs

1. What are the latest clinical trial findings for GARDASIL?
Recent studies confirm long-term protection up to 10 years with high efficacy against targeted HPV types and a favorable safety profile. Trials are exploring expanded age groups and potential therapeutic roles.

2. How does GARDASIL compare with its competitors?
GARDASIL’s broad serotype coverage (nine types) and extensive approval base give it a competitive advantage over vaccines like Cervarix, which covers fewer types. Ongoing clinical trials and new formulations aim to further consolidate its market position.

3. What is the current market outlook for GARDASIL?
The global market is expected to grow at a CAGR of approximately 7%, reaching over $6 billion by 2027, driven by increased vaccination initiatives and expanding indications.

4. Are there any recent regulatory updates affecting GARDASIL?
Yes. The FDA and EMA continue to endorse GARDASIL 9 for various age groups, including adults up to 45, facilitating broader clinical and commercial deployment.

5. What future innovations can influence GARDASIL’s market share?
Development of therapeutic vaccines, thermostable formulations, combination vaccines, and broader serotype coverage could enhance preventive strategies and reinforce GARDASIL’s leadership.

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Sources

[1] Merck & Co., Inc. GARDASIL Data Sheet. (2022).
[2] U.S. Food and Drug Administration (FDA). GARDASIL 9 approval updates. (2021).
[3] IQVIA Institute. Global HPV vaccine market report. (2022).
[4] World Health Organization (WHO). Human papillomavirus vaccines and cervical cancer prevention. (2022).