Moffitt logo
    Search

    Choose a type to search within:

    All Doctors Clinical Trials Researchers
    search icon
    • Schedule
      New Patients
       
      Referring Physicians
    • Locations
      Magnolia
       
      McKinley
       
      Wesley Chapel
       
      International Plaza
       
      Moffitt at Memorial
       
      Fowler
       
      Telecomm/Intellicenter
    • Find a Doctor
    • MyMoffitt Portal
      Log In
       
      Enroll
    • Donate
    • 1-888-663-3488
    • image Search
    • Cancer Types & Treatments
        Cancers We Treat
      • Adrenal
      • Anal
      • Appendiceal (Appendix)
      • Astrocytoma
      • Basal Cell Carcinoma
      • Bladder
      • Bone Metastasis
      • Brain
      • Brain Tumor
      • Breast
      • Cervical
      • Cholangiocarcinoma (Bile Duct )
      • Colon
      • Colorectal
      • Cutaneous T-Cell Lymphoma
      • Ductal Carcinoma In Situ
      • Endometrial (Uterine)
      • Esophageal
      • Gallbladder
      • Gastrointestinal Carcinoid Tumor
      • GIST (Gastrointestinal Stromal Tumor)
      • Glioblastoma
      • Head and Neck
      • HER2 Positive Breast
      • Hodgkin Lymphoma
      • Inflammatory Breast
      • Invasive Ductal Carcinoma
      • Kidney (Renal Cell)
      • Leukemia
      • Liver (Hepatocellular)
      • Lung
      • Lymphomas (Hodgkin and Non-Hodgkin)
      • Melanoma
      • Meningioma
      • Merkel Cell Carcinoma
      • Mesothelioma
      • Metastatic Breast
      • Multiple Myeloma-Plasma Cell Tumor
      • Myelodysplastic Syndromes (MDS)
      • Neuroendocrine Tumor
      • Neurofibromatosis
      • Non-Hodgkin Lymphoma
      • Oral Cavity (Mouth)
      • Oral Cavity or Throat
      • Osteosarcoma
      • Ovarian
      • Pancoast Tumor
      • Pancreatic
      • Penile
      • Pituitary Adenoma
      • Prostate
      • Rectal
      • Sarcoma
      • Skin (Nonmelanoma)
      • Skull Base Tumors
      • Small Intestine
      • Spinal Tumor
      • Squamous Cell Carcinoma
      • Stomach (Gastric)
      • Testicular
      • Throat
      • Thymoma
      • Thyroid
      • Tongue
      • Tracheal
      • Triple Negative Breast
      • Vaginal
      • Vulvar
        Cancer Diagnostics and Treatments
      • Blood & Bone Marrow Transplant
      • Cardio-Oncology
      • Chemotherapy
      • Clinical Pathways
      • Clinical Trials
      • Endoscopic Procedures
      • Fertility Preservation
      • Gynecologic Oncology
      • Immunotherapy
      • Interventional Pain Management
      • Interventional Radiology
      • Personalized Medicine
      • Pharmacy
      • Radiation Therapy
      • Rehabilitation Services
      • Supportive Care Medicine
      • Surgical Care
      • Systemic Therapy
      • Targeted Therapy
      • Tumor Board
        Diagnostic Services
      • Radiology – Diagnostic Imaging and Interventional Radiology
      • Genetic Counseling and Genetic Testing
      • Pathology
      • Labwork and Bloodwork
      • Cancer Screenings
    • Patients & Families
        Patients and Families Resources Overview
      • International Referral Services
      • Moffitt Virtual Visits
      • Taking Care of Your Health
        Preparing For Your Appointment
      • Scheduling Your Appointment
      • MyMoffitt Patient Portal
      • Patient and Family Orientation
      • Patient Rights and Responsibilities
      • Medical Records
      • Traveling for Cancer Treatment
        Insurance & Financial Information
      • Insurance Coverage
      • Health Exchange
      • Medicare Coverage
      • Copay Assistance Program
      • Financial Assistance
      • Financial Information
      • Obtain a Cost Estimate
      • Understanding Your Bill
      • Frequently Asked Questions
        Programs & Support Services
        Patient and Family-Centered Care
        Cancer Survivorship
        Caregivers and Families
    • For Healthcare Professionals
        For Healthcare Professionals Overview
      • Clinical Perspectives
        Programs & Services
      • Adolescent & Young Adult (AYA)
      • Anesthesiology
      • BMT and Cellular Immunotherapy
      • Breast Oncology
      • Cardio-Oncology
      • Cutaneous Oncology
      • Diagnostic Imaging and Interventional Radiology
      • Endocrine Oncology
      • Gastrointestinal Oncology
      • Genetic Counseling
      • Genitourinary Oncology
      • Gynecologic Oncology
      • Head and Neck Oncology
      • Immunotherapy
      • Malignant Hematology
      • Moffitt Malignant Hematology & Cellular Therapy at Memorial Healthcare System
      • Neuro-Oncology
      • Pathology
      • Pharmacy
      • Radiation Oncology
      • Sarcoma
      • Screening & Prevention
      • Senior Adult Oncology
      • Supportive Care Medicine
      • Thoracic Oncology
        Physician Relations
        Continuing Education
      • Provider Conferences
      • Moffitt Grand Rounds
      • Multidisciplinary Programs
    • Research
        Research Overview
        CCSG Programs
      • Cancer Biology and Evolution
      • Cancer Epidemiology
      • Health Outcomes & Behavior
      • Immuno-Oncology
      • Molecular Medicine
        Divisions and Departments
      • Biostatistics and Bioinformatics
      • Cancer Epidemiology
      • Drug Discovery
      • Health Outcomes and Behavior
      • Immunology
      • Integrated Mathematical Oncology
      • Machine Learning
      • Metabolism and Physiology
      • Molecular Oncology
      • Tumor Biology
        Centers and Institutes
      • Institutes
      • Centers of Excellence
        Shared Resources
      • Analytic Microscopy
      • Biostatistics and Bioinformatics
      • Cancer Pharmacokinetics and Pharmacodynamics
      • Cell Therapies
      • Chemical Biology
      • Collaborative Data Services
      • Flow Cytometry
      • Gene Targeting
      • Molecular Genomics
      • Participant Research, Interventions, and Measurement Core (PRISM)
      • Proteomics and Metabolomics
      • Quantitative Imaging Core
      • Small Animal Imaging Lab
      • Tissue
        Research Education and Training
      • Office of Postdoctoral Affairs
      • Office of Graduate Affairs
      • Office of Undergraduate and Visiting Scholar Affairs
      • What We Provide
        Community Outreach, Engagement, and Equity
      • About Us
      • Catchment Area Cancer Data
      • Moffitt Outreach in the Community
      • Research in the Community
      • Education and Outreach Resources
      • Get Involved
        Innovation and Industry Alliances
      • Available Technologies
      • Business of Biotech
      • Events
      • Internship Programs
      • Technology And Innovation Fund
      • Contact Us
    • Training & Education
        Training and Education Overview
      • Moffitt Innovators of Tomorrow Symposium
        Medical Education
      • Program Staff/Contact Us
      • Our Training Programs
      • Salary and Benefits
        Research Education and Training
      • Office of Postdoctoral Affairs
      • Office of Graduate Affairs
      • Office of Undergraduate and Visiting Scholar Affairs
      • What We Provide
      • Where Are They Now
        Nursing Education
      • Oncology Nurse Residency Program
      • Ambulatory Care Oncology Nurse Residency Program
      • Registered Nurse
      • Nurse Anesthetist
      • Nurse Practitioner
        Health Professional Education
        Continuing Education
        Other Educational Programs
    • Give
        Give Overview
        Ways to Give
      • Cash, Stock or Other Assets
      • Planned Giving
      • Philanthropic Foundation Giving
      • Corporate Partnership
      • Employer Matching Gifts
      • Endowment Gifts
      • Other Ways to Donate
        Get Involved
      • Become a Member
      • Join a Community Partner Event
      • Volunteer Your Time
      • Miles for Moffitt
      • Magnolia
      • Mission Possible Sarasota Luncheon
      • Discovery Series Webinars
        Why Give?
      • About the Moffitt Foundation
      • FAQ
      • Financials and Stewardship
      • Contact the Foundation
      • You Can Make a Difference
      • 2021 Annual Foundation Impact Report
    1. Home
    2. Newsroom
    3. Press Release Archive
    4. 2011
    5. New England Journal of Medicine Publishes Efficacy and Safety Data for GARDASIL® in Males
    • click to share
      Facebook
      Twitter
      Linkedin
      Pinterest
      Email
    • click to print

    New England Journal of Medicine Publishes Efficacy and Safety Data for GARDASIL® in Males

    February 02, 2011

    WHITEHOUSE STATION, N.J. – Merck (known as MSD outside the United States
    and Canada) announced today that data from the pivotal Phase III study with GARDASIL®
    [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] in males
    were published in the February 3 issue of the New England Journal of Medicine (NEJM).

    In this study, GARDASIL was 89 percent effective against human papillomavirus (HPV) types 6- and 11- related genital warts in males aged 16 through 26. This Phase III study is the only study to demonstrate the efficacy of an HPV vaccine in males, and provided data that supported the U.S. Food and Drug Administration (FDA) approval of GARDASIL in October 2009 for the prevention of genital warts caused by HPV types 6 and 11 in boys and men ages 9 to 26 years.

    In December 2010, GARDASIL was approved for the prevention of anal cancer caused
    by HPV types 16 and 18 and for the prevention of anal intraepithelial neoplasia (AIN) grades 1,
    2 and 3 (anal dysplasias and precancerous lesions) caused by HPV types 6, 11, 16 and 18, in
    males and females 9 through 26 years of age, based on a substudy within this Phase III study.

    “This publication as well as the recent FDA approval of GARDASIL to prevent anal
    cancer caused by HPV types 16 and 18 underscores the importance of vaccinating both males
    and females to help prevent certain HPV-related diseases,” said Dr. Anna Giuliano, chair,
    Department of Epidemiology and Genetics, and Program Leader Cancer Epidemiology at the
    Moffitt Cancer in Tampa, Florida, and the study’s lead author.

    GARDASIL helps protect against the four types of HPV, specifically types 6, 11, 16, and
    18, that cause the most disease. It is estimated that HPV types 16 and 18 account for
    approximately 80 percent of anal cancers, 75 percent of cervical cancers, 70 percent of vaginal
    cancers and 40 to 50 percent of vulvar cancers. HPV types 6 and 11 cause approximately
    90 percent of all genital warts cases.

    About HPV and GARDASIL
    In the United States, an estimated 75 to 80 percent of males and females will be infected
    with HPV in their lifetime. For most, HPV will clear on its own. However, for those who don't
    clear certain types, HPV can cause cervical, vaginal and vulvar cancers in women and anal
    cancer and genital warts in men and women. There is no way to predict who will or will not
    clear the virus.

    GARDASIL was first approved in the United States in June 2006. GARDASIL is
    indicated for use in girls and young women 9 through 26 years of age for the prevention of
    cervical, vulvar, vaginal and anal cancers caused by HPV types 16 and 18; genital warts
    (condylomata acuminata) caused by HPV types 6 and 11; and precancerous or dysplastic
    lesions caused by HPV types 6, 11, 16 and 18. GARDASIL is also approved in the United
    States for use in boys and men ages 9 through 26 years of age for the prevention of anal cancer
    caused by HPV types 16 and 18 and genital warts caused by HPV types 6 and 11; and
    precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.

    Important information about GARDASIL
    GARDASIL does not eliminate the necessity for women to continue to undergo
    recommended cervical cancer screening.

    Recipients of GARDASIL should not discontinue anal cancer screening if it has been
    recommended by a health care provider.

    GARDASIL has not been demonstrated to provide protection against diseases from
    vaccine and non-vaccine HPV types to which a person has previously been exposed through
    sexual activity.

    GARDASIL is not intended to be used for treatment of active external genital lesions;
    cervical, vulvar, vaginal, and anal cancers; cervical intraepithelial neoplasia, vulvar
    intraepithelial neoplasia, vaginal intraepithelial neoplasia, or anal intraepithelial neoplasia.
    GARDASIL has not been demonstrated to protect against disease due to HPV types not
    contained in the vaccine.

    Not all vulvar, vaginal and anal cancers are caused by HPV, and GARDASIL protects
    only against those vulvar, vaginal and anal cancers caused by HPV Types 16 and 18.
    Select safety information
    GARDASIL is contraindicated in individuals with hypersensitivity, including severe
    allergic reactions to yeast, or after a previous dose of GARDASIL.

    Because vaccinees may develop syncope, sometimes resulting in falling with injury,
    observation for 15 minutes after administration is recommended. Syncope, sometimes
    associated with tonic-clonic movements and other seizure-like activity, has been reported
    following vaccination with GARDASIL. When syncope is associated with tonic-clonic
    movements, the activity is usually transient and typically responds to restoring cerebral
    perfusion.

    GARDASIL is not recommended for use in pregnant women.

    The most common adverse reaction was headache. Common adverse reactions that
    were observed among recipients of GARDASIL at a frequency of at least 1.0 percent and
    greater than placebo were: fever, nausea, dizziness; and injection-site pain, swelling, erythema,
    pruritus and bruising.

    Dosage and administration for GARDASIL
    GARDASIL is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL should be
    administered in three separate intramuscular injections in the deltoid region of the upper arm or
    in the higher anterolateral area of the thigh. The following dosage schedule is recommended:
    First dose at elected date, second dose two months after the first dose and the third dose six
    months after the first dose.

    GARDASIL is approved in 122 countries
    GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine,
    Recombinant] (sold in some countries as SILGARD®) has been approved in 122 countries, and
    additional applications are currently under review with regulatory agencies in many more
    countries around the world.

    About Merck
    Today's Merck is a global healthcare leader working to help the world be well. Merck is
    known as MSD outside the United States and Canada. Through our prescription medicines,
    vaccines, biologic therapies, and consumer care and animal health products, we work with
    customers and operate in more than 140 countries to deliver innovative health solutions. We
    also demonstrate our commitment to increasing access to healthcare through far-reaching
    policies, programs and partnerships. For more information, visit www.merck.com.

    Forward-Looking Statement
    This news release includes “forward-looking statements” within the meaning of the safe
    harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such
    statements may include, but are not limited to, statements about the benefits of the merger
    between Merck and Schering-Plough, including future financial and operating results, the
    combined company’s plans, objectives, expectations and intentions and other statements that
    are not historical facts. Such statements are based upon the current beliefs and expectations of
    Merck’s management and are subject to significant risks and uncertainties. Actual results may
    differ from those set forth in the forward-looking statements.
    The following factors, among others, could cause actual results to differ from those set
    forth in the forward-looking statements: the possibility that the expected synergies from the
    merger of Merck and Schering-Plough will not be realized, or will not be realized within the
    expected time period; the impact of pharmaceutical industry regulation and health care
    legislation; the risk that the businesses will not be integrated successfully; disruption from the
    merger making it more difficult to maintain business and operational relationships; Merck’s
    ability to accurately predict future market conditions; dependence on the effectiveness of
    Merck’s patents and other protections for innovative products; the risk of new and changing
    regulation and health policies in the United States and internationally and the exposure to
    litigation and/or regulatory actions.
    Merck undertakes no obligation to publicly update any forward-looking statement,
    whether as a result of new information, future events or otherwise. Additional factors that could
    cause results to differ materially from those described in the forward-looking statements can be
    found in Merck’s 2009 Annual Report on Form 10-K and the company’s other filings with the
    Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
    # # #

    Twitter

    Tweets by MoffittNews
    footer logo
    • BROWSE
      • Cancer Types & Treatments
      • Careers
      • Clinical Trials
      • Diagnostic Services
      • Education & Training
      • Locations
      • Patients & Families
      • Research
    • ABOUT
      • About Moffitt
      • Available Technologies
      • Calendar of Events
      • Clinical Perspectives
      • Community Benefit
      • Diversity
      • Endeavor
      • Newsroom
      • Our Outcomes
      • Partnerships
      • Taking Care of Your Health
    • ACTION
      • Appointments
      • Find a Doctor
      • Patient Portal
      • Refer a Patient
      • Referring Provider Portal
      • Staff Login
      • Staff Access
      • Volunteer
      • Ways to Give
    Call Today 1-888-663-3488
    Link to FaceBook
    Facebook
    Link to Twitter
    Twitter
    Link to Instagram
    Instagram
    Link to YouTube
    YouTube
    nci designated comprehensive cancer center award
    nccn award
    magnet recognized award
    diversity inc award
    • Site Map
    • Privacy Policy
    • Terms & Conditions
    • Unsubscribe
    • State Nonprofit Disclosures
    • Donor Privacy
    • Notice of Privacy Practices
    • Visitor Policy
    ©Copyright 2023 Moffitt Cancer Center
    ✕

    Request an Appointment at Moffitt Cancer Center

    Please call 1-888-663-3488 for support from a Moffitt representative. New Patients and Healthcare Professionals can submit an online form by selecting the appropriate button below. Existing patients can call 1-888-663-3488. Click here for a current list of insurances accepted at Moffitt.

    NEW PATIENTS To request a new patient appointment, please fill out the online form or call 1-888-663-3488.

    REFERRING PHYSICIANS Providers and medical staff can refer patients by submitting our online referral form.

    Moffit now offers Virtual Visits for patients. If you are eligible for a virtual appointment, our scheduling team will discuss this option further with you.


    Moffitt Cancer Center is committed to the health and safety of our patients and their families. For more information on how we’re protecting our new and existing patients, visit our COVID-19 Info Hub

    ✕

    Access Your Portal

    For Patients

    A secure website for patients to access their medical care at Moffitt.

    PATIENT PORTAL LOGIN

    For Physicians

    An online resource for referring physicians and their staff.

    PROVIDER PORTAL LOGIN

    For Moffitt Staff

    For Moffitt faculty & staff members to access MoffittNet applications.

    STAFF PORTAL LOGIN

    ✕

    Call: 1-888-663-3488

    Call: 1-888-663-3488

    Our patient services specialists can assist you with scheduling an appointment, questions about medical records, insurance, billing and more.

    Patient Appointment Center Hours: 7 a.m. to 7 p.m. Monday - Friday; 8 a.m. to noon Saturday