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In Phase III Data Merck's Gardasil Was Efficacious Against Anal Disease Caused by HPV-6,11,16 and 18

Investigational Data Also Presented on Efficacy Against HPV 6,11,16 and 18 -Related Persistent Infection, CIN and EGL in Women Aged 24 Through 45 Naïve to the Relevant HPV Type

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Feb 17, 2010 - Merck & Co., Inc. announced today that in new Phase III data, GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] was 77.5 percent (95 percent CI: 39.6, 93.3) efficacious against anal intraepithelial neoplasia (AIN) associated with human papillomavirus (HPV) types 6, 11, 16 and 18 in 16-to-26 year-old men who have sex with men. The data were presented at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) conference in Monte Carlo, Monaco.

“We are excited to learn more about the potential of GARDASIL to help prevent HPV and HPV-related cancers and diseases in both men and women,” said Richard M. Haupt, M.D., MPH, executive director, Merck Research Laboratories.

GARDASIL is approved in the U.S. for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts 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 U.S. for use in boys and men ages 9 through 26 years of age for the prevention of genital warts (condylomata acuminata) caused by HPV types 6 and 11.

It is estimated that HPV types 16 and 18 account for 70 percent of cervical and vaginal cancer cases, and up to 50 percent of vulvar cancer cases and 85 percent of anal cancer cases. Types 6 and 11 cause approximately 90 percent of all genital warts cases.

Data on efficacy against intra anal disease

The ability of GARDASIL to prevent HPV 6, 11, 16 and 18-AIN and anal cancer in males was evaluated in a randomized, double-blind, placebo-controlled trial. A total of 598 16- to 26- year old men who have sex with men received at least one dose of GARDASIL or placebo at the time of enrollment, and then again at two and six months.

This evaluation of efficacy of GARDASIL against HPV-related anal disease was conducted in a population of men having sex with men because of the known high risk of anal infection that occurs in this group.

The per-protocol efficacy (PPE) population was the pre-defined primary population for this study. As defined, this group included men who were not infected with the relevant HPV vaccine type at the start of the study, and who did not become infected with that HPV vaccine type during the course of the vaccination series (seronegative and HPV DNA-negative to the relevant HPV vaccine type at day one, and HPV DNA-negative through the vaccination series to month seven). The cases of the primary endpoint of AIN and anal cancer were counted starting after month seven with an average follow up of 2.5 years.

In this PPE analysis, GARDASIL prevented 77.5 percent (95 percent CI: 39.6, 93.3) of HPV 6, 11, 16, and 18-related AIN and anal cancer. A total of 29 men were diagnosed with HPV 6, 11, 16 or 18-related AIN during the study, with 24 cases in the placebo group and five in the vaccine group. No cases of HPV 11 or 18-related AIN were observed in the vaccine group. No cases of anal cancer were seen in either the placebo or vaccine group.

In the study, 69 percent of the vaccine group and 64 percent of the placebo group reported one or more adverse events (AEs). These were predominantly injection-site AEs (60 percent of the vaccine group and 54 percent of the placebo group). Serious adverse events were reported rarely and occurred comparably in the vaccine (0.4 percent) and placebo (0.6 percent) groups, and none were deemed to be vaccine-related by the study investigators.

48 month end of study data for use of GARDASIL in women ages 24 through 45 also presented

A separate, double-blind, placebo-controlled study was designed to evaluate the ability of GARDASIL to prevent HPV 6,11,16,18-related persistent infection, cervical and genital disease in women ages 24 through 45. The study enrolled 3,817 women with no history of cervical disease, Loop Electrosurgical Excision Procedure (LEEP), hysterectomy or genital warts in the past five years. The women in the study received GARDASIL (n=1910) or placebo (n=1907) at day one and again at months two and six. HPV-related infection, cervical and genital disease was monitored every six months with Pap testing, genital inspection and cervicovaginal sampling.

In this new end-of-study per protocol efficacy analysis of women naïve to the respective vaccine types when they entered the study, GARDASIL was 88.7 percent (95 percent CI: 78.1.; 94.8) efficacious against persistent infection, CIN or EGL (including vulvar intraepithelial neoplasia [VIN], vaginal intraepithelial neoplasia [VaIN] and condyloma) associated with HPV types 6, 11, 16 and 18.

In this study, 87 percent of the vaccine group and 81 percent of the placebo group reported one or more AEs. These were predominantly injection-site AEs (77 percent of the vaccine group and 64 percent of the placebo group). Serious adverse events were reported rarely and occurred comparably in the vaccine (0.7 percent) and placebo (0.8 percent) groups, and none were deemed to be vaccine-related by the study investigators.

HPV: a virus that affects both men and women

HPV is a common virus. There are more than 40 types of HPV that are passed on through genital contact – most often during vaginal and anal sex. Most sexually active people, including more than half of American men, will have HPV at some time in their lives. According to the Centers for Disease Control and Prevention (CDC), in the U.S. alone, an estimated 20 million men and women are currently infected with HPV, and another 6.2 million people become newly infected each year.

"For most people, HPV does not cause any long-term clinical problems, however for some women, certain types of HPV can cause cervical cancer, vulvar cancer and vaginal cancer. In men and women these same types can also cause anal cancer and other types can lead to the development of genital warts. Nearly 5,000 people are diagnosed with anal cancer each year in the US," said Joel Palefsky, M.D. University of California San Francisco. In the US, it is estimated in 2009, that approximately 11,200 new cases of invasive cervical cancer were expected to be diagnosed, in addition to 2,100 new cases of vaginal cancer and 3,500 new cases of vulvar cancer.

Important information about GARDASIL[Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant]

GARDASIL is approved in the U.S. for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts 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 U.S. for use in boys and men ages 9 through 26 years of age for the prevention of genital warts (condylomata acuminata) caused by HPV types 6 and 11.

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

GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] 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, and vaginal cancers; cervical intraepithelial neoplasia, vulvar intraepithelial neoplasia, or vaginal intraepithelial neoplasia.

GARDASIL has not been demonstrated to protect against disease due to HPV types not contained in the vaccine.

Not all vulvar and vaginal cancers are caused by HPV, and GARDASIL protects only against those vulvar and vaginal 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 vaccines 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 119 countries

GARDASIL (sold in some countries as SILGARD®) has been approved in 119 countries, and additional applications are currently under review with regulatory agencies in many more countries around the world.

About Merck

Today's Merck is working to help the world be well. Through our medicines, vaccines, biologic therapies, and consumer and animal 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 programs that donate and deliver our products to the people who need them. Merck. Be Well. 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, due to, among other things, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry; 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 U.S. 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 2008 Annual Report on Form 10-K, Schering-Plough's Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2009, the proxy statement filed by Merck on June 25, 2009 and each company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site:( www.sec.gov.)

Prescribing Information and Patient Product Information for GARDASIL® are attached and is also available at www.gardasil.com.

GARDASIL® is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.

9883612

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use GARDASIL safely and effectively. See full prescribing information for GARDASIL.

GARDASIL

[Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]

Suspension for intramuscular injection

Initial U.S. Approval: 2006

--------------- RECENT MAJOR CHANGES ---------------

 

Indications and Usage (1)    
Girls and Women (1.1)   10/2009
Boys and Men (1.2)   10/2009
Limitations of GARDASIL Use and Effectiveness (1.3)   05/2009
Warnings and Precautions (5)    
Syncope (5.1)   06/2009
--------------- INDICATIONS AND USAGE ---------------

GARDASIL is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine:

 

  • Cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18
  • Genital warts (condyloma acuminata) caused by HPV types 6 and 11

And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:

 

  • Cervical intraepithelial neoplasia (CIN) grade 2/3 and Cervical adenocarcinoma in situ (AIS)
  • Cervical intraepithelial neoplasia (CIN) grade 1
  • Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3
  • Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3

GARDASIL is indicated in boys and men 9 through 26 years of age for the prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11. (1)

Limitations of GARDASIL Use and Effectiveness

 

  • GARDASIL does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. (1.3) (17.1)
  • GARDASIL has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity. (1.3) (14.3) (14.4)
  • GARDASIL is not intended to be used for treatment of active external genital lesions; cervical, vulvar, and vaginal cancers; CIN; VIN; or VaIN. (1.3)
  • GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine. (1.3) (14.5)
  • Not all vulvar and vaginal cancers are caused by HPV, and GARDASIL protects only against those vulvar and vaginal cancers caused by HPV 16 and 18. (1.3)
  • GARDASIL does not protect against genital diseases not caused by HPV. (1.3)
  • Vaccination with GARDASIL may not result in protection in all vaccine recipients. (1.3)

--------------- DOSAGE AND ADMINISTRATION ---------------

0.5-mL suspension for intramuscular injection at the following schedule: 0, 2 months, 6 months. (2.1)

--------------- DOSAGE FORMS AND STRENGTHS ---------------

 

  • 0.5-mL suspension for injection as a single-dose vial and prefilled syringe (3) (11)

--------------- CONTRAINDICATIONS ---------------

 

  • Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL. (4) (11)

--------------- WARNINGS AND PRECAUTIONS ---------------

 

  • 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 by maintaining a supine or Trendelenburg position. (5.1)

--------------- ADVERSE REACTIONS ---------------

The most common adverse reaction was headache. Common adverse reactions (frequency of at least 1.0% and greater than AAHS control or saline placebo) are fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus, and bruising. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Merck & Co., Inc. at 1-877-888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

--------------- DRUG INTERACTIONS ---------------

GARDASIL may be administered concomitantly with RECOMBIVAX HB. (7.1)

--------------- USE IN SPECIFIC POPULATIONS ---------------

Safety and effectiveness of GARDASIL have not been established in the following populations:

 

  • Pregnant women. Physicians are encouraged to register pregnant women exposed to GARDASIL by calling 1-800-986-8999 so that Merck can monitor maternal and fetal outcomes. (8.1)
  • Children below the age of 9 years. (8.4)
  • Immunocompromised individuals. Response to GARDASIL may be diminished. (8.6)
  • Individuals 27 years of age and older. (8.1) (14.6)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 10/2009

 
 
FULL PRESCRIBING INFORMATION: CONTENTS*

 

1

 

    INDICATIONS AND USAGE

 

      1.1 Girls and Women
      1.2 Boys and Men
 

 

    1.3 Limitations of GARDASIL Use and Effectiveness
2

 

    DOSAGE AND ADMINISTRATION

 

      2.1 Dosage
      2.2 Method of Administration
3

 

    DOSAGE FORMS AND STRENGTHS

 

4

 

    CONTRAINDICATIONS

 

5

 

    WARNINGS AND PRECAUTIONS

 

      5.1 Syncope
      5.2 Managing Allergic Reactions
6

 

    ADVERSE REACTIONS

 

      6.1 Clinical Trials Experience
      6.2 Postmarketing Experience
7

 

    DRUG INTERACTIONS

 

      7.1 Use with RECOMBIVAX HB
      7.2 Use with Hormonal Contraceptives
      7.3 Use with Systemic Immunosuppressive Medications
8

 

    USE IN SPECIFIC POPULATIONS

 

      8.1 Pregnancy
      8.3 Nursing Mothers
      8.4 Pediatric Use
      8.5 Geriatric Use
      8.6 Immunocompromised Individuals
10

 

    OVERDOSAGE

 

11

 

    DESCRIPTION

 

12

 

    CLINICAL PHARMACOLOGY

 

      12.1 Mechanism of Action
13

 

    NONCLINICAL TOXICOLOGY

 

      13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14

 

    CLINICAL STUDIES

 

      14.1 Prophylactic Efficacy – HPV Types 6, 11, 16, and 18 in Girls and Women 16 Through 26 Years of Age
      14.2 Prophylactic Efficacy – HPV Types 6, 11, 16, and 18 in Boys and Men 16 Through 26 Years of Age
      14.3 Population Impact in Girls and Women 16 Through 26 Years of Age
      14.4 Population Impact in Boys and Men 16 Through 26 Years of Age
      14.5 Overall Population Impact
      14.6 Other Studies
      14.7 Immunogenicity
      14.8 Studies with RECOMBIVAX HB
16

 

    HOW SUPPLIED/STORAGE AND HANDLING

 

17

 

    PATIENT COUNSELING INFORMATION

 

      17.1 Information for the Patient, Parent, or Guardian
      17.2 FDA-Approved Patient Labeling
 
*Sections or subsections omitted from the full prescribing information are not listed.

 

 
FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

1.1 Girls and Women

GARDASIL®1 is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine:

 

  • Cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18
  • Genital warts (condyloma acuminata) caused by HPV types 6 and 11

And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:

 

  • Cervical intraepithelial neoplasia (CIN) grade 2/3 and Cervical adenocarcinoma in situ (AIS)
  • Cervical intraepithelial neoplasia (CIN) grade 1
  • Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3
  • Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3

1.2 Boys and Men

GARDASIL is indicated in boys and men 9 through 26 years of age for the prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11.

1.3 Limitations of GARDASIL Use and Effectiveness

The health care provider should inform the patient, parent, or guardian that vaccination does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care. [See Patient Counseling Information (17.1).]

GARDASIL has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity. [See Clinical Studies (14.3, 14.4).]

GARDASIL is not intended to be used for treatment of active external genital lesions; cervical, vulvar, and vaginal cancers; CIN; VIN; or VaIN.

GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine. [See Clinical Studies (14.5).]

Not all vulvar and vaginal cancers are caused by HPV, and GARDASIL protects only against those vulvar and vaginal cancers caused by HPV 16 and 18.

GARDASIL does not protect against genital diseases not caused by HPV.

Vaccination with GARDASIL may not result in protection in all vaccine recipients.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage

GARDASIL should be administered intramuscularly as a 0.5-mL dose at the following schedule: 0, 2 months, 6 months. [See Clinical Studies (14.7).]

2.2 Method of Administration

For intramuscular use only.

Shake well before use. Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine. GARDASIL should not be diluted or mixed with other vaccines. After thorough agitation, GARDASIL is a white, cloudy liquid. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the product if particulates are present or if it appears discolored.

GARDASIL should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.

Syncope has been reported following vaccination with GARDASIL and may result in falling with injury; observation for 15 minutes after administration is recommended. [See Warnings and Precautions (5.1).]

Single-Dose Vial Use

Withdraw the 0.5-mL dose of vaccine from the single-dose vial using a sterile needle and syringe and use promptly.

Prefilled Syringe Use With and Without Needle Guard (Safety) Device

Prefilled Syringe With Needle Guard (Safety) Device

Instructions for using the prefilled single-dose syringes preassembled with needle guard (safety) device

(Graphic Omitted)

NOTE: Please use the enclosed needle for administration. If a different needle is chosen, it should fit securely on the syringe and be no longer than 1 inch to ensure proper functioning of the needle guard device. Two detachable labels are provided which can be removed after the needle is guarded.

At any of the following steps, avoid contact with the Trigger Fingers to keep from activating the safety device prematurely.

Remove Syringe Tip Cap and Needle Cap. Attach Luer Needle by pressing both Anti-Rotation Tabs to secure syringe and by twisting the Luer Needle in a clockwise direction until secured to the syringe. Remove Needle Sheath. Administer injection per standard protocol as stated above under DOSAGE AND ADMINISTRATION. Depress the Plunger while grasping the Finger Flange until the entire dose has been given. The Needle Guard Device will NOT activate to cover and protect the needle unless the ENTIRE dose has been given. While the Plunger is still depressed, remove needle from the vaccine recipient. Slowly release the Plunger and allow syringe to move up until the entire needle is guarded. For documentation of vaccination, remove detachable labels by pulling slowly on them. Dispose in approved sharps container.

Prefilled Syringe Without Needle Guard (Safety) Device

This package does not contain a needle guard (safety device) or a needle. Shake well before use. Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe. Administer the entire dose as per standard protocol.

3 DOSAGE FORMS AND STRENGTHS

GARDASIL is a suspension for intramuscular administration available in 0.5-mL single dose vials and prefilled syringes. See Description (11) for the complete listing of ingredients.

4 CONTRAINDICATIONS

Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL. [See Description (11).]

5 WARNINGS AND PRECAUTIONS

5.1 Syncope

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 by maintaining a supine or Trendelenburg position.

5.2 Managing Allergic Reactions

Appropriate medical treatment and supervision must be readily available in case of anaphylactic reactions following the administration of GARDASIL.

6 ADVERSE REACTIONS

Overall Summary of Adverse Reactions

Headache, fever, nausea, and dizziness; and local injection site reactions (pain, swelling, erythema, pruritus, and bruising) occurred after administration with GARDASIL.

Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with GARDASIL and may result in falling with injury; observation for 15 minutes after administration is recommended. [See Warnings and Precautions (5.1).]

Anaphylaxis has been reported following vaccination with GARDASIL.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

Studies in Girls, Women, Boys, and Men 9 Through 26 Years of Age

In 6 clinical trials (4 Amorphous Aluminum Hydroxyphosphate Sulfate [AAHS]-controlled, 1 saline placebo-controlled, and 1 uncontrolled), 14,273 individuals were administered GARDASIL or AAHS control or saline placebo on the day of enrollment, and approximately 2 and 6 months thereafter, and safety was evaluated using vaccination report cards (VRC)-aided surveillance for 14 days after each injection of GARDASIL or AAHS control or saline placebo in these individuals. The individuals who were monitored using VRC-aided surveillance included 8180 individuals 9 through 26 years of age at enrollment who received GARDASIL and 6093 individuals who received AAHS control or saline placebo. Few individuals (0.2%) discontinued due to adverse reactions. The race distribution of the girls and women in the safety population was as follows: 62.3% White; 17.6% Hispanic (Black and White); 6.8% Asian; 6.7% Other; 6.4% Black; and 0.3% American Indian. The race distribution of the boys and men in the safety population was as follows: 42.0% White; 19.7% Hispanic (Black and White); 11.0% Asian; 11.2% Other; 15.9% Black; and 0.1% American Indian.

Common Injection-Site Adverse Reactions in Girls and Women 9 Through 26 Years of Age

The injection site adverse reactions that were observed among recipients of GARDASIL at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients are shown in Table 1.

Table 1 Injection-Site Adverse Reactions in Girls and Women 9 Through 26 Years of Age*

 

 

Adverse Reaction

(1 to 5 Days Postvaccination)

 

GARDASIL

(N = 5088)

%

 

AAHS Control**

(N = 3470)

%

 

Saline Placebo

(N = 320)

%

 

Injection Site

 

     
Pain 83.9 75.4 48.6
Swelling 25.4 15.8 7.3
Erythema 24.7 18.4 12.1
Pruritus 3.2 2.8 0.6
Bruising 2.8 3.2 1.6
he injection-site adverse reactions that were observed among 
          recipients of GARDASIL were at a frequency of at least 1.0% and also 
          at a greater frequency than that observed among AAHS control or 
          saline placebo recipients.

          
            **AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate
          
Common Injection-Site Adverse Reactions in Boys and Men 9 Through 26 Years of Age

The injection site adverse reactions that were observed among recipients of GARDASIL at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients are shown in Table 2.

Table 2 Injection-Site Adverse Reactions in Boys and Men 9 Through 26 Years of Age*

 

 

Adverse Reaction

(1 to 5 Days Postvaccination)

 

GARDASIL

(N = 3092)

%

 

AAHS Control **

(N = 2029)

%

 

Saline Placebo

(N = 274)

%

 

Injection Site

 

     
Pain 61.5 50.8 41.6
Erythema 16.7 14.1 14.5
Swelling 13.9 9.6 8.2
 
he injection-site adverse reactions that were observed among recipients of GARDASIL were at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients. **AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate

 

Evaluation of Injection-Site Adverse Reactions by Dose in Girls and Women 9 Through 26 Years of Age

An analysis of injection-site adverse reactions in girls and women by dose is shown in Table 3. Of those girls and women who reported an injection-site reaction, 94.3% judged their injection-site adverse reaction to be mild or moderate in intensity.

Table 3 Postdose Evaluation of Injection-Site Adverse Reactions in Girls and Women 9 Through 26 Years of Age

(1 to 5 Days Postvaccination)

 

 
    GARDASIL (% occurrence)

 

  AAHS Control* (% occurrence)

 

  Saline Placebo (% occurrence)

 

 
Adverse Reaction

 

  Post- dose

1

N** = 5011

 

  Post- dose

2

N = 4924

 

  Post- dose

3

N = 4818

 

  Post- dose

1

N = 3410

 

  Post- dose

2

N = 3351

 

  Post- dose

3

N = 3295

 

Posted: February 2010

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