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

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Feb 2, 2011 - 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).

Prescribing Information and Patient Product Information for GARDASIL® is available at http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf and http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_ppi.pdf.

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)     12/2010
    Boys and Men (1.2)     12/2010
    Limitations of GARDASIL Use and Effectiveness (1.3)     12/2010
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, vaginal, and anal 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
  • Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3

GARDASIL is indicated in boys and men 9 through 26 years of age for the prevention of the following diseases caused by HPV types included in the vaccine:

 

  • Anal 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:

 

  • Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. (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)
  • Recipients of GARDASIL should not discontinue anal cancer screening if it has been recommended by a health care provider. (1.3) (17)
  • 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) (14.4) (14.5)
  • GARDASIL is not intended to be used for treatment of active external genital lesions; cervical, vulvar, vaginal, and anal cancers; CIN; VIN; VaIN, or AIN. (1.3)
  • GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine. (1.3) (14.4) (14.5)
  • 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 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 Sharp & Dohme Corp., a subsidiary of 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) or with Menactra and Adacel. (7.2)

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 Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., 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) (14.7)

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

Revised: 12/2010

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 Menactra and Adacel
      7.3 Use with Hormonal Contraceptives
      7.4 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 Prophylactic Efficacy – Anal Disease Caused by HPV Types 6, 11, 16, and 18 in Boys and Men 16 Through 26 Years of Age in the MSM Sub-study
      14.4 Population Impact in Girls and Women 16 Through 26 Years of Age
      14.5 Population Impact in Boys and Men 16 Through 26 Years of Age
      14.6 Overall Population Impact
      14.7 Other Studies
      14.8 Immunogenicity
      14.9 Studies with RECOMBIVAX HB [hepatitis B vaccine (recombinant)]
      14.10 Studies with Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] and Adacel [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)]
16

 

    HOW SUPPLIED/STORAGE AND HANDLING

 

17

 

    PATIENT COUNSELING INFORMATION

 

*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, vaginal, and anal 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
  • Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3

1.2 Boys and Men

GARDASIL is indicated in boys and men 9 through 26 years of age for the prevention of the following diseases caused by HPV types included in the vaccine:

 

  • Anal 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:

 

  • Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3

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).]

Recipients of GARDASIL should not discontinue anal cancer screening if it has been recommended by a health care provider. [See Patient Counseling Information (17).]

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 (14.4, 14.5).]

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

GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine. [See Clinical Studies (14.4, 14.5).]

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 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 (14.8).]

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 = 3093)
%

 

  AAHS Control **
(N = 2029)
%

 

  Saline
Placebo
(N = 274)
%

 

Injection Site            
Pain   61.4   50.8   41.6
Erythema   16.7   14.1   14.5
Swelling   13.9   9.6   8.2
Hematoma   1.0   0.3   3.3
 
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

 

    Post-
dose
1
N =315

 

    Post-
dose
2
N = 301

 

    Post-
dose
3
N = 300

 

Pain     63.4     60.7     62.7     57.0     47.8     49.6     33.7     20.3     27.3
Mild/Moderate     62.5     59.7     61.2     56.6     47.3     48.9     33.3     20.3     27.0
Severe     0.9     1.0     1.5     0.4     0.5     0.6     0.3     0.0     0.3
Swelling***     10.2     12.8     15.1     8.2     7.5     7.6     4.4     3.0     3.3
Mild/Moderate     9.6     11.9     14.2     8.1     7.2     7.3    

Posted: February 2011

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