The initial planned analysis of this study, an analysis of male study participants aged 16 to 26 who had not been infected with at least one of the four HPV types before the start of the study through one month after receiving their third dose of the vaccine or placebo, has been completed. This analysis was predetermined in the study protocol to be conducted after at least 32 cases of external genital lesions were observed. The study is ongoing, and additional data will be submitted to global regulatory agencies once available.

Merck remains on track to submit a supplemental Biologics License Application for GARDASIL to the U.S. Food and Drug Administration by the end of 2008 for the use of GARDASIL in boys and men ages 9 to 26 for the prevention of external genital lesions caused by HPV types 6, 11, 16 and 18. Other regulatory submissions around the world will occur as planned.

GARDASIL is not currently approved for males in the United States. GARDASIL is indicated 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 Reduced External Genital Lesions in Males by 90 Percent

The placebo-controlled, Phase III study was designed to determine the efficacy of GARDASIL in males against HPV 6, 11, 16, and 18-related external genital lesions, a composite endpoint that included: 1) genital warts (condylomata), 2) penile/perineal/perianal intraepithelial neoplasia (or PIN; PIN 2/3 can be pre-cursors to cancer) and 3) penile/perineal/perianal cancer. Penile/perineal/perianal is defined as related to or affecting the penis (penile), the area between the anus and the scrotum (perineal), or the opening of the rectum to the outside of the body (perianal).

The study evaluated approximately 3,400 heterosexual males 16 through 23 years of age and approximately 600 men 16 to 26 years of age who have sex with men. Participants were randomized in a 1-to-1 ratio to receive either GARDASIL or placebo at day one, two months and six months, with 36 months of planned follow-up from day one. At the time of vaccination, participants had no evidence of genital lesions, no history of genital warts and five or fewer lifetime sexual partners.

In the study, GARDASIL was 90.4 percent effective at reducing external genital lesions (3 cases in the vaccine group vs. 31 cases in placebo group; 95 percent CI: 69.2, 98.1, p-value <0.001). The three cases seen among those vaccinated with GARDASIL were cases of genital warts, resulting in GARDASIL being 89.4 percent effective in preventing genital warts (95 percent CI: 65.5, 97.9). For penile/perineal/perianal intraepithelial neoplasia or PIN, there were no cases in the vaccine group vs. 3 cases of PIN 1 or PIN 2/3 in the placebo group. There were no cases of penile/perineal/perianal cancer in either vaccine or placebo group. At the time of this analysis, the study had a mean duration of about 29 months.

No vaccine-related serious adverse events were reported in this study. A slightly higher proportion of study participants reported injection-site adverse events in the vaccine group compared to placebo (60.1 percent vs. 53.7 percent).

GARDASIL Also Achieved Statistical Significance on Both Secondary Endpoints

Two secondary endpoints also were evaluated in this pivotal study and results from these analyses were presented at EUROGIN. GARDASIL was 85.6 percent effective at reducing persistent infection (15 cases in the vaccine group vs. 101 cases in the placebo group; 95 percent CI: 75.1, 92.2, p-value <0.001). Persistent infection is when the same HPV type is detected through swabs or biopsies over two or more consecutive visits six months apart. In addition, GARDASIL was 44.7 percent effective at reducing "anytime" HPV DNA detection (136 cases in the vaccine group vs. 241 cases in the placebo group; 95 percent CI: 31.5, 55.6, p-value <0.001). "Anytime" HPV DNA detection means HPV DNA is found through swabs or biopsies at any visit; persistent infection is a part of "anytime" HPV DNA detection.

Additional Important Information about GARDASIL

GARDASIL is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL.

The health care provider should inform the patient, parent or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening.

GARDASIL is not recommended for use in pregnant women.

Vaccination with GARDASIL may not result in protection in all vaccine recipients. GARDASIL is not intended to be used for treatment of active genital warts, cervical, vaginal and vulvar cancers, cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN) or vaginal intraepithelial neoplasia (VaIN).

GARDASIL has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity. GARDASIL has not been shown to protect against diseases due to HPV types not contained in the vaccine.

Not all vulvar and vaginal cancers are caused by human papillomavirus (HPV), and GARDASIL protects only against those vulvar and vaginal cancers caused by HPV types 16 and 18.

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.

In addition, syncope has been reported following vaccination with GARDASIL, sometimes resulting in falling with injury. Observation for 15 minutes after administration is recommended.

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.

Human Papillomavirus: A Virus that Affects Both Men and Women

According to the Centers for Disease Control and Prevention, 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, HPV goes away on its own. However, certain low-risk types of HPV can cause external genital lesions. More than one million cases of external genital lesions in men and women occur each year in the U.S. and more than 30 million occur each year worldwide. In addition for women, certain high-risk types of HPV, if unrecognized and untreated, can lead to cervical cancer.

HPV is a virus that can infect the genital region of men and women. There are an estimated 30 to 40 types of genital HPV. HPV transmission can happen with any kind of intimate genital contact with someone who has HPV; sexual intercourse is not needed. Most sexually active people will have HPV at some time in their lives.

Other Information about GARDASIL

In 1995, Merck entered into a license agreement and research collaboration with CSL Limited of Australia relating to technology used in GARDASIL. GARDASIL also is the subject of other third-party licensing agreements.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.

Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.

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

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

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 (1) 9/2008

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

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. (11).

WARNINGS AND PRECAUTIONS

• Women who receive GARDASIL should continue to undergo cervical cancer screening. (17.1)
• GARDASIL has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity. (14.2)
• GARDASIL is not intended to be used for treatment of active genital warts; cervical, vulvar, and vaginal cancers; CIN; VIN; or VaIN. (5.1)
• GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine. (14.3)
• 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.

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)

Syncope has been reported following vaccination with GARDASIL, sometimes resulting in falling with injury; observation for 15 minutes after administration is recommended. (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 and pediatric males of any age. (8.4)

• Women 27 years of age and older. (14.4).

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

Revised: 09/2008

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

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 Limitations of GARDASIL Use and Effectiveness

5.2 Immunocompromised Individuals

5.3 Managing Allergic Reactions

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Post-Marketing 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

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 Women 16 Through 26 Years of Age

14.2 Effectiveness of GARDASIL in Prevention of HPV Types 6-, 11-, 16-, or 18-Related Disease in Women 16 Through 26 Years of Age, Regardless of Current or Prior Exposure to Vaccine HPV Types

14.3 Effectiveness of GARDASIL in Prevention of Any HPV Type Related Genital Disease in Women 16 Through 26 Years of Age, Regardless of Current or Prior Infection with Vaccine or Non-Vaccine HPV Types

14.4 Other Studies

14.5 Immunogenicity

14.6 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.

GARDASIL^®

[Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] 9682308

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

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

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 (14.5).]

2.2 Method of Administration

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.

Do not administer GARDASIL intravenously, intradermally, or subcutaneously.

Syncope has been reported following vaccination with GARDASIL and may result in falling with injury; observation for 15 minutes after administration is recommended.

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

[OBJECT 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 Limitations of GARDASIL Use and Effectiveness

The health care provider should inform the patient, parent, or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care.

GARDASIL has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity. [See Clinical Studies (14.2).]

GARDASIL is not intended to be used for treatment of active genital warts; 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 (14.3).]

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.

5.2 Immunocompromised Individuals

The immunologic response to GARDASIL may be diminished in immunocompromised individuals [See Drug Interactions (7.3)].

5.3 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 has been reported following vaccination with GARDASIL and may result in falling with injury; observation for 15 minutes after administration is recommended.

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 and Women 9 Through 26 Years of Age

In 5 clinical trials (3 Amorphous Aluminum Hydroxyphosphate Sulfate [AAHS]-controlled, 1 saline placebo-controlled, and 1 uncontrolled), 8878 subjects 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 subjects. The subjects who were monitored using VRC-aided surveillance included 5088 girls and women 9 through 26 years of age at enrollment who received GARDASIL and 3790 girls and women who received AAHS control or saline placebo. Few subjects (0.1%) discontinued due to adverse reactions. The race distribution of the study subjects 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.

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*
  Adverse Reaction (1 to 5 Days Postvaccination)	GARDASIL (N = 5088) %	Â	AAHS Control ** (N = 3470) %	Â	Saline Placebo (N = 320) %
Injection Site Pain Swelling Erythema Pruritus Bruising	83.9 25.4 24.7 3.2 2.8	Â	75.4 15.8 18.4 2.8 3.2	Â	48.6 7.3 12.1 0.6 1.6
* The 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 2. Overall, 94.3% of girls and women who received GARDASIL judged their injection-site adverse reaction to be mild or moderate in intensity.

Table 2 Postdose Evaluation of Injection-Site Adverse Reactions (1 to 5 Days Postvaccination)

Â

GARDASIL (% occurrence)

Â

AAHS Control* (% occurrence)

Â

Saline Placebo (% occurrence)

Adverse Reaction

Post- dose 1 N** = 5011

Â

Post- dose 2 N = 4924

Â

Post- dose 3 N = 4818

Â

Post- dose 1 N = 3410

Â

Post- dose 2 N = 3351

Â

Post- dose 3 N = 3295

Â

Post- dose 1 N = 315

Â

Post- dose 2 N = 301

Â

Post- dose 3 N = 300

Pain Mild/Moderate Severe

63.4 62.5 0.9

Â

60.7 59.7 1.0

Â

62.7 61.2 1.5

Â

57.0 56.6 0.4

Â

47.8 47.3 0.5

Â

49.6 48.9 0.6

Â

33.7 33.3 0.3

Â

20.3 20.3 0.0

Â

27.3 27.0 0.3

Swelling*** Mild/Moderate Severe

10.2 9.6 0.6

Â

12.8 11.9 0.8

Â

15.1 14.2 0.9

Â

8.2 8.1 0.2

Â

7.5 7.2 0.2

Â

7.6 7.3 0.2

Â

4.4 4.4 0.0

Â

3.0 3.0 0.0

Â

3.3 3.3 0.0

Erythema*** Mild/Moderate Severe

9.2 9.0 0.2

Â

12.1 11.7 0.3

Â

14.7 14.3 0.4

Â

9.8 9.5 0.3

Â

8.4 8.4 0.1

Â

8.9 8.8 0.1

Â

7.3 7.3 0.0

Â

5.3 5.3 0.0

Â

5.7 5.7 0.0

*AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate **N = Number of subjects with follow up ***Intensity of swelling and erythema was measured by size (inches): Mild = 0 to (<=)1; Moderate = >1 to (<=)2; Severe = >2. Â

Common Systemic Adverse Reactions in Girls and Women 9 Through 26 Years of Age

Headache was the most commonly reported systemic adverse reaction in both treatment groups (GARDASIL = 28.2% and AAHS control or saline placebo = 28.4%). Fever was the next most commonly reported systemic adverse reaction in both treatment groups (GARDASIL = 13.0% and AAHS control or saline placebo = 11.2%).

Adverse reactions that were observed among recipients of GARDASIL, at a frequency of greater than or equal to 1.0% where the incidence in the GARDASIL group was greater than or equal to the incidence in the AAHS control or saline placebo group, are shown in Table 3.

Table 3 Common Systemic Adverse Reactions (GARDASIL ≥ Control)*
Adverse Reactions (1 to 15 Days Postvaccination)	GARDASIL (N = 5088) %	Â	AAHS control** or Saline Placebo (N = 3790) %
Pyrexia Nausea Dizziness Diarrhea Vomiting Cough Toothache Upper respiratory tract infection Malaise Arthralgia Insomnia Nasal congestion	13.0 6.7 4.0 3.6 2.4 2.0 1.5 1.5 1.4 1.2 1.2 1.1	Â	11.2 6.5 3.7 3.5 1.9 1.5 1.4 1.5 1.2 0.9 0.9 0.9
* The adverse reactions in this table are those that were observed among recipients of GARDASIL at a frequency of at least 1.0% and greater than or equal to those observed among AAHS control or saline placebo recipients. **AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate

Evaluation of Fever by Dose in Girls and Women 9 Through 26 Years of Age

An analysis of fever in girls and women by dose is shown in Table 4.

Table 4 Postdose Evaluation of Fever (1 to 5 Days Postvaccination)
Â	GARDASIL (% occurrence)					Â	AAHS Control* or Saline Placebo (% occurrence)
Temperature ( °F)	Postdose 1 N** = 4945	Â	Postdose 2 N = 4804	Â	Postdose 3 N = 4671	Â	Postdose 1 N = 3681	Â	Postdose 2 N = 3564	Â	Postdose 3 N = 3467
(>=)100 to <102	3.7	Â	4.1	Â	4.4	Â	3.1	Â	3.8	Â	3.6
(>=)102	0.3	Â	0.5	Â	0.5	Â	0.2	Â	0.4	Â	0.5
*AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate **N = Number of subjects with follow up

Serious Adverse Reactions in the Entire Study Population

A total of 237 subjects out of 25,274 total subjects (9- through 45-year-old girls and women; and 9- through 15-year-old boys) who received both GARDASIL (N = 13,686) and AAHS control (N = 11,004) or saline placebo (N = 584) reported a serious systemic adverse reaction following any vaccination visit during the clinical trials for GARDASIL.

Out of the entire study population (25,274 subjects), only 0.05% of the reported serious systemic adverse reactions were judged to be vaccine related by the study investigator. The most frequently reported serious systemic adverse reactions for GARDASIL compared to AAHS control or saline placebo and regardless of causality were:

Headache [0.02% GARDASIL (3 cases) vs. 0.02% AAHS Control (2 cases)],

Gastroenteritis [0.02% GARDASIL (3 cases) vs. 0.02% AAHS Control (2 cases)],

Appendicitis [0.03% GARDASIL (4 cases) vs. 0.01% AAHS Control (1 case)],

Pelvic inflammatory disease [0.02% GARDASIL (3 cases) vs. 0.04% AAHS Control (4 cases)],

Urinary tract infection [0.02% GARDASIL (2 cases) vs. 0.02% AAHS Control (2 cases)],

Pneumonia [0.02% GARDASIL (2 cases) vs. 0.02% AAHS Control (2 cases)],

Pyelonephritis [0.02% GARDASIL (2 cases) vs. 0.03% AAHS Control (3 cases)],

Pulmonary embolism [0.02% GARDASIL (2 cases) vs. 0.02% AAHS Control (2 cases)].

One case (0.007% GARDASIL: 0.0% AAHS Control or Saline Placebo) of bronchospasm; and 2 cases (0.02% GARDASIL: 0.0% AAHS Control or Saline Placebo) of asthma were reported as serious systemic adverse reactions that occurred following any vaccination visit.

In addition, there was 1 subject in the clinical trials, in the group that received GARDASIL, who reported two injection-site serious adverse reactions (injection-site pain and injection-site joint movement impairment).

Deaths in the Entire Study Population

Across the clinical studies, 24 deaths were reported in 25,274 (GARDASIL N = 13,686; AAHS Control N = 11,004, saline placebo N = 584) subjects (9- through 45-year-old girls and women; and 9- through 15-year-old boys). The events reported were consistent with events expected in healthy adolescent and adult populations. The most common cause of death was motor vehicle accident (4 subjects who received GARDASIL and 3 AAHS Control subjects), followed by overdose/suicide (2 subjects who received GARDASIL and 2 subjects who received AAHS Control), and pulmonary embolus/deep vein thrombosis (1 subject who received GARDASIL and 1 AAHS Control subject). In addition, there were 2 cases of sepsis, 1 case of pancreatic cancer, 1 case of arrhythmia, 1 case of pulmonary tuberculosis, 1 case of hyperthyroidism, 1 case of post-operative pulmonary embolism and acute renal failure, and 1 case of systemic lupus erythematosus in the group that received GARDASIL; 1