New Study Reinforces Safety Profile of Gardasil, the Cervical Cancer Vaccine

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Aug 18, 2009 - Merck is proud to have introduced GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant], the world's first cervical cancer vaccine, a vaccine that can also help to prevent vulvar and vaginal cancers and genital warts caused by HPV types 6, 11, 16 and 18. The paper being published in JAMA on Aug. 19 by the Centers for Disease Control and Prevention (CDC) is another important milestone in the medical community's ongoing effort to monitor the safety of vaccines, including GARDASIL.

"We are pleased that the study published by JAMA today further reinforces the safety profile of GARDASIL. We welcome continued study and discussion about the safety of this important vaccine," said Richard M. Haupt, M.D., MPH, pediatrician and head of the clinical program for GARDASIL. "Our children, our parents, our spouses and we, ourselves, are vaccinated with the same vaccines that we distribute to the public every day. Merck knows that our customers make choices about the medicines and vaccines used by their families, too. That is why we remain committed to providing timely and comprehensive information about the safety and efficacy of our products."

Nearly 500,000 women are diagnosed with cervical cancer each year around the world, and 50 years after the advent of pap testing, an average of 30 American women are still diagnosed with cervical cancer each day. HPV types 16 and 18 cause approximately 70 percent of cervical cancer cases.

The VAERS database that was the primary source for the CDC's paper is one of the many mechanisms used to assess the safety of vaccines. Merck also monitors vaccine safety by conducting comprehensive analyses of adverse events reported to Merck, and we share these adverse event analyses with the CDC, the U.S. Food and Drug Administration (FDA) and regulatory and medical authorities around the world to support their efforts. Merck is also conducting a post-marketing surveillance study in girls and women to assess the safety of the vaccine in routine use. CDC and FDA are also conducting studies. These analyses are in addition to the robust safety data generated from clinical trials of more than 25,000 people that were the basis for the approval of GARDASIL in more than 100 countries around the world. We also continue to follow patients in our clinical studies. After carefully reviewing all of the information available to us about reported adverse events including the findings in the JAMA paper, Merck continues to be confident in the safety profile of GARDASIL.

While no vaccine or medicine is completely without risk, leading health organizations throughout the world including the CDC and the European Medicines Agency (EMEA) have reviewed the available safety and efficacy information about GARDASIL and continue to recommend its use.

While it is difficult to determine the exact number of doses administered, since its launch in 2006 more than 50 million doses of GARDASIL have been distributed worldwide as part of the global fight against these HPV diseases.

Merck is committed to the prevention of HPV diseases including cervical, vaginal and vulvar cancers as well as genital warts caused by the HPV types included in GARDASIL. Education is a critical component toward achieving that goal. As such, Merck will continue to provide independent grant support to professional medical associations that develop and distribute their own educational information about HPV and cervical cancer to broad audiences, including underserved communities.

GARDASIL is approved for use in the U.S. in girls and women 9 to 26 years of age for the prevention of cervical, vulvar, and vaginal cancers; precancerous or dysplastic lesions and genital warts caused by HPV Types 6, 11, 16 and 18. GARDASIL (sold in some countries as SILGARD®) has been approved in 112 countries, and additional applications are currently under review with regulatory agencies in many more countries around the world.

Important information about GARDASIL

GARDASIL does not substitute for routine cervical cancer screening, and women who receive GARDASIL should continue to undergo screening.

GARDASIL has not been demonstrated to provide protection against diseases from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity. GARDASIL is not intended to be used for treatment of active genital warts; cervical, vulvar, and vaginal cancers; cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN) or vaginal intraepithelial neoplasia (VaIN).

GARDASIL has not been demonstrated to protect against diseases 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 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

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 over a six-month period with the first dose at an elected date, the second dose two months after the first dose, and the third dose six months after the first dose.

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, 2008, 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.

# # #

Prescribing information and patient product information for GARDASIL® is attached.

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)    
Indications (1.1)   09/2008
Limitations of GARDASIL Use and Effectiveness (1.2)   05/2009
Contraindications (4)   09/2008
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

Limitations of GARDASIL Use and Effectiveness

 

  • Women who receive GARDASIL should continue to undergo cervical cancer screening. (1.2) (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. (1.2) (14.2)
  • GARDASIL is not intended to be used for treatment of active genital warts; cervical, vulvar, and vaginal cancers; CIN; VIN; or VaIN. (1.2)
  • GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine. (1.2) (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. (1.2)
  • GARDASIL does not protect against genital diseases not caused by HPV. (1.2)
  • Vaccination with GARDASIL may not result in protection in all vaccine recipients. (1.2)

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

 

  • 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.

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 and pediatric males of any age. (8.4)
  • Immunocompromised individuals. Response to GARDASIL may be diminished. (8.6)
  • Women 27 years of age and older. (14.4).

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

Revised: 06/2009

FULL PRESCRIBING INFORMATION:

CONTENTS* 1 INDICATIONS AND USAGE

1.1 Indications

1.2 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 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

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 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.

FULL PRESCRIBING INFORMATION1 INDICATIONS AND USAGE

1.1 Indications

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 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. [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 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.

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. [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 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)

%

 

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
          
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)

 

  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 4.4 3.0 3.3
Severe 0.6 0.8 0.9 0.2 0.2 0.2 0.0 0.0 0.0
Erythema*** 9.2 12.1 14.7 9.8 8.4 8.9 7.3 5.3 5.7
Mild/Moderate 9.0 11.7 14.3 9.5 8.4 8.8 7.3 5.3 5.7
Severe 0.2 0.3 0.4 0.3 0.1 0.1 0.0 0.0 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.

 

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)

%

 

AAHS control** or Saline Placebo (N = 3790)

%

 

Pyrexia 13.0 11.2
Nausea 6.7 6.5
Dizziness 4.0 3.7
Diarrhea 3.6 3.5
Vomiting 2.4 1.9
Cough 2.0 1.5
Toothache 1.5 1.4
Upper respiratory tract infection 1.5 1.5
Malaise 1.4 1.2
Arthralgia 1.2 0.9
Insomnia 1.2 0.9
Nasal congestion 1.1 0.9
 
he 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)

 

  GARDASIL (% occurrence)

 

AAHS Control* or Saline Placebo (% occurrence)

 

Temperature

(°F)

 

 

Postdose 1 N** = 4945

 

Postdose 2 N = 4804

 

Postdose 3 N = 4671

 

Postdose 1 N = 3681

 

Postdose 2 N = 3564

 

Postdose 3 N = 3467

 

‰¥100 to <102 3.7 4.1 4.4 3.1 3.8 3.6

Posted: August 2009

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