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| Share Name | Share Symbol | Market | Type |
|---|---|---|---|
| Qiagen NV | TG:QIA | Tradegate | Ordinary Share |
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From Jul 2019 to Jul 2024
The Government of Rwanda, together with QIAGEN N.V. (NASDAQ: QGEN, F:QIA) and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the launch, in Kigali, Rwanda, of a comprehensive national cervical cancer prevention program that includes vaccination with GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] for appropriate girls 12 to 15 years of age and modern molecular diagnostic screening for women between the ages of 35 and 45.
Rwanda is the first nation in Africa to offer a comprehensive prevention program that incorporates both HPV vaccination and HPV testing. Rwanda has a population of 2.72 million women ages 15 years and older. Cervical cancer ranks as the most frequent cancer in women of all ages in Rwanda.
"It is our goal to create a comprehensive, coordinated program that includes HPV vaccination, cancer screening with HPV DNA testing, and treatment in order to address the nation's unmet needs for cervical cancer-related health services," said Dr. Richard Sezibera, Rwanda’s Minister of Health. "This vaccination and screening program brings us one step closer to reaching our goal of protecting the girls and women in our country. We are pleased to have the support of Merck and QIAGEN on this important government initiative."
During the first three years of the national prevention program the Ministry of Health, with the support of Merck, will offer GARDASIL to appropriate girls 12 to 15 years of age, while QIAGEN's DNA-based molecular diagnostic HPV tests – the digene HC2 HPV DNA Test and the careHPV Test – will be offered to women between the ages of 35 and 45. QIAGEN’s careHPV test has been designed to reach women where access to medical care is more challenging – the portable testing system can be performed in any health clinic setting by healthcare workers with minimal lab training.
Merck will provide more than two million doses of GARDASIL to the Government of Rwanda at no cost, while QIAGEN will provide 250,000 HPV screening tests at no cost along with all necessary equipment and training to successfully perform the tests. Thereafter, the Government of Rwanda will continue routine vaccination of appropriate 12 year old girls, and Merck will provide GARDASIL at a discounted access price that is made available for national vaccination programs in GAVI-eligible countries. Similarly, QIAGEN will make its HPV tests accessible under a tiered-market pricing structure designed to enable developing countries to establish and maintain the use of HPV testing within national cervical cancer screening and treatment programs.
"Over eighty-five percent of cervical cancer cases occur in the world's poorest countries, having an impact on the women affected, their families and their communities," said Dr. Mark Feinberg, chief public health and science officer, Merck Vaccines. "Reducing the incidence of cervical cancer is a very important public health goal. Through this collaboration with the Government of Rwanda, QIAGEN and numerous global public health organizations working in the country to introduce HPV vaccination and HPV DNA testing, women and girls in Rwanda will have greater access to a comprehensive cervical cancer prevention program. We hope this initiative by the Government of Rwanda provides a helpful model for other resource-limited countries to consider as they work to develop their own programs."
GARDASIL is approved in the United States 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 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, for the prevention of anal dysplasias and precancerous lesions caused by HPV types 6, 11, 16 and 18, and the prevention of genital warts caused by HPV types 6 and 11.
Merck and QIAGEN announced plans to launch a collaborative HPV vaccination and HPV screening program in September 2009 to help prevent cervical cancer. In addition to their own separate initiatives, the two companies committed to jointly provide up to five million doses of GARDASIL and 500,000 HPV tests to developing countries at no charge. As the first recipient of this collaborative effort, Rwanda will become the first GAVI-eligible country to implement a comprehensive program involving both HPV vaccination and HPV DNA-based molecular testing to improve access to cervical cancer prevention programs. QIAGEN and Merck continue to reach out to select GAVI-eligible countries to explore the feasibility of implementing cervical cancer reduction programs.
"Expanding access to HPV testing, regardless of where a woman lives, is a commitment of QIAGEN to help reduce the tremendous burden of cervical cancer, particularly in the developing world. Women in Rwanda, and in other countries where our DNA-based molecular diagnostic tests are available, are being screened for prevention of this potentially life-threatening disease with the most modern diagnostic detection technology available,” said Peer Schatz, chief executive officer of QIAGEN N.V. “In many countries women are the cornerstone of families and their communities. It is unfortunate that cervical cancer, which effective measures can help to prevent, often strikes women in their prime years of productivity. We are pleased to partner with the Republic of Rwanda and Merck to introduce this comprehensive program that will greatly expand access to HPV testing and vaccination, which together can help reduce the burden of this disease. We believe this program will demonstrate the positive impact that these types of collaborations can have in terms of improving healthcare.”
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.
HPV testing
HPV testing can identify women with high-risk HPV infections that can cause cervical cancer. These tests enable diagnosis and treatment to be under taken before cervical cancer develops. The digene HPV Test is approved in Europe and FDA approved in the United States where it is used as a screening test. In the United States, it is approved to be used together with a Pap test in women 30 years and older. In Europe, it is CE marked and approved as an initial general population screening test either alone or together with a Pap test. It is also used as a follow-up to inconclusive Pap test results and as a post-cervical cancer treatment follow-up.
To help ensure that HPV testing can reach women in all regions of the world, QIAGEN has developed the careHPV Test, a portable HPV DNA test for public-health programs in low-resource countries that can be run in settings with no main electricity or running water and can provide same-day test results. The careHPV test is CE-marked and pending WHO prequalification. The cervical cancer prevention collaboration with Merck will include donations of both the digene HPV Test and the careHPV Test.
HPV and cervical cancer
HPV is a widespread virus that is transmitted through sexual contact. 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.
Cervical cancer is estimated to develop in approximately 500,000 women annually around the world. After breast cancer, cervical cancer is considered the second most common malignancy found in women. The World Health Organization estimates that only about five percent of women in the developing world have been screened for cervical disease in the previous five years compared to 75 percent in the developed world.
Other Merck and QIAGEN access efforts in the developing world
Merck is pursuing a systematic and thoughtful approach to improve access to GARDASIL in the developing world through four key pillars: innovation, partnerships, pricing and implementation. In 2007 at the Clinton Global Initiative, Merck made a pledge to donate at least three million doses of GARDASIL through the GARDASIL® Access Program, which is enabling organizations and institutions in eligible lowest income countries to gain operational experience designing and implementing HPV vaccination projects.
The collaboration between Merck and QIAGEN represents a new commitment and approach that is in addition to, and distinct from, the charitable GARDASIL® Access Program.
QIAGEN is working to improve access to cervical cancer screening through its QIAGENcares corporate social responsibility program. Through the QIAGENcares program, QIAGEN is developing the rapid, portable careHPV Test for low-resource settings and health clinics in the developing world and has committed to donating 1.5 million HPV tests to developing countries with the aim of expanding access to cervical cancer screening in areas with the highest disease burden. In addition to its donation to Rwanda, QIAGEN currently provides HPV tests to programs in China and India.
About the Government of Rwanda
Visit www.moh.gov.rw
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.
About QIAGEN
QIAGEN N.V., a Netherlands holding company, is the leading global provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are used to make such isolated bio-molecules visible. QIAGEN has developed and markets more than 500 sample and assay products as well as automated solutions for such consumables. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN's assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the digene HPV Test, which is regarded as a "gold standard" in testing for high-risk types of human papillomavirus (HPV), the primary cause of cervical cancer, as well as a broad suite of solutions for infectious disease testing and companion diagnostics. QIAGEN employs nearly 3,600 people in over 30 locations worldwide. Further information about QIAGEN can be found at www.QIAGEN.com.
Merck's 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 2010 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® are attached and 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
Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6695132&lang=en
9883616
HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 injectionInitial 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) 04/2011INDICATIONS 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:
And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:
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:
And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:
Limitations of GARDASIL Use and Effectiveness:
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
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
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:
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 04/2011
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 Effectiveness2
DOSAGE AND ADMINISTRATION
2.1 Dosage 2.2 Method of Administration3
DOSAGE FORMS AND STRENGTHS
4
CONTRAINDICATIONS
5
WARNINGS AND PRECAUTIONS
5.1 Syncope 5.2 Managing Allergic Reactions6
ADVERSE REACTIONS
6.1 Clinical Trials Experience 6.2 Postmarketing Experience7
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 Medications8
USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Immunocompromised Individuals10
OVERDOSAGE
11
DESCRIPTION
12
CLINICAL PHARMACOLOGY
12.1 Mechanism of Action13
NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14
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 Age14.3 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 Studies in Women 27 Through 45 Years of Age 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:
And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:
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:
And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:
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.
GARDASIL has not been demonstrated to prevent HPV-related CIN 2/3 or worse in women older than 26 years of age. [See Clinical Studies (14.7).]
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
This package does not contain 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 45 Years of Age) and Boys and Men (9 Through 26 Years of Age)
In 7 clinical trials (5 Amorphous Aluminum Hydroxyphosphate Sulfate [AAHS]-controlled, 1 saline placebo-controlled, and 1 uncontrolled), 18,083 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 10,088 individuals 9 through 45 years of age at enrollment who received GARDASIL and 7,995 individuals who received AAHS control or saline placebo. Few individuals (0.2%) discontinued due to adverse reactions. The race distribution of the 9- through 26-year-old 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 24- through 45-year-old women in the safety population of Study 6 was as follows: 20.6% White; 43.2% Hispanic (Black and White); 0.2% Other; 4.8% Black; 31.2% Asian; and 0.1% American Indian. The race distribution of the 9- through 26-year-old 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 1Injection-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)%
SalinePlacebo(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 *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 SulfateCommon 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 2Injection-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)%
SalinePlacebo(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 *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 SulfateEvaluation 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 3Postdose 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)
AdverseReaction
Post-dose1N** =5011
Post-dose2N = 4924
Post-dose3N = 4818
Post-dose1N = 3410
Post-dose2N = 3351
Post-dose3N = 3295
Post-dose1N = 315
Post-dose2N = 301
Post-dose3N = 300
PainMild/ModerateSevere
63.462.50.9
60.759.71.0
62.761.21.5
57.056.60.4
47.847.30.5
49.648.90.6
33.733.30.3
20.320.30.0
27.327.00.3
Swelling***Mild/ModerateSevere
10.29.60.6
12.811.90.8
15.114.20.9
8.28.10.2
7.57.20.2
7.67.30.2
4.44.40.0
3.03.00.0
3.33.30.0
Erythema***Mild/ModerateSevere
9.29.00.2
12.111.70.3
14.714.30.4
9.89.50.3
8.48.40.1
8.98.80.1
7.37.30.0
5.35.30.0
5.75.70.0
*AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate **N = Number of individuals with follow-up ***Intensity of swelling and erythema was measured by size (inches): Mild = 0 to ≤1; Moderate = >1 to ≤2; Severe = >2.Evaluation of Injection-Site Adverse Reactions by Dose in Boys and Men 9 Through 26 Years of Age
An analysis of injection-site adverse reactions in boys and men by dose is shown in Table 4. Of those boys and men who reported an injection-site reaction, 96.4% judged their injection-site adverse reaction to be mild or moderate in intensity.
Table 4Postdose Evaluation of Injection-Site Adverse Reactions in Boys and Men 9 Through 26 Years of Age(1 to 5 Days Postvaccination)
GARDASIL(% occurrence)
AAHS Control*(% occurrence)
Saline Placebo(% occurrence)
AdverseReaction
Post-dose1N** =3003
Post-dose2N = 2898
Post-dose3N = 2826
Post-dose1N = 1950
Post-dose2N = 1854
Post-dose3N = 1799
Post-dose1N = 269
Post-dose2N = 263
Post-dose3N = 259
PainMild/ModerateSevere
44.744.50.2
36.936.40.5
34.434.10.3
38.437.90.4
28.228.20.1
25.825.50.3
27.527.50.0
20.520.20.4
16.216.20.0
Swelling***Mild/ModerateSevere
5.65.30.2
6.66.20.3
7.77.10.5
5.65.40.2
4.54.50.0
4.14.00.1
4.84.80.0
1.51.50.0
3.53.10.4
Erythema***Mild/ModerateSevere
7.26.80.3
8.07.70.2
8.78.30.3
8.38.00.2
6.36.20.1
5.75.60.1
7.17.10.0
5.75.70.0
5.05.00.0
*AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate **N = Number of individuals 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 5.
Table 5Common Systemic Adverse Reactions in Girls and Women 9 Through 26 Years of Age(GARDASIL ≥Control)*
Adverse Reactions(1 to 15 Days Postvaccination)
GARDASIL(N = 5088)%
AAHS Control** or SalinePlacebo(N = 3790)%
PyrexiaNauseaDizzinessDiarrheaVomitingCoughToothacheUpper respiratory tract infectionMalaiseArthralgiaInsomniaNasal congestion
13.06.74.03.62.42.01.51.51.41.21.21.1
11.26.53.73.51.91.51.41.51.20.90.90.9
* 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 SulfateCommon Systemic Adverse Reactions in Boys and Men 9 Through 26 Years of Age
Headache was the most commonly reported systemic adverse reaction in both treatment groups (GARDASIL = 12.3% and AAHS control or saline placebo = 11.2%). Fever was the next most commonly reported systemic adverse reaction in both treatment groups (GARDASIL = 8.3% and AAHS control or saline placebo = 6.5%).
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 group that received GARDASIL was greater than or equal to the incidence in the AAHS control or saline placebo group, are shown in Table 6.
Table 6Common Systemic Adverse Reactions in Boys and Men 9 Through 26 Years of Age(GARDASIL ≥Control)*
Adverse Reactions(1 to 15 Days Postvaccination)
GARDASIL(N = 3093)%
AAHS Control** or SalinePlacebo(N = 2303)%
HeadachePyrexiaOropharyngeal painDiarrheaNasopharyngitisNauseaUpper respiratory tract infectionAbdominal pain upperMyalgiaDizzinessVomiting
12.38.32.82.72.62.01.51.41.31.21.0
11.26.52.12.22.61.01.01.40.70.90.8
*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 SulfateEvaluation 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 7.
Table 7Postdose Evaluation of Fever in Girls and Women 9 Through 26 Years of Age(1 to 5 Days Postvaccination)
GARDASIL(% occurrence)
AAHS Control* or Saline Placebo(% occurrence)
Temperature(°F)
Postdose 1N** = 4945
Postdose 2N = 4804
Postdose 3N = 4671
Postdose 1N = 3681
Postdose 2N = 3564
Postdose 3N = 3467
≥100 to
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