Vaccine Information: GARDASIL
GARDASIL- human papillomavirus type 6 l1 capsid protein antigen, human papillomavirus type 11 l1 capsid protein antigen, human papillomavirus type 16 l1 capsid protein antigen and human papillomavirus type 18 l1 capsid protein antigen injection, suspension
Merck Sharp & Dohme LLC
1 INDICATIONS AND USAGE
1.1 Girls and Women
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
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.
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.
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 |
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.
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 |
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.
GARDASIL(% occurrence) | AAHS Control *(% occurrence) | Saline Placebo(% occurrence) | |||||||
---|---|---|---|---|---|---|---|---|---|
Adverse Reaction | Post-dose 1N † = 5011 | Post-dose 2N = 4924 | Post-dose 3N = 4818 | Post-dose 1N = 3410 | Post-dose 2N = 3351 | Post-dose 3N = 3295 | Post-dose 1N = 315 | Post-dose 2N = 301 | Post-dose 3N = 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 |
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.
GARDASIL(% occurrence) | AAHS Control *(% occurrence) | Saline Placebo(% occurrence) | |||||||
---|---|---|---|---|---|---|---|---|---|
Adverse Reaction | Post-dose 1N † = 3003 | Post-dose 2N = 2898 | Post-dose 3N = 2826 | Post-dose 1N = 1950 | Post-dose 2N = 1854 | Post-dose 3N = 1799 | Post-dose 1N = 269 | Post-dose 2N = 263 | Post-dose 3N = 259 |
Pain | 44.7 | 36.9 | 34.4 | 38.4 | 28.2 | 25.8 | 27.5 | 20.5 | 16.2 |
Mild/Moderate | 44.5 | 36.4 | 34.1 | 37.9 | 28.2 | 25.5 | 27.5 | 20.2 | 16.2 |
Severe | 0.2 | 0.5 | 0.3 | 0.4 | 0.1 | 0.3 | 0.0 | 0.4 | 0.0 |
Swelling ‡ | 5.6 | 6.6 | 7.7 | 5.6 | 4.5 | 4.1 | 4.8 | 1.5 | 3.5 |
Mild/Moderate | 5.3 | 6.2 | 7.1 | 5.4 | 4.5 | 4.0 | 4.8 | 1.5 | 3.1 |
Severe | 0.2 | 0.3 | 0.5 | 0.2 | 0.0 | 0.1 | 0.0 | 0.0 | 0.4 |
Erythema ‡ | 7.2 | 8.0 | 8.7 | 8.3 | 6.3 | 5.7 | 7.1 | 5.7 | 5.0 |
Mild/Moderate | 6.8 | 7.7 | 8.3 | 8.0 | 6.2 | 5.6 | 7.1 | 5.7 | 5.0 |
Severe | 0.3 | 0.2 | 0.3 | 0.2 | 0.1 | 0.1 | 0.0 | 0.0 | 0.0 |
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.
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 |
Common 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.
Adverse Reactions (1 to 15 Days Postvaccination) | GARDASIL(N = 3093)% | AAHS Control † or Saline Placebo(N = 2303)% |
---|---|---|
Headache | 12.3 | 11.2 |
Pyrexia | 8.3 | 6.5 |
Oropharyngeal pain | 2.8 | 2.1 |
Diarrhea | 2.7 | 2.2 |
Nasopharyngitis | 2.6 | 2.6 |
Nausea | 2.0 | 1.0 |
Upper respiratory tract infection | 1.5 | 1.0 |
Abdominal pain upper | 1.4 | 1.4 |
Myalgia | 1.3 | 0.7 |
Dizziness | 1.2 | 0.9 |
Vomiting | 1.0 | 0.8 |
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 7.
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 <102 | 3.7 | 4.1 | 4.4 | 3.1 | 3.8 | 3.6 |
≥102 | 0.3 | 0.5 | 0.5 | 0.2 | 0.4 | 0.5 |
Evaluation of Fever by Dose in Boys and Men 9 Through 26 Years of Age
An analysis of fever in boys and men by dose is shown in Table 8.
GARDASIL(% occurrence) | AAHS Control * or Saline Placebo(% occurrence) | |||||
---|---|---|---|---|---|---|
Temperature(°F) | Postdose 1N † = 2972 | Postdose 2N = 2849 | Postdose 3N = 2792 | Postdose 1N = 2194 | Postdose 2N = 2079 | Postdose 3N = 2046 |
≥100 to <102 | 2.4 | 2.5 | 2.3 | 2.1 | 2.2 | 1.6 |
≥102 | 0.6 | 0.5 | 0.5 | 0.5 | 0.3 | 0.3 |
Serious Adverse Reactions in the Entire Study Population
Across the clinical studies, 258 individuals (GARDASIL N = 128 or 0.8%; placebo N = 130 or 1.0%) out of 29,323 (GARDASIL N = 15,706; AAHS control N = 13,023; or saline placebo N = 594) individuals (9- through 45-year-old girls and women; and 9- through 26-year-old boys and men) reported a serious systemic adverse reaction.
Of the entire study population (29,323 individuals), 0.04% of the reported serious systemic adverse reactions were judged to be vaccine related by the study investigator. The most frequently (frequency of 4 cases or greater with either GARDASIL, AAHS control, saline placebo, or the total of all three) reported serious systemic adverse reactions, 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 (5 cases) vs. 0.01% AAHS control (1 case)],
Pelvic inflammatory disease [0.02% GARDASIL (3 cases) vs. 0.03% AAHS control (4 cases)],
Urinary tract infection [0.01% GARDASIL (2 cases) vs. 0.02% AAHS control (2 cases)],
Pneumonia [0.01% GARDASIL (2 cases) vs. 0.02% AAHS control (2 cases)],
Pyelonephritis [0.01% GARDASIL (2 cases) vs. 0.02% AAHS control (3 cases)],Pulmonary embolism [0.01% GARDASIL (2 cases) vs. 0.02% AAHS control (2 cases)].
One case (0.006% GARDASIL; 0.0% AAHS control or saline placebo) of bronchospasm; and 2 cases (0.01% 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 individual 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, 40 deaths (GARDASIL N = 21 or 0.1%; placebo N = 19 or 0.1%) were reported in 29,323 (GARDASIL N = 15,706; AAHS control N = 13,023, saline placebo N = 594) individuals (9- through 45-year-old girls and women; and 9- through 26-year-old boys and men). The events reported were consistent with events expected in healthy adolescent and adult populations. The most common cause of death was motor vehicle accident (5 individuals who received GARDASIL and 4 individuals who received AAHS control), followed by drug overdose/suicide (2 individuals who received GARDASIL and 6 individuals who received AAHS control), gunshot wound (1 individual who received GARDASIL and 3 individuals who received AAHS control), and pulmonary embolus/deep vein thrombosis (1 individual who received GARDASIL and 1 individual who received AAHS control). 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, 1 case of traumatic brain injury/cardiac arrest, 1 case of systemic lupus erythematosus, 1 case of cerebrovascular accident, 1 case of breast cancer, and 1 case of nasopharyngeal cancer in the group that received GARDASIL; 1 case of asphyxia, 1 case of acute lymphocytic leukemia, 1 case of chemical poisoning, and 1 case of myocardial ischemia in the AAHS control group; and 1 case of medulloblastoma in the saline placebo group.
Systemic Autoimmune Disorders in Girls and Women 9 Through 26 Years of Age
In the clinical studies, 9- through 26-year-old girls and women were evaluated for new medical conditions that occurred over the course of follow-up. New medical conditions potentially indicative of a systemic autoimmune disorder seen in the group that received GARDASIL or AAHS control or saline placebo are shown in Table 9. This population includes all girls and women who received at least one dose of GARDASIL or AAHS control or saline placebo, and had safety data available.
Conditions | GARDASIL(N = 10,706) | AAHS Control * or Saline Placebo(N = 9412) |
---|---|---|
n (%) | n (%) | |
N = Number of individuals enrolled | ||
n = Number of individuals with specific new Medical Conditions | ||
NOTE: Although an individual may have had two or more new Medical Conditions, the individual is counted only once within a category. The same individual may appear in different categories. | ||
| ||
Arthralgia/Arthritis/Arthropathy † | 120 (1.1) | 98 (1.0) |
Autoimmune Thyroiditis | 4 (0.0) | 1 (0.0) |
Celiac Disease | 10 (0.1) | 6 (0.1) |
Diabetes Mellitus Insulin-dependent | 2 (0.0) | 2 (0.0) |
Erythema Nodosum | 2 (0.0) | 4 (0.0) |
Hyperthyroidism ‡ | 27 (0.3) | 21 (0.2) |
Hypothyroidism § | 35 (0.3) | 38 (0.4) |
Inflammatory Bowel Disease ¶ | 7 (0.1) | 10 (0.1) |
Multiple Sclerosis | 2 (0.0) | 4 (0.0) |
Nephritis # | 2 (0.0) | 5 (0.1) |
Optic Neuritis | 2 (0.0) | 0 (0.0) |
Pigmentation Disorder Þ | 4 (0.0) | 3 (0.0) |
Psoriasis ß | 13 (0.1) | 15 (0.2) |
Raynaud’s Phenomenon | 3 (0.0) | 4 (0.0) |
Rheumatoid Arthritis à | 6 (0.1) | 2 (0.0) |
Scleroderma/Morphea | 2 (0.0) | 1 (0.0) |
Stevens-Johnson Syndrome | 1 (0.0) | 0 (0.0) |
Systemic Lupus Erythematosus | 1 (0.0) | 3 (0.0) |
Uveitis | 3 (0.0) | 1 (0.0) |
All Conditions | 245 (2.3) | 218 (2.3) |
Systemic Autoimmune Disorders in Boys and Men 9 Through 26 Years of Age
In the clinical studies, 9- through 26-year-old boys and men were evaluated for new medical conditions that occurred over the course of follow-up. New medical conditions potentially indicative of a systemic autoimmune disorder seen in the group that received GARDASIL or AAHS control or saline placebo are shown in Table 10. This population includes all boys and men who received at least one dose of GARDASIL or AAHS control or saline placebo, and had safety data available.
Conditions | GARDASIL(N = 3093) | AAHS Control * or Saline Placebo(N = 2303) |
---|---|---|
n (%) | n (%) | |
N = Number of individuals who received at least one dose of either vaccine or placebo | ||
n = Number of individuals with specific new Medical Conditions | ||
NOTE: Although an individual may have had two or more new Medical Conditions, the individual is counted only once within a category. The same individual may appear in different categories. | ||
Alopecia Areata | 2 (0.1) | 0 (0.0) |
Ankylosing Spondylitis | 1 (0.0) | 2 (0.1) |
Arthralgia/Arthritis/Reactive Arthritis | 30 (1.0) | 17 (0.7) |
Autoimmune Thrombocytopenia | 1 (0.0) | 0 (0.0) |
Diabetes Mellitus Type 1 | 3 (0.1) | 2 (0.1) |
Hyperthyroidism | 0 (0.0) | 1 (0.0) |
Hypothyroidism † | 3 (0.1) | 0 (0.0) |
Inflammatory Bowel Disease ‡ | 1 (0.0) | 2 (0.1) |
Myocarditis | 1 (0.0) | 1 (0.0) |
Proteinuria | 1 (0.0) | 0 (0.0) |
Psoriasis | 0 (0.0) | 4 (0.2) |
Skin Depigmentation | 1 (0.0) | 0 (0.0) |
Vitiligo | 2 (0.1) | 5 (0.2) |
All Conditions | 46 (1.5) | 34 (1.5) |
Safety in Concomitant Use with RECOMBIVAX HB ® [hepatitis B vaccine (recombinant)] in Girls and Women 16 Through 23 Years of Age
The safety of GARDASIL when administered concomitantly with RECOMBIVAX HB® [hepatitis B vaccine (recombinant)] was evaluated in an AAHS-controlled study of 1871 girls and women with a mean age of 20.4 years [see Clinical Studies (14.10)]. The race distribution of the study individuals was as follows: 61.6% White; 23.8% Other; 11.9% Black; 1.6% Hispanic (Black and White); 0.8% Asian; and 0.3% American Indian. The rates of systemic and injection-site adverse reactions were similar among girls and women who received concomitant vaccination as compared with those who received GARDASIL or RECOMBIVAX HB [hepatitis B vaccine (recombinant)].
Safety in Concomitant Use 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)]
The safety of GARDASIL when administered concomitantly 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)] was evaluated in a randomized study of 1040 boys and girls with a mean age of 12.6 years [see Clinical Studies (14.11)]. The race distribution of the study subjects was as follows: 77.7% White; 1.4% Multi-racial; 12.3% Black; 6.8% Hispanic (Black and White); 1.2% Asian; 0.4% American Indian, and 0.2% Indian.
There was an increase in injection-site swelling reported at the injection site for GARDASIL (concomitant = 10.9%, non-concomitant = 6.9%) when GARDASIL was administered concomitantly with Menactra and Adacel as compared to non-concomitant (separated by 1 month) vaccination. The majority of injection-site swelling adverse experiences were reported as being mild to moderate in intensity.
Safety in Women 27 Through 45 Years of Age
The adverse reaction profile in women 27 through 45 years of age was comparable to the profile seen in girls and women 9 through 26 years of age.
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