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Sexually transmitted diseases (STDs) are infections that are transmitted during any type of sexual exposure, including intercourse (vaginal or anal), oral sex, and the sharing of sexual devices, such as vibrators. In the professional medical arena, STDs are referred to as STIs (sexually transmitted infections). This terminology is used because many infections are frequently temporary. Some STDs are infections that are transmitted by persistent and close skin-to-skin contact, including during sexual intimacy. Although treatment exists for many STDs, others currently are usually incurable, such as HIV, HPV, hepatitis B and C, and HHV-8. Furthermore, many infections can be present in, and be spread by, patients who do not have symptoms.
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Headache, fever, nausea, and dizziness; and local injection site reactions (pain, swelling, erythema, pruritus, and bruising) occurred after administration with GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) .
Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) and may result in falling with injury; observation for 15 minutes after administration is recommended. [See WARNINGS AND PRECAUTIONS.]
Anaphylaxis has been reported following vaccination with GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) .
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.
In 6 clinical trials (4 Amorphous Aluminum Hydroxyphosphate Sulfate [AAHS]-controlled, 1 saline placebo-controlled, and 1 uncontrolled), 14,273 individuals were administered GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) or AAHS control or saline placebo in these individuals. The individuals who were monitored using VRC-aided surveillance included 8180 individuals 9 through 26 years of age at enrollment who received GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) and 6093 individuals who received AAHS control or saline placebo. Few individuals (0.2%) discontinued due to adverse reactions. The race distribution of the girls and women in the safety population was as follows: 62.3% White; 17.6% Hispanic (Black and White); 6.8% Asian; 6.7% Other; 6.4% Black; and 0.3% American Indian. The race distribution of the boys and men in the safety population was as follows: 42.0% White; 19.7% Hispanic (Black and White); 11.0% Asian; 11.2% Other; 15.9% Black; and 0.1% American Indian.
The injection site adverse reactions that were observed among recipients of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients are shown in Table 1.
Table 1 : Injection-Site Adverse Reactions in Girls and Women
9 Through 26 Years of Age*
| Adverse Reaction (1 to 5 Days Post vaccination) |
GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) (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 |
| *The injection-site adverse reactions that
were observed among recipients of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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 |
|||
The injection site adverse reactions that were observed among recipients of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients are shown in Table 2.
Table 2 : Injection-Site Adverse Reactions in Boys and Men
9 Through 26 Years of Age*
| Adverse Reaction (1 to 5 Days Postvaccination) |
GARDASIL (N = 3092)% |
AAHS Control ** (N = 2029) % |
Saline Placebo (N = 274) % |
| Injection Site | |||
| Pain | 61.5 | 50.8 | 41.6 |
| Erythema | 16.7 | 14.1 | 14.5 |
| Swelling | 13.9 | 9.6 | 8.2 |
| *The injection-site adverse reactions that
were observed among recipients of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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 |
|||
An analysis of injection-site adverse reactions in girls and women by dose is shown in Table 3. Of those girls and women who reported an injection-site reaction, 94.3% judged their injection-site adverse reaction to be mild or moderate in intensity.
Table 3 : Postdose Evaluation of Injection-Site Adverse Reactions
in Girls and Women 9 Through 26 Years of Age (1 to 5 Days Postvaccination)
| Adverse Reaction | GARDASIL (% occurrence) | AAHS Control* (% occurrence) | Saline Placebo (% occurrence) | ||||||
| Post-dose1 N** =5011 |
Post-dose2 N = 4924 |
Post-dose3 N = 4818 |
Post-dose1 N =3410 |
Post-dose2 N = 3351 |
Post-dose3 N = 3295 |
Post-dose1 N = 315 |
Post-dose2 N = 301 |
Post-dose3 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 individuals with follow-up ***Intensity of swelling and erythema was measured by size (inches): Mild = 0 to ≤ 1; Moderate = > 1 to ≤ 2; Severe = > 2. |
|||||||||
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 4 : Postdose Evaluation of Injection-Site Adverse Reactions
in Boys and Men 9 Through 26 Years of Age (1 to 5 Days Postvaccination)
| Adverse Reaction | GARDASIL (% occurrence) | AAHS Control* (% occurrence) | Saline Placebo (% occurrence) | ||||||
| Post-dose1 N** =3002 |
Post-dose2 N = 2897 |
Post-dose3 N = 2825 |
Post-dose1 N =1950 |
Post-dose2 N = 1853 |
Post-dose3 N = 1799 |
Post-dose1 N = 269 |
Post-dose2 N = 263 |
Post-dose3 N = 259 |
|
| Pain | 44.7 | 36.9 | 34.4 | 38.4 | 28.2 | 25.8 | 27.5 | 20.5 | 16.2 |
| Mild/Moderate | 44.5 | 36.5 | 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 |
| *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. |
|||||||||
Headache was the most commonly reported systemic adverse reaction in both treatment groups (GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) = 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) = 13.0% and AAHS control or saline placebo = 11.2%).
Adverse reactions that were observed among recipients of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) , at a frequency of greater than or equal to 1.0% where the incidence in the GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) group was greater than or equal to the incidence in the AAHS control or saline placebo group, are shown in Table 5.
Table 5 : Common Systemic Adverse Reactions in Girls and
Women 9 Through 26 Years of Age (GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) ≥ Control)*
| Adverse Reactions (1 to 15 Days Postvaccination) |
GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) (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 |
| *The adverse reactions in this table are
those that were observed among recipients of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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 |
||
Headache was the most commonly reported systemic adverse reaction in both treatment groups (GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) = 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) = 8.2% and AAHS control or saline placebo = 6.5%).
Adverse reactions that were observed among recipients of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) , at a frequency of greater than or equal to 1.0% where the incidence in the group that received GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) was greater than or equal to the incidence in the AAHS control or saline placebo group, are shown in Table 6.
Table 6: Common Systemic Adverse Reactions in Boys and Men
9 Through 26 Years of Age (GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) ≥ Control)*
| Adverse Reactions (1 to 15 Days Postvaccination) |
GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) (N = 3092) % |
AAHS control** or Saline Placebo (N = 2303) % |
| Headache | 12.3 | 11.2 |
| Pyrexia | 8.2 | 6.5 |
| Pharyngolaryngeal 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 |
| *The adverse reactions in this table are
those that were observed among recipients of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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 |
||
An analysis of fever in girls and women by dose is shown in Table 7.
Table 7 : Postdose Evaluation of Fever in Girls and Women
9 Through 26 Years of Age (1 to 5 Days Postvaccination)
| Temperature (° F) | GARDASIL (% occurrence) | AAHS Control *or Saline Placebo (% occurrence) | ||||
| 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 |
| ≥ 102 | 0.3 | 0.5 | 0.5 | 0.2 | 0.4 | 0.5 |
| *AAHS Control = Amorphous Aluminum Hydroxyphosphate
Sulfate **N = Number of individuals with follow-up |
||||||
An analysis of fever in boys and men by dose is shown in Table 8.
Table 8 : Postdose Evaluation of Fever in Boys and Men 9
Through 26 Years of Age (1 to 5 Days Postvaccination)
| Temperature (° F) | GARDASIL (% occurrence) | AAHS Control* or Saline Placebo (% occurrence) | ||||
| Postdose 1 N**= 2971 |
Postdose 2 N = 2847 |
Postdose 3 N= 2791 |
Postdose 1 N = 2194 |
Postdose 2 N = 2079 |
Postdose 3 N = 2046 |
|
| ≥ 100 to < 102 | 2.4 | 2.5 | 2.3 | 2.1 | 2.1 | 1.6 |
| ≥ 102 | 0.6 | 0.5 | 0.5 | 0.6 | 0.3 | 0.3 |
| *AAHS Control = Amorphous Aluminum Hydroxyphosphate
Sulfate **N = Number of individuals with follow-up |
||||||
Across the clinical studies, 255 individuals (GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) N = 126 or 0.8%; Placebo N = 129 or 1.0%) out of 29,323 (GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) , AAHS control, saline placebo, or the total of all three) reported serious systemic adverse reactions, regardless of causality, were:
Headache [0.02% GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) (3 cases) vs. 0.02% AAHS Control (2 cases)],
Gastroenteritis [0.02% GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) (3 cases) vs. 0.02% AAHS Control (2 cases)],
Appendicitis [0.03% GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) (5 cases) vs. 0.01% AAHS Control (1 case)],
Pelvic inflammatory disease [0.02% GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) (3 cases) vs. 0.03% AAHS Control
(4 cases)],
Urinary tract infection [0.01% GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) (2 cases) vs. 0.02% AAHS Control (2
cases)],
Pneumonia [0.01% GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) (2 cases) vs. 0.02% AAHS Control (2 cases)],
Pyelonephritis [0.01% GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) (2 cases) vs. 0.02% AAHS Control (3 cases)],
Pulmonary embolism [0.01% GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) (2 cases) vs. 0.02% AAHS Control (2 cases)].
One case (0.006% GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) ; 0.0% AAHS Control or Saline Placebo) of bronchospasm; and 2 cases (0.01% GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) ; 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) , who reported two injection-site serious adverse reactions (injection-site pain and injection-site joint movement impairment).
Across the clinical studies, 37 deaths (GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) N = 18 or 0.1%; Placebo N = 19 or 0.1%) were reported in 29,323 (GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) and 4 individuals who received AAHS Control), followed by drug overdose/suicide (2 individuals who received GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) and 6 individuals who received AAHS Control), gun shot wound (1 individual who received GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) and 3 individuals who received AAHS Control), and pulmonary embolus/deep vein thrombosis (1 individual who received GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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, and 1 case of systemic lupus erythematosus in the group that received GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) ; 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.
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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) or AAHS control or saline placebo, and had safety data available.
Table 9 : Summary of Girls and Women 9 Through 26 Years of
Age Who Reported an Incident Condition Potentially Indicative of a Systemic
Autoimmune Disorder After Enrollment in Clinical Trials of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) , Regardless
of Causality
| Conditions | GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) (N = 10,706) n (%) |
AAHS Control* or Saline Placebo (N = 9412) n (%) |
| 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§ | 4 (0.0) | 3 (0.0) |
| Psoriasis# | 13 (0.1) | 15 (0.2) |
| Raynaud's Phenomenon | 3 (0.0) | 4 (0.0) |
| Rheumatoid Arthritis†† | 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) |
| *AAHS Control = Amorphous Aluminum Hydroxyphosphate
Sulfate **Arthralgia/Arthritis/Arthropathy includes the following terms: Arthralgia, Arthritis, Arthritis reactive, and Arthropathy ***Hyperthyroidism includes the following terms: Basedow's disease, Goiter, Toxic nodular goiter, and Hyperthyroidism †Hypothyroidism includes the following terms: Hypothyroidism and thyroiditis ‡Inflammatory bowel disease includes the following terms: Colitis ulcerative, Crohn's disease, and Inflammatory bowel disease ¶Nephritis includes the following terms: Nephritis, Glomerulonephritis minimal lesion, Glomerulonephritis proliferative §Pigmentation disorder includes the following terms: Pigmentation disorder, Skin depigmentation, and Vitiligo #Psoriasis includes the following terms: Psoriasis, Pustular psoriasis, and Psoriatic arthropathy ††Rheumatoid arthritis includes juvenile rheumatoid arthritis. One woman counted in the rheumatoid arthritis group reported rheumatoid arthritis as an adverse experience at Day 130. 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. |
||
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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) or AAHS control or saline placebo, and had safety data available.
Table 10 : Summary of Boys and Men 9 Through 26 Years of
Age Who Reported an Incident Condition Potentially Indicative of a Systemic
Autoimmune Disorder After Enrollment in Clinical Trials of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) , Regardless
of Causality
| Conditions | GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) (N = 3092) n (%) |
AAHS Control* or Saline Placebo (N = 2303) n (%) |
| Alopecia Areata | 1 (0.0) | 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*** | 0 (0.0) | 2 (0.1) |
| Myocarditis | 1 (0.0) | 1 (0.0) |
| Proteinuria | 1 (0.0) | 0 (0.0) |
| Psoriasis | 0 (0.0) | 2 (0.1) |
| Vitiligo | 2 (0.1) | 5 (0.2) |
| All Conditions | 43 (1.4) | 32 (1.4) |
| *AAHS Control = Amorphous Aluminum Hydroxyphosphate
Sulfate **Hypothyroidism includes the following terms: Hypothyroidism and Autoimmune thyroiditis ***Inflammatory bowel disease includes the following terms: Colitis ulcerative and Crohn's disease 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. |
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The safety of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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. 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) or RECOMBIVAX HB hepatitis B vaccine.
The following adverse events have been spontaneously reported during post-approval use of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) . Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.
Blood and lymphatic system disorders: Autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, lymphadenopathy.
Respiratory, thoracic and mediastinal disorders: Pulmonary embolus.
Gastrointestinal disorders: Nausea, pancreatitis, vomiting.
General disorders and administration site conditions: Asthenia, chills, death, fatigue, malaise.
Immune system disorders: Autoimmune diseases, hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
Nervous system disorders: Acute disseminated encephalomyelitis, dizziness, Guillain-Barré syndrome, headache, motor neuron disease, paralysis, seizures, syncope (including syncope associated with tonicclonic movements and other seizure-like activity) sometimes resulting in falling with injury, transverse myelitis.
Vascular disorders: Deep venous thrombosis.
Results from clinical studies indicate that GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) may be administered concomitantly (at a separate injection site) with RECOMBIVAX HB hepatitis B vaccine (recombinant) [see Clinical Studies]. Coadministration of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) with other vaccines has not been studied.
In clinical studies, 13,293 women (GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) N = 6644; AAHS control or saline placebo N = 6649) who had post-Month 7 follow-up used hormonal contraceptives for a total of 17,597 person-years (65.1% of the total follow-up time in the studies). Use of hormonal contraceptives or lack of use of hormonal contraceptives among study participants did not alter immune response in the per protocol efficacy (PPE) population.
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines [see Use in Specific Populations].
Last reviewed on RxList: 1/26/2010
This monograph has been modified to include the generic and brand name in many instances.
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