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Cervarix

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Cervarix

SIDE EFFECTS

The most common local adverse reactions ( ≥ 20% of subjects) were pain, redness, and swelling at the injection site.

The most common general adverse events ( ≥ 20% of subjects) were fatigue, headache, myalgia, gastrointestinal symptoms, and arthralgia.

Clinical Studies 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 with rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice. There is the possibility that broad use of CERVARIX (human papillomavirus bivalent vaccine) could reveal adverse reactions not observed in clinical trials.

Studies in Females 10 Through 25 Years of Age: The safety of CERVARIX (human papillomavirus bivalent vaccine) was evaluated by pooling data from controlled and uncontrolled clinical trials involving 23,713 females 10 through 25 years of age in the pre-licensure clinical development program. In these studies, 12,785 females (10 through 25 years of age) received at least one dose of CERVARIX (human papillomavirus bivalent vaccine) and 10,928 females received at least one dose of a control [Hepatitis A Vaccine containing 360 EL.U. (10 through 14 years of age), Hepatitis A Vaccine containing 720 EL.U. (15 through 25 years of age), or Al(OH)3 (500 mcg, 15 through 25 years of age)].

Data on solicited local and general adverse events were collected by subjects or parents using standardized diary cards for 7 consecutive days following each vaccine dose (i.e., day of vaccination and the next 6 days). Unsolicited adverse events were recorded with diary cards for 30 days following each vaccination (day of vaccination and 29 subsequent days). Parents and/or subjects were also asked at each study visit about the occurrence of any adverse events and instructed to immediately report serious adverse events throughout the study period. These studies were conducted in North America, Latin America, Europe, Asia, and Australia. Overall, the majority of subjects were white (59%), followed by Asian (26%), Hispanic (9%), black (3%), and other racial/ethnic groups (3%).

Solicited Adverse Events: The reported frequencies of solicited local injection site reactions (pain, redness, and swelling) and general adverse events (fatigue, fever, gastrointestinal symptoms, headache, arthralgia, myalgia, and urticaria) within 7 days after vaccination in females 10 through 25 years of age are presented in Table 1. An analysis of solicited local injection site reactions by dose is presented in Table 2. Local reactions were reported more frequently with CERVARIX (human papillomavirus bivalent vaccine) when compared with the control groups; in ≥ 84% of recipients of CERVARIX (human papillomavirus bivalent vaccine) , these local reactions were mild to moderate in intensity. Compared with dose 1, pain was reported less frequently after doses 2 and 3 of CERVARIX (human papillomavirus bivalent vaccine) , in contrast to redness and swelling where there was a small increased incidence. There was no increase in the frequency of general adverse events with successive doses.

Table 1. Rates of Solicited Local Adverse Reactions and General Adverse Events in Females 10 Through 25 Years of Age Within 7 Days of Vaccination (Total Vaccinated Cohorta)

Adverse Reaction/Event CERVARIX (human papillomavirus bivalent vaccine)
(10-25 yrs)
%
HAV 720b
(15-25 yrs)
%
HAV 360c
(10-14 yrs)
%
Al(OH)3 Controld
(15-25 yrs)
%
Local Adverse Reaction N = 6,431 N = 3,079 N = 1,027 N = 549
   Pain 91.8 78.0 64.2 87.2
   Redness 48.0 27.6 25.2 24.4
   Swelling 44.1 19.8 17.3 21.3
General Adverse Event N = 6,432 N = 3,079 N = 1,027 N = 549
   Fatigue 55.0 53.7 42.3 53.6
   Headache 53.4 51.3 45.2 61.4
   GIe 27.8 27.3 24.6 32.8
   Fever ( ≥ 99.5°F) 12.8 10.9 16.0 13.5
   Rash 9.6 8.4 6.7 10.0
  N = 5,881 N = 3,079 N = 1,027
   Myalgiaf 49.1 44.9 33.1
   Arthralgiaf 20.8 17.9 19.9
   Urticariaf 7.4 7.9 5.4
a Total vaccinated cohort included subjects with at least one documented dose (N).
b HAV 720 = Hepatitis A Vaccine control group [720 EL.U. of antigen and 500 mcg Al(OH)3].
c HAV 360 = Hepatitis A Vaccine control group [360 EL.U. of antigen and 250 mcg of Al(OH)3].
d Al(OH)3 Control = control containing 500 mcg Al(OH)3.
e GI = Gastrointestinal symptoms, including nausea, vomiting, diarrhea, and/or abdominal pain.
f Adverse events solicited in a subset of subjects.

Table 2. Rates of Solicited Local Adverse Reactions in Females 10 Through 25 Years of Age by Dose Within 7 Days of Vaccination (Total Vaccinated Cohorta)

Adverse Reaction CERVARIX (human papillomavirus bivalent vaccine)
(10-25 yrs)
%
HAV 720b
(15-25 yrs)
%
HAV 360c
(10-14 yrs)
%
Al(OH)3 Controld
(15-25 yrs)
%
Post-Dose Post-Dose Post-Dose Post-Dose
1 2 3 1 2 3 1 2 3 1 2 3
N 6,415 6,197 5,936 3,070 2,919 2,758 1,027 1,021 1,011 546 521 500
Pain 86.9 76.2 78.7 65.6 54.4 56.1 48.5 38.5 36.9 79.1 66.8 72.4
Pain, Grade 3e 7.5 5.7 7.7 2.0 1.4 2.0 0.8 0.2 1.6 9.0 6.0 8.6
Redness 27.8 29.6 35.6 16.6 15.2 16.1 15.6 13.3 12.1 11.5 11.5 15.6
Redness, > 50 mm 0.2 0.5 1.0 0.1 0.1 0.0 0.1 0.2 0.1 0.2 0.0 0.0
Swelling 22.7 25.2 32.7 10.5 9.4 10.5 9.4 8.6 7.6 10.3 10.4 12.0
Swelling, > 50 mm 1.2 1.0 1.3 0.2 0.2 0.2 0.4 0.3 0.0 0.0 0.0 0.0
a Total vaccinated cohort included subjects with at least one documented dose (N).
b HAV 720 = Hepatitis A Vaccine control group [720 EL.U. of antigen and 500 mcg Al(OH)3].
c HAV 360 = Hepatitis A Vaccine control group [360 EL.U. of antigen and 250 mcg of Al(OH)3].
d Al(OH)3 Control = control containing 500 mcg Al(OH)3.
e Defined as spontaneously painful or pain that prevented normal daily activities.

The pattern of solicited local adverse reactions and general adverse events following administration of CERVARIX (human papillomavirus bivalent vaccine) was similar between the age cohorts (10 through 14 years and 15 through 25 years).

Unsolicited Adverse Events: The frequency of unsolicited adverse events that occurred within 30 days of vaccination ( ≥ 1% for CERVARIX (human papillomavirus bivalent vaccine) and greater than any of the control groups) in females 10 through 25 years of age are presented in Table 3.

Table 3. Rates of Unsolicited Adverse Events in Females 10 Through 25 Years of Age Within 30 Days of Vaccination ( ≥ 1% For CERVARIX (human papillomavirus bivalent vaccine) and Greater Than HAV 720, HAV 360, or Al(OH)3 Control) (Total Vaccinated Cohorta)

Adverse Event CERVARIX (human papillomavirus bivalent vaccine)
%
(N = 6,654)
HAV 720b
%
(N = 3,186)
HAV 360c
%
(N = 1,032)
Al(OH)3 Controld
%
(N = 581)
Headache 5.3 7.6 3.3 9.3
Nasopharyngitis 3.6 3.4 5.9 3.3
Influenza 3.2 5.6 1.3 1.9
Pharyngolaryngeal pain 2.9 2.7 2.2 2.2
Dizziness 2.2 2.6 1.5 3.1
Upper respiratory infection 2.0 1.3 6.7 1.5
Chlamydia infection 2.0 4.4 0.0 0.0
Dysmenorrhea 2.0 2.3 1.9 4.0
Pharyngitis 1.5 1.8 2.2 0.5
Injection site bruising 1.4 1.8 0.7 1.5
Vaginal infection 1.4 2.2 0.1 0.9
Injection site pruritus 1.3 0.5 0.6 0.2
Back pain 1.1 1.3 0.7 3.1
Urinary tract infection 1.0 1.4 0.3 1.2
a Total vaccinated cohort included subjects with at least one dose administered (N).
b HAV 720 = Hepatitis A Vaccine control group [720 EL.U. of antigen and 500 mcg Al(OH)3].
c HAV 360 = Hepatitis A Vaccine control group [360 EL.U. of antigen and 250 mcg of Al(OH)3].
d Al(OH)3 Control = control containing 500 mcg Al(OH)3.

New Onset Autoimmune Diseases (NOADs): The pooled safety database, which included controlled and uncontrolled trials which enrolled females 10 through 25 years of age, was searched for new medical conditions indicative of potential new onset autoimmune diseases. Overall, the incidence of potential NOADs, as well as NOADs, in the group receiving CERVARIX (human papillomavirus bivalent vaccine) was 0.8% (95/12,533) and comparable to the pooled control group (0.8%, 87/10,730) during the 4.3 years of follow-up (mean 3.0 years) (Table 4).

In the largest randomized, controlled trial (Study 2) which enrolled females 15 through 25 years of age and which included active surveillance for potential NOADs, the incidence of potential NOADs and NOADs was 0.8% among subjects who received CERVARIX (human papillomavirus bivalent vaccine) (78/9,319) and 0.8% among subjects who received Hepatitis A Vaccine [720 EL.U. of antigen and 500 mcg Al(OH)3] control (77/9,325).

Table 4. Incidence of New Medical Conditions Indicative of Potential New Onset Autoimmune Disease and New Onset Autoimmune Disease Throughout the Follow-up Period Regardless of Causality in Females 10 Through 25 Years of Age (Total Vaccinated Cohorta)

  CERVARIX
(N = 12,533)
Pooled Control Groupb
(N = 10,730)
n (%)c n (%)c
Total Number of Subjects With at Least One Medical Condition 95 (0.8) 87 (0.8)
Arthritisd 9 (0.0) 4 (0.0)
Celiac disease 2 (0.0) 5 (0.0)
Dermatomyositis 0 (0.0) 1 (0.0)
Diabetes mellitus insulin-dependent (Type 1 or unspecified) 5 (0.0) 5 (0.0)
Erythema nodosum 3 (0.0) 0 (0.0)
Hyperthyroidisme 14 (0.1) 15 (0.1)
Hypothyroidismf 30 (0.2) 28 (0.3)
Inflammatory bowel diseaseg 8 (0.1) 4 (0.0)
Multiple sclerosis 4 (0.0) 1 (0.0)
Myelitis transverse 1 (0.0) 0 (0.0)
Optic neuritis/Optic neuritis retrobulbar 3 (0.0) 1 (0.0)
Psoriasish 8 (0.1) 11 (0.1)
Raynaud's phenomenon 0 (0.0) 1 (0.0)
Rheumatoid arthritis 4 (0.0) 3 (0.0)
Systemic lupus erythematosusi 2 (0.0) 3 (0.0)
Thrombocytopeniaj 1 (0.0) 1 (0.0)
Vasculitisk 1 (0.0) 3 (0.0)
Vitiligo 2 (0.0) 2 (0.0)
a Total vaccinated cohort included subjects with at least one documented dose (N).
b Pooled Control Group = Hepatitis A Vaccine control group [720 EL.U. of antigen and 500 mcg Al(OH)3], Hepatitis A Vaccine control group [360 EL.U. of antigen and 250 mcg of Al(OH)3], and a control containing 500 mcg Al(OH)3.
c n (%): number and percentage of subjects with medical condition.
d Term includes reactive arthritis and arthritis.
e Term includes Basedow's disease, goiter, and hyperthyroidism.
f Term includes thyroiditis, autoimmune thyroiditis, and hypothyroidism.
g Term includes colitis ulcerative, Crohn's disease, proctitis ulcerative, and inflammatory bowel disease.
h Term includes psoriatic arthropathy, nail psoriasis, guttate psoriasis, and psoriasis.
i Term includes systemic lupus erythematosus and cutaneous lupus erythematosus.
j Term includes idiopathic thrombocytopenic purpura and thrombocytopenia.
k Term includes leukocytoclastic vasculitis and vasculitis.

Serious Adverse Events: In the pooled safety database, inclusive of controlled and uncontrolled studies, which enrolled females 10 through 72 years of age, 5.3% (862/16,142) of subjects who received CERVARIX (human papillomavirus bivalent vaccine) and 5.9% (814/13,811) of subjects who received control reported at least one serious adverse event, without regard to causality, during the entire follow-up period (up to 7.4 years).

Among females 10 through 25 years of age enrolled in these clinical studies, 6.4% of subjects who received CERVARIX (human papillomavirus bivalent vaccine) and 7.2% of subjects who received the control reported at least one serious adverse event during the entire follow-up period (up to 7.4 years).

Deaths: In completed and ongoing studies which enrolled 57,323 females 9 through 72 years of age, 37 deaths were reported during the 7.4 years of follow-up: 20 in subjects who received CERVARIX (human papillomavirus bivalent vaccine) (0.06%, 20/33,623) and 17 in subjects who received control (0.07%, 17/23,700). Causes of death among subjects were consistent with those reported in adolescent and adult female populations. The most common causes of death were motor vehicle accident (5 subjects who received CERVARIX (human papillomavirus bivalent vaccine) ; 5 subjects who received control) and suicide (2 subjects who received CERVARIX (human papillomavirus bivalent vaccine) ; 5 subjects who received control), followed by neoplasm (3 subjects who received CERVARIX (human papillomavirus bivalent vaccine) ; 2 subjects who received control), autoimmune disease (3 subjects who received CERVARIX (human papillomavirus bivalent vaccine) ; 1 subject who received control), infectious disease (3 subjects who received CERVARIX (human papillomavirus bivalent vaccine) ; 1 subject who received control), homicide (2 subjects who received CERVARIX (human papillomavirus bivalent vaccine) ; 1 subject who received control), cardiovascular disorders (2 subjects who received CERVARIX (human papillomavirus bivalent vaccine) ), and death of unknown cause (2 subjects who received control). Among females 10 through 25 years of age, 31 deaths were reported (0.05%, 16/29,467 of subjects who received CERVARIX (human papillomavirus bivalent vaccine) and 0.07%, 15/20,192 of subjects who received control.

Postmarketing Experience

In addition to reports in clinical trials, worldwide voluntary reports of adverse events received for CERVARIX (human papillomavirus bivalent vaccine) since market introduction (2007) are listed below. This list includes serious events or events which have suspected causal association to CERVARIX (human papillomavirus bivalent vaccine) . Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccination.

Immune System Disorders: Allergic reactions (including anaphylactic and anaphylactoid reactions), angioedema, erythema multiforme.

Nervous System Disorders: Syncope or vasovagal responses to injection (sometimes accompanied by tonic-clonic movements).

Read the Cervarix (human papillomavirus bivalent vaccine) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Concomitant Vaccine Administration

There are no data to assess the concomitant use of CERVARIX (human papillomavirus bivalent vaccine) with other vaccines. Do not mix CERVARIX (human papillomavirus bivalent vaccine) with any other vaccine in the same syringe or vial.

Hormonal Contraceptives

Among 7,693 subjects 15 through 25 years of age in Study 2 (CERVARIX (human papillomavirus bivalent vaccine) , N = 3,821 or Hepatitis A Vaccine 720 EL.U., N = 3,872) who used hormonal contraceptives for a mean of 2.8 years, the observed efficacy of CERVARIX (human papillomavirus bivalent vaccine) was similar to that observed among subjects who did not report use of hormonal contraceptives.

Immunosuppressive Therapies

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to CERVARIX [see Use in Specific Populations].

Last reviewed on RxList: 10/30/2009
This monograph has been modified to include the generic and brand name in many instances.

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