ADVERSE REACTIONS
VAQTA is generally well tolerated; adverse reactions usually are mild and transient.
Clinical Studies
In combined clinical trials, 16,252 doses of VAQTA were administered to 9181 healthy children, adolescents, and adults. VAQTA was generally well tolerated.
No serious vaccine-related adverse experiences were observed during clinical trials. The Monroe Efficacy Study
In this study, 1037 healthy children and adolescents, 2 through 16 years of age, received a primary dose of ~25U of hepatitis A vaccine and a booster 6, 12, or 18 months later, or placebo. Subjects were observed during a 5-day period for fever and local complaints and during a 14-day period for systemic complaints. Injection-site complaints, generally mild and transient, were the most frequently reported complaints. Table 5 summarizes the local and systemic complaints (>/=1%) reported in this study, without regard to causality. There were no significant differences in the rates of any complaints between vaccine and placebo recipients after Dose 1.
Table 5
Local and Systemic Complaints (>/=1%) in Healthy Children and Adolescents from
The Monroe Efficacy Study
|
Reaction
|
VAQTA
|
Placebo*, **/* |
|
Dose 1 * |
Booster
|
| Injection-Site Complaints |
|
Pain
|
6.4% (33/515) |
3.4% (16/475) |
6.3% (32/510) |
|
Tenderness
|
4.9% (25/515) |
1.7% (8/475) |
6.1% (31/510) |
|
Erythema
|
1.9% (10/515) |
0.8% (4/475) |
1.8% (9/510) |
|
Swelling
|
1.7% (9/515) |
1.5% (7/475) |
1.6% (8/510) |
|
Warmth
|
1.7% (9/515) |
0.6% (3/475) |
1.6% (8/510) |
| Systemic Complaints |
|
Abdominal Pain
|
1.2% (6/519) |
1.1% (5/475) |
1.0% (5/518) |
|
Pharyngitis
|
1.2% (6/519) |
0% (0/475) |
0.8% (4/518) |
|
Headache
|
0.4% (2/519) |
0.8% (4/475) |
1.0% (5/518) |
|
*No statistically significant differences between the two groups.
|
| **/* Second injection of placebo not administered because code for the trial was broken.
|
|
Children/Adolescents--2 through 18 Years of Age
In combined clinical trials (including Monroe Efficacy Study participants) involving 2615 healthy children and adolescents who received one or more ~25U doses of hepatitis A vaccine, fever and local complaints were observed during a 5-day period following vaccination and systemic complaints during a 14-day period following vaccination. Injection-site complaints, generally mild and transient, were the most frequently reported complaints. Listed below are the complaints (>/=1%) reported, without regard to causality, in decreasing order of frequency within each body system.
LOCALIZED INJECTION-SITE REACTIONS
Pain (18.7%); tenderness (16.9%); warmth (8.6%); erythema (7.5%); swelling (7.3%); ecchymosis (1.3%). BODY AS A WHOLE
Fever (>/=102°F, Oral) (3.1%); abdominal pain (1.6%). DIGESTIVE SYSTEM
Diarrhea (1.0%); vomiting (1.0%). NERVOUS SYSTEM/PSYCHIATRIC
Headache (2.3%). RESPIRATORY SYSTEM
Pharyngitis (1.5%); upper respiratory infection (1.1%); cough (1.0%). LABORATORY FINDINGS
Very few laboratory abnormalities were reported and included isolated reports of elevated liver function tests, eosinophilia, and increased urine protein.
Adults--19 Years of Age and Older
In combined clinical trials involving 1512 healthy adults who received one or more ~50U doses of hepatitis A vaccine, fever and local complaints were observed during a 5-day period following vaccination and systemic complaints during a 14-day period following vaccination. Injection-site complaints, generally mild and transient, were the most frequently reported complaints. Listed below are the complaints (>/=1%) reported, without regard to causality, in decreasing order of frequency within each body system.
LOCALIZED INJECTION-SITE REACTIONS
Tenderness (52.7%); pain (51.1%); warmth (17.4%); swelling (13.8%); erythema (13.1%); ecchymosis (1.5%); pain/soreness (1.2%). BODY AS A WHOLE
Asthenia/fatigue (3.9%); fever (2.7%); abdominal pain (1.3%). DIGESTIVE SYSTEM
Diarrhea (2.5%); nausea (2.3%). MUSCULOSKELETAL SYSTEM
Myalgia (1.9%); arm pain (1.3%); back pain (1.1%); stiffness (1.0%). NERVOUS SYSTEM/PSYCHIATRIC
Headache (16.0%). RESPIRATORY SYSTEM
Pharyngitis (2.7%); upper respiratory infection (2.7%); nasal congestion (1.1%). UROGENITAL SYSTEM
Menstruation disorder (1.1%).
ALLERGIC REACTIONS
Local and/or systemic allergic reactions that occurred in <1% of children/adolescents or adults in clinical trials regardless of causality included: LOCAL
Injection site pruritus and/or rash.
SYSTEMIC
Bronchial constriction; asthma; wheezing; edema/swelling; rash; generalized erythema; urticaria; pruritus; eye irritation/itching; dermatitis. (See CONTRAINDICATIONS and WARNINGS.)
As with any vaccine, there is the possibility that use of VAQTA in very large populations might reveal adverse experiences not observed in clinical trials. Marketed Experience
The following additional adverse reactions have been reported with use of the marketed vaccine.
NERVOUS SYSTEM
Very rarely, Guillain-Barré syndrome, cerebellar ataxia.
HEMIC and LYMPHATIC SYSTEM
Very rarely, thrombocytopenia.
Post-marketing Safety Study
In a post-marketing safety study, a total of 42,110 people >/=2 years of age received 1 or 2 doses of VAQTA. There was no serious, vaccine-related, adverse event identified among the 42,110 vaccine recipients in this study. There was no vaccine-related, adverse event identified that had not been reported in earlier clinical trials with VAQTA. Diarrhea/gastroenteritis, resulting in outpatient visits (in adults), was determined by the investigator to be the only vaccine-related nonserious adverse event in the study. VAQTA was generally well tolerated in this study. (See CLINICAL PHARMACOLOGY, Post-marketing Safety Study.)
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