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.
The most common solicited adverse events were injection site soreness (22%) and fatigue (14%).
In 36 clinical studies, a total of 13,495 doses of ENGERIX-B were administered to 5,071 healthy adults and children who were initially seronegative for hepatitis B markers, and healthy neonates. All subjects were monitored for 4 days post-administration. Frequency of adverse events tended to decrease with successive doses of ENGERIX-B.
Using a symptom checklist, the most frequently reported adverse events were injection site soreness (22%) and fatigue (14%). Other events are listed below. Parent or guardian completed forms for children and neonates. Neonatal checklist did not include headache, fatigue, or dizziness.
Incidence 1% to 10% of Injections: Nervous System Disorders: Dizziness, headache.
General Disorders and Administration Site Conditions: Fever (>37.5°C), injection site erythema, injection site induration, injection site swelling.
Incidence <1% of Injections: Infections and Infestations: Upper respiratory tract illnesses.
Blood and Lymphatic System Disorders: Lymphadenopathy.
Metabolism and Nutrition Disorders: Anorexia.
Psychiatric Disorders: Agitation, insomnia.
Nervous System Disorders: Somnolence, tingling.
Vascular Disorders: Flushing, hypotension.
Gastrointestinal Disorders: Abdominal pain/cramps, constipation, diarrhea, nausea, vomiting.
Skin and Subcutaneous Tissue Disorders: Erythema, petechiae, pruritus, rash, sweating, urticaria.
Musculoskeletal and Connective Tissue Disorders: Arthralgia, back pain, myalgia, pain/stiffness in arm, shoulder, or neck.
General Disorders and Administration Site Conditions: Chills, influenza-like symptoms, injection site ecchymosis, injection site pain, injection site pruritus, irritability, malaise, weakness.
6.2 Postmarketing Experience
In addition to reports in clinical trials, worldwide voluntary reports of adverse events received for ENGERIX-B since market introduction (1990) are listed below. This list includes serious adverse events or events which have a suspected causal connection to components of ENGERIX-B.
The following adverse events have been identified during postapproval use of ENGERIX-B. Because these events are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine.
Infections and Infestations: Herpes zoster, meningitis.
Blood and Lymphatic System Disorders: Thrombocytopenia.
Immune System Disorders: Allergic reaction, anaphylactoid reaction, anaphylaxis. An apparent hypersensitivity syndrome (serum sickness-like) of delayed onset has been reported days to weeks after vaccination, including: arthralgia/arthritis (usually transient), fever, and dermatologic reactions such as urticaria, erythema multiforme, ecchymoses, and erythema nodosum.
Nervous System Disorders: Encephalitis, encephalopathy, migraine, multiple sclerosis, neuritis, neuropathy including hypoesthesia, paresthesia, Guillain-Barré syndrome and Bell’s palsy, optic neuritis, paralysis, paresis, seizures, syncope, transverse myelitis.
Eye Disorders: Conjunctivitis, keratitis, visual disturbances.
Ear and Labyrinth Disorders: Earache, tinnitus, vertigo.
Cardiac Disorders: Palpitations, tachycardia.
Vascular Disorders: Vasculitis.
Respiratory, Thoracic and Mediastinal Disorders: Apnea, bronchospasm including asthma-like symptoms.
Gastrointestinal Disorders: Dyspepsia.
Skin and Subcutaneous Tissue Disorders: Alopecia, angioedema, eczema, erythema multiforme including Stevens-Johnson syndrome, erythema nodosum, lichen planus, purpura.
Musculoskeletal and Connective Tissue Disorders: Arthritis, muscular weakness.
General Disorders and Administration Site Conditions: Injection site reaction.
Investigations: Abnormal liver function tests.