The skin has an important role to play in the fluid and temperature regulation of the body. If enough skin area is injured, the ability to maintain that control can be lost. The skin also acts as a protective barrier against the bacteria and viruses that inhabit the world outside the body.
The anatomy of the skin is complex, and there are many structures within the layers of the skin. There are three layers:
The amount of damage that a burn can cause depends upon its location, its depth, and how much body surface area that it involves.
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Because clinical trials are conducted under widely varying conditions, adverse event 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. As with any vaccine, there is the possibility that broad use of TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) could reveal adverse events not observed in clinical trials.
The safety of TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) has been evaluated in clinical trials involving the administration of approximately 7,500 doses to more than 2,500 individuals.
Of 773 volunteers who participated in the comparative trial conducted in the United States, 389 subjects received at least 1 dose of TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) (0-, 1-, and 6-month schedule) and 384 received at least 1 dose each of ENGERIX-B and HAVRIX as separate but simultaneous injections. Solicited adverse events reported following the administration of TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) are shown in Table 5, compared with adverse events reported after administration of ENGERIX-B and HAVRIX.
Table 5. Rate of Adverse Events Reported After Administration of TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) or ENGERIX-B and HAVRIX
| Adverse Event | TWINRIX | ENGERIX-B | HAVRIX | |||||
| Dose 1 | Dose 2 | Dose 3 | Dose 1 | Dose 2 | Dose 3 | Dose 1 | Dose 2 | |
| Local | (N = 385) % | (N = 382) % | (N = 374) % | (N = 382) % | (N = 376) % | (N = 369) % | (N = 382) % | (N = 369) % |
| Soreness | 37 | 35 | 41 | 41 | 25 | 30 | 53 | 47 |
| Redness | 8 | 9 | 11 | 6 | 7 | 9 | 7 | 9 |
| Swelling | 4 | 4 | 6 | 3 | 5 | 5 | 5 | 5 |
| Adverse Event | TWINRIX | ENGERIX-B and HAVRIX | ||||||
| Dose 1 | Dose 2 | Dose 3 | Dose 1 | Dose 2 | Dose 3 | |||
| General | (N = 385) | (N = 382) | (N = 374) | (N = 382) | (N = 376) | (N = 369) | ||
| General | % | % | % | % | % | % | ||
| Headache | 22 | 15 | 13 | 19 | 12 | 14 | ||
| Fatigue | 14 | 13 | 11 | 14 | 9 | 10 | ||
| Diarrhea | 5 | 4 | 6 | 5 | 3 | 3 | ||
| Nausea | 4 | 3 | 2 | 7 | 3 | 5 | ||
| Fever | 4 | 3 | 2 | 4 | 2 | 4 | ||
| Vomiting | 1 | 1 | 0 | 1 | 1 | 1 | ||
Adverse reactions seen with TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) were similar to those observed after vaccination with the monovalent components. The frequency of solicited adverse events did not increase with successive doses of TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) . Most events reported were considered by the subjects as mild and self-limiting and did not last more than 48 hours.
In a clinical trial in which TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) was given on a 0-, 7-, and 21- to 30-day schedule followed by a booster dose at 12 months, solicited local or general adverse events were comparable to those seen in other clinical trials of TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) given on a 0-, 1-, and 6-month schedule.
Among 2,299 subjects in 14 clinical trials, the following adverse experiences were reported to occur within 30 days following vaccination with the frequency shown below. Adverse experiences within 30 days of vaccination in the US clinical trial of TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) given on a 0-, 7-, and 21- to 30-day schedule followed by a booster dose at 12 months were similar to those reported in other clinical trials and post marketing surveillance.
Incidence 1% to 10% of Injections, Seen in Clinical Trials With TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) :
Local Reactions at Injection Site: Induration.
Respiratory System: Upper respiratory tract infections.
Incidence <1% of Injections, Seen in Clinical Trials With TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) :
Local Reactions at Injection Site: Pruritus, ecchymoses.
Body as a Whole: Sweating, weakness, flushing, influenza-like symptoms.
Cardiovascular System: Syncope.
Gastrointestinal System: Abdominal pain, anorexia, vomiting.
Musculoskeletal System: Arthralgia, myalgia, back pain.
Nervous System: Migraine, paresthesia, vertigo, somnolence, insomnia, irritability, agitation, dizziness.
Respiratory System: Respiratory tract illnesses.
Skin and Appendages: Rash, urticaria, petechiae, erythema. Incidence <1% of Injections, Seen in Clinical Trials With HAVRIXa and/or ENGERIX-Bb:
Body as a Whole: Tingling.b
Cardiovascular System: Hypotension.b
Gastrointestinal: Constipation,b dysgeusia.a
Hematologic/lymphatic: Lymphadenopathy.a+b
Musculoskeletal System: Elevation of creatine phosphokinase.a
Nervous System: Hypertonic episode,a photophobia.a
Postmarketing Reports: Worldwide voluntary reports of adverse events received for TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) , HAVRIX, and/or ENGERIX-B since market introduction of these vaccines are listed below. These lists include serious events or events which have suspected causal connections to components of these or other vaccines or drugs. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.
Postmarketing Reports With TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) :
Body as a Whole: Anaphylaxis/anaphylactoid reactions and allergic reactions.
Hypersensitivity: Arthritis, serum sickness-like syndrome days to weeks after vaccination including arthralgia/arthritis (usually transient), fever, urticaria, erythema multiforme, ecchymoses, and erythema nodosum.
Cardiovascular System: Tachycardia/palpitations.
Skin and Appendages: Erythema multiforme, hyperhydrosis, angioedema, eczema, herpes zoster, erythema nodosum, alopecia.
Gastrointestinal System: Jaundice, hepatitis, abnormal liver function tests, dyspepsia.
Hematologic/lymphatic: Thrombocytopenia.
Nervous System: Convulsions, paresis, encephalopathy, neuropathy, myelitis, Guillain-Barre syndrome, multiple sclerosis, Bell's palsy, transverse myelitis, optic neuritis.
Respiratory System: Dyspnea, bronchospasm including asthma-like symptoms.
Special Senses: Conjunctivitis, visual disturbances, tinnitus, earache.
Postmarketing Reports With HAVRIX and/or ENGERIX-B: Worldwide voluntary reports of adverse events received for HAVRIX and/or ENGERIX-B but not already reported for TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) are listed below.
Hypersensitivity: Stevens-Johnson syndrome.b Special Senses: Keratitis.b
Other: Congenital abnormality.a
aFollowing HAVRIX.
bFollowing ENGERIX-B.
a+bFollowing either HAVRIX or ENGERIX-B.
Reporting of Adverse Events: The US Department of Health and Human Services has established VAERS to accept reports of suspected adverse events after the administration of any vaccine, including, but not limited to, the reporting of events required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS forms and information is 1-800-822-7967.23 Reporting forms may also be obtained at the VAERS website at www.vaers.hhs.gov.
No information provided.
References
23. Centers for Disease Control and Prevention. Vaccine adverse event reporting system - United States. MMWR 1990;39(41):730-733.
Last reviewed on RxList: 4/30/2007
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