|• Clinical trialsClinical trials involving the administration of 2,476 doses of Fendrix to 82 pre-haemodialysis and haemodialysis patients and to 713 healthy subjects ≥ 15 years of age allowed to document the reactogenicity of the vaccine. |
Pre-haemodialysis and haemodialysis patientsThe reactogenicity profile of Fendrix in a total of 82 pre-haemodialysis and haemodialysis patients was generally comparable to that seen in healthy subjects. Adverse reactions reported in a clinical trial following primary vaccination with Fendrix and considered as being related or possibly related to vaccination have been categorised by frequency.
Nervous system disorders:Very common: headacheGastrointestinal disorders:Common: gastrointestinal disorder
|Frequencies are reported as:
||(≥1/100 to <1/10)
||(≥1/1,000 to <1/100)
||(≥1/10,000 to <1/1,000)
General disorders and administration site conditionsVery common: fatigue, pain Common: fever, injection site swelling, redness Unsolicited symptoms considered to be at least possibly related to vaccination were uncommonly reported and consisted of rigors, other injection site reaction and maculo-papular rash.
Healthy subjectsThe reactogenicity profile of Fendrix in healthy subjects was generally comparable to that seen in pre-haemodialysis and haemodialysis patients. In a large double-blind randomised comparative study, healthy subjects were enrolled to receive a three dose primary course of Fendrix (N= 713) or a commercially available hepatitis B vaccine (N= 238) at 0, 1, 2 months. The most common adverse reactions reported were local reactions at the injection site. Vaccination with Fendrix induced more transient local symptoms as compared to the comparator vaccine, with pain at the injection site being the most frequently reported solicited local symptom. However, solicited general symptoms were observed with similar frequencies in both groups. Adverse reactions reported in a clinical trial following primary vaccination with Fendrix and considered as being at least possibly related to vaccination have been categorised by frequency. Nervous system disorders:Common: headacheEar and labyrinth disorders:Rare: vertigoGastrointestinal disorders:Common: gastrointestinal disorderMuskuloskeletal and connective tissue disorders:Rare: tendinitis, back painInfections and infestations:Rare: viral infection
General disorders and administration site conditionsVery common: injection site swelling, fatigue, pain, rednessCommon: feverUncommon: other injection site reactionRare: rigors, hot flushes, thirst, astheniaImmune system disorders:Rare: allergyPsychiatric disorders:Rare: nervousnessNo increase in the incidence or severity of these adverse reactions was seen with subsequent doses of the primary vaccination schedule. No increase in the reactogenicity was observed after the booster vaccination with respect to the primary vaccination. • Experience with hepatitis B vaccine:Following widespread use of hepatitis B vaccines, in very rare cases, syncope, paralysis, neuropathy, neuritis (including Guillain-Barré syndrome, optic neuritis and multiple sclerosis), encephalitis, encephalopathy, meningitis and convulsions have been reported. The causal relationship to the vaccine has not been established.Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness have also been reported very rarely with hepatitis B vaccines.