Twinrix Adverse Reactions

Local and general adverse events reported following primary vaccination with Twinrix were categorised by frequency.
Adverse reactions reported are listed according to the following frequency: Very common: ≥1/10; Common: ≥1/100 and <1/10; Uncommon: ≥1/1,000 and <1/100; Rare: ≥1/10,000 and <1/1,000; Very rare: <1/10,000.
Adults and adolescents of 16 years of age and above: The safety profile presented as follows is based on data from more than 6,000 subjects who received either the standard 0, 1, 6 month schedule or the accelerated 0, 7, 21 days schedule. (See Table 1.)


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In a comparative study it was noted that the frequency of solicited adverse events following the administration of Twinrix is not different from the frequency of solicited adverse events following the administration of the monovalent vaccines.
In a clinical trial where Twinrix was administered at 0, 7, 21 days, solicited general symptoms were reported with the same categories of frequency as defined previously. After a fourth dose given at month 12, the incidence of systemic adverse reactions was comparable to that seen after vaccination at 0, 7, 21 days.
Children of 1 to 15 years of age inclusive: Clinical trials involved the administration of 1,537 doses of Twinrix as a two dose schedule to 778 subjects from 1 year up to and including 15 years of age. (See Table 2.)


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