Twinrix Adult Adverse Reactions

Summary of the safety profile: The safety profile presented as follows is based on a pooled analysis of events per dose from more than 6,000 subjects who received either the standard 0, 1, 6 month schedule (n=5,683) or the accelerated 0, 7, 21 days schedule (n=320). The most commonly reported adverse reactions following Twinrix Adult administration with the standard 0, 1, 6 month schedule are pain and redness occurring in a per dose frequency of 37.6% and 17.0% respectively.
In the two clinical trials in which Twinrix Adult was administered at 0, 7, 21 days, overall solicited general and local symptoms were reported with the same categories of frequency as defined as follows. After a fourth dose given at month 12, the incidence of systemic and local adverse reactions was comparable to that seen after vaccination at 0, 7, 21 days.
In comparative studies, it was noted that the frequency of solicited adverse events following the administration of Twinrix Adult is not different from the frequency of solicited adverse events following the administration of the monovalent vaccines.
Tabulated list of adverse reactions: Frequencies are reported as: Very common ≥1/10; Common ≥1/100 to <1/10; Uncommon ≥1/1,000 to <1/100; Rare ≥1/10,000 to <1/1,000; Very rare <1/10,000. (See table.)

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