Twinrix Adult Adverse Reactions

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.
Frequencies per dose are defined as follows: Very common: ≥ 10%; Common: ≥ 1% and < 10%; Uncommon: ≥ 0.1% and < 1%; Rare: ≥ 0.01% and < 0.1%; Very rare: < 0.01%.
Clinical Trial Data: See Table 1.

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Post Marketing Data: These adverse reactions have been reported with either Twinrix or with GlaxoSmithKline monovalent hepatitis A or B vaccines. (See Table 2.)

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In a comparative study, 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.
In a clinical trial where Twinrix Adult 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.