Dosage: A dose of 1.0 ml Twinrix is recommended for adults, adolescents and children aged from 1 year upwards.
Primary vaccination schedules: Adults and adolescents of 16 years of age and above: The
standard primary course of vaccination with Twinrix consists of three doses, the first administered at the
elected date, the second one month later and the third six months after the
exceptional circumstances in adults, when travel is anticipated within one
month or more after initiating the vaccination course, but where insufficient
time is available to allow the standard 0, 1, 6 month schedule to be completed,
a schedule of three intramuscular injections given at 0, 7 and 21 days may be
used. When this schedule is applied, a fourth dose is recommended 12 months
after the first dose.
Children of 1 to 15 years of age: The standard primary
course of vaccination with Twinrix consists
of two doses, the first is administered at the elected date and the second
between six and twelve months after the first dose. As
protection against hepatitis B infection will not be obtained in all vaccinees
until after the second dose, it is important that the second dose be administered
to assure protection against hepatitis B infection.
recommended schedule should be adhered to. Once initiated, the primary course
of vaccination should be completed with the same vaccine.
Booster dose: Long-term
antibody persistence data following vaccination with Twinrix in adults with a 0, 1, 6 month schedule are available for
up to 15 years after vaccination.
anti-HBs and anti-HAV antibody titres observed following a primary vaccination
course with the combined vaccine are in the range of what is seen following
vaccination with the monovalent vaccines. Following vaccination with Twinrix in adults, the kinetics of
antibody decline are similar to what has been observed after vaccination with
the monovalent vaccines.
guidelines for booster vaccination can therefore be drawn from experience with
the monovalent vaccines.
Hepatitis B: The need
for a booster dose of hepatitis B vaccine in healthy individuals who have
received a full primary vaccination course has not been established; however
some official vaccination programmes currently include a recommendation for a
booster dose of hepatitis B vaccine and these should be respected.
categories of subjects or patients exposed to HBV (e.g. haemodialysis or
immunocompromised patients) a precautionary attitude should be considered to
ensure a protective antibody level ≥10 IU/l.
Hepatitis A: It is not yet fully established whether immunocompetent individuals who have
responded to hepatitis A vaccination will require booster doses, as protection
in the absence of detectable antibodies may be ensured by immunological memory.
Guidelines for boosting are based on the assumption that antibodies are
required for protection; anti-HAV antibodies have been shown to persist for at
least 10 years.
situations where a booster dose of both hepatitis A and hepatitis B are
desired, Twinrix can be given.
Alternatively, subjects primed with Twinrix may
be administered a booster dose of either of the monovalent vaccines. The safety
and immunogenicity of Twinrix administered
as a booster dose following a two dose primary vaccination course have not been
Method of Administration: Twinrix should be injected intramuscularly into the
deltoid region of the upper arm in adults, adolescents and children. The
anterolateral thigh may be used in infants.
Since intradermal injection or intramuscular administration
into the gluteal muscle could lead to a suboptimal response to the vaccine,
these routes should be avoided. Exceptionally, Twinrix can be administered subcutaneously to subjects with
thrombocytopenia or bleeding disorders since bleeding may occur following an
intramuscular administration to these subjects. However, this route of
administration may result in suboptimal immune response to the vaccine.