Microsoft word - cspvivot10710.docx
NAME OF THE MEDICINE
Oral Typhoid Vaccine
Vivotif Oral is an oral, live, attenuated typhoid vaccine for active immunization against
typhoid and contains Salmonella typhi
strain Ty21a. Each enteric coated capsule
contains not fewer than 2 x 109 viable organisms. Each capsule also contains the
following excipients: ethylene glycol, sucrose, ascorbic acid, protein hydrolysate,
lactose, magnesium stearate, hydroxypropyl methylcellulose phthalate, gelatin,
titanium dioxide, erythrosine ci45430, iron oxide yellow ci77492, iron oxide red
ci77491, dibutyl phthalate, diethyl phthalate.
The attenuated Ty21a strain is a mutant of Salmonella typhi
, which is deficient in the
enzyme UDP-4-galactose epimerase. This results in the organisms being unable to
effectively metabolize galactose. When grown in the presence of adequate amounts
of galactose, the organism accumulates galactose-containing metabolites and
ultimately undergoes spontaneous lysis. In the presence of a restricted supply of
galactose the organism develops the smooth lipopolysaccharide coat believed to be
necessary for immune response. In the intestine, where galactose is normally
present, it is however unable to survive for long. The vaccine strain cannot be
detected in the stools after 3 days following oral ingestion. CLINICAL TRIALS
In one clinical study conducted in Egypt, in children above 6 years of age, oral
ingestion of the vaccine as a solution preceded by a dose of sodium bicarbonate to
reduce gastric activity (in order to reduce lysis of the organism in the stomach),
provided approximately 95% protection against typhoid. In another study, conducted
in Chile, enteric coated capsules provided approximately 70% protection. The
duration of protection conferred by Vivotif Oral remains to be fully established.
However, repeat vaccination is not considered necessary within 12 months after
Vivotif Oral is indicated for active immunisation against typhoid in adults and children
above 6 years of age. Effectiveness in children below 6 years of age is not known at
Product Information CONTRA-INDICATIONS
Primary and acquired immunodeficiency, including that from treatment with
immunosuppressive and antimitotic drugs, acute febrile illness: acute intestinal
infection, allergic reactions to a previous dose, and hypersensitivity to the vaccine or
to any of the inactive components.
No data are currently available about the efficacy of Vivotif Oral in individuals with
blood dyscrasias, leukaemia, lymphoma or any type of malignant neoplasm affecting
the bone marrow or lymphatic system. These individuals may fail to develop
protection because of their disturbed immune functions.
In the case of acute febrile illnesses and acute gastro-intestinal illness as well as
during and up to 3 days after treatment with antibiotics, Vivotif Oral should not be
taken due to possible inhibition of the growth of the vaccine organisms.
The capsules must be swallowed whole and not chewed because of the destruction
of the organism by gastric acid.
See also “Interactions with Other Medicines
.” Pregnancy - Category B2
Studies in animals are inadequate but available data show no evidence of an
increased occurrence of foetal damage. Interactions with Other Medicines
The vaccine should not be administered concurrently with antibiotics or other drugs
(eg. sulphonamides) that are active against salmonellae. The vaccine should be
administered first and at least 3 days should elapse between the final dose of the
vaccine and such drugs.
The simultaneous administration of Vivotif Oral Typhoid Vaccine and parenteral (live
attenuated) yellow fever vaccine, or inactivated vaccines, or oral polio vaccines, or
parenteral immunoglobulin preparations, has been reported not to interfere with the
immune response. See also under “Anti-Malaria Prophylaxis”
with Other Medicines”. Anti-Malaria Prophylaxis
In the case of planned anti-malarial prophylaxis, immunisation with Vivotif Oral
Typhoid Vaccine should precede anti-malaria prophylaxis. The interval between the
last dose of Vivotif Oral Typhoid Vaccine and the beginning of anti-malarial
prophylaxis should, in general, be at least 3 days.
If anti-malaria prophylaxis has been started, the minimum interval between the last
dose of anti-malaria prophylaxis and the first dose of Vivotif Oral Typhoid Vaccine
should be at least 3 days.
This 3-day interval should generally be regarded as optimal. Chloroquine and/or pyrimethamine/sulfadoxine
Vivotif Oral Typhoid Vaccine can be given with chloroquine and/or
pyrimethamine/sulfadoxine. In these studies, the anti-malarials were given first,
followed 12 hours later by Vivotif Oral Typhoid capsule.
Mefloquine can be given concomitantly with Vivotif Oral Typhoid Vaccine. A lower
IgG response was observed compared to taking Vivotif Oral Typhoid Vaccine alone,
however the immune response was not affected and vaccine efficacy was not
Atavoquone and proguanil, fixed combination
Atavaquone and proguanil (fixed combination formulation) may be given
concomitantly with Vivotif Oral Typhoid Vaccine. Proguanil
Proguanil, when given alone, should be administered only if 10 days or more have
elapsed since the final dose of Vivotif Oral Typhoid Vaccine.
ADVERSE EFFECTS Clinical Trials
The following adverse effects were reported as common (in accordance with CIOMS
definition of <1/10 and >1/100) and were generally mild – constipation, abdominal
cramps, diarrhoea, nausea, vomiting, anorexia, fever, headache and urticarial
exanthema. Postmarketing Data
The following additional adverse effects have been reported very rarely (CIOMS
definition: <1/10,000) during postmarketing surveillance.
Skin reactions such as dermatitis, exanthema, pruritus and urticaria, anaphylaxis,
asthenia, malaise, tiredness, shivering, paraesthesia, dizziness, arthralgia and
myalgia. DOSAGE AND ADMINISTRATION
The Vivotif Oral Typhoid Vaccine capsule should be swallowed whole and must not
be chewed. The capsule should be taken approximately one hour before a meal,
with cold or lukewarm (temperature not to exceed body temperature e.g. 37º C (98.6º
F) drink, on alternate days, 1, 3 and 5.
The complete immunisation schedule, irrespective of age, for adults and children
above 6 years of age, is the ingestion of one capsule on each of days 1, 3 and 5. Re-immunisation
An optimal booster schedule for Vivotif Oral Typhoid Vaccine has not been
determined. Booster doses, consisting of 3 capsules on Days 1, 3 and 5 are
recommended every 3 years.
See also “Interactions with Other Medicines
Doses five-fold higher than the recommended dose caused only mild, mainly gastro-
intestinal adverse reactions which did not require medical treatment. Overdosing can
increase the possibility of shedding S. typhi
Ty21a organism in the faeces.
PRESENTATION AND STORAGE CONDITIONS
Store between +2 and +8°C in a dry place and protected from light. Every package
shows an expiry date and the product should not be used after this date.
Each carton contains 3 capsules in a blister pack. Each enteric coated capsule
contains not fewer than 2 x 109 viable cells of Salmonella typhi
strain Ty21a. NAME AND ADDRESS OF MANUFACTURER AND SPONSOR
Crucell Switzerland AG
SWITZERLAND SPONSOR: Australia
CSL Limited ABN 99 051 588 348
45 Poplar Road
Parkville Victoria 3052
Product Information New Zealand
CSL Biotherapies (NZ) Ltd
666 Great South Road
Penrose Auckland 6
NEW ZEALAND POISONS SCHEDULE
S4 DATE OF APPROVAL
7 July 2010
Vivotif® is a Registered Trademark of Crucell Switzerland AG
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