
VAQTA has demonstrated excellent seroconversion rates post-dose
1 and 2 in separate
clinical trials in children 12 to 23 months of age and
children and adolescents 2 to 18 years of age, with Geometric
Mean Titers (GMTs) ranging from 6,900 to 10,000 mlU/mL
after the second dose.
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No cases of hepatitis A were reported among
recipients of VAQTA over 9 years of follow-up in a 1991
landmark study.1
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In the same 1991 landmark study, of the
1,037 children vaccinated with VAQTA, there were no clinically
confirmed cases of hepatitis A reported after Day 16.1
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VAQTA offers flexible dosing and scheduling.
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VAQTA is indicated
for active immunization against disease caused by hepatitis
A virus (HAV) in persons 12 months of age and older.
Primary immunization should be given at least 2 weeks
prior to expected exposure to HAV.
The dosing regimen
for VAQTA 0.5 mL (~25U) consists of 2 doses, the first
given at 12 months to 18 years
of age, and a booster dose given 6 to 18 months afterwards.
Select safety information
VAQTA is contraindicated in individuals who are hypersensitive to any component
of the vaccine. Hepatitis A vaccine should not be administered to persons with
a history of a severe reaction to a prior dose of hepatitis A vaccine or to
a vaccine component.
Individuals who develop symptoms suggestive of hypersensitivity after an injection
of hepatitis A vaccine should not receive further injections of the vaccine.
In combined clinical trials involving healthy children 12 to 23 months of
age and children and adolescents 2 to 18 years of age, the most commonly reported
complaints (>2% of injections) in one or both of these groups were localized
injection-site reactions (pain/tenderness/soreness, warmth, erythema, swelling),
fever, diarrhea, vomiting, irritability, upper respiratory infection, rhinorrhea,
cough, rash, otitis media, and headache.
The total duration of the protective effect of VAQTA in healthy vaccinees
is unknown at present.
As with any vaccine, vaccination with VAQTA may not result in a protective
response in all susceptible vaccinees.
Before administering VAQTA, please read the Prescribing
Information.
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