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Early
protection with VAQTA
VAQTA: Excellent short- and long-term
effectiveness
The landmark VAQTA efficacy trial
of a 2-dose series in children 2 to 16 years of age in
Monroe, New York (N=1,037) and a 9-year follow-up study.1,2
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Adapted from Werzberger et al 19922;
Werzberger et al 20021;
and Data on
File, 1991.3 |
| d |
An initial double-blind, placebo-controlled
study was conducted to evaluate the efficacy of a hepatitis
A vaccine in a community with recurrent outbreaks.2 |
| e |
June 24, 1991: Study began (1,037 children
enrolled/vaccinated on an ongoing
basis until November 5, 1991).2 |
| f |
November 19, 1991: Study unblinded (placebo recipients
vaccinated).2 |
- Prior to the study, Monroe,
NY was a community with a hepatitis A disease incidence
of up to 300 times the national average and recurrent
outbreaks.2
- No cases of hepatitis A occurred among recipients
of VAQTA after day 16 of the study.1,g
- No cases of hepatitis
A were reported among recipients of VAQTA over 9 years
of follow-up.1
gThe average incubation period for hepatitis
A is 28 days,4 suggesting that cases observed prior to
this point may have been due to exposure prior to vaccination.
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 afterward.
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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