Understand the Chance for Protection Against Hepatitis A Virus (HAV)*
IN 3 CLINICAL STUDIES, 80% TO 98% OF VACCINEES HAD SEROCONVERTED BY DAY 15 AFTER A SINGLE DOSE OF HAVRIX1
In 3 clinical studies, >400 healthy, seronegative adults aged 18 to 50 years were given a single 1440 EL.U. dose of HAVRIX. By Day 15, 80% to 98% of vaccinees had already seroconverted (anti-HAV ≥20 mIU/mL [lower limit of antibody measurement by assay]), with geometric mean antibody titers (GMTs) of seroconverters ranging from 264-339 mIU/mL at Day 15 and 335-637 mIU/mL by 1 month following vaccination.1
The GMTs obtained following a single dose of HAVRIX are at least several times higher than that expected following receipt of immune globulin.1
IN 2 CLINICAL TRIALS, 100% OF VACCINEES WERE SEROPOSITIVE 1 MONTH FOLLOWING A 6-MONTH BOOSTER OF HAVRIX1
In 2 clinical trials, a 1440 EL.U. booster dose of HAVRIX was given 6 months following the initial dose. At 1 month following the booster dose, 100% (n=269) of vaccinees had seropositive anti-HAV titers (GMT 3,318-5,925 mIU/mL). The titers obtained from this additional dose approximate those observed several years after natural infection.1
In a subset of vaccinees (n=89), a single dose of HAVRIX 1440 EL.U. elicited specific anti-HAV neutralizing antibodies in more than 94% of vaccinees when measured 1 month after vaccination. These neutralizing antibodies persisted until Month 6. One hundred percent of vaccinees had neutralizing antibodies when measured after a booster dose given at month 6.1
HAVRIX 1440 EL.U. is only indicated for ages 19 and older. Some study subjects were under age 19.
Indication for HAVRIX
HAVRIX is a vaccine indicated for active immunization against disease caused by hepatitis A virus (HAV). HAVRIX is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV.
Important Safety Information for HAVRIX
- Severe allergic reaction (eg, anaphylaxis) after a previous dose of any hepatitis A-containing vaccine, or to any component of HAVRIX, including neomycin, is a contraindication to administration of HAVRIX
- The tip caps of the prefilled syringes for HAVRIX contain natural rubber latex, which may cause allergic reactions
- Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
- Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to HAVRIX
- In clinical trials with HAVRIX in children 11 to 25 months of age, the most common solicited adverse reactions were injection-site pain and redness, irritability, drowsiness, and loss of appetite
- In clinical trials with HAVRIX in adults and children 2 years of age and older, the most common solicited adverse reactions were injection-site soreness and headache
- Vaccination with HAVRIX may not result in protection in all vaccine recipients
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