VAQTA is indicated for the prevention of disease caused by hepatitis A virus (HAV) in persons 12 months of age and older. The primary dose should be given at least 2 weeks prior to expected exposure to HAV.

Adult Clinical Data for VAQTA—Antibody Persistence

6-year response demonstrated in adults 19 years of age and older who received VAQTA

In a clinical study, hepatitis A antibody response in adults who were administered 2 doses of VAQTA 6 months apart was shown to persist for at least 6 years.

Detectable levels of anti-HAV antibodies (≥10 mIU/mL) in adults were present in:

100%

(378/378)

of subjects, with a geometric mean titer (GMT) of 1,734 mIU/mL

at 1 year

99.2%

(252/254)

of subjects, with a GMT of 687 mIU/mL

at 2 to 3 years

99.1%

(219/221)

of subjects, with a GMT of 605 mIU/mL

at 4 years

99.4%

(170/171)

of subjects, with a GMT of 684 mIU/mL

at 6 years

Detectable levels of anti-HAV antibodies (≥10 mIU/mL) in adults were present in:

100%

(378/378)

of subjects, with a geometric mean titer
(GMT) of 1,734 mIU/mL

at 1 year

99.2%

(252/254)

of subjects, with a GMT of 687 mIU/mL

at 2 to 3 years

99.1%

(219/221)

of subjects, with a GMT of 605 mIU/mL

at 4 years

99.4%

(170/171)

of subjects, with a GMT of 684 mIU/mL

at 6 years

HAV=hepatitis A virus.

Six years postvaccination, patients had a GMT of 684 mIU/mL.

Anti-HAV antibodies ≥10 mIU/mL indicate seroconversion.

The total duration of the protective effect of VAQTA in healthy vaccinees is unknown at present.

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Indication for VAQTA

VAQTA® (Hepatitis A Vaccine, Inactivated) is indicated for the prevention of disease caused by hepatitis A virus (HAV) in persons 12 months of age and older. The primary dose should be given at least 2 weeks prior to expected exposure to HAV.

Dosage and Administration for VAQTA

Adults (19 years of age and older): The vaccination schedule consists of a primary 1 mL dose administered intramuscularly and a 1 mL booster dose administered intramuscularly 6 to 18 months later.

Booster Immunization Following Another Manufacturer's Hepatitis A Vaccine: A booster dose of VAQTA may be given at 6 to 12 months following a primary dose of Havrix*.

*Havrix is a registered trademark of GlaxoSmithKline.

Do not administer VAQTA to individuals with a history of immediate and/or severe allergic or hypersensitivity reactions (eg, anaphylaxis) after a previous dose of any hepatitis A vaccine, or to individuals who have had an anaphylactic reaction to any component of VAQTA, including neomycin.

Do not administer VAQTA® (Hepatitis A Vaccine, Inactivated) to individuals with a history of immediate and/or severe allergic or hypersensitivity reactions (eg, anaphylaxis) after a previous dose of any hepatitis A vaccine, or to individuals who have had an anaphylactic reaction to any component of VAQTA, including neomycin.

The vial stopper and the syringe plunger stopper and tip cap contain dry natural latex rubber that may cause allergic reactions in latex-sensitive individuals.

The most common local adverse reactions and systemic adverse events (≥15%) reported in different clinical trials across different age groups when VAQTA was administered alone or concomitantly were:

  • Adults 19 years of age and older: injection-site pain, tenderness, or soreness (67.0%), injection site warmth (18.2%), and headache (16.1%).

Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to VAQTA and may not be protected against HAV infection after vaccination.

Hepatitis A virus has a relatively long incubation period (approximately 20 to 50 days). VAQTA may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at the time of vaccination.

In clinical trials in children, VAQTA was concomitantly administered with one or more of the following US-licensed vaccines: Measles, Mumps, and Rubella Virus Vaccine, Live; Varicella Vaccine, Live; Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine, Adsorbed; Measles, Mumps, Rubella, and Varicella Vaccine, Live; Pneumococcal 7-valent Conjugate Vaccine; and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate). Safety and immunogenicity were similar for concomitantly administered vaccines compared to separately administered vaccines.

The total duration of the protective effect of VAQTA in healthy vaccinees is unknown at present.

Vaccination with VAQTA may not result in a protective response in all susceptible vaccinees.

Before administering VAQTA, please read the accompanying Prescribing Information. The Patient Information also is available.

VAQTA® (Hepatitis A Vaccine, Inactivated) is indicated for the prevention of disease caused by hepatitis A virus (HAV) in persons 12 months of age and older. The primary dose should be given at least 2 weeks prior to expected exposure to HAV.

Dosage and Administration for VAQTA

Adults (19 years of age and older): The vaccination schedule consists of a primary 1 mL dose administered intramuscularly and a 1 mL booster dose administered intramuscularly 6 to 18 months later.

Booster Immunization Following Another Manufacturer's Hepatitis A Vaccine: A booster dose of VAQTA may be given at 6 to 12 months following a primary dose of Havrix*.

*Havrix is a registered trademark of GlaxoSmithKline.

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US-VAQ-00504 02/21