Indication

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.

Select Safety Information for VAQTA® (Hepatitis A Vaccine, Inactivated)

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.

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:

  • Children 12 through 23 months of age: injection-site pain/tenderness (37.0%), injection-site erythema (21.2%), and fever (16.4% when administered alone, and 27.0% when administered concomitantly).
  • Children/Adolescents 2 through 18 years of age: injection-site pain (18.7%).
  • Adults 19 years of age and older: injection-site pain, tenderness, or soreness (67.0%), injection-site warmth (18.2%), and headache (16.1%).

Safety and effectiveness in infants below 12 months of age have not been established.

Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to VAQTA® (Hepatitis A Vaccine, Inactivated) and may not be protected against HAV infection after vaccination.

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.

Children/Adolescents (12 months through 18 years of age): The vaccination schedule consists of a primary 0.5-mL dose administered intramuscularly and a 0.5-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.

Before administering VAQTA® (Hepatitis A Vaccine, Inactivated), please read the Prescribing Information.

Dosage and Administration

Age Formulation Primary dose Booster dose
Children and adolescents (12 months to 18 years of age) 0.5 mL (≈25 U) At elected date 6 to 18 months after initial dose
Adults (19 years of age and older) 1.0 mL (≈50 U) At elected date 6 to 18 months after initial dose
  Children and adolescents (12 months to 18 years of age) Adults (19 years of age and older)
Formulation 0.5 mL (≈25U) 1.0 mL (≈50U)
Primary dose At elected date At elected date
Booster dose 6 to 18 months after initial dose 6 to 18 months after initial dose
  • Pediatric and adult formulation — VAQTA is available in both vials and prefilled syringes.

Administration

For intramuscular use only

  • Shake the single-dose vial or single-dose prefilled syringe well to obtain a slightly opaque, white suspension before withdrawal and use.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • Discard if the suspension does not appear homogenous or if extraneous particulate matter remains or discoloration is observed.

For adults, adolescents, and children older than 2 years of age, the deltoid muscle is the preferred site for intramuscular injection. For children 12 through 23 months of age, the anterolateral area of the thigh is the preferred site for intramuscular injection.

Single-dose vial use

  • Withdraw and administer entire dose of VAQTA intramuscularly using a sterile needle and syringe.

Single-dose prefilled syringe use

  • Securely attach a needle by twisting in a clockwise direction.
  • Administer dose of VAQTA intramuscularly.

Indication

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.

Select Safety Information for VAQTA® (Hepatitis A Vaccine, Inactivated)

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.

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:

  • Children 12 through 23 months of age: injection-site pain/tenderness (37.0%), injection-site erythema (21.2%), and fever (16.4% when administered alone, and 27.0% when administered concomitantly).
  • Children/Adolescents 2 through 18 years of age: injection-site pain (18.7%).
  • Adults 19 years of age and older: injection-site pain, tenderness, or soreness (67.0%), injection-site warmth (18.2%), and headache (16.1%).

Safety and effectiveness in infants below 12 months of age have not been established.

Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to VAQTA® (Hepatitis A Vaccine, Inactivated) and may not be protected against HAV infection after vaccination.

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.

Children/Adolescents (12 months through 18 years of age): The vaccination schedule consists of a primary 0.5-mL dose administered intramuscularly and a 0.5-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.

Before administering VAQTA® (Hepatitis A Vaccine, Inactivated), please read the Prescribing Information.

VACC-1159573-0005 02/17