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.

Storage and Handling

Condition on Arrival

  • Should not have been frozen; refrigerate on arrival.

Storage

  • Store vaccine at 2°C to 8°C (36°F to 46°F); DO NOT FREEZE since freezing destroys potency.

How Supplied

    VAQTA is available in single-dose vials and prefilled Luer-Lok® syringes.

    Pediatric/Adolescent formulations

    Pediatric/Adolescent formulations

    25 U/0.5 mL in single-dose vials and prefilled Luer-Lok® syringes

    • Box of ten 0.5-mL single-dose vials, NDC 0006-4831-41
    • Carton of six 0.5-mL prefilled single-dose Luer-Lok® syringes with tip caps, NDC 0006-4095-09
    • Carton of ten 0.5-mL prefilled single-dose Luer-Lok® syringes with tip caps, NDC 0006-4095-02

    Adult formulations

    Adult formulation

    50 U/1.0 mL in single-dose vials and prefilled Luer-Lok® syringes

    • 1-mL single-dose vial, NDC 0006-4841-00
    • Box of ten 1-mL single-dose vials, NDC 0006-4841-41
    • Carton of six 1-mL prefilled single-dose Luer-Lok® syringes with tip caps, NDC 0006-4096-09
    • Carton of ten 1-mL prefilled single-dose Luer-Lok® syringes with tip caps, NDC 0006-4096-02

    Brands mentioned are the trademarks of their respective owners.

General Tips

  • If you have questions about the condition of the vaccine at the time of delivery, you should immediately place vaccine in recommended storage and call the Merck Vaccine Customer Center at 877.VAX.MERCK (877.829.6372).
  • Rotate stock so that the shortest-dated vaccine is used first.5
  • Ensure that the refrigerator is plugged into an outlet in a protected area where it cannot be disconnected accidentally.5
  • VFC providers should separate and identify VFC and other vaccines purchased with public funds within the storage unit. In addition, clearly label the space where the vaccine is placed to help staff choose the appropriate vaccine.5
  • It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of infectious agents from one person to another.
  • For general questions concerning the proper storage and handling of Merck vaccines, please contact the Merck Vaccine Customer Helpline at 800.MERCK.90 (800.637.2590), Monday through Friday, 8:00 AM to 7:00 PM ET.
  • See CDC.gov for additional general vaccine tips.
  • CDC=Centers for Disease Control and Prevention; VFC=Vaccines for Children.

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