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Pediatric storage and handling for VAQTA

Condition on arrival

Should not be frozen. Refrigerate on arrival.1

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 prefilled Luer-Lok® syringes.

Pediatric/Adolescent formulations

Prefilled Luer-Lok® syringes

  • Carton of ten 0.5-mL prefilled single-dose Luer-Lok® syringes with tip caps, NDC 0006-4095-02

Not shown actual size
NDC 0006-4095-02

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 doses with the earliest expiration dates are used first.1
  • Ensure that the refrigerator is plugged into an outlet in a protected area where it cannot be disconnected accidentally.1
  • Vaccines For Children (VFC) Program 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.1
  • 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.2
  • 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.

References

  1. Centers for Disease Control and Prevention (CDC). Vaccine Storage and Handling Toolkit. Last reviewed March 29, 2024. Accessed June 25, 2024. https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf
  2. Kroger A, Bahta L, Long S, Sanchez P. General best practice guidelines for immunization. Best practices guidance of the Advisory Committee on Immunization Practices (ACIP). Centers for Disease Control and Prevention (CDC). Updated August 1, 2023. Accessed June 25, 2024. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html

Indication for VAQTA®(Hepatitis A Vaccine, Inactivated)

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

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.

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%).

 

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 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.

Indication for VAQTA®(Hepatitis A Vaccine, Inactivated)

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

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.

VAQTA® (Hepatitis A Vaccine, Inactivated) is indicated for the prevention of

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.

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%).

 

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 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.

Do not administer VAQTA to individuals with a history of immediate and/or

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.