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.

Pediatric Product Information for VAQTA® (Hepatitis A Vaccine, Inactivated)—Efficacy

GOGo Two VAQTA® (Hepatitis A Vaccine, Inactivated) to Help Prevent Hepatitis AVAQTA

TO HELP PREVENT HEPATITIS A

Demonstrated early and long-term vaccine efficacy

A landmark study was done to evaluate the efficacy of VAQTA in children 2 to 16 years of age, along with a 9-year follow-up study.4,5,a

  • In the Monroe study, VAQTA demonstrated 100% efficacy against hepatitis A.4,5
  • No cases of hepatitis A were reported after day 50.4
  • In a 9-year follow-up study, no cases of hepatitis A were reported in those who received a second dose of VAQTA.5

Video: VAQTA demonstrated 100% efficacy against hepatitis A in the landmark Monroe Study

ref1

Reference

  1. Centers for Disease Control and Prevention (CDC). Vaccine Storage and Handling Toolkit. https://www.cdc.gov/vaccines/hcp/admin/ storage/toolkit/storage-handling-toolkit.pdf. Published January 2019. Accessed December 3, 2019.
  1. aAn initial double-blind, placebo-controlled study was conducted to evaluate the efficacy of a hepatitis A vaccine in a community with recurrent outbreaks. In this study, 1,037 children were enrolled/vaccinated on an ongoing basis until November 5, 1991. On November 19, 1991, the study was unblinded, and placebo recipients were vaccinated.4
ref2

Reference

  1. Tang SS. Profile of pediatric visits: annualized estimates by source of payment, patient age, physician specialty, well vs sick visit, office setting, practice ownership, physician employment status & geographic location 2004–2007. American Academy of Pediatrics. https://www.aap.org/en-us/Documents/practicet_Profile_Pediatric_Visits.pdf. Updated April 2010. Accessed December 3, 2019.
ref4

Reference

  1. Werzberger A, Mensch B, Kuter B, et al. A controlled trial of a formalin-inactivated hepatitis A vaccine in healthy children. N Engl J Med. 1992;327(7):453–457.
ref5

Reference

  1. Werzberger A, Mensch B, Nalin DR, et al. Effectiveness of hepatitis A vaccine in a former frequently affected community: 9 years’ followup after the Monroe field trial of VAQTA. Vaccine. 2002;20(13–14):1699–1701.

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

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.

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:

  • 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%).
  • Adult 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 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 Prescribing Information.

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.


US-VAQ-00082 02/20