Indication for VAQTA® (Hepatitis A Vaccine, Inactivated)

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.

Dosage and Administration for VAQTA® (Hepatitis A Vaccine, Inactivated)

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.

Adults (19 years of age and older): The vaccination schedule consists of a primary 1.0-mL dose administered intramuscularly and a 1.0-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 trade-mark 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%).
  • 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.

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.

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.

VAQTA may be administered concomitantly with Immune Globulin, human, using separate sites and syringes.

It is not known whether VAQTA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. VAQTA should be given to a pregnant woman only if clearly needed.

It is not known whether VAQTA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VAQTA is administered to a nursing woman.

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

In clinical trials in adults, VAQTA was concomitantly administered with typhoid Vi polysaccharide and yellow fever vaccines. Safety and immunogenicity were similar for concomitantly administered vaccines compared to separately administered vaccines.

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

Adult Product Information for VAQTA® (Hepatitis A Vaccine, Inactivated)—Immunogenicity

Excellent immunogenicity in adult patients

99.9% seroconversion rate at 4 weeks after the second dose in adults
Post-dose 1 and 2 seroconversion rates in combined clinical studies in healthy adults
19 years of age and older receiving VAQTA (50 U/1.0 mL)

95%
(95% CI:94%, 96%)

99.9%
(95% CI:99.4%, 100%)

Seroconversion(%)

Post-dose 1
(n=1,411)

Post-dose 2
(n=1,244)

Immunogenicity data were combined from 5 randomized clinical studies in adults 19 years of age and older who received VAQTA (50 U/1.0 mL). These patients had a geometric mean titer (GMT) of 37 mIU/mL (95% CI: 35, 38) after the first dose and 6,013 mIU/mL (95% CI: 5,592, 6,467) after the second dose. A GMT of ≥10 mIU/mL indicates seroconversion.

Seroconversion rates at 4 weeks post-booster dose from a clinical study in healthy adults who received 2 doses of VAQTA
Seroconversion rates by time to booster dose in healthy adults
19 years of age and older receiving VAQTA (50 U/1.0 mL)
Months after first dose that the booster dose was given Percentage of adults who were seropositive GMT
  • 6
  • 12
  • 18
  • 100% (n=1,201)
  • 98% (n=91)
  • 100% (n=84)
  • 5,987 (95% CI: 5,561, 6,445)
  • 4,896 (95% CI: 3,589, 6,679)
  • 6,043 (95% CI: 4,687, 7,793)

Additional data were collected from the patients who participated in the combined efficacy studies for adults (n=1,411) to determine seroconversion rates with booster doses at different time points.

Indication for VAQTA® (Hepatitis A Vaccine, Inactivated)

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.

Dosage and Administration for VAQTA® (Hepatitis A Vaccine, Inactivated)

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.

Adults (19 years of age and older): The vaccination schedule consists of a primary 1.0-mL dose administered intramuscularly and a 1.0-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 trade-mark 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%).
  • 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.

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.

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.

VAQTA may be administered concomitantly with Immune Globulin, human, using separate sites and syringes.

It is not known whether VAQTA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. VAQTA should be given to a pregnant woman only if clearly needed.

It is not known whether VAQTA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VAQTA is administered to a nursing woman.

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

In clinical trials in adults, VAQTA was concomitantly administered with typhoid Vi polysaccharide and yellow fever vaccines. Safety and immunogenicity were similar for concomitantly administered vaccines compared to separately administered vaccines.

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

VACC-1159573-0006 12/17