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Pediatric clinical data for VAQTA—Immunogenicity

VAQTA demonstrated 100% efficacy* after the second dose in both children and adolescents.a,b,c,d

*The efficacy of VAQTA in 1 through 18 year-olds was based upon immunogenicity measured 4 to 6 weeks following vaccination.

Vaccination with VAQTA may not result in a protective response in all susceptible vaccinees.

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

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Clinical study designs

aThe efficacy of VAQTA was evaluated in a clinical trial that included children 12 through 23 months of age who were randomized to receive the first dose of VAQTA with or without M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live) and VARIVAX® (Varicella Virus Vaccine Live) and the second dose of VAQTA with or without Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) and optionally either oral poliovirus vaccine (no longer licensed in the US) or IPOL (Poliovirus Vaccine Inactivated).

bPost dose 1: anti-HAV GMT = 48 mIU/mL (95% CI: 44.7, 51.6). Post dose 2: anti-HAV GMT = 6920 mIU/mL (95% CI: 6136, 7801).

cImmunogenicity data were combined from 11 randomized clinical studies in children and adolescents 2 through 18 years of age who received VAQTA (25 U/0.5 mL). These included administration of VAQTA in varying doses and regimens (N=404 received 25 U/0.5 mL), the Monroe Efficacy Study (N=973), and comparison studies for process and formulation changes (N=1238).

dPost dose 1: anti-HAV geometric mean titer (GMT) = 43 mIU/mL (95% CI: 40, 45). Post dose 2: anti-HAV GMT = 10,077 mIU/mL (95% CI: 9394, 10,810).

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Review dosage and administration

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.