Pediatric Product Information for VAQTA® (Hepatitis A Vaccine, Inactivated)—Immunogenicity
VAQTA demonstrated 100% seroconversion rates after the second dose in both children and adolescents.a
- aData were collected at 4 to 6 weeks following vaccination in all age groups.
bIn initially seronegative children who received VAQTA with or without other vaccines.
cIn combined clinical studies in children and adolescents 2 to 18 years of age.
VAQTA showed excellent seroconversion rates post-dose 1 and 2 in separate clinical trials in:
- Children 12 to 23 months of age
- Children and adolescents 2 to 18 years of age
Geometric mean titers (GMTs) ranged from 6,920 to 10,077 mlU/mL after the second dose.
- Seroconversion was defined as antibody levels ≥10 mIU/mL.
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Excellent immunogenicity in pediatric patients
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® (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.