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Vaccine Detail

VAQTA
Vaccine Information
  • Product Name: Hepatitis A Vaccine, Inactivated
  • Tradename: VAQTA
  • Manufacturer: Merck & Co, Inc
  • Vaccine Ontology ID: VO_0000118
  • CDC CVX code: 52, 83
  • Type: Inactivated or "killed" vaccine
  • Status: Licensed
  • Location Licensed: USA (License #0002)
  • Host Species for Licensed Use: Human
  • Antigen: Hepatitis A Vaccine, Inactivated
  • Preparation: VAQTA [Hepatitis A Vaccine, Inactivated] is an inactivated whole virus vaccine derived from hepatitis A virus (HAV) grown in cell culture in human MRC-5 diploid fibroblasts. It contains inactivated virus of a strain which was originally derived by further serial passage of a proven attenuated strain. The virus is grown, harvested, purified by a combination of physical and high performance liquid chromatographic techniques developed at the Merck Research Laboratories, formalin inactivated, and then adsorbed onto amorphous aluminum hydroxyphosphate sulfate. One milliliter of the vaccine contains approximately 50 units (U) of hepatitis A virus antigen, which is purified and formulated without a preservative (FDA: VAQTA).
  • Immunization Route: Intramuscular injection (i.m.)
  • Storage: Store vaccine at 2-8°C (36-46°F).
  • Approved Age for Licensed Use: Ages 12 months and older (FDA: VAQTA).
  • Contraindication: Hepatitis A vaccine should not be administered to persons with a history of a severe reaction to a prior dose of hepatitis A vaccine or to a vaccine component.
  • Description: Indication: Lowering the age indication for VAQTA from two years to 12 months of age (FDA: VAQTA).

    VAQTA is indicated for active immunization against disease caused by hepatitis A virus in persons 12 months of age and older. Primary immunization should be given at least 2 weeks prior to expected exposure to Hepatitis A Virus (HAV).
Host Response

Human Response

  • Vaccination Protocol: The protective efficacy, immunogenicity and safety of VAQTA were evaluated in a randomized, double-blind, placebo-controlled study involving 1037 healthy children and adolescents ages 2 through 16 years in a U.S. community with recurrent outbreaks of hepatitis A. Subjects were administered with either VAQTA or placebo (FDA: VAQTA)
  • Immune Response: No cases of Hepatitis A have been confirmed in response to vaccination with VAQTA.
  • Side Effects: Injection Site Reactions included: pain, redness and swelling. Systemic Reactions included: rash and fever.
  • Description: The total duration of protective effect of VAQTA is unknown.

Horse Response

  • Vaccination Protocol: A clinical study was performed in 537 healthy adults, 18 to 83 years of age. The subjects were administered with a booster dose of VAQTA and HAVRIX†† (hepatitis A vaccine, inactivated) given at 6 or 12 months following an initial dose of HAVRIX (FDA: VAQTA).
  • Immune Response: When VAQTA was given as a booster dose following HAVRIX, the vaccine produced an adequate immune response, seropositivity and booster response were both high in all subjects.
References
FDA: VAQTA: FDA: VAQTA vaccine information [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm110017.htm]