HAVRIX SUMMARY
HAVRIX (Hepatitis A Vaccine, Inactivated) is a noninfectious hepatitis A vaccine developed and manufactured by GlaxoSmithKline Biologicals. The virus (strain HM175) is propagated in MRC5 human diploid cells. After removal of the cell culture medium, the cells are lysed to form a suspension. This suspension is purified through ultrafiltration and gel permeation chromatography procedures. Treatment of this lysate with formalin ensures viral inactivation. HAVRIX contains a sterile suspension of inactivated virus; viral antigen activity is referenced to a standard using an enzyme linked immunosorbent assay (ELISA), and is therefore expressed in terms of ELISA Units (EL.U.).
HAVRIX is indicated for active immunization of persons >/=2 years of age against disease caused by hepatitis A virus (HAV).
HAVRIX will not prevent hepatitis caused by other agents such as hepatitis B virus, hepatitis C virus, hepatitis E virus, or other pathogens known to infect the liver.
Immunization with HAVRIX is indicated for those people desiring protection against hepatitis A. Primary immunization should be completed at least 2 weeks prior to expected exposure to HAV.
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NEWS HIGHLIGHTS
Published Studies Related to Havrix (Hepatitis A Vaccine)
Safety and immunogenicity of concomitant vaccination with the cell-culture based Japanese Encephalitis vaccine IC51 and the hepatitis A vaccine HAVRIX1440 in healthy subjects: A single-blind, randomized, controlled Phase 3 study. [2009.07.16]
In travellers often several pre-departure immunizations are indicated, thus data are needed about possible interactions between vaccines. This Phase 3 study investigated the immunogenicity and safety of IC51 (JE vaccine) and HAVRIX1440 (hepatitis A vaccine) when administered alone or concomitantly to healthy subjects...
Effects of a nurse-managed program on hepatitis A and B vaccine completion among homeless adults. [2009.01]
BACKGROUND: Hepatitis B virus (HBV) infection constitutes a major health problem for homeless persons... The finding that White homeless persons were the least likely to complete the vaccine series suggests that programs tailored to address their unique cultural issues are needed.
Immunological efficacy of a three-dose schedule of hepatitis A vaccine in HIV-infected adults: HEPAVAC study. [2008.11.01]
BACKGROUND: The immunogenicity of vaccines, including vaccine against hepatitis A virus (HAV), is impaired in patients with HIV infection, requiring revised immunization regimens... CONCLUSIONS: In HIV-infected adults, immunogenicity of hepatitis A vaccine is poor. Three doses of vaccine were safe and increased antibody titers.
Therapeutic vaccination of chronic hepatitis C nonresponder patients with the peptide vaccine IC41. [2008.05]
BACKGROUND & AIMS: IC41 is a synthetic peptide vaccine containing 7 relevant hepatitis C virus (HCV) T-cell epitopes and the T helper cell (Th)1/Tc1 adjuvant poly-L-arginine. IC41 has been shown to be safe and to induce HCV-specific interferon (IFN)-gamma-secreting CD4+ and CD8+ T cells in healthy volunteers. We aimed to investigate whether IC41 is able to induce HCV-specific T-cell responses also in chronic hepatitis C patients... CONCLUSIONS: This study showed that the HCV peptide vaccine IC41 can induce HCV-specific Th1/Tc1 responses in a subset of difficult to treat HCV nonresponder patients despite persisting viremia. However, changes in HCV RNA occurred only in single patients. Because strongest T-cell responses were associated with HCV RNA decline, further studies with optimized vaccine regimens and combination therapies have been initiated.
Immunogenicity, safety, and interchangeability of two inactivated hepatitis A vaccines in Chilean children. [2008.05]
OBJECTIVES: To compare the immunogenicity, safety, and interchangeability of two pediatric hepatitis A vaccines, Avaxim 80U-Pediatric and Havrix 720, in Chilean children... CONCLUSIONS: No significant difference in seroconversion rates was seen 14 days after a single dose of vaccine. A two-dose schedule with either vaccine or with Havrix/Avaxim provided a strong booster response. Both vaccines were well tolerated and can be recommended for routine vaccination of Chilean children. Avaxim 80 may be used to complete a vaccine schedule begun with Havrix 720.
Clinical Trials Related to Havrix (Hepatitis A Vaccine)
Phase III, Open, Comparative Study in Healthy Adults Aged 18-50 Years Administered With Hepatyrix or Havrix + Typherix or Tiphim Vi, to Compare Reactogenicity and Immunogenicity. [Active, not recruiting]
To evaluate the immunogenicity, reactogenicity and safety of Hepatyrix when compared to the
concomitant administration of Typherix and Havrix, and when compared to the administration of
monovalent vaccines, Havrix or Typhim Vi. Furthermore, the study will evaluate the
persistence of anti-Vi and anti-HAV antibodies up to 36 months after administration of the
first dose of the study vaccine.
Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella [Oka/Merck] Virus Vaccine Live Safety Study [Completed]
Two doses each of Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella
[Oka/Merck] Virus Vaccine Live will be given concomitantly or non-concomitantly. Safety
data will be collected following each vaccination.
Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age [Completed]
This is a study to evaluate the immunogenicity and safety of GSK Biologicals 2-dose
inactivated hepatitis A vaccine when administered with a pneumococcal conjugate vaccine in
children as young as 15 months of age
Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Measles/Mumps/Rubella Vaccine & a Varicella (Chickenpox) Vaccine in Healthy Children [Active, not recruiting]
This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose
inactivated hepatitis A vaccine when administered with a measles/mumps/rubella vaccine and a
varicella (chickenpox) vaccine in children as young as 15 months of age.
Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Diphtheria, Tetanus & Pertussis Vaccine (DTaP) Vaccine & a Haemophilus Influenza Type B (Hib) Vaccine in Healthy Children 15 m of Age [Completed]
This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose
inactivated hepatitis A vaccine when administered with a diphtheria, tetanus and pertussis
combination (DTaP) vaccine and a Haemophilus influenza type B (Hib) vaccine in children as
young as 15 months of age
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Page last updated: 2009-10-20
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