Hepatitis A Vaccine, Inactivated has been approved in the United States and in the European Union and in the Other Countries

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

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Hepatitis A Vaccine, Inactivated studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
104147 (HAV-245) IV A multicentric, post-marketing surveillance to monitor the safety and reactogenicity of GlaxoSmithKline Biologicals’ Hepatitis A vaccine (Havrix™) administered in Korean population.
208109/139 (HAV-139) IV Evaluation of the safety and immunogenicity of a Hepatitis A Vaccine in Patients with Chronic Viral Hepatitis B and C and chronic liver disease of other etiology.
208109/141 (HAV-130) IV A pilot open group study to compare the immunogenicity, reactogenicity and safety of a standard course of hepatitis A vaccine in: HIV positive individuals with haemophilia, HIV negative individuals with haemophilia, HIV negative healthy adult male controls.
208109/166 (HAV-166) IV A double-blind, randomized, placebo controlled study to evaluate the safety and immunogenicity of HavrixÒ in subjects with human immunodeficiency virus (HIV) infection
208109/206 (HAV-206) IV An open multicentric post-marketing surveillance study of the inactivated hepatitis A vaccine (Havrix™), injected according to the prescribing information enclosed, in healthy children and adults.
208109/210 (HAV-210) IV A Phase 4, open, comparative, multicenter study of the immunogenicity and safety of SmithKline Beecham Biologicals' inactivated hepatitis A vaccine (Havrix) 720 EL.U/ 0.5 ml on a 0, 6-month schedule, administered by intramuscular injection, either to children aged (1) 15 to 18 months old or (2) 11 to 13 months old, when compared to 23 to 25 month-old children; and to determine the immune responses following co-administration of routine childhood vaccines, DTPa and Hib in the 15 to 18 month age group.
208109/228 (HAV-228) IV A phase IV open study to assess the anamnestic response to a single intramuscular injection of GlaxoSmithKline (GSK) Biologicals’ hepatitis A vaccine, Havrix™ Junior (containing 720 EL.U of hepatitis A antigen) in healthy adult subjects who have had a previously documented seropositive status following a full course of primary vaccination with GlaxoSmithKline Biologicals’ hepatitis A vaccine, Havrix™ (containing 720 EL.U of hepatitis A antigen)
270362/010 (TypHA-010) IV A phase IV, open study of re-vaccination with GlaxoSmithKline Biologicals’ Vi polysaccharide typhoid vaccine (TYPHERIX™) in subjects, who were previously administered a primary vaccination with GlaxoSmithKline Biologicals’ combined Vi polysaccharide typhoid and inactivated hepatitis A vaccine (HEPATYRIX™) or with GlaxoSmithKline Biologicals’ Vi polysaccharide typhoid vaccine, TYPHERIX™.
104951 (HPV-033) III A phase III, double-blind, randomized, controlled study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ HPV-16/18 L1 VLP AS04 vaccine administered intramuscularly according to a 0, 1, 6 month schedule in healthy female subjects aged 10–14 years. HPV-16/18 L1 VLP AS04 vaccine (HPV): GSK Biologicals’ prophylactic human papillomavirus (HPV) vaccine that contains HPV-16 and HPV-18 L1 proteins (which assemble into virus-like particles (VLP)) formulated with AS04 adjuvant.
208109/085 (HAV-085) III A randomized, controlled, double-blind field efficacy trial of SmithKline Beecham Biologicals' inactivated hepatitis A vaccine using a recombinant DNA hepatitis B vaccine, Engerix-B as control.
208109/127 (HAV-116) III Open study of the immunogenicity and reactogenicity of SmithKline Beecham Biologicals' inactivated hepatitis A vaccine administered to hemophiliac patients.
208109/145 (HAV-132) III A study to assess the immunogenicity and reactogenicity of hepatitis A vaccine administered subcutaneously to patients with congenital coagulation disorders using a single primary dose and a booster at six months at a dose of 1440 ELU (in 1 ml) to adults and 720 ELU (in 0.5 ml) to children.
208109/188 (HAV-188) III Open study in healthy 2-month old infants to evaluate the immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ inactivated hepatitis A vaccine (720 EL.U of antigen pr 0.5 ml) injected at the age of 2, 4 and 6 months. (All infants received DTPa-IPV/Hib vaccine simultaneously in the opposite limb).
208109/220 (HAV-220) III A Phase IIIb, open, randomized, controlled, multicenter study of the immunogenicity and safety of GSK Biologicals' inactivated hepatitis A vaccine (Havrix®) [720 El.U/ 0.5 mL dose] administered on a 0, 6-month schedule concomitantly with Wyeth Lederle's pneumococcal conjugate vaccine (Prevnar™) in healthy children 15 months of age. HAV (Havrix®): hepatitis A vaccine; PCV (Prevnar™): licensed pneumococcal conjugate vaccine.
208109/229 (HAV-229) III A Phase IIIb, open, multicenter study of the immunogenicity and safety of one dose of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine (HavrixÒ) [720 EL.U/0.5 ml dose] administered to healthy children who were seropositive for anti-HAV prior to a primary vaccination course with HavrixÒ in study HAV-210 and to a control group of healthy children who are non-immune for hepatitis A.
208141/040 III A double-blind, randomized, controlled study to evaluate the immunogenicity and safety of a GlaxoSmithKline Biologicals’ investigational vaccination regimen in healthy female subjects aged 10 – 17 years.
270362/002 (TypHA-002) III A phase III open study designed to evaluate the immunogenicity and reactogenicity of a booster dose of Havrix 1440TM in healthy volunteers previously vaccinated with a single dose of SB Biologicals’ combined Vi polysaccharide typhoid and inactivated hepatitis A vaccine.
270362/004 (TypHA-004) III A single-blind, randomized study to evaluate the immunogenicity and reactogenicity of two production lots of GlaxoSmithKline Biologicals’ combined Vi polysaccharide typhoid and inactivated hepatitis A vaccine (HEPATYRIXÔ) stored between 2 °C to 8 °C for either 0 to 12 or 24 to 36 months, respectively, and administered as a single dose to healthy adult volunteers 18 to 50 years of age with a booster dose of inactivated hepatitis A vaccine (HAVRIXÔ 1440) given at Month 6.
270362/006 (TypHA-006) III A phase III, open, randomized, multicentric study to compare the reactogenicity and immunogenicity of GlaxoSmithKline Biologicals’ combined Vi polysaccharide typhoid vaccine and inactivated hepatitis A vaccine, Hepatyrix™, to that elicited by GlaxoSmithKline Biologicals’ hepatitis A vaccine, Havrix™ administered singly or concomitantly with GlaxoSmithKline Biologicals’ Vi polysaccharide vaccine, Typherix™, and to that elicited by Aventis Pasteur’s monovalent Vi polysaccharide vaccine, Typhim Vi, administered intramuscularly to healthy subjects aged 18-65 years.
270362/008 & 009 III A phase III, open, randomized, multicentric study to compare the reactogenicity and immunogenicity of two GlaxoSmithKline Biologicals’ investigational vaccines to that elicited by GlaxoSmithKline Biologicals’ hepatitis A vaccine, Havrix™ administered singly or concomitantly with GlaxoSmithKline Biologicals’ investigational vaccine, and to that elicited by a commercial vaccine, administered intramuscularly to healthy subjects aged 18-65 years. Havrix™ = HAV (hepatitis A vaccine).
580299/013 (HPV-013) & 104896 (EXT HPV-013 Month 18) & 104902 (EXT HPV-013 Month 24) III 580299/013 (HPV-013): A Phase III, double-blind, randomized, controlled study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ HPV-16/18 L1/AS04 vaccine administered intramuscularly according to a 0, 1, 6 month schedule in healthy female subjects aged 10-14 years. 104896 (EXT HPV-013 Month 18) & 104902 (EXT HPV-013 Month 24): A long-term, open follow-up of the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 AS04 vaccine in healthy female subjects vaccinated in study HPV-013. HPV-16/18 L1 AS04 vaccine: GlaxoSmithKline (GSK) Biologicals’ human papillomavirus vaccine
106208 II A phase II, randomized, controlled study to assess the reactogenicity and immunogenicity of an investigational vaccination regimen.
710158/002 II A phase II, open, randomized, controlled primary vaccination study to evaluate the immunogenicity, safety and reactogenicity of three doses of an experimental vaccine using either a 0-2-4 month or 0-1-6 month schedule to healthy adolescents between 12 and 18 years of age.