Hepatitis A Vaccine

Identification

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Name
Hepatitis A Vaccine
Accession Number
DB10989  (DB10309)
Type
Biotech
Groups
Approved
Biologic Classification
Vaccines
Other vaccines
Description

Two types of HAV vaccines are currently available internationally: 1. Formaldehyde-inactivated vaccines: Inactivated HAV vaccines are used in most countries. Monovalent inactivated HAV vaccines are available in paediatric dose (0.5 ml) for children aged 1 year to 15 years, and in adult dose (1 ml). 2. Live attenuated vaccines (based on H2 or LA-1 HAV strains): These vaccines are manufactured and used mainly in China and India.

Inactivated hepatitis A vaccines are safe and highly effective. Traditionally, a two-dose schedule is recommended, particularly in travellers at substantial risk of contracting hepatitis A and in immunocompromised individuals. However, in healthy individuals, comparable effectiveness has been achieved with a single dose.

The Chinese live attenuated hepatitis A vaccines have been shown to be safe and highly protective (95%) against clinical infection for at least 3 years. Among the adverse effects from Hepatitis A vaccine injection are fatigue, fever > 99.5°F (37.5°C), induration, redness, and swelling of the injection site and malaise. Anorexia and nausea could be possible side effects.

Synonyms
  • Hepatitis A vaccine, inactivated
Product Ingredients
IngredientUNIICASInChI Key
Hepatitis A virus strain CR 326F antigen (formaldehyde inactivated)Q04Q922K9QNot AvailableNot applicable
Hepatitis A virus strain HM175 antigen (formaldehyde inactivated)5BFC8LZ6LQNot AvailableNot applicable
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
AvaximSuspensionIntramuscularSanofi Pasteur Limited1999-05-27Not applicableCanada
Avaxim - Pediatric -(5ml Vial)SuspensionIntramuscularSanofi Pasteur LimitedNot applicableNot applicableCanada
Avaxim - Pediatric -(syringe)SuspensionIntramuscularSanofi Pasteur Limited2003-04-09Not applicableCanada
EpaxalLiquidIntramuscularBerna Biotech Ltd2000-01-112015-01-01Canada
HavrixInjection, suspension1440 [iU]/1mLIntramuscularA-S Medication Solutions2007-04-13Not applicableUs
HavrixInjection, suspension1440 [iU]/1mLIntramuscularDispensing Solutions, Inc.2007-04-13Not applicableUs
HavrixInjection, suspension1440 [iU]/1mLIntramuscularDispensing Solutions, Inc.2007-04-13Not applicableUs
HavrixInjection, suspension1440 [iU]/1mLIntramuscularGlaxoSmithKline Biologicals SA2007-04-13Not applicableUs
HavrixInjection, suspension720 [iU]/0.5mLIntramuscularGlaxoSmithKline Biologicals SA2007-02-16Not applicableUs
Havrix - 720unit/ml SusSuspensionIntramuscularGlaxosmithkline Inc1994-12-312001-10-03Canada
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
TwinrixHepatitis A Vaccine (720 unit) + Hepatitis B Vaccine (Recombinant) (20 mcg)SuspensionIntramuscularGlaxosmithkline Inc1997-09-23Not applicableCanada
TwinrixHepatitis A virus strain HM175 antigen (formaldehyde inactivated) (720 [iU]/1mL) + Hepatitis B virus subtype ADW2 HBSAG surface protein antigen (20 ug/1mL)Injection, suspensionIntramuscularGlaxoSmithKline Biologicals SA2007-06-07Not applicableUs
TwinrixHepatitis A virus strain HM175 antigen (formaldehyde inactivated) (720 [iU]/1mL) + Hepatitis B virus subtype ADW2 HBSAG surface protein antigen (20 ug/1mL)Injection, suspensionIntramuscularA-S Medication Solutions2007-06-07Not applicableUs
Twinrix JuniorHepatitis A Vaccine (360 unit) + Hepatitis B Vaccine (Recombinant) (10 mcg)SuspensionIntramuscularGlaxosmithkline Inc1998-11-06Not applicableCanada
VivaximHepatitis A Vaccine (160 unit) + Typhoid Vi polysaccharide vaccine (25 mcg)Solution; SuspensionIntramuscularSanofi Pasteur Limited2005-11-09Not applicableCanada
Categories
UNII
Not Available
CAS number
Not Available

Pharmacology

Indication

Hepatitis A vaccine is indicated for active immunization against disease caused by hepatitis A virus (HAV). It is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV.

HAVRIX® will not prevent hepatitis infection caused by other agents such as hepatitis B virus, hepatitis C virus, hepatitis E virus or other pathogens known to infect the liver. In areas of low to intermediate prevalence of hepatitis A, immunization with HAVRIX® is particularly recommended in subjects who are, or will be, at increased risk of infection such as: * Travelers: Persons traveling to areas where the prevalence of hepatitis A is high. These areas include Africa, Asia, the Mediterranean basin, the Middle East, Central and South America.

  • Armed Forces: Armed Forces personnel who travel to higher endemicity areas or to areas where hygiene is poor have an increased risk of HAV infection. Active immunization is indicated for these individuals.
  • Persons for whom Hepatitis A is an Occupational Hazard: These include employees in day-care centres, nursing, medical and paramedical personnel in hospitals and institutions, especially gastroenterology and pediatric units, sewage workers, and food handlers, among others.
  • Persons for whom there is an Increased Risk of Transmission of Hepatitis A: e.g. homosexuals, persons with multiple sexual partners, abusers of injectable drugs, hemophiliac patients.
  • Contacts of Infected Persons: Since virus shedding of infected persons may occur for a prolonged period, active immunization of close contacts is recommended.
  • Specific Population Groups known to have Higher Incidence of Hepatitis A: e.g. North American Indians, Inuits, recognized community-wide HAV epidemics.
  • Subjects with chronic liver disease or who are at risk of developing chronic liver disease e.g. Hepatitis B (HB) and Hepatitis C (HC) chronic carriers and alcohol abusers.
Pharmacodynamics

Elevation of Anti-Hepatitis A antibodies which gives protection against Hepatitis A infection.

Mechanism of action

The hepatitis A virus belongs to the picornavirus family. It is one of several hepatitis viruses that cause systemic disease with pathology in the liver. The incubation period for hepatitis A averages 28 days (range: 15 to 50 days). The course of hepatitis A infection is extremely variable, ranging from asymptomatic infection to icteric hepatitis and death. The presence of antibodies to HAV confers protection against hepatitis A infection. However, the lowest titer needed to confer protection has not been determined.

Additional Data Available
Adverse Effects

Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.

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Additional Data Available
Contraindications

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

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Additional Data Available
Blackbox Warnings

Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.

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Absorption

Vaccine is intended for intramuscular injection. Evaluation of pharmacokinetic properties is not required for vaccines.

Volume of distribution

Evaluation of pharmacokinetic properties is not required for vaccines.

Protein binding

Evaluation of pharmacokinetic properties is not required for vaccines.

Metabolism

Evaluation of pharmacokinetic properties is not required for vaccines.

Route of elimination

Evaluation of pharmacokinetic properties is not required for vaccines.

Half life

Evaluation of pharmacokinetic properties is not required for vaccines.

Clearance

Evaluation of pharmacokinetic properties is not required for vaccines.

Toxicity

Health injuries are not known or expected under normal use. LD50: No data available.

Affected organisms
Not Available
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
2-MethoxyethanolThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with 2-Methoxyethanol.
25-desacetylrifapentineThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with 25-desacetylrifapentine.
6-Deoxyerythronolide BThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with 6-Deoxyerythronolide B.
9-(N-methyl-L-isoleucine)-cyclosporin AThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with 9-(N-methyl-L-isoleucine)-cyclosporin A.
AbataceptThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Abatacept.
AbetimusThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Abetimus.
Acetic acidThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Acetic acid.
Acetyl sulfisoxazoleThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Acetyl sulfisoxazole.
ActeosideThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Acteoside.
AdalimumabThe therapeutic efficacy of Hepatitis A Vaccine can be decreased when used in combination with Adalimumab.
Additional Data Available
  • Extended Description
    Extended Description

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  • Severity
    Severity

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  • Evidence Level
    Evidence Level

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  • Action
    Action

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Food Interactions
Not Available

References

General References
  1. MSDS [Link]
  2. WHO website [Link]
  3. product info [Link]
  4. Havrix Monograph [Link]
External Links
PubChem Substance
347911071
Drugs.com
Drugs.com Drug Page
AHFS Codes
  • 80:12.00 — Vaccines

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1Active Not RecruitingPreventionHealthy Volunteers1
1CompletedBasic ScienceHealthy Volunteers1
1CompletedPreventionHepatitis C Viral Infection / Human Immunodeficiency Virus (HIV) Infections1
1CompletedPreventionPlasmodium Infections1
1CompletedPreventionRespiratory Synctial Virus1
2Active Not RecruitingPreventionVaccine Response Impaired1
2CompletedOtherMeningococcal Disease / Meningococcal Infections1
2CompletedPreventionDengue Diseases / Dengue Fever / Dengue Hemorrhagic Fever / Dengue Virus1
2CompletedPreventionDengue Fever / Dengue Hemorrhagic Fever1
2CompletedPreventionDiseases Caused by Measles, Mumps, Rubella and Varicella Viruses / Measles-Mumps-Rubella-Varicella Vaccine / Mumps / Rubella / Rubeola / Varicella1
2CompletedPreventionEncephalitis, Japanese B / Hepatitis A1
2CompletedPreventionHealthy Volunteers / Norovirus / Norovirus, Prevention1
2CompletedPreventionHepatitis A1
2CompletedPreventionMeningococcal Infections1
2CompletedPreventionMumps / Rubella / Rubeola1
2CompletedPreventionResponse to Hepatitis A Vaccine1
2CompletedPreventionStreptococcal Infections / Streptococcus Pneumoniae and Nontypable Haemophilus Influenzae / Streptococcus Pneumoniae Vaccines1
2CompletedPreventionViral Hepatitis B1
2CompletedTreatmentBipolar Disorder (BD) / Depression / Human Immunodeficiency Virus (HIV) Infections / Schizoaffective Disorders / Schizophrenic Disorders / Substance Abuse1
2CompletedTreatmentHuman Immunodeficiency Virus (HIV) Infections1
2RecruitingBasic ScienceAstrocytomas / Gliomas / Oligodendrogliomas1
2RecruitingPreventionPlasmodium Infections1
2TerminatedBasic ScienceTransplant-Related Cancer1
2TerminatedTreatmentBladder Cancers / Cancer, Breast / Malignant Neoplasm of Colon1
2, 3TerminatedPreventionInfections, Cytomegalovirus1
2, 3Unknown StatusPreventionHepatitis A / Varicella1
3Active Not RecruitingPreventionHepatitis A Vaccine2
3CompletedPreventionCervical Cancers / Precancerous Conditions1
3CompletedPreventionCervical Intraepithelial Neoplasia (CIN) / Papillomavirus Infection1
3CompletedPreventionEncephalitis, Japanese B1
3CompletedPreventionEncephalitis, Japanese B / Hepatitis A1
3CompletedPreventionFlu caused by Influenza3
3CompletedPreventionHaemophilus Influenzae Infections / Pneumococcal Diseases / Streptococcal Infections / Streptococcus Pneumoniae1
3CompletedPreventionHaemophilus Influenzae Type B / Neisseria Meningitidis1
3CompletedPreventionHepatitis A4
3CompletedPreventionHepatitis A Virus Infection1
3CompletedPreventionHepatitis A / Hepatitis A Vaccine1
3CompletedPreventionHepatitis A / Meningococcal Disease / Meningococcal Meningitis / Viral Hepatitis B1
3CompletedPreventionHepatitis A / Salmonella Typhi Infection / Viral Hepatitis B1
3CompletedPreventionHepatitis A / Viral Hepatitis B5
3CompletedPreventionHerpes Simplex1
3CompletedPreventionHerpes Simplex Infection1
3CompletedPreventionHuman Papillomavirus (HPV) Infection / Papillomavirus Infections / Papillomavirus Vaccines1
3CompletedPreventionInflammation, Brain1
3CompletedPreventionMeasles; Mumps; Rubella1
3CompletedPreventionMeningococcal Infections / Meningococcal Serogroup A, C, W-135, Y Diseases1
3CompletedPreventionMeningococcal Meningitis1
3CompletedPreventionMeningococcal Vaccines1
3CompletedPreventionMumps / Rubella / Rubeola2
3CompletedPreventionPapillomavirus Infections1
3CompletedPreventionPneumonia & AOM Caused by S. Pneumoniae & H. Influenzae / Streptococcal Infections1
3CompletedPreventionStreptococcal Infections1
3CompletedTreatmentHuman Immunodeficiency Virus (HIV) Infections1
3RecruitingPreventionInfections, Pneumococcal / Vaccines, Pneumococcal1
3RecruitingPreventionMeningococcal Infections1
3Unknown StatusPreventionHepatitis A / Human Immunodeficiency Virus (HIV) Infections / Viral Hepatitis B1
3WithdrawnBasic ScienceHuman Immunodeficiency Virus (HIV) Infections1
3WithdrawnPreventionPapillomavirus Infections1
4Active Not RecruitingBasic ScienceFlu caused by Influenza / Healthy Adults / Hepatitis A / Salmonella Typhi Infection1
4Active Not RecruitingPreventionPneumonia, Pneumococcal1
4CompletedOtherMeningococcal Serogroup B1
4CompletedPreventionChickenpox / Hepatitis A / Mumps / Rubella / Rubeola1
4CompletedPreventionCrohn's Disease (CD) / Hepatitis A / Inflammatory Bowel Diseases (IBD) / Ulcerative Colitis (UC)1
4CompletedPreventionFlu caused by Influenza1
4CompletedPreventionFlu caused by Influenza / Influenza Infection2
4CompletedPreventionHepatitis A8
4CompletedPreventionHepatitis A Virus2
4CompletedPreventionHepatitis A / Hepatitis A Virus1
4CompletedPreventionHepatitis A / Mumps / Rubella / Rubeola1
4CompletedPreventionHepatitis A / Viral Hepatitis B5
4CompletedPreventionHepatitis A / Viral Hepatitis B / Viral Hepatitis Vaccines1
4CompletedPreventionHuman Immunodeficiency Virus (HIV) Infections1
4CompletedPreventionHuman Immunodeficiency Virus (HIV) Infections / Viral Hepatitis B1
4CompletedPreventionInflammation, Brain1
4CompletedPreventionParatyphoid Fever / Salmonella Typhi Infection2
4CompletedPreventionViral Hepatitis B1
4Enrolling by InvitationPreventionHepatitis A1
4RecruitingPreventionHepatitis A / Human Immunodeficiency Virus (HIV) / Vaccine Response Impaired1
4RecruitingPreventionHepatitis A / Rubeola / Varicella1
4RecruitingPreventionHuman Papillomavirus Infections1
4TerminatedPreventionAcellular Pertussis / Diphtheria / Hepatitis A / Pertussis / Tetanus1
4Unknown StatusPreventionAntibody Response After Vaccination1
4Unknown StatusPreventionMeasurement of Immune Response to Hepatitis A / Measurement of Immune Response to Prevenar131
4Unknown StatusPreventionViral Hepatitis B2
4WithdrawnPreventionHepatitis A1
Not AvailableActive Not RecruitingNot AvailableInfections, Pneumococcal1
Not AvailableCompletedNot AvailableRheumatoid Arthritis / Spondylarthritis / Vasculitis1
Not AvailableCompletedPreventionHepatitis1
Not AvailableCompletedPreventionHepatitis A1
Not AvailableCompletedPreventionHepatitis A / Hepatitis C Viral Infection / Medication Adherence / Risk Behaviors / Substance Abuse, Intravenous / Viral Hepatitis B1
Not AvailableCompletedTreatmentHuman Immunodeficiency Virus (HIV) Infections4
Not AvailableEnrolling by InvitationPreventionCystic Fibrosis (CF) / Hepatitis A / Tuberculosis Infection / Viral Hepatitis B1
Not AvailableRecruitingPreventionAutoimmune Rheumatologic Disease1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
LiquidIntramuscular
Injection, suspensionIntramuscular1440 [iU]/1mL
Injection, suspensionIntramuscular720 [iU]/0.5mL
SuspensionIntramuscular
Injection, suspensionIntramuscular
SuspensionIntramuscular
Injection, suspensionIntramuscular25 [iU]/0.5mL
Injection, suspensionIntramuscular50 [iU]/1mL
SuspensionIntramuscular50 unit
Solution; suspensionIntramuscular
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Taxonomy

Classification
Not classified

Drug created on December 01, 2015 13:04 / Updated on September 16, 2019 14:22