Hepatitis A Vaccine

Overview

Hepatitis A viral infection can lead to significant morbidity and mortality, with signs and symptoms that include anorexia, nausea, vomiting, and liver failure. Known by several trade names, such as Havrix and Twinrix, the Hepatitis A vaccine has been formulated for immunization against hepatitis A virus (HAV) infection and safely confers strong protection against the disease caused by infection with this virus. In the US, the approved vaccine is inactivated while live Hepatitis A vaccines are currently available in other countries.

Background

Indication

Hepatitis A vaccine is indicated for immunization against hepatitis A virus (HAV) infection in patients aged 12 months and older, and the first dose should be administered at least 2 weeks before expected exposure to the Hepatitis A virus.

Associated Conditions

Hepatitis A
Disease caused by Salmonella typhi

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age	2025/03/03	NCT06855160	Phase 3	Recruiting	GlaxoSmithKline
Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age	2025/02/13	NCT06824181	Phase 3	Recruiting	Sanofi
Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age	2025/02/13	NCT06824194	Phase 3	Recruiting	Sanofi
A Study on the Immune Response and Safety of the Second Dose of an Investigational Chickenpox Vaccine When Given to Healthy Children 3 Months After a First Dose at 12 to 15 Months of Age	2025/02/03	NCT06806137	Phase 3	Recruiting	GlaxoSmithKline
A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age	2024/12/18	NCT06740630	Phase 3	Recruiting	GlaxoSmithKline
A Study on the Safety of an Investigational Chickenpox Vaccine, When Given to Healthy Children, 12 to 15 Months of Age	2024/11/18	NCT06693895	Phase 3	Recruiting	GlaxoSmithKline
Immunogenicity and Safety of Inactivated and Live-attenuated HAV Vaccine Among Thai Healthy Children and Adolescents	2024/03/07	NCT06298708	Phase 3	Completed	Chiang Mai University
Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa	2023/04/03	NCT05794230	Phase 3	Active, not recruiting	Sanofi Pasteur, a Sanofi Company
A Study on the Immune Response and Safety of Various Potencies of an Investigational Chickenpox Vaccine Compared With a Marketed Chickenpox Vaccine, Given to Healthy Children 12 to 15 Months of Age	2021/10/19	NCT05084508	Phase 2	Completed	GlaxoSmithKline
Pfs230D1M-EPA/AS01 Vaccine, a Transmission Blocking Vaccine Against Plasmodium Falciparum, in an Age De-Escalation Trial of Children and a Family Compound Trial in Mali	2019/04/17	NCT03917654	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Twinrix Paediatric	GlaxoSmithKline Biologicals S.A.,Rue de l'Institut, 89,B-1330 Rixensart,Belgium	Authorised	2/10/1997
Ambirix	GlaxoSmithKline Biologicals S.A.,Rue de l'Institut, 89,B-1330 Rixensart,Belgium	Authorised	8/30/2002

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
AVAXIM VACCINE	SANOFI PASTEUR	SIN10611P	INJECTION	160 u/0.5 ml	1/6/1999
HAVRIX JUNIOR VACCINE 720 elisa units/0.5 ml	GSK Biologicals, Branch of SmithKline Beecham Pharma GmbH & Co. KG (primary packager), GlaxoSmithKline Biologicals SA	SIN09728P	INJECTION	720 elisa units/0.5ml	5/4/1998
HAVRIX 1440 VACCINE 1440 elisa units/ml	GSK Biologicals, Branch of SmithKline Beecham Pharma GmbH & Co. KG (primary packager), GlaxoSmithKline Biologicals SA	SIN08683P	INJECTION	1440 elisa units/ml	4/30/1996
VAQTA VACCINE 50U/ml	Merck Sharp & Dohme LLC	SIN13717P	INJECTION	50U/ml	10/30/2009
VAQTA VACCINE 25 u/0.5 ml	Merck Sharp & Dohme LLC	SIN10007P	INJECTION	25 u/0.5 ml	9/17/1998

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Hepatitis A Vaccine (Human Diploid Cell),Inactivated	Merck, Inc.	国药准字SJ20140055	生物制品	注射剂	7/16/2020
Hepatitis A Vaccine (Human Diploid Cell),Inactivated	艾美行动生物制药有限公司	国药准字S20153002	生物制品	注射剂	3/16/2020
Hepatitis A Vaccine (Human Diploid Cell),Inactivated	Merck, Inc.	国药准字SJ20140108	生物制品	注射剂	7/16/2020
Hepatitis A Vaccine (Human Diploid Cell),Inactivated	艾美行动生物制药有限公司	国药准字S20153005	生物制品	注射剂	3/16/2020
Hepatitis A Vaccine (Human Diploid Cell),Inactivated	Merck, Inc.	国药准字SJ20140107	生物制品	注射剂	7/16/2020
Hepatitis A Vaccine (Human Diploid Cell),Inactivated	艾美行动生物制药有限公司	国药准字S20153004	生物制品	注射剂	3/16/2020
Hepatitis A Vaccine (Human Diploid Cell),Inactivated	艾美行动生物制药有限公司	国药准字S20153003	生物制品	注射剂	3/16/2020
Hepatitis A Vaccine (Human Diploid Cell),Inactivated	Merck, Inc.	国药准字SJ20140056	生物制品	注射剂	7/16/2020
Hepatitis A Vaccine (Human Diploid Cell),Inactivated	北京科兴生物制品有限公司	国药准字S20020069	生物制品	注射剂	9/26/2024
Hepatitis A Vaccine (Human Diploid Cell),Inactivated	北京科兴生物制品有限公司	国药准字S20020035	生物制品	注射剂	9/26/2024

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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