Related Experiment Video
Updated: Aug 14, 2026

Induction of Drug-Induced, Autoimmune Hepatitis in BALB/c Mice for the Study of Its Pathogenic Mechanisms
Published on: May 29, 2020
Vaccination against hepatitis A in children aged 12 to 24 months [corrected]
1Centro de Investigación Médica, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile. katia@med.puc.cl
Insights
This study found that an inactivated hepatitis A vaccine is safe and effective for toddlers aged 12-24 months. The vaccine demonstrated good immunogenicity, providing a strong immune response in young children.
Area of Science:
- Pediatric infectious diseases
- Vaccinology
Background:
- Current hepatitis A vaccines have age restrictions, with some licensed for children over 2 years and others over 1 year.
- Routine hepatitis A vaccination is recommended for children in high-endemicity areas, but data for toddlers aged 1-2 years is limited.
Purpose of the Study:
- To evaluate the safety and immunogenicity of an inactivated hepatitis A vaccine in children aged 12-24 months.
- To assess the reactogenicity and immune response following a two-dose vaccination schedule.
Main Methods:
- An open clinical study involving 120 seronegative children aged 12-24 months.
- Administered two doses of an inactivated hepatitis A vaccine (Havrix pediatric) on a 0, 6-month schedule.
- Monitored for local and general symptoms and measured antibody levels.
Main Results:
- The most common side effects were injection site pain and irritability.
- No serious adverse events were associated with the vaccine.
- High antibody levels against hepatitis A were observed: 159 mIU/mL after the first dose and 2,939 mIU/mL after the booster dose.
Conclusions:
- The inactivated hepatitis A vaccine is well-tolerated in toddlers aged 12-24 months.
- The vaccine effectively elicits a robust immune response in this age group.
- Supports the potential use of this vaccine in younger children in high-risk areas.
Background:
Current hepatitis A vaccines are either licensed for children >2 years of age, as in the U.S. or Chile, or >1 year of age, as in Europe and other parts of the world. Recent recommendations for immunization against hepatitis A have included routine vaccination of children in areas or regions of higher endemicity. However, data on hepatitis A vaccination in toddlers aged between 1 and 2 years are scarce.
Methods:
This open clinical study investigated the reactogenicity and immunogenicity of two doses (0, 6-month schedule) of an inactivated hepatitis A vaccine (Havrix pediatric, Glaxco SmithKline Biologicals, Rixensart, Belgium) in 120 seronegative children aged 12-24 months.
Results:
Pain at the injection site and irritability were the most frequently reported local and general symptoms, respectively. No serious adverse events related to the study vaccine were reported. One month after the first dose, all but one subject had antibodies against hepatitis A with a GMT of 159 mIU/mL. After the booster dose, all had antibodies with a GMT of 2,939 mIU/mL.
Conclusions:
Our data show that the inactivated hepatitis A vaccine was well tolerated by these toddlers and that the vaccine elicits a good immune response.
Related Concept Videos
Vaccinations
Chickenpox
Poliomyelitis
Yellow Fever
Hepatitis
Viral Hepatitis I: Introduction

