Immunogenicity and Safety Evaluation of Inactivated Hepatitis A Vaccine in Healthy Adults and Children
This study aims to evaluate the safety and effectiveness of an inactivated Hepatitis A vaccine in healthy adults and children, by measuring the seroconversion rate of anti-Hepatitis A virus antibodies 30 days after the second vaccination.
Hepatitis A Vaccine for Adults
+ Hepatitis A Vaccine for Children
+ Sanofi's Hepatitis A Vaccine Study
Digestive System Diseases
+ Liver Diseases
+ Hepatitis
Prevention Study
Summary
Study start date: August 20, 2026
Actual date on which the first participant was enrolled.This clinical trial is all about evaluating the safety and effectiveness of a vaccine called Healive®, which is designed to prevent hepatitis A in healthy adults and children aged 1 year and older. The study is particularly interested in understanding how well the vaccine works in two different age groups: adults (16 years and above) and children (1 to less than 16 years). The importance of this study lies in its potential to provide a reliable solution for preventing hepatitis A, a contagious liver disease, in a broad age range. The trial involves 680 participants in total. Adults will receive a 1 mL dose of Healive®, while children will receive either a 0.5 mL dose of Healive® or a comparable vaccine, Avaxim®. Participants in the children's group will be randomly assigned to receive one of these two vaccines. Everyone involved will receive two doses of their assigned vaccine, six months apart. The study's primary focus is to measure the percentage of participants who develop protective antibodies against hepatitis A 30 days after their second vaccination. This helps researchers understand how well the vaccine prompts the body's immune response.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.680 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 1 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.5 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
Active ComparatorGroup IV
ExperimentalGroup 5
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location