Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Thai Children and Adolescents Lacking Protective Antibody Levels After a Single Dose of Live-attenuated Hepatitis A Vaccine

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Hepatitis A virus (HAV) remains a common infection in Thai children. Two HAV vaccines are available: inactivated vaccine (I-HAV, 2 doses) and live-attenuated vaccine (L-HAV, single dose), but neither is included in Thailand's national immunization program. Our previous randomized, active-controlled, open-label, non-inferiority trial trial found that some participants remained seronegative after one L-HAV dose (anti-HAV IgG \<1 S/CO) (preliminary data). This study aims to evaluate the immunogenicity and safety of an additional dose of I-HAV in healthy Thai children and adolescents who did not develop protective antibody levels after a single dose of L-HAV.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 20
Healthy Volunteers: t
View:

• Thai children and adolescents who previously participated in the previous RCT study

• Previously randomized to receive one dose of L-HAV vaccine within the past 1 year (+/- 2 months)

• Have not demonstrate a seropositivity against HAV (anti-HAV IgG \<1 S/CO) at 1 month after L-HAV vaccination

• Participants and/or caregivers gives written inform consent/assent form

Locations
Other Locations
Thailand
Department of Pediatrics, Faculty of Medicine, Chiang Mai University
RECRUITING
Chiang Mai
Contact Information
Primary
Tavitiya Sudjaritruk, MD, PhD
tavitiya.s@cmu.ac.th
+66-53-936471
Backup
Natchaya Kunanitthaworn, MD
natchaya.k@cmu.ac.th
+66-53-936461
Time Frame
Start Date: 2025-05-25
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 36
Treatments
Experimental: Inactivated HAV vaccine (I-HAV)
An additional dose of inactivated hepatitis A vaccination for participants who have seronegative (anti-HAV IgG \<1 S/CO) at baseline (1 year after a single dose of live-attenuated hepatitis A vaccine).
Related Therapeutic Areas
Sponsors
Leads: Chiang Mai University
Collaborators: Faculty of Medicine, Chiang Mai University

This content was sourced from clinicaltrials.gov