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HAVPhase 3HAV-RCTNCT06298708

Immunogenicity and Safety of Inactivated and Live-attenuated HAV Vaccine Among Thai Healthy Children and Adolescents

A Phase 3 study testing Mevac-A vaccine and Havrix 720 Junior in people with HAV and Hepatitis A, run by Chiang Mai University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hepatitis A virus (HAV) vaccine is an effective strategy to prevent natural HAV infection. In Thailand, there are 2 types of HAV vaccine available, including inactivated HAV vaccine and live-attenuated HAV vaccine. Read more about this study

Who is it for?
Ages 18 months to 18 yearsHealthy volunteers can take part
Conditions the study is for
HAV, Hepatitis A, Hep A
What is being tested?
Mevac-A vaccine and Havrix 720 Junior
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteThailand
Study dates
27 Apr 2024to 9 Dec 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 months to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Age between 18 months and 18 years
  • Has healthy status
  • Has no history of hepatitis A infection or previous hepatitis A disease
  • Has never received hepatitis A vaccine (from vaccine booklet or parental history)
  • Participants and/or caregivers gives written inform consent/assent form

Who cannot join

  • Has acute illness within 4 weeks before enrollment
  • Has fever with jaundice within 4 weeks before enrollment
  • Has underlying disease of thrombocytopenia, coagulopathy, hemophilia A or B, neurologic disease, immunocompromised condition, chronic liver disease, chronic hepatitis B or C infection
  • Has received immunosuppressive agents or immunomodulatory agents, corticosteroid >2 mg/kg/day or 20 mg/day within 6 months before enrollment
  • Has received blood or blood component, or intravenous immunoglobulin within 6 months before enrollment
  • Has received any lived-attenuated vaccine within 30 days before enrollment
Show all 11Show fewer
  • Has history of severe allergy to vaccine or vaccine component, including aluminum hydroxide, 2-phenoxyethanol, neomycin, formaldehyde, gentamicin sulfate, or has history of anaphylaxis or severe allergic reactions following vaccination
  • Women planning for pregnancy, pregnant women or lactating women
  • Women in childbearing age who cannot use contraceptive methods during study participation
  • Is concurrently involved in other clinical trials in which receiving an investigational vaccine or study drug as part of study participation
  • Have any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Department of Pediatrics, Faculty of Medicine, Chiang Mai University

    Chiang Mai, 50200

Other trials in Thailand

About this study

Official title: Comparison of Immunogenicity and Safety of Inactivated and Live-attenuated Hepatitis A Virus Vaccine Among Thai Healthy Children and Adolescents: A Randomized, Active-controlled, Open-label, Non-inferiority Trial

Hepatitis A virus (HAV) vaccine is an effective strategy to prevent natural HAV infection. In Thailand, there are 2 types of HAV vaccine available, including inactivated HAV vaccine and live-attenuated HAV vaccine. This study aims to compare the immunogenicity and safety of inactivated and lived-attenuated HAV vaccine among Thai healthy children and adolescents age 18 months to 18 years.

Read the detailed description

Hepatitis A virus (HAV) infection is one of the common cause of viral hepatitis in children and adolescents in developing countries, including Thailand. This virus is easily transmitted through ingestion of contaminated food and water or through direct contact with an infectious person. Generally, HAV causes acute hepatitis, ranging mild illness to severe fulminant hepatitis (acute liver failure), but does not cause chronic liver disease. HAV vaccine is an effective strategy to prevent natural HAV infection as well as serious consequences of the illness.

Currently, there are 2 types of HAV vaccine available in Thailand, including (1) inactivated vaccine (I-HAV) which is recommended for 2 doses, 6 months apart and is approved for children age 1 year and above; and (2) live-attenuated vaccine (L-HAV) which is recommended for 1 dose and is approved for children age 18 months and above. However, these vaccines have not included in the Thailand Expanded Programme on Immunization (EPI) yet. Thus, vaccination coverage rate is suboptimal in the country. Moreover, the information regarding immunogenicity and safety of both vaccines is limited.

This is a randomized, active-controlled, open-label, non-inferiority trial which aims to compare the immunogenicity and safety of a marketed inactivated (I-HAV) and a live-attenuated HAV vaccine (L-HAV) among Thai healthy children and adolescents age 18 months to 18 years. This study will provide important information about the immunogenicity and safety profiles of both vaccines in Thai healthy youth as well as demonstrate the associated factors of HAV vaccine-elicited immunity in this population.

Being tested
Mevac-A vaccine, Havrix 720 Junior
Keywords
HAV vaccine, immunogenicity, safety, randomized controlled trial
Medical subject headings
Hepatitis A, Vaccine-Preventable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mevac-A vaccineBiological

    Mevac-A: A freeze-dried live-attenuated hepatitis A vaccine.

    Dose and administration: a freeze-dried live-attenuated vaccine, subcutaneous injection of 0.5 ml will be administered for 1 time.

  • Havrix 720 JuniorBiological

    Havrix 720 Junior: An inactivated hepatitis A vaccine, 720 ELISA units per 0.5 ml of formaldehyde-inactivated hepatitis A virus (HM175 hepatitis A virus strain).

    Dose and administration: a pre-filled syringe, intramuscular injection of 0.5 ml will be administered for 2 times with 6-month interval.

Study groups in NCT06298708
Study groupRoleWhat they receive
L-HAVExperimentalLive-attenuated hepatitis A vaccine.
Receives: Biological: Mevac-A vaccine
I-HAVActive comparatorInactivated hepatitis A vaccine.
Receives: Biological: Havrix 720 Junior

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anti-HAV immunoglobulin G (IgG) seroconversion rate

    Anti-HAV IgG seroconversion rate (anti-HAV IgG >= 1.0 S/CO) after the first vaccination for L-HAV group and after the second vaccination for I-HAV group, among participants with anti-HAV IgG <1.0 S/CO at baseline.

    Measured: L-HAV group: 4 weeks after the first vaccination. I-HAV group: 4 weeks after the second vaccination

Secondary outcomes (1)

  1. Geometric mean concentration (GMC) of anti-HAV IgG level

    Geometric mean concentration (GMC) of anti-HAV IgG level before the first vaccination, 4 weeks after the first vaccination, and 4 weeks after the second vaccination (for I-HAV group only).

    Measured: Baseline (before the first vaccination), 4 weeks after the first vaccination, and 4 weeks after the second vaccination (for I-HAV group only).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2024
  2. Study start27 Apr 2024
  3. Primary completion9 Dec 2024
  4. Study completion9 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06298708
Sponsor's protocol ID
PED-2566-0634
Acronym
HAV-RCT
Status last verified
May 2025
First submitted
1 Mar 2024
Last updated
4 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make individual participant data (IPD) available for this study.

Publications

  • Kunanitthaworn N, Mueangmo O, Saheng J, Wongjak W, Lertsiriladakul T, Chaito T, Nantarat P, Sudjaritruk T. Seroprevalence of hepatitis A virus antibodies among children and adolescents living in Northern Thailand: an implication for hepatitis A immunization. Sci Rep. 2023 Oct 13;13(1):17432. doi: 10.1038/s41598-023-44643-0.

    PubMed 37833325

  • Ma F, Yang J, Kang G, Sun Q, Lu P, Zhao Y, Wang Z, Luo J, Wang Z. Comparison of the safety and immunogenicity of live attenuated and inactivated hepatitis A vaccine in healthy Chinese children aged 18 months to 16 years: results from a randomized, parallel controlled, phase IV study. Clin Microbiol Infect. 2016 Sep;22(9):811.e9-811.e15. doi: 10.1016/j.cmi.2016.06.004. Epub 2016 Jun 23.

    PubMed 27345175

  • Liu XE, Wushouer F, Gou A, Kuerban M, Li X, Sun Y, Zhang J, Liu Y, Li J, Zhuang H. Comparison of immunogenicity between inactivated and live attenuated hepatitis A vaccines: a single-blind, randomized, parallel-group clinical trial among children in Xinjiang Uighur Autonomous Region, China. Hum Vaccin Immunother. 2013 Jul;9(7):1460-5. doi: 10.4161/hv.24366. Epub 2013 Apr 9.

    PubMed 23571173

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mevac-A vaccine and Havrix 720 Junior in people with HAV and Hepatitis A, run by Chiang Mai University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anti-HAV immunoglobulin G (IgG) seroconversion rate (time frame: L-HAV group: 4 weeks after the first vaccination. I-HAV group: 4 weeks after the second vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06298708, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.

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