Last reviewed · How we verify
NCT06978621: HAV-2
Immunogenicity and Safety of I-HAV in Healthy Thai Children and Adolescents Lacking Protective Antibody After L-HAV
Phase 3 trial testing Inactivated hepatitis A vaccine (I-HAV) in Hepatitis A in 36 participants. Currently enrolling.
31 August 2025
Quick facts
| Lead sponsor | Chiang Mai University |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 36 |
| Start date | 25 May 2025 |
| Primary completion | 31 August 2025 |
| Estimated completion | 30 September 2025 |
| Sites | 1 location across Thailand |
Drugs / interventions tested
- Inactivated hepatitis A vaccine (I-HAV) — full drug profile →
Conditions studied
- Hepatitis A — all drugs for Hepatitis A →
- Hepatitis A Virus — all drugs for Hepatitis A Virus →
- Vaccine-Preventable Diseases — all drugs for Vaccine-Preventable Diseases →
Sponsor
Chiang Mai University
Who can join
Adults 18 Months to 20, any sex, with Hepatitis A or Hepatitis A Virus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06978621
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hepatitis A
Currently open trials in the same condition.
- NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective · recruiting
- NCT06058416 — Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old · Phase 4 · active not recruiting
Other Chiang Mai University trials
Trials by the same sponsor.
- NCT07366775 — A Telenursing Program to Support Diabetes Self-Management · NA · active not recruiting
- NCT07032610 — Long-term Immunogenicity of L-HAV Vaccine Among Healthy Thai Children and Adolescents · not yet recruiting
- NCT06905041 — Preoperative Anemia Affected to Postoperative Outcomes in Liver Resection · not yet recruiting
- NCT07476404 — Re-bleeding in Giant Meningioma and Intraoperative Hydroxyethyl Starch (HES) Fluid Therapy · completed
- NCT06820944 — Theobromine From Cocoa and Cardiovascular Risk Factors · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06978621 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chiang Mai University
- Last refreshed: 17 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06978621.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing