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NCT06058416
Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old
Phase 4 trial testing Healive (hepatitis A vacine(human diploid cell), inactivated) in Hepatitis A in 1,092 participants. Participants enrolled and being followed up; not accepting new ones.
17 March 2028
Quick facts
| Lead sponsor | Sinovac Biotech Co., Ltd |
|---|---|
| Phase | Phase 4 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 1,092 |
| Start date | 24 October 2023 |
| Primary completion | 17 March 2028 |
| Estimated completion | 31 December 2029 |
| Sites | 1 location across China |
Drugs / interventions tested
- Healive (hepatitis A vacine(human diploid cell), inactivated) — full drug profile →
Conditions studied
- Hepatitis A — all drugs for Hepatitis A →
Sponsor
Sinovac Biotech Co., Ltd — full company profile →
Who can join
Adults 18 to 50, any sex, with Hepatitis A. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is conducted among people aged 18-50 in Dandong City, an area with a high incidence of hepatitis A in recent years. 1000 qualified pariticipants with signed informed consent will be screened for anti-HAV antibodies by collecting blood sample of 3ml. One dose of hepatitis A vaccine will be administrated to all the pariticipants. Negative anti-HAV antibodies-negative subjects will recieve the second dose of hepatitis A vaccination, and 400 of them will be randomly selected and assigned to 4 groups with different interval of vaccination(6 month, 18 months, 36 months and 60 months). Blood samples will be collected before vaccination of each dose and on 28 days after each dose of vaccination to anti-HAV antibody test. Safety data will be collected within 28 days after each vaccination with a smartphone mini-program.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Immunogenicity and safety of hepatitis A vaccine at different vaccination intervals among adults aged 18 years and above: Interim results.
Chang L, Li Z, Liu Y, Fei S, et al · · 2025 · PMID 40391688 · DOI 10.1080/21645515.2025.2506294
Verify or expand the search:
- PubMed search for NCT06058416
- 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
- NCT06978621 — Immunogenicity and Safety of I-HAV in Healthy Thai Children and Adolescents Lacking Protective Antibody After L-HAV · Phase 3 · recruiting
Other Sinovac Biotech Co., Ltd trials
Trials by the same sponsor.
- NCT07418229 — Study to Evaluate the Safety of a Lyophilized RSV mRNA Vaccine · Phase 1 · not yet recruiting
- NCT07416110 — Phase IIIb Clinical Trial to Evaluate Lot-to-lot Consistency of Sinovac Rabies Vaccine · Phase 3 · not yet recruiting
- NCT07055295 — Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Pre-exposure Prophylaxis Regimen · Phase 3 · not yet recruiting
- NCT07055893 — Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Simulated Post-exposure Prophylaxis Regimen · Phase 3 · not yet recruiting
- NCT07400003 — Study to Evaluate the Safety and Immunogenicity of a Lyophilized Herpes Zoster Virus mRNA Vaccine · Phase 1, PHASE2 · recruiting
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 NCT06058416 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sinovac Biotech Co., Ltd
- Last refreshed: 21 August 2024
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/NCT06058416.
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