NCT07793227 Hepatitis A Vaccine(Human Diploid Cell)(Sinovac Biotech Co. Ltd.) Hepatitis A Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07793227 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.

MCP evidence snapshot: 1 September 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.

Why NCT07793227 is a hot trial to watch

Hepatitis A is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07793227 is notable because it evaluates Hepatitis A Vaccine(Human Diploid Cell)(Sinovac Biotech Co. Ltd.) in a Phase 3 design sponsored by Sinovac Biotech Co., Ltd.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.

Trial landscape snapshot

Protocol design and endpoint interpretation

This is a Phase Ⅲ, open-label, single arm design combined with randomized, double-blind, active-controlled design trial to assess the immunogenicity and safety of different specifications of Healive® (the 0.5 mL pediatric dosage and the 1 mL adult dosage). A total of 680 healthy participants aged 1 year and above will be enrolled, including 200 participants aged 16 years and older (adult dose group), and 480 participants aged 1 to less than 16 years (pediatric dose group). For the adult dose group: open-label, single-arm design, 200 participants aged 16 years and above will be enrolled to receive Healive® (1.0 mL). For the pediatric dose group: double-blinded, randomized, positive-controlled design, 480 participants aged 1 to less than 16 years will be enrolled, and randomized in a 2:1 ratio to receive either Healive® (0.5 mL) or Avaxim® (0.5 mL). All participants will receive two doses of either Healive® or Avaxim® at 0 and 6 months.

Allocation is Randomized, masking is Quadruple, and the intervention model is Parallel Assignment. Planned enrollment of 680 participants across Vietnam shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.

• Seroconversion rate of anti-HAV antibodies (30 days after the second vaccination) — The seroconversion rate of anti-hepatitis A virus (HAV) antibodies 30 days after the second vaccination

Readout outlook and evidence gap

The current protocol points to Not reported as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.

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Asset and sponsor context

Drug & Asset MCP profile: Hepatitis A Vaccine(Human Diploid Cell)(Sinovac Biotech Co. Ltd.) is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.

Company & Deal Intelligence MCP profile: Sinovac Biotech Co., Ltd. is resolved to a normalized organization record in Beijing Shi, China. The organization workflow adds identity, location, portfolio and partnering context where available.

The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.

White space around this program

• Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
• Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
• Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
• Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
• Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.

What to monitor next

Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.

Bottom line

NCT07793227 provides a focused lens on Hepatitis A development. Its value will be determined by whether Hepatitis A Vaccine(Human Diploid Cell)(Sinovac Biotech Co. Ltd.) can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.

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