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Phase Ⅲ Clinical Trial of an Inactivated Hepatitis A Vaccine

NCT07793227 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 680

Last updated 2026-08-28

No results posted yet for this study

Summary

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.

Conditions

  • Hepatitis A Vaccine

Interventions

BIOLOGICAL

Inactivated Hepatitis A Vaccine (Human Diploid Cell) (1 mL)

Inactivated Hepatitis A Vaccine (Human Diploid Cell) manufactured by Sinovac, adult dose (≥ 16 years)

BIOLOGICAL

Inactivated Hepatitis A Vaccine (Human Diploid Cell) (0.5 mL)

Inactivated Hepatitis A Vaccine (Human Diploid Cell) manufactured by Sinovac, pediatric dose (1\~\<16 years)

BIOLOGICAL

Hepatitis A vaccine (inactivated, adsorbed)

Hepatitis A vaccine (inactivated, adsorbed) manufactured by Sanofi

Sponsors & Collaborators

  • DUC MINH MEDICAL JSC.

    collaborator UNKNOWN

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-20
Primary Completion
2027-09-15
Completion
2027-09-15

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07793227 on ClinicalTrials.gov