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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
680
Inactivated Hepatitis A Vaccine (Human Diploid Cell) manufactured by Sinovac, adult dose (≥ 16 years)
Inactivated Hepatitis A Vaccine (Human Diploid Cell) manufactured by Sinovac, pediatric dose (1\~\<16 years)
Hepatitis A vaccine (inactivated, adsorbed) manufactured by Sanofi
Hanoi Medical University
Hanoi, Vietnam
RECRUITINGSeroconversion rate of anti-HAV antibodies
The seroconversion rate of anti-hepatitis A virus (HAV) antibodies 30 days after the second vaccination
Time frame: 30 days after the second vaccination
Seropositive rate of anti-HAV antibodies
The seropositive rate of anti-HAV antibodies 30 days after the second vaccination
Time frame: 30 days after the second vaccination
Geometric mean concentration (GMC) of anti-HAV antibodies
The geometric mean concentration (GMC) of anti-HAV antibodies 30 days after the second vaccination
Time frame: 30 days after the second vaccination
Geometric mean fold rise (GMFR) of anti-HAV antibodies
The geometric mean fold rise (GMFR) of anti-HAV antibodies 30 days after the second vaccination
Time frame: 30 days after the second vaccination
Incidence of adverse events (AE)/adverse reactions (AR)
Incidence of adverse events (AE)/adverse reactions (AR) within 30 days after each vaccination
Time frame: 30 days after each vaccination
Incidence of adverse events (AE)/adverse reactions (AR)
Incidence of AE/AR within 7 days after each vaccination
Time frame: 7 days after each vaccination
Incidence of serious adverse events (SAE)
Incidence of serious adverse events (SAE) from first vaccination to 30 days after second vaccination
Time frame: From first vaccination to 30 days after second vaccination
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