Phase Ⅲ Clinical Trial of an Inactivated Hepatitis A Vaccine
ConditionHepatitis A Vaccine
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1+
SponsorSinovac Biotech Co., Ltd
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy participants aged 1 year and older;
Participants (and/or their legal guardians) are able to understand and sign the informed consent voluntarily;
Participants of reproductive potential and their sexual partners should voluntarily use effective contraception from signing the ICF to 30 days after the second vaccination and avoid donating sperm or eggs.
Participants should provide verifiable identification, to be contacted, and to contact the investigator during the study period.
Disqualifiers
Prior vaccination with any hepatitis A vaccine or combined vaccines containing HAV components;
Prior history of HAV infection;
Female participants of reproductive potential who are pregnant (including a positive urine pregnancy test) or have a pregnancy plan within 30 days after the second vaccination, or who are currently lactating;
Known allergy to vaccines or vaccines ingredients;
Trial design
Design model
Parallel
Treatments tested in this trial
Inactivated Hepatitis A Vaccine (Human Diploid Cell) (1 mL)
Biological/VaccineInactivated Hepatitis A Vaccine (Human Diploid Cell) manufactured by Sinovac, adult dose (≥ 16 years)
Inactivated Hepatitis A Vaccine (Human Diploid Cell) (0.5 mL)
Biological/VaccineInactivated Hepatitis A Vaccine (Human Diploid Cell) manufactured by Sinovac, pediatric dose (1\~\<16 years)
Hepatitis A vaccine (inactivated, adsorbed)
Biological/VaccineHepatitis A vaccine (inactivated, adsorbed) manufactured by Sanofi
Treatment groups
680 Participants
are divided into 5 treatment groupsGroup A: Adult dose, treatment group (≥16 years)Experimental treatment 1 intervention
Group B: Pediatric dose, treatment group (6~ <16 years)Experimental treatment 1 intervention
Group C: Pediatric dose, control group (6~ <16 years)Active comparator 1 intervention
Group D: Pediatric dose, treatment group (1~ <6 years)Experimental treatment 1 intervention
Group E: Pediatric dose, conrol group (1~ <6 years)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Seroconversion 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 vaccinationSecondary outcomes
1
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 vaccination2
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 vaccination3
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 vaccination4
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 vaccinationOther outcomes
1
The seroconversion rate of HAV antibodies
The seroconversion rate of HAV antibodies 30 days after the second vaccination in susceptible population
Time frame
30 days after the second vaccination2
The seropositive rate of anti-HAV antibodies
The seropositive rate of anti-HAV antibodies 30 days after the first vaccination
Time frame
30 days after the first vaccination3
The seroconversion rate of anti-HAV antibodies
The seroconversion rate of anti-HAV antibodies 30 days after the first vaccination
Time frame
30 days after the first vaccination4
The GMC of anti-HAV antibodies
The GMC of anti-HAV antibodies 30 days after the first vaccination
Time frame
30 days after the first vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sinovac Biotech Co., Ltd
Lead sponsor
DUC MINH MEDICAL JSC.
Collaborator
Source ClinicalTrials.gov