Safety and Immunogenicity Study of Thiomersal-free Hepatitis E Vaccine in People Ages 16 Years an… (NCT06564116) | Clinical Trial Compass
CompletedPhase 4
Safety and Immunogenicity Study of Thiomersal-free Hepatitis E Vaccine in People Ages 16 Years and Above
China612 participantsStarted 2023-03-22
Plain-language summary
The purpose of this study is to evaluate the safety and non-inferior immunogenicity of thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli) compared with licensed Recombinant Hepatitis E Vaccine (Escherichia Coli) when administered in participants ages 16 years and above.
Who can participate
Age range16 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged 16 years and above when administered with the first dose of vaccine;
✓. Axillary temperature is 37.2 ℃ or less;
✓. Clinically determined as healthy and eligible for vaccination by the investigators after inquiring about the medical history and relevant physical examinations;
✓. Willing to participate in this study and sign informed consent form (ICF). Participants aged 16-17 years should sign ICF jointly by themselves and their guardians;
✓. Able to comply with the request of study protocol and complete every visit;
✓. Females with negative urine pregnancy test results;
✓. Negative serological markers for hepatitis E (HEV-Ab).
Exclusion criteria
✕. Females who are pregnant or breastfeeding, or planning to be pregnant within the next 8 months;
✕. Administration of hepatitis E vaccine before the study;
✕. Use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period;
✕. Long-term (for more than 14 days) use of immunosuppressant, immunoregulation therapy or corticosteroid systemic therapy within 6 months before the first dose of the study vaccine, excluding local treatment ( such as ointment, eye drops, inhalants or nasal sprays);
What they're measuring
1
Seroconversion rate of anti-HEV IgG at Month 7
Timeframe: Month 7
2
Anti-HEV IgG geometric mean concentration (GMC) at Month 7
Timeframe: Month 7
3
Adverse events within 0-7 days after each vaccination
Timeframe: Day 7
4
Adverse events within 8-30 days after each vaccination
Timeframe: Day 30
5
Serious adverse events and pregnancy from the 1st dose vaccination to 6 months after the last vaccination
✕. Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine, or plan to use during the study period;
✕. Administration of any inactivated vaccines within 14 days preceding enrollment (other vaccines besides live-attenuated vaccines, including recombinant vaccines, subunit vaccines, polysaccharide conjugate vaccines, synthetic peptide vaccines, etc ), or live-attenuated vaccines within 28 days preceding enrollment;
✕. Had a fever (axillary temperature is 38.0℃ or higher) within 3 days prior to, or any acute illness requiring systemic antibiotics or antiviral treatment within 5 days prior to vaccination;
✕. Plan to participate in any other clinical trial during the study period;