Safety and Immunogenicity Study of Thiomersal-free Hepatitis E Vaccine in People Ages 16 Years and Above

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 612

Inclusion Criteria

Inclusion Criteria: 1. Aged 16 years and above when administered with the first dose of vaccine; 2. Axillary temperature is 37.2 ? or less; 3. Clinically determined as healthy and eligible for vaccination by the investigators after inquiring about the medical history and relevant physical examinations; 4. 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; 5. Able to comply with the request of study protocol and complete every visit; 6. Females with negative urine pregnancy test results; 7. Negative serological markers for hepatitis E (HEV-Ab). Exclusion Criteria: 1. Females who are pregnant or breastfeeding, or planning to be pregnant within the next 8 months; 2. Administration of hepatitis E vaccine before the study; 3. 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; 4. 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); 5. 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; 6. 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; 7. 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; 8. Plan to participate in any other clinical trial during the study period; 9. Immunodeficiency disorders, subjects with primary diseases of important organs, cancer or precancerous lesions, or any immune disease requiring treatment (such as systemic lupus erythematosus, rheumatoid arthritis, any condition resulting in asplenectomy or splenectomy, and other immune diseases that researchers believe may have an impact on the immune response); 10. Have a history of severe allergies, including history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain. 11. Asthma that needed emergency treatment, hospitalization, oral or intravenous corticosteroid to keep stable in the past two years; 12. Complicated with another severe internal disease(such as hypertension, cardiopathy, diabetes and hyperthyroidism etc); 13. Abnromal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or coagulopathy diagnosed by the doctor; 14. Epilepsy, excluding febrile seizures under 2 years old, alcoholic seizures within 3 years before abstinence, or simple epilepsy without treatment in the past 3 years; 15. Inability to comply with the study requirement due to psychological conditions, past or present severe mental disorders that have not been well controlled within the past 2 years, accident-causing behavior, or having suicidal tendencies in the past 5 years; 16. Other medical, psychological, social or occupational factors that, according to the investigators' judgment, which are inconsistent with the study protocol or affecting the subjects and/or guardians (trustees) to sign the informed consent; 17. Individuals without civil capacity.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Seroconversion rate of anti-HEV IgG at Month 7;Anti-HEV IgG geometric mean concentration (GMC) at Month 7;Adverse events within 0-7 days after each vaccination;Adverse events within 8-30 days after each vaccination;Serious adverse events and pregnancy from the 1st dose vaccination to 6 months after the last vaccination

Secondary Outcome Measures

Name	Time	Method

Related Trials

A study to evaluate the long-term safety and tolerability of SEP-363856 compared with an approved medicine in subjects with schizophrenia.

Phase 1

Sunovion Pharmaceuticals Inc.

Updated 3/14/2022

A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of Aprepitant for the Prevention of Postoperative Nausea and Vomiting (PONV)

Phase 1

Merck & Co., Inc

Updated 4/30/2019

A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of Aprepitant for the Prevention of Postoperative Nausea and Vomiting (PONV)

Phase 1

Merck Sharp & Dohme GesmbH

Updated 4/30/2019

A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate

Phase 1

ovo Nordisk A/S

Updated 10/22/2018

A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate

Phase 1

ovo Nordisk A/S

Updated 8/20/2018

A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate

Phase 1

ovo Nordisk A/S

Updated 7/23/2018

A Randomized, Double-Blind, Active Comparator, Non-Inferiority Study of Subcutaneously Administered Neugranin (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) or Pegfilgrastim in Subjects with Breast Cancer Receiving Myelosuppressive Chemotherapy (Doxorubicin/Docetaxel) - NA

Teva Pharmaceutical Works Private Limited Company

Updated 9/16/2013

A Randomized, Double-Blind, Active Comparator Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan/HCTZ Combination as Compared to Losartan Monotherapy in Pediatric Patients With Essential Hypertension - Pediatric Hypertension Efficacy Study

Phase 1

Merck & Co., Inc.

Updated 3/30/2020

A Randomized, Double-Blind, Active Comparator Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan/HCTZ Combination as Compared to Losartan Monotherapy in Pediatric Patients With Essential Hypertension - Pediatric Hypertension Efficacy Study

Phase 1

Merck Sharp & Dohme Ltd

Updated 6/30/2019

A Randomized, Double-Blind, Active Comparator Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan/HCTZ Combination as Compared to Losartan Monotherapy in Pediatric Patients With Essential Hypertension - Pediatric Hypertension Efficacy Study

Phase 1

MSD Finland Oy

Updated 6/30/2019

Safety and Immunogenicity Study of Thiomersal-free Hepatitis E Vaccine in People Ages 16 Years and Above

Recruitment & Eligibility

Study & Design

Related Trials

A study to evaluate the long-term safety and tolerability of SEP-363856 compared with an approved medicine in subjects with schizophrenia.

A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of Aprepitant for the Prevention of Postoperative Nausea and Vomiting (PONV)

A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of Aprepitant for the Prevention of Postoperative Nausea and Vomiting (PONV)

A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate

A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate

A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate

A Randomized, Double-Blind, Active Comparator, Non-Inferiority Study of Subcutaneously Administered Neugranin (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) or Pegfilgrastim in Subjects with Breast Cancer Receiving Myelosuppressive Chemotherapy (Doxorubicin/Docetaxel) - NA

A Randomized, Double-Blind, Active Comparator Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan/HCTZ Combination as Compared to Losartan Monotherapy in Pediatric Patients With Essential Hypertension - Pediatric Hypertension Efficacy Study

A Randomized, Double-Blind, Active Comparator Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan/HCTZ Combination as Compared to Losartan Monotherapy in Pediatric Patients With Essential Hypertension - Pediatric Hypertension Efficacy Study

A Randomized, Double-Blind, Active Comparator Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan/HCTZ Combination as Compared to Losartan Monotherapy in Pediatric Patients With Essential Hypertension - Pediatric Hypertension Efficacy Study

Clinical Trial Alerts

Clinical Trial Alerts