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UNKNOWNPHASE2

Clinical Trial to Evaluate the Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine (Hansenula Polymorpha)

Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine(Hansenula Polymorpha) in Healthy People Aged Aged From 6 Months to 59 Years

NCT04941261•National Vaccine and Serum Institute, China

View on ClinicalTrials.gov

Summary

Phase II clinical study will explore dose and safety, immunogenicity in 4 age groups, including 18-59 years old group, 6-17 years old group, 3-5 years old group, 6-35 months old group, with a total of 1716 subjects.

Eligibility

Age

0 - 59 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Age range: healthy people aged 6 months -59 years and and older who can provide legal identification;
•Inquired about medical history and physical examination, the investigator judged that the health condition is good;
•The subject and/or his legal guardian and/or his entrusted person can understand the study procedures and informed consent, voluntarily sign informed consent form, and be able to comply with the requirements of the clinical study protocol;
•Females of childbearing age (menarche to menopause) are not pregnant at the time of enrollment (negative urine pregnancy test), not breastfeeding, and have no birth plan within 12 months after enrollment; effective contraception will be taken within 2 weeks before enrollment;

Exclusion Criteria

•Axillary body temperature is not less than 37.3℃ (older than 14 years) before vaccination, and axillary body temperature is not less than 37.5℃ (14 years or younger) before vaccination;
•Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
•Have received immune enhancement or inhibitor therapy within 3 months (continuous oral or instillation for more than 14 days);
•Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
•Having serious congenital malformations or chronic diseases (including but not limited to:Down syndrome, thalassemia, heart disease, kidney disease, diabetes, autoimmune disease, genetic allergies, Guillain Barre syndrome, etc.);
•Asthenia or splenectomy, functional asthenia caused by any situation;
•Severe liver and kidney disease, severe cardiovascular disease, drug-uncontrollable hypertension (systolic blood pressure is not less than 140mmHg, diastolic blood pressure is not less than 90mmHg), high blood glucose, diabetic complications , Malignant tumors, various acute diseases or acute attacks of chronic diseases;
•Have a history of chronic gastrointestinal disease, current diarrhea or other digestive system diseases, gastroenteritis requiring treatment in the past 7 days;
•Have a history of abnormal coagulation function (such as coagulation factor deficiency, coagulopathy);
•Have a history of severe allergic reactions to vaccination; allergic to any component of the experimental vaccine
+7 more criteria

Locations (1)

qixian Center for Disease Control and Prevention

Hebi, Henan, China

Key Dates

Start Date

June 30, 2021

Primary Completion Date

February 28, 2024

Completion Date

March 30, 2024

Last Updated

October 28, 2022

Enrollment

1,716

ESTIMATED participants

Conditions

Norovirus InfectionsNorwalk Gastroenteritis

Interventions

middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine

BIOLOGICAL

high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine

BIOLOGICAL

placebo

BIOLOGICAL

Contacts

Xia shengli, bachelor

CONTACT

（+86）13592610137 1792865518@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 28, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Trial to Evaluate the Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine (Hansenula Polymorpha)

Inclusion Criteria

Exclusion Criteria

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