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COMPLETEDPHASE1

A Clinical Trial to Evaluate the Safety and Immunogenicity of Norovirus Bivalent Vaccine

A Randomized, Blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine (Hansenulapolymorpha) in Healthy People Aged 6 Months to 59 Years

NCT04188691•National Vaccine and Serum Institute, China

View on ClinicalTrials.gov

Summary

A total of 450 subjects were enrolled, divided into four age groups, including 18-59 years, 6-17 years, 3-5 years, and 6-35 months. There are three types of the test vaccine component in each age group. A total of 30 people in each dose group were vaccinated with the test vaccine or placebo 1 or placebo 2, respectively, in a ratio of 3: 1: 1. The 18-59-year-old, 6-17-year-old, and 3-5-year-old age groups were vaccinated 2 times at a time interval of 28 days. The 6-35 month age group is divided into two groups, Group 1 is inoculated with 2 doses interval of 28 days each, and Group 2 is inoculated with 3 doses interval of 28 days.

Detailed Description

From January to April 2020, this study was affected by the COVID-19 epidemic, which caused the two groups（6-17-year-old，3-5-year-old） of subjects to vaccinate beyond the window and deviate from the experimental plan. After communication between the researcher, the sponsor and the statistician, it was decided to restart the Phase I clinical trials of these two groups.

Eligibility

Age

0 - 59 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Aged 6 months to 59 years old, can provide legal identification of Chinese population;
•Based on medical history and physical examination, determined by the researcher as healthy;
•Volunteer legal guardians or trustees have the ability to understand (non-illiterate) research procedures, sign informed consent voluntarily with informed consent, and be able to comply with the requirements of clinical research protocols;
•Female subjects of childbearing age were not pregnant at the time of enrollment (negative urine pregnancy test), were not breastfeeding, and had no birth plan within the first 3 months after enrollment; effective contraceptive measures were taken within 2 weeks before enrollment.

Exclusion Criteria

•Axillary body temperature before inoculation on the day of entry\> 37.0 ℃;
•Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc .;
•Have a history of epilepsy, convulsions or convulsions, or a family history of mental illness;
•Those who received immunoenhancement or inhibitor therapy within 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;
•No spleen or spleen function defect caused by any situation;
•Severe liver and kidney disease, drug-uncontrollable hypertension (systolic blood pressure\> 140mmHg, diastolic blood pressure\> 90mmHg), diabetic complications, malignant tumors, various acute diseases or chronic attacks of acute diseases;
•Have a history of chronic gastrointestinal diseases, diarrhea or other digestive system diseases, and have had 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; are allergic to any component of the test vaccine;
+5 more criteria

Locations (1)

qixian Center for Disease Control and Prevention

Hebi, Henan, China

Key Dates

Start Date

November 28, 2019

Primary Completion Date

December 13, 2020

Completion Date

December 13, 2020

Last Updated

April 22, 2021

Enrollment

510

ACTUAL participants

Conditions

Norwalk GastroenteritisNorovirus Infections

Interventions

Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）

BIOLOGICAL

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

BIOLOGICAL

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

BIOLOGICAL

Normal saline

BIOLOGICAL

Aluminum adjuvant

BIOLOGICAL

A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years Old

NCT06944717

Norovirus Infections

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COMPLETEDPHASE1

A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants

NCT07254728

Norovirus Infections

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COMPLETEDPHASE1/PHASE2

Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines

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: April 22, 2021Data 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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A Clinical Trial to Evaluate the Safety and Immunogenicity of Norovirus Bivalent Vaccine

Inclusion Criteria

Exclusion Criteria

A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years Old

A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants

Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines

Admission Pattern Among Children With Gastro-intestinal Infections Before and During the Covid-19 Pandemic

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