CompletedPhase 1

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

China510 participantsStarted 2019-11-28

Plain-language 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.

Who can participate

Age range

6 Months – 59 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

AE of local and systemic reactions within 30 minutes after each dose

Timeframe: 30 minutes

All active AEs within 0-7 days after each dose

Timeframe: 7 days

All non-active collection AEs within 0-28（30） days after each dose

Timeframe: 28（30） days

All SAEs within 6 months after the last dose is vaccinated

Timeframe: 6 months

Trial details

NCT IDNCT04188691

SponsorNational Vaccine and Serum Institute, China

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12-13

View on ClinicalTrials.gov More Norwalk Gastroenteritis trials