UnknownPhase 2

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

China1,716 participantsStarted 2021-06-30

Plain-language 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.

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.

Exclusion criteria

Children aged 24 months and under are born prematurely (delivered before the 37th week of pregnancy), low-weight (birth weight for girls \<2300g, boys \<2500g) infants; Children 24 months of age and younger have a history of dystocia, birth asphyxia or other reasons, a history of neurological damage, severe chronic diseases (such as Down syndrome, sickle cell anemia, or neurological disorders).

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

the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination

Timeframe: through 30 minutes after each dose

the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination

Timeframe: through 7 days after each dose

the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination

Timeframe: through 30 days after each dose

the incidence of SAE from the first dose of vaccination to 6 months after the full course of vaccination

Timeframe: up to 6 months after the full course of vaccination

Antibody titer of HBGA-blocking antibody on the 14th day after the full course of vaccination

Timeframe: 14th day after the full course of vaccination

4-fold Seroconversion rate on the 14th day after the full course of vaccination

Timeframe: 14th day after the full course of vaccination

Trial details

NCT IDNCT04941261

SponsorNational Vaccine and Serum Institute, China

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-28

Contact for this trial

Xia shengli, bachelor

（+86）13592610137 1792865518@qq.com

View on ClinicalTrials.gov More Norovirus Infections trials

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.

Exclusion criteria

Children aged 24 months and under are born prematurely (delivered before the 37th week of pregnancy), low-weight (birth weight for girls \<2300g, boys \<2500g) infants; Children 24 months of age and younger have a history of dystocia, birth asphyxia or other reasons, a history of neurological damage, severe chronic diseases (such as Down syndrome, sickle cell anemia, or neurological disorders).

What they're measuring

the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination

Timeframe: through 30 minutes after each dose

the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination

Timeframe: through 7 days after each dose

the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination

Timeframe: through 30 days after each dose

the incidence of SAE from the first dose of vaccination to 6 months after the full course of vaccination

Timeframe: up to 6 months after the full course of vaccination

Antibody titer of HBGA-blocking antibody on the 14th day after the full course of vaccination

Timeframe: 14th day after the full course of vaccination

4-fold Seroconversion rate on the 14th day after the full course of vaccination

Timeframe: 14th day after the full course of vaccination