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Norovirus InfectionsPhase 3NCT05916326

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

A Phase 3 study testing Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha) in people with Norovirus Infections and Norwalk Gastroenteritis, run by National Vaccine and Serum Institute, China at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the Efficacy, Safety and Immunogenicity of the Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha) in Healthy People Aged 6 Months to 13 Years After Vaccination Read more about this study

Who is it for?
Ages 6 months to 13 yearsHealthy volunteers can take part
Conditions the study is for
Norovirus Infections, Norwalk Gastroenteritis
What is being tested?
Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8,000 participants
Where
3 sitesChina
Study dates
30 Jun 2023to 27 Jul 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 13 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Aged from 6 months to 13 years old, and can provide legal identity certificate;
  • Volunteers and/or their guardians have the ability to understand the study requirements and process, agree to participate in the clinical trial and sign the informed consent, and can participate in all planned follow-up visits ( by an authorized entrusted person on the premise of written authorization by the guardian the informed consent can be signed);
  • Those <12 months old: born in full-term pregnancy (gestational week 37-42 weeks) and birth weight ≥ 2.5kg.

Who cannot join

  • First dose exclusion criteria：
  • Axillary body temperature > 37.0°C ;
  • Have a history of chronic gastrointestinal diseases;
  • Had gastroenteritis requiring treatment or current diarrhea, vomiting or other digestive system diseases within 7 days;
  • Have a history of allergy to any excipients of the experimental vaccine (L-histidine, sodium chloride, aluminum hydroxide and water for injection, etc.);
  • Have a history of severe allergy to any vaccine or drug, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, Arthus reaction;
Show all 22Show fewer
  • Have been diagnosed with congenital or acquired immunodeficiency, or received immunosuppressant treatment, such as the application of systemic glucocorticoid therapy for more than 2 consecutive weeks 2 months before vaccination, such as prednisone or similar drugs > 5mg/day (note: use of topical and inhaled/nebulized steroids can participate);
  • Infectious diseases, such as: tuberculosis, viral hepatitis or parents infected with human immunodeficiency virus HIV;
  • Thrombocytopenia, any coagulation disorders, or intramuscular injection contraindications receiving anticoagulant therapy etc.;
  • The volunteer himself or his biological parents have a history of convulsions (except for febrile convulsions in children), epilepsy and mental illness;
  • Serious diseases or congenital malformations that may interfere with the conduct or completion of the research (including but not limited to: asthma and other respiratory diseases or during the attack of chronic bronchitis, Down syndrome, thalassemia, heart disease, encephalopathy, kidney disease, self immune diseases, genetic allergies, Guillain-Barre Syndrome, severe skin diseases, severe malnutrition, severe developmental disorders, etc.);
  • Asplenia, functional asplenia, and asplenia or splenectomy caused by any reason;
  • Have received blood or blood-related products or immune globulin within 3 months (hepatitis B immune globulin and rabies patient immune globulin are acceptable);
  • vaccinated inactivated/recombinant vaccines (non-live vaccines) within 7 days, and inoculate live attenuated vaccines or COVID-19 vaccines within 14 days;
  • Acute illness or acute exacerbation of chronic disease within 3 days;
  • Have taken antipyretic, analgesic or antiallergic drugs within 3 days;
  • Plan to move before the end of the study or leave the local area for a long time during the scheduled study visit;
  • Participating in or planning to participate in another interventional research during the study process;
  • The investigators believe that the volunteers have other conditions that may interfere with the evaluation of the research purpose;
  • <12 months old: the baby is born with abnormal labor process (dystocia, instrumental midwifery) or has a history of suffocation, nervous system damage, current pathological jaundice, perianal abscess, severe eczema;
  • If there have been serious adverse reactions after vaccination in the past, the investigator will determine whether the volunteer is enrolled or not according to the actual situation.
  • If items 1, 3, 13, 14, and 15 of the exclusion criteria are met, the volunteer's enrollment will be postponed.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Laishui County Center for Disease Control and Prevention

    Baoding, Hebei

  • Jingxing County Center for Disease Control and Prevention

    Shijiazhuang, Hebei

  • Zhao County Center for Disease Control and Prevention

    Shijiazhuang, Hebei

Other trials in China

About this study

Official title: A Phase III Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Protective Efficacy, Safety and Immunogenicity of Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula Polymorpha) in Healthy People Aged 6 Months to 13 Years

The purpose of this study is to evaluate the Efficacy, Safety and Immunogenicity of the Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha) in Healthy People Aged 6 Months to 13 Years After Vaccination

Being tested
Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha), placebo
Medical subject headings
Caliciviridae Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha)Biological

    Intramuscular injection of Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha) in the deltoid muscle of the upper arm

  • placeboBiological

    Intramuscular injection of placebo in the deltoid muscle of the upper arm

Study groups in NCT05916326
Study groupRoleWhat they receive
Experimental vaccine groupExperimentalNot described
Receives: Biological: Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha)
placebo groupPlacebo comparatorNot described
Receives: Biological: placebo
Experimental vaccine group（Immunogenic subgroup ）ExperimentalNot described
Receives: Biological: Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha)
placebo group（Immunogenic subgroup）Placebo comparatorNot described
Receives: Biological: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate efficacy of moderate/severe acute gastroenteritis caused by laboratory-confirmed (RT-PCR) infection with GI.1 or GII.4 norovirus after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha)

    Efficacy：The sum of the incidence rate of the placebo group and the incidence rate of the experimental group, divided by the incidence rate of the placebo group

    Measured: 14 days after the full course of vaccination to end of study（about two years）

Secondary outcomes (13)

  1. To evaluate the efficacy of against moderate/severe acute gastroenteritis caused by laboratory-confirmed (RT-PCR) infection with any strain of norovirus

    after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha)

    Efficacy：The sum of the incidence rate of the placebo group and the incidence rate of the experimental group, divided by the incidence rate of the placebo group

    Measured: 14 days after the full course of vaccination to end of study（about two years）

  2. To evaluate efficacy of any gastroenteritis caused by laboratory-confirmed (RT-PCR) infection with GI.1 or GII.4 norovirus after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha)

    Efficacy：The sum of the incidence rate of the placebo group and the incidence rate of the experimental group, divided by the incidence rate of the placebo group

    Measured: 14 days after the full course of vaccination to end of study（about two years）

  3. To evaluate the efficacy of any gastroenteritis caused by laboratory-confirmed (RT-PCR) infection with any strain of norovirus after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha)

    Efficacy：The sum of the incidence rate of the placebo group and the incidence rate of the experimental group, divided by the incidence rate of the placebo group

    Measured: 14 days after the full course of vaccination to end of study（about two years）

  4. IgG of NoV GI.1 and GII.4 after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha)

    only Immunogenic subgroup

    Measured: 14th day after the full course of vaccination

  5. HBGA-blocking antibody geometric mean titer (GMT) of NoV GI.1 and GII.4 after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha)

    only Immunogenic subgroup

    Measured: 14th day after the full course of vaccination

  6. Positive conversion rates of GMT for NoV GI.1 and GII.4 after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha)

    only Immunogenic subgroup

    Measured: 14th day after the full course of vaccination

  7. Compared to before vaccination，the growth multiple of GMT for NoV GI.1 and GII.4 antibodies after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha)

    only Immunogenic subgroup

    Measured: 14th day after the full course of vaccination

  8. HBGA-blocking antibodies Geometric mean titer (GMT) of NoV GI.1 and GII.4 after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha)

    only Immunogenic subgroup

    Measured: 180th,360th,540th,720th day after the full course of vaccination

  9. IgG of NoV GI.1 and GII.4 after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha)

    only Immunogenic subgroup

    Measured: 180th,360th,540th,720th day after the full course of vaccination

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

    Measured: The period after each dose to 30 minutes after the dose

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

    Measured: The period after each dose to 7 days after the dose

  12. the incidence and severity of non-solicited adverse reactions/events within 28 days after each dose of vaccination

    Measured: The period after each dose to 28 days after the dose

  13. the incidence of SAE from the first dose of vaccination to end of study

    Measured: the first dose of vaccination to end of study（about two years）

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2023
  2. Study start30 Jun 2023
  3. Primary completion27 Jul 2025
  4. Study completion27 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
8,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05916326
Sponsor's protocol ID
CXSL1700011-III
Status last verified
Dec 2025
First submitted
6 Jun 2023
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha) in people with Norovirus Infections and Norwalk Gastroenteritis, run by National Vaccine and Serum Institute, China at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate efficacy of moderate/severe acute gastroenteritis caused by laboratory-confirmed (RT-PCR) infection with GI.1 or GII.4 norovirus after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha) (time frame: 14 days after the full course of vaccination to end of study（about two years）). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05916326.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

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