Acute GastroenteritisPhase 1/2NCT04563533
Clinical Trial of Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris)
A Phase 1/2 study testing Low-dose vaccine and High-dose vaccine in people with Acute Gastroenteritis, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial summary
The purpose of the research is to evaluate the safety and tolerability of the tetravalent recombinant Norovirus vaccine at different doses, to initially explore the immunogenicity of the vaccine, and to determine the appropriate dose of the product for later clinical trials.This trial adopts the seamless design of… Read more about this study
- Who is it for?
- Ages 6 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Gastroenteritis
- What is being tested?
- Low-dose vaccine and High-dose vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 580 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2020to 29 Sep 2024
- Phase
- Phase 1/2
- 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 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Compliance with this clinical trial observation age is 6 weeks old and above, and can provide legal identification;
- The suspected and/or violating legal guardian has the ability to understand the research procedures and sign an informed consent form;
- Correct and/or prevent the legal guardian who has the ability to read, understand, fill in the diary card/contact card, and promise to participate regularly in accordance with the research requirements;
- The armpit body temperature of all people on the day of entry was <37.3℃;
- Standards for some groups of people:<12 months of age: singleton full-term pregnancy (37-42 weeks gestational week) and birth weight 2.5-4.0kg; women of childbearing age: agree to take effective contraceptive measures within 6 months after the first dose is implanted to the full exemption.
Who cannot join
- The population laboratory test indicators specified in the plan are abnormal and have clinical significance;
- A history of severe allergies to any component of the test vaccine, including L-histidine, sodium chloride, aluminum hydroxide, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergies Necrotic reaction (Arthus reaction); or any previous history of severe side effects of vaccines or drugs, such as: allergies, urticaria, skin eczema, dyspnea, angioedema, etc.;
- 3 days before vaccination, suffering from acute disease or in the acute attack of chronic disease (such as asthma, diabetes, thyroid disease, etc.);
- Have taken antipyretic or analgesics within 24 hours before the first dose of vaccination;
- Inoculate the inactivated vaccine within 7 days before the first dose of vaccine, and the live attenuated vaccine within 14 days;
- People suffering from the following diseases:①Suffered from digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the past 7 days;② Suffer from severe congenital malformations, severe developmental disorders, severe genetic defects, severe malnutrition, etc.;③ Suffering from thrombocytopenia, any coagulation disorders or receiving anticoagulant treatment and other intramuscular injection contraindications;④ Congenital or acquired immunodeficiency, or receive immunosuppressive therapy within 6 months (for example, systemic glucocorticoid prednisone or similar drugs have been used for more than 2 consecutive weeks within 6 months). Local medications (such as ointments, eye drops, inhalants or nasal sprays) should not exceed the recommended dose in the instructions or show any signs of systemic exposure;⑤ Has been diagnosed with infectious diseases, such as tuberculosis, viral hepatitis and/or human immunodeficiency virus (HIV) infection;⑥ Having convulsions, epilepsy, encephalopathy (such as congenital brain hypoplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral obstruction, infection, chemical drug poisoning, etc. caused brain nerve tissue damage, etc.) and a history of mental illness or family history;⑦ No spleen, functional asthenia, as well as any cause of asthenia or splenectomy;⑧ Suffering from severe cardiovascular disease (pulmonary heart disease, pulmonary edema), severe liver and kidney disease, diabetes with complications;
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- Have received blood or blood-related products, including immunoglobulins, within 3 months, or plan to use them during the study period (within 1 month after enrollment and full exemption);
- Any research or unregistered products (drugs, vaccines, biological products or devices) have been used within 3 months before enrollment, or planned to be used during the research period;
- Plan to move or leave the local area for a long time during the research period;
- Any situation that the researcher believes may interfere with the evaluation of the research purpose;
- Standards for certain groups of people:①<12 months old: IVF, multiple fetuses, currently suffering from perianal abscess, severe eczema, pathological jaundice, parents with HIV infection;② Persons ≥18 years of age: Physical examination before enrollment is hypertension (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) or hypotension (systolic blood pressure <89mmHg) (regardless of medication);③Women of childbearing age: are breast-feeding or pregnant (including a positive urine pregnancy test) or have a pregnancy plan during the study period (in the group to within 6 months after the full exemption).
Trial locations and contacts
1 site in 1 country.
China1 site
Liuzhou Center for Disease Control and Prevention
Liuzhou, Guangxi, 545000
About this study
Official title: Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Longkoma Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris) Implanted in Populations of 6 Weeks and Older
The purpose of the research is to evaluate the safety and tolerability of the tetravalent recombinant Norovirus vaccine at different doses, to initially explore the immunogenicity of the vaccine, and to determine the appropriate dose of the product for later clinical trials.This trial adopts the seamless design of phase I/IIa, which is carried out in two phases, phase I and phase IIa, phase I is the age/dose climbing phase, and phase IIa is the dose expansion phase.It is planned to enroll 580 subjects, divided into 5 age groups, including: young adults (18-59 years old, 60 people), adolescents (6 -17 years old, 60 people), and elderly (≥60 years old, 160 people) , Toddlers (2-5 years old, 140), infants (6 weeks to 23 months old, 160).The test vaccine contains recombinant HuNoV GI.1-VP1 protein, HuNoV GII.3-VP1 protein, HuNoV GII.4-VP1 protein, HuNoV GII.17-VP1 protein, and each dose contains 12.5μg/type/0.5ml/bottle (Low dose), 25μg/type/0.5ml/piece (high dose).
Read the detailed description
A single-center, randomized, blinded, multi-cohort, placebo-controlled trial design was adopted.This trial adopts the seamless design of phase I/IIa, which is carried out in two phases, phase I and phase IIa, phase I is the age/dose climbing phase, and phase IIa is the dose expansion phase.It is planned to enroll 580 subjects, divided into 5 age groups, including: young adults (18-59 years old, 60 people), adolescents (6 -17 years old, 60 people), and elderly (≥60 years old, 160 people) , Toddlers (2-5 years old, 140), infants (6 weeks to 23 months old, 160).Research phase and trial grouping: age/dose climbing phase: 340 subjects are planned to be enrolled in Liuzhou City, and they will be enrolled in the group according to the age order of young adults → adolescents and old people → toddlers → infants and young children. There are 10 cohorts, randomly divided into experimental group (low-dose or high-dose), placebo group (containing aluminum), and the random ratio of each entry stage is 2:1. Among them, infants and the elderly will be added a placebo group without aluminum adjuvant, test group (low dose or high dose), placebo group (aluminum), placebo (aluminum-free), the random ratio is 2:1:1; Dose expansion stage: It is planned to enroll 240 subjects in Rong'an County. The elderly, infants, and infants will be divided into 3 cohorts, and each age group will be randomly divided into low-dose or high-dose groups, with a random ratio of 1:1.According to the order of young adults → adolescents and elderly → toddlers → infants and young children, the dose is from low to high, and the investigator (including the main investigator and the field investigator) will review the safety of the low-dose/placebo group 7 days after the first dose. After the safety data is confirmed, you can enter the high-dose/placebo group for this age group to explore. After DSMB examines the safety data of the first dose of young and middle-aged people to 30 days after the full exemption and confirms safety, they can enter the adolescent and elderly age group; DSMB examines the safety and confirms the safety of the first dose of adolescents and the elderly to 30 days after the full exemption After that, you can enter the infant age group; the investigator (including the main investigator and the field investigator) will review the safety data 7 days after the first dose of the infant low-dose/placebo group and confirm the safety, then you can enter the infant age group explore. The three age groups (cohorts 4 and 6, 7 and 8, 9 and 10) of the elderly, toddlers, and infants can be entered into the corresponding age after the DSMB reviews the safety data of the first dose to 30 days after the full exemption and confirms the safety. In the dose expansion phase (cohorts 11, 12, 13), 80 subjects were enrolled in each cohort (of which, 40 were vaccinated with low-dose trial vaccine and 40 were vaccinated with high-dose trial vaccine).
- Conditions
- Acute Gastroenteritis
- Being tested
- Low-dose vaccine, High-dose vaccine, Placebo (containing aluminum), Placebo (without aluminum)
- Keywords
- prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose vaccineBiological
Active ingredients: recombinant ReNoV GI.1-VP1 protein, recombinant ReNoV GII.3-VP1 protein, recombinant ReNoV GII.4-VP1 protein and recombinant ReNoV GII.17-VP1 protein each 12.5μg.
Other ingredients: aluminum hydroxide adjuvant 0.25 mg, L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 1 μg, sodium dihydrogen phosphate: 47 μg, disodium hydrogen phosphate: 87 μg.
High-dose vaccineBiological
Active ingredients: recombinant ReNoV GI.1-VP1 protein, recombinant ReNoV GII.3-VP1 protein, recombinant ReNoV GII.4-VP1 protein and recombinant ReNoV GII.17-VP1 protein each 25μg.
Other ingredients: aluminum hydroxide adjuvant 0.25 mg, L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg.
Placebo (containing aluminum)Biological
Active ingredients: none Other ingredients: aluminum hydroxide adjuvant: 0.25 mg, L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg.
Placebo (without aluminum)Biological
Active ingredients: none Other ingredients: L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg.
| Study group | Role | What they receive |
|---|---|---|
| adults of phase I | Experimental | Healthy people aged 18-59 Receives: Biological: Low-dose vaccine; Biological: High-dose vaccine; Biological: Placebo (containing aluminum) |
| teenagers of phase I | Experimental | Healthy people aged 6-17 Receives: Biological: Low-dose vaccine; Biological: High-dose vaccine; Biological: Placebo (containing aluminum) |
| elderly of phase I | Placebo comparator | Healthy people 60 years old and above Receives: Biological: Low-dose vaccine; Biological: High-dose vaccine; Biological: Placebo (containing aluminum); Biological: Placebo (without aluminum) |
| Toddler of phase I | Experimental | Healthy people aged 2-5 Receives: Biological: Low-dose vaccine; Biological: High-dose vaccine; Biological: Placebo (containing aluminum) |
| Infants of phase I | Placebo comparator | 6 weeks old-2 years old healthy person Receives: Biological: Low-dose vaccine; Biological: High-dose vaccine; Biological: Placebo (containing aluminum); Biological: Placebo (without aluminum) |
| elderly of phase II | Experimental | Healthy people 60 years old and above Receives: Biological: Low-dose vaccine; Biological: High-dose vaccine |
| Toddler of phase II | Placebo comparator | Healthy people aged 2-5 Receives: Biological: Low-dose vaccine; Biological: High-dose vaccine |
| Infants of phase II | Experimental | 6 weeks old-2 years old healthy person Receives: Biological: Low-dose vaccine; Biological: High-dose vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of adverse events after intramuscular injection
The main observation methods of adverse reactions mainly include laboratory examination, local reactions and systemic reactions at the administration site.
Measured: 6 months after full vaccination
The positive conversion rate of norovirus antibody 30 days after the whole course of vaccination
For young adults, the elderly, young children, infants and young children, the 4-fold growth rate of norovirus IgA, IgG, and HBGA blocking antibodies and the positive conversion rate after immunity were analyzed 30 days after the full immunization.
Measured: 30 days after full immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start5 Aug 2020
- Primary completion29 Sep 2024
- Study completion29 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute GastroenteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center, randomized, blinded, multi-cohort, placebo-controlled trial design was adopted.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- teng huang, master, Principal investigator, Deputy Director of Vaccine Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563533
- Sponsor's protocol ID
- LKM-2020-NoV01
- Status last verified
- Sep 2024
- First submitted
- 28 Aug 2020
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Longkoma Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris) Implanted in Populations of 6 Weeks and Older
- ClinicalTrials.gov ID
- NCT04563533
- Acronym / sponsor ID
- LKM-2020-NoV01
- Conditions
- Acute Gastroenteritis
- Keywords
- prevention
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 29 Sep 2024 (actual)
- Study completion
- 29 Sep 2024 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the research is to evaluate the safety and tolerability of the tetravalent recombinant Norovirus vaccine at different doses, to initially explore the immunogenicity of the vaccine, and to determine the appropriate dose of the product for later clinical trials.This trial adopts the seamless design of phase I/IIa, which is carried out in two phases, phase I and phase IIa, phase I is the age/dose climbing phase, and phase IIa is the dose expansion phase.It is planned to enroll 580 subjects, divided into 5 age groups, including: young adults (18-59 years old, 60 people), adolescents (6 -17 years old, 60 people), and elderly (≥60 years old, 160 people) , Toddlers (2-5 years old, 140), infants (6 weeks to 23 months old, 160).The test vaccine contains recombinant HuNoV GI.1-VP1 protein, HuNoV GII.3-VP1 protein, HuNoV GII.4-VP1 protein, HuNoV GII.17-VP1 protein, and each dose contains 12.5μg/type/0.5ml/bottle (Low dose), 25μg/type/0.5ml/piece (high dose).
Detailed description
A single-center, randomized, blinded, multi-cohort, placebo-controlled trial design was adopted.This trial adopts the seamless design of phase I/IIa, which is carried out in two phases, phase I and phase IIa, phase I is the age/dose climbing phase, and phase IIa is the dose expansion phase.It is planned to enroll 580 subjects, divided into 5 age groups, including: young adults (18-59 years old, 60 people), adolescents (6 -17 years old, 60 people), and elderly (≥60 years old, 160 people) , Toddlers (2-5 years old, 140), infants (6 weeks to 23 months old, 160).Research phase and trial grouping: age/dose climbing phase: 340 subjects are planned to be enrolled in Liuzhou City, and they will be enrolled in the group according to the age order of young adults → adolescents and old people → toddlers → infants and young children. There are 10 cohorts, randomly divided into experimental group (low-dose or high-dose), placebo group (containing aluminum), and the random ratio of each entry stage is 2:1. Among them, infants and the elderly will be added a placebo group without aluminum adjuvant, test group (low dose or high dose), placebo group (aluminum), placebo (aluminum-free), the random ratio is 2:1:1; Dose expansion stage: It is planned to enroll 240 subjects in Rong'an County. The elderly, infants, and infants will be divided into 3 cohorts, and each age group will be randomly divided into low-dose or high-dose groups, with a random ratio of 1:1.According to the order of young adults → adolescents and elderly → toddlers → infants and young children, the dose is from low to high, and the investigator (including the main investigator and the field investigator) will review the safety of the low-dose/placebo group 7 days after the first dose. After the safety data is confirmed, you can enter the high-dose/placebo group for this age group to explore. After DSMB examines the safety data of the first dose of young and middle-aged people to 30 days after the full exemption and confirms safety, they can enter the adolescent and elderly age group; DSMB examines the safety and confirms the safety of the first dose of adolescents and the elderly to 30 days after the full exemption After that, you can enter the infant age group; the investigator (including the main investigator and the field investigator) will review the safety data 7 days after the first dose of the infant low-dose/placebo group and confirm the safety, then you can enter the infant age group explore. The three age groups (cohorts 4 and 6, 7 and 8, 9 and 10) of the elderly, toddlers, and infants can be entered into the corresponding age after the DSMB reviews the safety data of the first dose to 30 days after the full exemption and confirms the safety. In the dose expansion phase (cohorts 11, 12, 13), 80 subjects were enrolled in each cohort (of which, 40 were vaccinated with low-dose trial vaccine and 40 were vaccinated with high-dose trial vaccine).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- A single-center, randomized, blinded, multi-cohort, placebo-controlled trial design was adopted.
| Arm | Type | Receives |
|---|---|---|
| adults of phase I | Experimental | Biological: Low-dose vaccine, Biological: High-dose vaccine, Biological: Placebo (containing aluminum)Healthy people aged 18-59 |
| teenagers of phase I | Experimental | Biological: Low-dose vaccine, Biological: High-dose vaccine, Biological: Placebo (containing aluminum)Healthy people aged 6-17 |
| elderly of phase I | Placebo comparator | Biological: Low-dose vaccine, Biological: High-dose vaccine, Biological: Placebo (containing aluminum), Biological: Placebo (without aluminum)Healthy people 60 years old and above |
| Toddler of phase I | Experimental | Biological: Low-dose vaccine, Biological: High-dose vaccine, Biological: Placebo (containing aluminum)Healthy people aged 2-5 |
| Infants of phase I | Placebo comparator | Biological: Low-dose vaccine, Biological: High-dose vaccine, Biological: Placebo (containing aluminum), Biological: Placebo (without aluminum)6 weeks old-2 years old healthy person |
| elderly of phase II | Experimental | Biological: Low-dose vaccine, Biological: High-dose vaccineHealthy people 60 years old and above |
| Toddler of phase II | Placebo comparator | Biological: Low-dose vaccine, Biological: High-dose vaccineHealthy people aged 2-5 |
| Infants of phase II | Experimental | Biological: Low-dose vaccine, Biological: High-dose vaccine6 weeks old-2 years old healthy person |
Who may qualify
- Ages
- 6 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Compliance with this clinical trial observation age is 6 weeks old and above, and can provide legal identification;
- The suspected and/or violating legal guardian has the ability to understand the research procedures and sign an informed consent form;
- Correct and/or prevent the legal guardian who has the ability to read, understand, fill in the diary card/contact card, and promise to participate regularly in accordance with the research requirements;
- The armpit body temperature of all people on the day of entry was <37.3℃;
- Standards for some groups of people:<12 months of age: singleton full-term pregnancy (37-42 weeks gestational week) and birth weight 2.5-4.0kg; women of childbearing age: agree to take effective contraceptive measures within 6 months after the first dose is implanted to the full exemption.
Key exclusion criteria (11 listed)
- The population laboratory test indicators specified in the plan are abnormal and have clinical significance;
- A history of severe allergies to any component of the test vaccine, including L-histidine, sodium chloride, aluminum hydroxide, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergies Necrotic reaction (Arthus reaction); or any previous history of severe side effects of vaccines or drugs, such as: allergies, urticaria, skin eczema, dyspnea, angioedema, etc.;
- 3 days before vaccination, suffering from acute disease or in the acute attack of chronic disease (such as asthma, diabetes, thyroid disease, etc.);
- Have taken antipyretic or analgesics within 24 hours before the first dose of vaccination;
- Inoculate the inactivated vaccine within 7 days before the first dose of vaccine, and the live attenuated vaccine within 14 days;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose vaccineActive ingredients: recombinant ReNoV GI.1-VP1 protein, recombinant ReNoV GII.3-VP1 protein, recombinant ReNoV GII.4-VP1 protein and recombinant ReNoV GII.17-VP1 protein each 12.5μg. Other ingredients: aluminum hydroxide adjuvant 0.25 mg, L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 1 μg, sodium dihydrogen phosphate: 47 μg, disodium hydrogen phosphate: 87 μg. | Biological | Infants of phase I, Infants of phase II, Toddler of phase I, Toddler of phase II, adults of phase I, elderly of phase I, elderly of phase II, teenagers of phase I |
| High-dose vaccineActive ingredients: recombinant ReNoV GI.1-VP1 protein, recombinant ReNoV GII.3-VP1 protein, recombinant ReNoV GII.4-VP1 protein and recombinant ReNoV GII.17-VP1 protein each 25μg. Other ingredients: aluminum hydroxide adjuvant 0.25 mg, L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg. | Biological | Infants of phase I, Infants of phase II, Toddler of phase I, Toddler of phase II, adults of phase I, elderly of phase I, elderly of phase II, teenagers of phase I |
| Placebo (containing aluminum)Active ingredients: none Other ingredients: aluminum hydroxide adjuvant: 0.25 mg, L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg. | Biological | Infants of phase I, Toddler of phase I, adults of phase I, elderly of phase I, teenagers of phase I |
| Placebo (without aluminum)Active ingredients: none Other ingredients: L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg. | Biological | Infants of phase I, elderly of phase I |
Primary outcome
The number of adverse events after intramuscular injection
Time frame: 6 months after full vaccination
The main observation methods of adverse reactions mainly include laboratory examination, local reactions and systemic reactions at the administration site.
The positive conversion rate of norovirus antibody 30 days after the whole course of vaccination
Time frame: 30 days after full immunization
For young adults, the elderly, young children, infants and young children, the 4-fold growth rate of norovirus IgA, IgG, and HBGA blocking antibodies and the positive conversion rate after immunity were analyzed 30 days after the full immunization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
teng huang, master principal investigator
Deputy Director of Vaccine Clinical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Low-dose vaccine and High-dose vaccine in people with Acute Gastroenteritis, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site 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 5 inclusion and 11 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 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The number of adverse events after intramuscular injection (time frame: 6 months after full vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2024.