Acute Gastroenteropathy Due to NorovirusPhase 3NCT06524947
Clinical Trial of Protective Efficacy of Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris)
A Phase 3 study testing quadrivalent recombinant norovirus vaccine (Pichia pastoris) in people with Acute Gastroenteropathy Due to Norovirus, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 3 sites in China.
Trial summary
The purpose of the research is to evaluate the protective efficacy, immunogenicity, and safety of quadrivalent recombinant norovirus vaccine (Pichia Pastoris) in people aged 6 weeks to 13 years.A total of 6600 infants and children aged 6 weeks to 13 years old were enrolled in this study, which were divided into 3 age… Read more about this study
- Who is it for?
- Ages 6 weeks to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Gastroenteropathy Due to Norovirus
- What is being tested?
- quadrivalent recombinant norovirus vaccine (Pichia pastoris)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,600 participants
- Where
- 3 sitesChina
- Study dates
- 27 Jul 2024to 28 Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1.The subject's legal guardian agrees to participate in the trial (consent is also required for subjects 8 years of age and older), and can provide proof of legal identity, is fully informed and has signed an informed consent form, and understands and complies with the requirements of the trial protocol to participate in the follow-up visits.
- 2.The age of the subjects on the day of enrollment is not less than 6 weeks old and not more than 13 years old, regardless of gender.
- 3.Those younger than 12 months of age: 2.5kg ≤ birth weight ≤ 4.5kg, 37 weeks ≤ weeks of gestation ≤ 42 weeks, born in normal labor (excluding severe abnormal labor and history of severe asphyxia resuscitation).
Who cannot join
- 1.Allergic to or having a history of specific reactions to any component of the investigational vaccine; Previous history of severe allergy to any vaccine or drug (such as anaphylactic shock, laryngeal edema, anaphylactic purpura, local anaphylactic necrosis reaction (Arthus reaction), dyspnea, angioneurotic edema, etc.); People with allergic constitution.
- 2.A history of confirmed norovirus infection within 2 years.
- 3.Have a history of any of the following diseases or are suffering from serious diseases: ① Abnormal coagulation function: such as leukemia, congenital or acquired coagulation factor deficiency, aplastic anemia, thrombocytopenia and receiving anticoagulation therapy; ② Diseases affecting local observation: such as rational jaundice; ③Diseases affecting immune function: a history of congenital or acquired immunodeficiency or autoimmune disease; Uncontrolled lymphoproliferative diseases (such as chronic lymphocytic leukemia, Hodgkin's lymphoma, etc.); No spleen, or splenic surgery history, trauma history; ④Now suffering from infectious diseases: such as tuberculosis, viral hepatitis, etc； ⑤Neurological and psychiatric diseases: epilepsy, congenital brain hypoplasia, brain trauma, brain tumor, infection, brain nerve tissue damage caused by chemical and physical factors, etc., psychiatric history and family history； ⑥Other serious diseases that may interfere with the conduct or completion of the study: severe congenital malformations, severe developmental disorders, severe malnutrition, malignant tumors, congenital cardiovascular, liver, kidney diseases, etc.
- 4.Received blood or blood-related products (other than hepatitis B immunoglobulin) within 1 month prior to enrollment; Long-term use of systemic immunosuppressants or other immunomodulatory drugs within 3 months (defined as use for more than 14 days).
- 5.Have participated or are participating in other clinical trials (including drugs, biologics, or devices) within 3 months prior to enrollment.
- 6.The investigator believes that the subject has any disease or condition that could put the subject at risk, poor adherence or inability to complete the trial as required by the protocol, and conditions that interfere with the evaluation of vaccine response.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Hunan Center for Disease Control and Prevention
Changsha, Hunan, 410153
Sichuan Center for Disease Control and Prevention
Chengdu, Sichuan, 610041
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Nanning, Guangxi, 530028
About this study
Official title: Phase III Clinical Trial to Evaluate the Protective Efficacy, Immunogenicity, and Safety of Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris) Implanted in People Aged 6 Weeks to 13 Years
The purpose of the research is to evaluate the protective efficacy, immunogenicity, and safety of quadrivalent recombinant norovirus vaccine (Pichia Pastoris) in people aged 6 weeks to 13 years.A total of 6600 infants and children aged 6 weeks to 13 years old were enrolled in this study, which were divided into 3 age groups: 1400 children (6-13 years old), 2200 toddler (2-5 years old), and 3000 infants (6-23 months old).Subjects of all ages were randomly assigned to the test group and the control group in a 1:1 ratio.All subjects received 3 doses of the experimental vaccine at 30 day intervals.
Read the detailed description
Overall design: A multicenter, randomized, double-blind, placebo-controlled trial was designed.
The purpose of the research is to evaluate the protective efficacy, immunogenicity, and safety of quadrivalent recombinant norovirus vaccine (Pichia Pastoris) in people aged 6 weeks to 13 years.A total of 6600 infants and children aged 6 weeks to 13 years old were enrolled in this study, which were divided into 3 age groups: 1400 children (6-13 years old), 2200 toddler (2-5 years old), and 3000 infants (6-23 months old).Subjects of all ages were randomly assigned to the test group and the control group in a 1:1 ratio.All subjects received 3 doses of the experimental vaccine at 30 day intervals.
Protective effectiveness evaluation:All subjects entered the observation period 7 days after completing the first dose of immunization. Stool and/or vomit samples (if applicable) from all AGE cases occurring during the observation period were collected and AGE caused by Norovirus was identified by PCR.Primary protective efficacy was calculated using data from primary endpoint cases that occurred between 7 days after completion of full immunization and the end of the observation period.
Immunogenicity evaluation:For the immunogenic subgroup of subjects (120 subjects before the study number of each age group in a clinical trial site, a total of 360 subjects), blood samples were collected before the first dose of immunization, 31 days after the second dose of immunization, 31 days, 180 days, 1 year and 2 years after the total immunization, and blood samples were 2.5~3.0ml each time.It is used to detect anti-norovirus IgG antibody, tissue Blood group antigen (HBGA) blocking antibody, and to detect the immunogenicity of anti-norovirus.
Safety evaluation:Adverse events (AE) and serious adverse events (SAE) : All enrolled subjects collected AE 30 minutes after each dose of vaccine, enlisted AE 0-7 days, non-enlisted AE 0-30 days, and SAE from the first dose to 180 days after full immunization.
- Conditions
- Acute Gastroenteropathy Due to Norovirus
- Being tested
- quadrivalent recombinant norovirus vaccine (Pichia pastoris), quadrivalent recombinant norovirus vaccine (Pichia pastoris) placebo
- Keywords
- prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quadrivalent recombinant norovirus vaccine (Pichia pastoris)Biological
Subjects were given three doses of quadrivalent recombinant norovirus vaccine (Pichia pastoris) at a 30-day interval.
Main ingredients: recombinant ReNoV GI.1-VP1 protein, recombinant ReNoV GII.3-VP1 protein, recombinant ReNoVGII.4-VP1 protein, recombinant ReNoV GII.17-VP1 protein, aluminum hydroxide adjuvant, histidine, sodium chloride, tween 80, disodium phosphate, disodium hydrogen phosphate
quadrivalent recombinant norovirus vaccine (Pichia pastoris) placeboBiological
Subjects were given three doses of quadrivalent recombinant norovirus vaccine (Pichia pastoris) placebo at a 30-day interval.
Main ingredients: aluminum hydroxide adjuvant, histidine, sodium chloride, tween 80, disodium phosphate, disodium hydrogen phosphate
| Study group | Role | What they receive |
|---|---|---|
| Infant experimental group (6 weeks -23 months) | Experimental | At least 6 weeks old but less than 2 years old. Receives: Biological: quadrivalent recombinant norovirus vaccine (Pichia pastoris) |
| Infant placebo control group (6 weeks -23 months) | Placebo comparator | At least 6 weeks old but less than 2 years old. Receives: Biological: quadrivalent recombinant norovirus vaccine (Pichia pastoris) placebo |
| Toddler experimental group (2-5 years old) | Experimental | At least 2 years old but less than 6 years old. Receives: Biological: quadrivalent recombinant norovirus vaccine (Pichia pastoris) |
| Toddler placebo control group (2-5 years old) | Placebo comparator | At least 2 years old but less than 6 years old. Receives: Biological: quadrivalent recombinant norovirus vaccine (Pichia pastoris) placebo |
| Children experimental group (6-13 years old) | Experimental | At least 6 years of age but under 14 years of age. Receives: Biological: quadrivalent recombinant norovirus vaccine (Pichia pastoris) |
| Children placebo control group (6-13 years old) | Placebo comparator | At least 6 years of age but under 14 years of age. Receives: Biological: quadrivalent recombinant norovirus vaccine (Pichia pastoris) placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protective efficacy against AGE caused by four genotypes of norovirus
Protective efficacy against AGE caused by the four genotypes included in the prophylactic vaccine (GI.1, GII.3, GII.4, GII.17) (co-infections of rotavirus and adenovirus were excluded) after 7 days of full immunization until the end of the observation period.Protective efficacy = 1 - (person-years of incidence in the vaccine group/person-years of incidence in the placebo group) × 100%; person-years of incidence = (number of cases of AGE (excluding co-infections with rotavirus and adenovirus) caused by the four genotypes included in the vaccine (GI.1, GII.3, GII.4, and GII.17) after 7 days of 3 doses of the vaccine/number of person-years of observation) × 100%.
Measured: From 7 days after full immunization to 2 years after 7 days after after full immunization
Geometric mean titers (GMT) of IgG antibody
Geometric mean titers of IgG antibodies against norovirus (GI.1, GII.3, GII.4, GII.17) were measured at 31 days after 2 doses, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization.
Measured: 31 days after 2 doses, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization
Geometric mean titers (GMT) of HBGA blocking antibody
Geometric mean titers of HBGA blocking antibodies against norovirus (GI.1, GII.3, GII.4, GII.17) were measured at 31 days after 2 doses of immunization, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization.
Measured: at 31 days after 2 doses of immunization, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization
Positive conversion rate of IgG antibodies
Positive conversion rate of IgG antibody against norovirus (GI.1, GII.3, GII.4, GII.17) at 31 days after 2 doses, 31 days after full immunization, 180 days after full immunization, 1 year and 2 years after full immunization.
Measured: 31 days after 2 doses, 31 days after full immunization, 180 days after full immunization, 1 year and 2 years after full immunization
Positive conversion rate of HBGA blocking antibody
The positive conversion rate of HBGA blocking antibodies against norovirus (GI.1, GII.3, GII.4, GII.17) was measured at 31 days after 2 doses of immunization, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization.
Measured: 31 days after 2 doses of immunization, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization
Geometric mean titers Growth multiplier of IgG antibody
Geometric mean titers Growth multiplier of IgG antibody at 31 days after 2 doses of immunization and at 31 days after full immunization.
Measured: at 31 days after 2 doses of immunization and at 31 days after full immunization
Geometric mean titers Growth multiplier of HBGA blocking antibody
Geometric mean titers Growth multiplier of HBGA blocking antibody at 31 days after 2 doses of immunization and at 31 days after full immunization.
Measured: at 31 days after 2 doses of immunization and at 31 days after full immunization
Occurrence of any adverse event
Occurrence of any adverse event within 30 minutes of each dose of vaccination.
Measured: within 30 minutes of each dose of vaccination
Occurrence of recruited adverse event
Occurrence of recruited adverse event between day 0 and day 7 after each dose of vaccination.
Measured: between day 0 and day 7 after each dose of vaccination
Occurrence of non-recruited adverse event
Occurrence of non-recruited adverse event between day 0 and day 30 after each dose of vaccination.
Measured: between day 0 and day 30 after each dose of vaccination
Occurrence of serious adverse event
Occurrence of serious adverse event from the first dose to 180 days after full immunization.
Measured: from the first dose to 180 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 posted29 Jul 2024
- Study start27 Jul 2024
- Primary completion28 Mar 2027 (estimated)
- Study completion28 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Gastroenteropathy Due to NorovirusStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6,600 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, Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524947
- Sponsor's protocol ID
- LKM-2023-NoV01
- Status last verified
- Jan 2025
- First submitted
- 19 Jul 2024
- Last updated
- 23 Jan 2025
- 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 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Trial to Evaluate the Protective Efficacy, Immunogenicity, and Safety of Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris) Implanted in People Aged 6 Weeks to 13 Years
- ClinicalTrials.gov ID
- NCT06524947
- Acronym / sponsor ID
- LKM-2023-NoV01
- Conditions
- Acute Gastroenteropathy Due to Norovirus
- Keywords
- prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6,600 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jul 2024 (actual)
- Primary completion
- 28 Mar 2027 (estimated)
- Study completion
- 28 Mar 2027 (estimated)
- First posted
- 29 Jul 2024 (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 protective efficacy, immunogenicity, and safety of quadrivalent recombinant norovirus vaccine (Pichia Pastoris) in people aged 6 weeks to 13 years.A total of 6600 infants and children aged 6 weeks to 13 years old were enrolled in this study, which were divided into 3 age groups: 1400 children (6-13 years old), 2200 toddler (2-5 years old), and 3000 infants (6-23 months old).Subjects of all ages were randomly assigned to the test group and the control group in a 1:1 ratio.All subjects received 3 doses of the experimental vaccine at 30 day intervals.
Detailed description
Overall design: A multicenter, randomized, double-blind, placebo-controlled trial was designed.
The purpose of the research is to evaluate the protective efficacy, immunogenicity, and safety of quadrivalent recombinant norovirus vaccine (Pichia Pastoris) in people aged 6 weeks to 13 years.A total of 6600 infants and children aged 6 weeks to 13 years old were enrolled in this study, which were divided into 3 age groups: 1400 children (6-13 years old), 2200 toddler (2-5 years old), and 3000 infants (6-23 months old).Subjects of all ages were randomly assigned to the test group and the control group in a 1:1 ratio.All subjects received 3 doses of the experimental vaccine at 30 day intervals.
Protective effectiveness evaluation:All subjects entered the observation period 7 days after completing the first dose of immunization. Stool and/or vomit samples (if applicable) from all AGE cases occurring during the observation period were collected and AGE caused by Norovirus was identified by PCR.Primary protective efficacy was calculated using data from primary endpoint cases that occurred between 7 days after completion of full immunization and the end of the observation period.
Immunogenicity evaluation:For the immunogenic subgroup of subjects (120 subjects before the study number of each age group in a clinical trial site, a total of 360 subjects), blood samples were collected before the first dose of immunization, 31 days after the second dose of immunization, 31 days, 180 days, 1 year and 2 years after the total immunization, and blood samples were 2.5~3.0ml each time.It is used to detect anti-norovirus IgG antibody, tissue Blood group antigen (HBGA) blocking antibody, and to detect the immunogenicity of anti-norovirus.
Safety evaluation:Adverse events (AE) and serious adverse events (SAE) : All enrolled subjects collected AE 30 minutes after each dose of vaccine, enlisted AE 0-7 days, non-enlisted AE 0-30 days, and SAE from the first dose to 180 days after full immunization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Infant experimental group (6 weeks -23 months) | Experimental | Biological: quadrivalent recombinant norovirus vaccine (Pichia pastoris)At least 6 weeks old but less than 2 years old. |
| Infant placebo control group (6 weeks -23 months) | Placebo comparator | Biological: quadrivalent recombinant norovirus vaccine (Pichia pastoris) placeboAt least 6 weeks old but less than 2 years old. |
| Toddler experimental group (2-5 years old) | Experimental | Biological: quadrivalent recombinant norovirus vaccine (Pichia pastoris)At least 2 years old but less than 6 years old. |
| Toddler placebo control group (2-5 years old) | Placebo comparator | Biological: quadrivalent recombinant norovirus vaccine (Pichia pastoris) placeboAt least 2 years old but less than 6 years old. |
| Children experimental group (6-13 years old) | Experimental | Biological: quadrivalent recombinant norovirus vaccine (Pichia pastoris)At least 6 years of age but under 14 years of age. |
| Children placebo control group (6-13 years old) | Placebo comparator | Biological: quadrivalent recombinant norovirus vaccine (Pichia pastoris) placeboAt least 6 years of age but under 14 years of age. |
Who may qualify
- Ages
- 6 weeks to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 1.The subject's legal guardian agrees to participate in the trial (consent is also required for subjects 8 years of age and older), and can provide proof of legal identity, is fully informed and has signed an informed consent form, and understands and complies with the requirements of the trial protocol to participate in the follow-up visits.
- 2.The age of the subjects on the day of enrollment is not less than 6 weeks old and not more than 13 years old, regardless of gender.
- 3.Those younger than 12 months of age: 2.5kg ≤ birth weight ≤ 4.5kg, 37 weeks ≤ weeks of gestation ≤ 42 weeks, born in normal labor (excluding severe abnormal labor and history of severe asphyxia resuscitation).
Key exclusion criteria (6 listed)
- 1.Allergic to or having a history of specific reactions to any component of the investigational vaccine; Previous history of severe allergy to any vaccine or drug (such as anaphylactic shock, laryngeal edema, anaphylactic purpura, local anaphylactic necrosis reaction (Arthus reaction), dyspnea, angioneurotic edema, etc.); People with allergic constitution.
- 2.A history of confirmed norovirus infection within 2 years.
- 3.Have a history of any of the following diseases or are suffering from serious diseases: ① Abnormal coagulation function: such as leukemia, congenital or acquired coagulation factor deficiency, aplastic anemia, thrombocytopenia and receiving anticoagulation therapy; ② Diseases affecting local observation: such as rational jaundice; ③Diseases affecting immune function: a history of congenital or acquired immunodeficiency or autoimmune disease; Uncontrolled lymphoproliferative diseases (such as chronic lymphocytic leukemia, Hodgkin's lymphoma, etc.); No spleen, or splenic surgery history, trauma history; ④Now suffering from infectious diseases: such as tuberculosis, viral hepatitis, etc； ⑤Neurological and psychiatric diseases: epilepsy, congenital brain hypoplasia, brain trauma, brain tumor, infection, brain nerve tissue damage caused by chemical and physical factors, etc., psychiatric history and family history； ⑥Other serious diseases that may interfere with the conduct or completion of the study: severe congenital malformations, severe developmental disorders, severe malnutrition, malignant tumors, congenital cardiovascular, liver, kidney diseases, etc.
- 4.Received blood or blood-related products (other than hepatitis B immunoglobulin) within 1 month prior to enrollment; Long-term use of systemic immunosuppressants or other immunomodulatory drugs within 3 months (defined as use for more than 14 days).
- 5.Have participated or are participating in other clinical trials (including drugs, biologics, or devices) within 3 months prior to enrollment.
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 |
|---|---|---|
| quadrivalent recombinant norovirus vaccine (Pichia pastoris)Subjects were given three doses of quadrivalent recombinant norovirus vaccine (Pichia pastoris) at a 30-day interval. Main ingredients: recombinant ReNoV GI.1-VP1 protein, recombinant ReNoV GII.3-VP1 protein, recombinant ReNoVGII.4-VP1 protein, recombinant ReNoV GII.17-VP1 protein, aluminum hydroxide adjuvant, histidine, sodium chloride, tween 80, disodium phosphate, disodium hydrogen phosphate | Biological | Children experimental group (6-13 years old), Infant experimental group (6 weeks -23 months), Toddler experimental group (2-5 years old) |
| quadrivalent recombinant norovirus vaccine (Pichia pastoris) placeboSubjects were given three doses of quadrivalent recombinant norovirus vaccine (Pichia pastoris) placebo at a 30-day interval. Main ingredients: aluminum hydroxide adjuvant, histidine, sodium chloride, tween 80, disodium phosphate, disodium hydrogen phosphate | Biological | Children placebo control group (6-13 years old), Infant placebo control group (6 weeks -23 months), Toddler placebo control group (2-5 years old) |
Primary outcome
Protective efficacy against AGE caused by four genotypes of norovirus
Time frame: From 7 days after full immunization to 2 years after 7 days after after full immunization
Protective efficacy against AGE caused by the four genotypes included in the prophylactic vaccine (GI.1, GII.3, GII.4, GII.17) (co-infections of rotavirus and adenovirus were excluded) after 7 days of full immunization until the end of the observation period.Protective efficacy = 1 - (person-years of incidence in the vaccine group/person-years of incidence in the placebo group) × 100%; person-years of incidence = (number of cases of AGE (excluding co-infections with rotavirus and adenovirus) caused by the four genotypes included in the vaccine (GI.1, GII.3, GII.4, and GII.17) after 7 days of 3 doses of the vaccine/number of person-years of observation) × 100%.
Geometric mean titers (GMT) of IgG antibody
Time frame: 31 days after 2 doses, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization
Geometric mean titers of IgG antibodies against norovirus (GI.1, GII.3, GII.4, GII.17) were measured at 31 days after 2 doses, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization.
Geometric mean titers (GMT) of HBGA blocking antibody
Time frame: at 31 days after 2 doses of immunization, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization
Geometric mean titers of HBGA blocking antibodies against norovirus (GI.1, GII.3, GII.4, GII.17) were measured at 31 days after 2 doses of immunization, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization.
Positive conversion rate of IgG antibodies
Time frame: 31 days after 2 doses, 31 days after full immunization, 180 days after full immunization, 1 year and 2 years after full immunization
Positive conversion rate of IgG antibody against norovirus (GI.1, GII.3, GII.4, GII.17) at 31 days after 2 doses, 31 days after full immunization, 180 days after full immunization, 1 year and 2 years after full immunization.
Positive conversion rate of HBGA blocking antibody
Time frame: 31 days after 2 doses of immunization, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization
The positive conversion rate of HBGA blocking antibodies against norovirus (GI.1, GII.3, GII.4, GII.17) was measured at 31 days after 2 doses of immunization, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization.
Geometric mean titers Growth multiplier of IgG antibody
Time frame: at 31 days after 2 doses of immunization and at 31 days after full immunization
Geometric mean titers Growth multiplier of IgG antibody at 31 days after 2 doses of immunization and at 31 days after full immunization.
Geometric mean titers Growth multiplier of HBGA blocking antibody
Time frame: at 31 days after 2 doses of immunization and at 31 days after full immunization
Geometric mean titers Growth multiplier of HBGA blocking antibody at 31 days after 2 doses of immunization and at 31 days after full immunization.
Occurrence of any adverse event
Time frame: within 30 minutes of each dose of vaccination
Occurrence of any adverse event within 30 minutes of each dose of vaccination.
Occurrence of recruited adverse event
Time frame: between day 0 and day 7 after each dose of vaccination
Occurrence of recruited adverse event between day 0 and day 7 after each dose of vaccination.
Occurrence of non-recruited adverse event
Time frame: between day 0 and day 30 after each dose of vaccination
Occurrence of non-recruited adverse event between day 0 and day 30 after each dose of vaccination.
Occurrence of serious adverse event
Time frame: from the first dose to 180 days after full immunization
Occurrence of serious adverse event from the first dose to 180 days after full immunization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
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
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing quadrivalent recombinant norovirus vaccine (Pichia pastoris) in people with Acute Gastroenteropathy Due to Norovirus, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. 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 6 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: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Protective efficacy against AGE caused by four genotypes of norovirus (time frame: From 7 days after full immunization to 2 years after 7 days after after full immunization). The study lists 11 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 23 Jan 2025.