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

Primary Purpose

Norovirus Infections, Norwalk Gastroenteritis

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula polymorpha)
placebo
Sponsored by
National Vaccine and Serum Institute, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Norovirus Infections

Eligibility Criteria

6 Months - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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; 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Placebo Comparator

    Experimental

    Placebo Comparator

    Arm Label

    Experimental vaccine group

    placebo group

    Experimental vaccine group(Immunogenic subgroup )

    placebo group(Immunogenic subgroup)

    Arm Description

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    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
    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
    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
    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
    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
    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
    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
    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
    the incidence and severity of adverse reactions/events within 30 minutes after each dose of vaccination
    the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination
    the incidence and severity of non-solicited adverse reactions/events within 28 days after each dose of vaccination
    the incidence of SAE from the first dose of vaccination to end of study

    Full Information

    First Posted
    June 6, 2023
    Last Updated
    June 14, 2023
    Sponsor
    National Vaccine and Serum Institute, China
    Collaborators
    Lanzhou Institute of Biological Products Co., Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05916326
    Brief Title
    Phase III Clinical Trial to Evaluate the Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula Polymorpha)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    June 2025 (Anticipated)
    Study Completion Date
    July 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Vaccine and Serum Institute, China
    Collaborators
    Lanzhou Institute of Biological Products Co., Ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Norovirus Infections, Norwalk Gastroenteritis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    8000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental vaccine group
    Arm Type
    Experimental
    Arm Title
    placebo group
    Arm Type
    Placebo Comparator
    Arm Title
    Experimental vaccine group(Immunogenic subgroup )
    Arm Type
    Experimental
    Arm Title
    placebo group(Immunogenic subgroup)
    Arm Type
    Placebo Comparator
    Intervention Type
    Biological
    Intervention Name(s)
    Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula polymorpha)
    Intervention Description
    Intramuscular injection of Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula polymorpha) in the deltoid muscle of the upper arm
    Intervention Type
    Biological
    Intervention Name(s)
    placebo
    Intervention Description
    Intramuscular injection of placebo in the deltoid muscle of the upper arm
    Primary Outcome Measure Information:
    Title
    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)
    Description
    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
    Time Frame
    14 days after the full course of vaccination to end of study(about two years)
    Secondary Outcome Measure Information:
    Title
    To evaluate the efficacy of against moderate/severe acute gastroenteritis caused by laboratory-confirmed (RT-PCR) infection with any strain of norovirus
    Description
    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
    Time Frame
    14 days after the full course of vaccination to end of study(about two years)
    Title
    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)
    Description
    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
    Time Frame
    14 days after the full course of vaccination to end of study(about two years)
    Title
    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)
    Description
    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
    Time Frame
    14 days after the full course of vaccination to end of study(about two years)
    Title
    IgG of NoV GI.1 and GII.4 after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula polymorpha)
    Description
    only Immunogenic subgroup
    Time Frame
    14th day after the full course of vaccination
    Title
    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)
    Description
    only Immunogenic subgroup
    Time Frame
    14th day after the full course of vaccination
    Title
    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)
    Description
    only Immunogenic subgroup
    Time Frame
    14th day after the full course of vaccination
    Title
    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)
    Description
    only Immunogenic subgroup
    Time Frame
    14th day after the full course of vaccination
    Title
    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)
    Description
    only Immunogenic subgroup
    Time Frame
    180th,360th,540th,720th day after the full course of vaccination
    Title
    IgG of NoV GI.1 and GII.4 after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula polymorpha)
    Description
    only Immunogenic subgroup
    Time Frame
    180th,360th,540th,720th day after the full course of vaccination
    Title
    the incidence and severity of adverse reactions/events within 30 minutes after each dose of vaccination
    Time Frame
    The period after each dose to 30 minutes after the dose
    Title
    the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination
    Time Frame
    The period after each dose to 7 days after the dose
    Title
    the incidence and severity of non-solicited adverse reactions/events within 28 days after each dose of vaccination
    Time Frame
    The period after each dose to 28 days after the dose
    Title
    the incidence of SAE from the first dose of vaccination to end of study
    Time Frame
    the first dose of vaccination to end of study(about two years)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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; 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yun Kang
    Phone
    (+86)13911277806
    Email
    kangyun@sinopharm.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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