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Phase II Clinical Trial of the Inactivated Rotavirus Vaccine

Primary Purpose

Rotavirus Infections, Diarrhea

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
IRV on a 0- and 28-day schedule
IRV on a 0-, 28- and 56-day schedule
Placebo on Day 0, 28
Placebo on Day 0, 28, 56
Sponsored by
Institute of Medical Biology, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rotavirus Infections focused on measuring Rotavirus Infections, Inactivated Rotavirus Vaccine, Diarrhea

Eligibility Criteria

2 Months - 71 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age Requirement: Infants and toddlers aged 2 to 71 months at the time of enrollment. Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents. Informed Consent: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time. No Previous Rotavirus Vaccination: Infants and toddlers enrolled in the study should not have received any rotavirus vaccines before enrollment. Exclusion Criteria: First Dose Exclusion Criteria Subjects meeting any of the following exclusion criteria will be not eligible for enrollment: Temperature Requirement: Axillary body temperature prior to vaccination is up to 37.3°C or more. Allergic History: Subjects have a history of allergies to any component of the investigational vaccine (e.g., aluminum hydroxide), any history of vaccine allergies, suspected allergies, or any other severe adverse reactions. Vaccine History: Subjects received any inactivated vaccines or subunit vaccines within 7 days (including the 7th day) prior to vaccination with the investigational vaccine, or any other live attenuated vaccines or COVID-19 vaccines within 14 days (including the 14th day) prior to vaccination. Health Conditions: Subjects have known congenital abnormalities, developmental disorders, genetic defects, or severe malnutrition, among other conditions. Immune-Related Diseases: Subjects have compromised primary or secondary immune function, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune diseases. Gastrointestinal Conditions: Subjects have a history of intussusception or chronic gastrointestinal diseases. Neurological and Mental Health: Subjects have a history of seizures, convulsions, cerebral palsy, epilepsy, mental illness, or a family history of such conditions. Acute Illness: Subjects have experienced acute illnesses (e.g., fever) within 3 days prior to vaccination with the investigational vaccine. Immune Therapy: Subjects have received immune-enhancing or immune-suppressing therapy within the last 3 months (continuous oral or intravenous administration for more than 14 days) prior to vaccination. Coagulation Abnormalities: Subjects have a history of coagulation disorders (e.g., coagulation factor deficiency, coagulation disorders). Organ Removal History: Subjects have a history of organ removal (e.g., thyroid, pancreas, liver, spleen) or have asplenia syndrome. Participation in Other Clinical Studies: Subjects are currently or have plans to participate in other clinical studies before enrollment. Special Conditions for Children Aged 24 Months and Below: For such children, additional exclusion criteria include difficult birth, resuscitation after suffocation, a history of neurological damage, premature birth (delivery before the 37th week of gestation), and low birth weight (less than 2500 grams). Investigator's Discretion: The final exclusion criterion is the investigator's discretion to determine whether a subject is suitable for participation in the study. Contraindication of the second and third doses of vaccine Severe Adverse Reactions: Subjects experienced severe adverse reactions after receiving the previous vaccine dose. No Longer Meeting Inclusion Criteria or Meeting First Dose Exclusion Criteria: New conditions that disqualify them from meeting inclusion criteria or that meet the exclusion criteria for the first dose occur after receiving the previous dose, as determined by the investigator. Vaccination with Other Rotavirus Vaccines During the Study: Subjects received other rotavirus vaccines during the study period. Other Exclusion Reasons as Determined by the Investigator: The investigator determines other reasons for exclusion.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Placebo Comparator

    Arm Label

    Tolldlers (7-71 months old, two-dose)

    Infants (2-6 months old, three-dose)

    Placebo in Tolldlers (7-71 months old, two-dose)

    Placebo in Infants (2-6 months old, three-dose)

    Arm Description

    Inactivated Rotavirus vaccine (Vero cell) in toddlers aged 7-71 months old on Day 0, 28

    Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on Day 0, 28, 56

    Two doses of placebo at the vaccination schedule of Day 0, 28

    Three doses of placebo at the vaccination schedule of Day 0, 28, 56

    Outcomes

    Primary Outcome Measures

    Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
    Neutralizing antibody assay will be performed using the neutralization and ELISA method.
    Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
    Neutralizing antibody assay will be performed using the neutralization and ELISA method.
    Immunogenicity index-geometric mean increase (GMI) of neutralizing antibody
    Neutralizing antibody assay will be performed using the neutralization and ELISA method.
    Immunogenicity index-geometric mean increase (GMI) of neutralizing antibody
    Neutralizing antibody assay will be performed using the neutralization and ELISA method.
    Immunogenicity index-seroconversion rates of neutralizing antibody
    Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seroconversion will be defined as a change from seronegative (<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline.
    Immunogenicity index-seroconversion rates of neutralizing antibody
    Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seroconversion will be defined as a change from seronegative (<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline.

    Secondary Outcome Measures

    Safety index-incidence of adverse reactions/events
    Incidence of adverse reactions/events after the first dose vaccination.
    Safety index-incidence of adverse reactions/events
    Incidence of adverse reactions/events after the second dose vaccination.
    Safety index-incidence of adverse reactions/events
    Incidence of adverse reactions/events after the third dose vaccination.
    Safety index-incidence of solicited adverse reactions/events
    Incidence of solicited adverse reactions/events after the first dose vaccination.
    Safety index-incidence of solicited adverse reactions/events
    Incidence of solicited adverse reactions/events after the second dose vaccination.
    Safety index-incidence of solicited adverse reactions/events
    Incidence of solicited adverse reactions/events after the third dose vaccination.
    Safety index-incidence of unsolicited adverse reactions/events
    Incidence of unsolicited adverse reactions/events after the first dose vaccination.
    Safety index-incidence of unsolicited adverse reactions/events
    Incidence of unsolicited adverse reactions/events after the second dose vaccination.
    Safety index-incidence of unsolicited adverse reactions/events
    Incidence of unsolicited adverse reactions/events after the third dose vaccination.
    Safety index-incidence of serious adverse events
    Occurrence of serious adverse reactions/events after vaccination.

    Full Information

    First Posted
    October 8, 2023
    Last Updated
    October 8, 2023
    Sponsor
    Institute of Medical Biology, Chinese Academy of Medical Sciences
    Collaborators
    Henan Center for Disease Control and Prevention
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06080906
    Brief Title
    Phase II Clinical Trial of the Inactivated Rotavirus Vaccine
    Official Title
    Immunogenicity and Safety of the Inactivated Rotavirus Vaccine (Vero Cells) in Toddlers and Infants Aged From 2 to 71 Months: A Randomized, Double-blinded, Placebo-controlled Phase II Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 17, 2023 (Anticipated)
    Primary Completion Date
    February 17, 2025 (Anticipated)
    Study Completion Date
    June 17, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institute of Medical Biology, Chinese Academy of Medical Sciences
    Collaborators
    Henan Center for Disease Control and Prevention

    4. Oversight

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

    5. Study Description

    Brief Summary
    This study is a randomized, double-blinded, placebo-controlled phase 2 clinical trial to evaluate the immunogenicity and safety of Inactivated Rotavirus Vaccine (IRV) in children (aged 2-71 months). Primary immunogenicity endpoints in two age groups are the anti-RV neutralizing antibody geometric mean titers (GMTs) 28 days after the final dose, anti-RV neutralizing antibody geometric mean increase (GMI), and seroconversion rates between baseline and 28 days after the final dose. The secondary safety endpoints are the number of adverse events/reactions within 30 minutes after each dose, the number of solicited adverse events/reactions within 7 days after each dose, the number of unsolicited adverse events/reactions within 28/30 days after each dose, and the number of serious adverse events (SAE) between the first dose up to 6 months after the final dose. The exploratory endpoints are the anti-RV IgG and IgA antibody GMT 28 days after the final dose, GMI and seroconversion rates of anti-RV IgG and IgA antibody between baseline and 28 days after the final dose, GMT and seropositive rates of anti-RV neutralizing antibody, IgG antibody and IgA antibody 90, 180, and 360 days after the final dose. Besides, as the exploratory endpoint, the GMT, GMI, and seroconversion rates of cross-neutralizing antibodies against G3 and G9 type of RV, gene transcription differences in peripheral blood mononuclear cells on Day 0 and 28 after the final dose will be assessed.
    Detailed Description
    This is a randomized, double-blinded, placebo-controlled phase 2 clinical trial to evaluate immunogenicity and safety of IRV performed in 600 subjects (aged 2-71 months). Then, 300 toddlers (aged 7-71 months) and 300 infants (aged 2-6 months) will be eligible for parallel enrollment after assessing through medical history and physical examination. Subjects from each age group will be randomly assigned to the vaccine group or placebo group in a ratio of 3:1, that is, 225 subjects of all age groups will be injected with the vaccine while 75 subjects with the placebo. Toddlers (aged 7-71 months) will receive an injection of the vaccine or placebo in the anterolateral midthigh or deltoid muscle of the upper arm on Day 0 and 28. Infants (aged 2-6 months) will receive an injection of the vaccine or placebo in the anterolateral midthigh or deltoid muscle of the upper arm on Day 0, 28, and 56. There would be 140 subjects in each age group chosen voluntarily for the immune persistence cohort according to the order of enrollment. The duration of toddlers (aged 7-71 months) for intervention is approximately 1 month. Thus, the duration of each subject enrolled in the immune persistence cohort will be approximately 13 months while the duration of the rest of the subjects in the study will be approximately 7 months. The duration of infants (aged 2-6 months) for intervention is approximately 2 months. Thus, the duration of each subject enrolled in the immune persistence cohort will be approximately 14 months while the duration of the rest of the subjects in the study will be approximately 8 months. For safety assessment, the observation and evaluation of adverse events (AE) from Day 0 to Days 28/30 after each dose, and serious adverse events (SAE) between the first dose up to 6 months after the final dose will be evaluated by diary/contact cards, active reports by subjects' legal guardians, or investigators' phone calls as well as face-to-face visits. Meanwhile, subjects will be observed at the site for at least 30 minutes after each dose. For immunogenicity assessment, neutralizing antibodies against the strain from which the vaccine is based (homologous ZTR-68 strain (G1P[8]), IgG antibodies, IgA antibodies of all subjects, and neutralizing antibodies against the G3 and G9 type RV in 140 subjects of each age group will be assessed. For the exploratory endpoint, the gene transcription level of PBMC will be examined for the preliminary exploration of the possible mechanism of the Inactivated Rotavirus Vaccine (Vero Cells).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rotavirus Infections, Diarrhea
    Keywords
    Rotavirus Infections, Inactivated Rotavirus Vaccine, Diarrhea

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    300 toddlers (aged 7-71 months) and 300 infants (aged 2-6 months) will be eligible for parallel enrollment
    Masking
    ParticipantInvestigator
    Masking Description
    Double-blinded
    Allocation
    Randomized
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tolldlers (7-71 months old, two-dose)
    Arm Type
    Experimental
    Arm Description
    Inactivated Rotavirus vaccine (Vero cell) in toddlers aged 7-71 months old on Day 0, 28
    Arm Title
    Infants (2-6 months old, three-dose)
    Arm Type
    Experimental
    Arm Description
    Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on Day 0, 28, 56
    Arm Title
    Placebo in Tolldlers (7-71 months old, two-dose)
    Arm Type
    Placebo Comparator
    Arm Description
    Two doses of placebo at the vaccination schedule of Day 0, 28
    Arm Title
    Placebo in Infants (2-6 months old, three-dose)
    Arm Type
    Placebo Comparator
    Arm Description
    Three doses of placebo at the vaccination schedule of Day 0, 28, 56
    Intervention Type
    Biological
    Intervention Name(s)
    IRV on a 0- and 28-day schedule
    Intervention Description
    Inactivated Rotavirus vaccine (Vero Cells) of 320EU/0.5ml on Day 0, 28
    Intervention Type
    Biological
    Intervention Name(s)
    IRV on a 0-, 28- and 56-day schedule
    Intervention Description
    Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on Day 0, 28, 56
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo on Day 0, 28
    Intervention Description
    Two doses of placebo at the vaccination schedule of Day 0, 28
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo on Day 0, 28, 56
    Intervention Description
    Three doses of placebo at the vaccination schedule of Day 0, 28, 56
    Primary Outcome Measure Information:
    Title
    Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
    Description
    Neutralizing antibody assay will be performed using the neutralization and ELISA method.
    Time Frame
    Day 28 after the second vaccination
    Title
    Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
    Description
    Neutralizing antibody assay will be performed using the neutralization and ELISA method.
    Time Frame
    Day 28 after the third vaccination
    Title
    Immunogenicity index-geometric mean increase (GMI) of neutralizing antibody
    Description
    Neutralizing antibody assay will be performed using the neutralization and ELISA method.
    Time Frame
    Between baseline and day 28 after the second vaccination
    Title
    Immunogenicity index-geometric mean increase (GMI) of neutralizing antibody
    Description
    Neutralizing antibody assay will be performed using the neutralization and ELISA method.
    Time Frame
    Between baseline and day 28 after the third vaccination
    Title
    Immunogenicity index-seroconversion rates of neutralizing antibody
    Description
    Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seroconversion will be defined as a change from seronegative (<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline.
    Time Frame
    Between baseline and day 28 after the second vaccination
    Title
    Immunogenicity index-seroconversion rates of neutralizing antibody
    Description
    Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seroconversion will be defined as a change from seronegative (<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline.
    Time Frame
    Between baseline and day 28 after the third vaccination
    Secondary Outcome Measure Information:
    Title
    Safety index-incidence of adverse reactions/events
    Description
    Incidence of adverse reactions/events after the first dose vaccination.
    Time Frame
    0-30 minutes after the first dose vaccination
    Title
    Safety index-incidence of adverse reactions/events
    Description
    Incidence of adverse reactions/events after the second dose vaccination.
    Time Frame
    0-30 minutes after the second dose vaccination
    Title
    Safety index-incidence of adverse reactions/events
    Description
    Incidence of adverse reactions/events after the third dose vaccination.
    Time Frame
    0-30 minutes after the third dose vaccination
    Title
    Safety index-incidence of solicited adverse reactions/events
    Description
    Incidence of solicited adverse reactions/events after the first dose vaccination.
    Time Frame
    Day 0 to 7 after the first dose vaccination
    Title
    Safety index-incidence of solicited adverse reactions/events
    Description
    Incidence of solicited adverse reactions/events after the second dose vaccination.
    Time Frame
    Day 0 to 7 after the second dose vaccination
    Title
    Safety index-incidence of solicited adverse reactions/events
    Description
    Incidence of solicited adverse reactions/events after the third dose vaccination.
    Time Frame
    Day 0 to 7 after the third dose vaccination
    Title
    Safety index-incidence of unsolicited adverse reactions/events
    Description
    Incidence of unsolicited adverse reactions/events after the first dose vaccination.
    Time Frame
    Day 0 to 28 after the first dose vaccination
    Title
    Safety index-incidence of unsolicited adverse reactions/events
    Description
    Incidence of unsolicited adverse reactions/events after the second dose vaccination.
    Time Frame
    Day 0 to 28/30 after the second dose vaccination
    Title
    Safety index-incidence of unsolicited adverse reactions/events
    Description
    Incidence of unsolicited adverse reactions/events after the third dose vaccination.
    Time Frame
    Day 0 to 30 after the third dose vaccination
    Title
    Safety index-incidence of serious adverse events
    Description
    Occurrence of serious adverse reactions/events after vaccination.
    Time Frame
    From the beginning of the vaccination up to 6 months after the last vaccination completed
    Other Pre-specified Outcome Measures:
    Title
    Immunogenicity index-geometric mean titer (GMT) of IgG antibody
    Description
    IgG antibody assay will be performed using the ELISA method.
    Time Frame
    Day 28 after the second vaccination
    Title
    Immunogenicity index-geometric mean titer (GMT) of IgG antibody
    Description
    IgG antibody assay will be performed using the ELISA method.
    Time Frame
    Day 28 after the third vaccination
    Title
    Immunogenicity index-geometric mean increase (GMI) of IgG antibody
    Description
    IgG antibody assay will be performed using the ELISA method.
    Time Frame
    Between baseline and day 28 after the second vaccination
    Title
    Immunogenicity index-geometric mean increase (GMI) of IgG antibody
    Description
    IgG antibody assay will be performed using the ELISA method.
    Time Frame
    Between baseline and day 28 after the third vaccination
    Title
    Immunogenicity index-seroconversion rates of IgG antibody
    Description
    IgG antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (≤1:16) to seropositive (>1:16), or a ≥4-fold increase from baseline.
    Time Frame
    Between baseline and day 28 after the second vaccination
    Title
    Immunogenicity index-seroconversion rates of IgG antibody
    Description
    IgG antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (≤1:16) to seropositive (>1:16), or a ≥4-fold increase from baseline.
    Time Frame
    Between baseline and day 28 after the third vaccination
    Title
    Immunogenicity index-geometric mean titer (GMT) of IgA antibody
    Description
    IgA antibody assay will be performed using the ELISA method.
    Time Frame
    Day 28 after the second vaccination
    Title
    Immunogenicity index-geometric mean titer (GMT) of IgA antibody
    Description
    IgA antibody assay will be performed using the ELISA method.
    Time Frame
    Day 28 after the third vaccination
    Title
    Immunogenicity index-geometric mean increase (GMI) of IgA antibody
    Description
    IgA antibody assay will be performed using the ELISA method.
    Time Frame
    Between baseline and day 28 after the second vaccination
    Title
    Immunogenicity index-geometric mean increase (GMI) of IgA antibody
    Description
    IgA antibody assay will be performed using the ELISA method
    Time Frame
    Between baseline and day 28 after the third vaccination
    Title
    Immunogenicity index-seroconversion rates of IgA antibody
    Description
    IgA antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline.
    Time Frame
    Between baseline and day 28 after the second vaccination
    Title
    Immunogenicity index-seroconversion rates of IgA antibody
    Description
    IgA antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline.
    Time Frame
    Between baseline and day 28 after the third vaccination
    Title
    Immunogenicity index-geometric mean titer (GMT) of IgG antibody
    Description
    IgG antibody assay will be performed using the ELISA method.
    Time Frame
    Day 90,180 and 360 after the second vaccination
    Title
    Immunogenicity index-geometric mean titer (GMT) of IgG antibody
    Description
    IgG antibody assay will be performed using the ELISA method.
    Time Frame
    Day 90,180 and 360 after the third vaccination
    Title
    Immunogenicity index-seropositive rates of IgG antibody
    Description
    IgG antibody assay will be performed using the ELISA method. Seropositivity will be defined as the seropositive results (>1:16).
    Time Frame
    Day 90,180 and 360 after the second vaccination
    Title
    Immunogenicity index-seropositive rates of IgG antibody
    Description
    IgG antibody assay will be performed using the ELISA method. Seropositivity will be defined as the seropositive results (>1:16).
    Time Frame
    Day 90,180 and 360 after the third vaccination
    Title
    Immunogenicity index-geometric mean titer (GMT) of IgA antibody
    Description
    IgA antibody assay will be performed using the ELISA method.
    Time Frame
    Day 90,180 and 360 after the second vaccination
    Title
    Immunogenicity index-geometric mean titer (GMT) of IgA antibody
    Description
    IgA antibody assay will be performed using the ELISA method.
    Time Frame
    Day 90,180 and 360 after the third vaccination
    Title
    Immunogenicity index-seropositve rates of IgA antibody
    Description
    IgA antibody assay will be performed using the ELISA method. Seropositivity will be defined as the seropositive results (≥1:8).
    Time Frame
    Day 90,180 and 360 after the second vaccination
    Title
    Immunogenicity index-seropositive rates of IgA antibody
    Description
    IgA antibody assay will be performed using the ELISA method. Seropositivity will be defined as the seropositive results (≥1:8).
    Time Frame
    Day 90,180 and 360 after the third vaccination
    Title
    Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
    Description
    Neutralizing antibody assay will be performed using the neutralization and ELISA method.
    Time Frame
    Day 90,180 and 360 after the second vaccination
    Title
    Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
    Description
    Neutralizing antibody assay will be performed using the neutralization and ELISA method.
    Time Frame
    Day 90,180 and 360 after the third vaccination
    Title
    Immunogenicity index-seropositive rates of neutralizing antibody
    Description
    Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seropositivity will be defined as the seropositive results (≥1:8).
    Time Frame
    Day 90,180 and 360 after the second vaccination
    Title
    Immunogenicity index-seroconversion rates of neutralizing antibody
    Description
    Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seropositivity will be defined as the seropositive results (≥1:8).
    Time Frame
    Day 90,180 and 360 after the third vaccination
    Title
    Immunogenicity index-geometric mean titer (GMT) of cross- neutralizing antibody
    Description
    Neutralizing antibody assay will be performed using the neutralization and ELISA method.
    Time Frame
    Day 28 after the second vaccination
    Title
    Immunogenicity index-geometric mean titer (GMT) of cross-neutralizing antibody
    Description
    Neutralizing antibody assay will be performed using the neutralization and ELISA method.
    Time Frame
    Day 28 after the third vaccination
    Title
    Immunogenicity index-geometric mean increase (GMI) of cross-neutralizing antibody
    Description
    Neutralizing antibody assay will be performed using the neutralization and ELISA method.
    Time Frame
    Between baseline and day 28 after the second vaccination
    Title
    Immunogenicity index-geometric mean increase (GMI) of cross-neutralizing antibody
    Description
    Neutralizing antibody assay will be performed using the neutralization and ELISA method.
    Time Frame
    Between baseline and day 28 after the thrid vaccination
    Title
    Immunogenicity index-seroconversion rates of cross-neutralizing antibody
    Description
    Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seroconversion will be defined as a change from seronegative (<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline.
    Time Frame
    Between baseline and day 28 after the second vaccination
    Title
    Immunogenicity index-seroconversion rates of cross-neutralizing antibody
    Description
    Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seroconversion will be defined as a change from seronegative (<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline.
    Time Frame
    Between baseline and day 28 after the thrid vaccination
    Title
    mRNA sequencing analysis of peripheral blood monouclear cells(PBMCs)
    Description
    Differentially expressed genes of infants(2-6 months)between baseline and day 28 after the third vaccination will be measured by mRNA sequencing
    Time Frame
    Between baseline and day 28 after the third vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Months
    Maximum Age & Unit of Time
    71 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age Requirement: Infants and toddlers aged 2 to 71 months at the time of enrollment. Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents. Informed Consent: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time. No Previous Rotavirus Vaccination: Infants and toddlers enrolled in the study should not have received any rotavirus vaccines before enrollment. Exclusion Criteria: First Dose Exclusion Criteria Subjects meeting any of the following exclusion criteria will be not eligible for enrollment: Temperature Requirement: Axillary body temperature prior to vaccination is up to 37.3°C or more. Allergic History: Subjects have a history of allergies to any component of the investigational vaccine (e.g., aluminum hydroxide), any history of vaccine allergies, suspected allergies, or any other severe adverse reactions. Vaccine History: Subjects received any inactivated vaccines or subunit vaccines within 7 days (including the 7th day) prior to vaccination with the investigational vaccine, or any other live attenuated vaccines or COVID-19 vaccines within 14 days (including the 14th day) prior to vaccination. Health Conditions: Subjects have known congenital abnormalities, developmental disorders, genetic defects, or severe malnutrition, among other conditions. Immune-Related Diseases: Subjects have compromised primary or secondary immune function, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune diseases. Gastrointestinal Conditions: Subjects have a history of intussusception or chronic gastrointestinal diseases. Neurological and Mental Health: Subjects have a history of seizures, convulsions, cerebral palsy, epilepsy, mental illness, or a family history of such conditions. Acute Illness: Subjects have experienced acute illnesses (e.g., fever) within 3 days prior to vaccination with the investigational vaccine. Immune Therapy: Subjects have received immune-enhancing or immune-suppressing therapy within the last 3 months (continuous oral or intravenous administration for more than 14 days) prior to vaccination. Coagulation Abnormalities: Subjects have a history of coagulation disorders (e.g., coagulation factor deficiency, coagulation disorders). Organ Removal History: Subjects have a history of organ removal (e.g., thyroid, pancreas, liver, spleen) or have asplenia syndrome. Participation in Other Clinical Studies: Subjects are currently or have plans to participate in other clinical studies before enrollment. Special Conditions for Children Aged 24 Months and Below: For such children, additional exclusion criteria include difficult birth, resuscitation after suffocation, a history of neurological damage, premature birth (delivery before the 37th week of gestation), and low birth weight (less than 2500 grams). Investigator's Discretion: The final exclusion criterion is the investigator's discretion to determine whether a subject is suitable for participation in the study. Contraindication of the second and third doses of vaccine Severe Adverse Reactions: Subjects experienced severe adverse reactions after receiving the previous vaccine dose. No Longer Meeting Inclusion Criteria or Meeting First Dose Exclusion Criteria: New conditions that disqualify them from meeting inclusion criteria or that meet the exclusion criteria for the first dose occur after receiving the previous dose, as determined by the investigator. Vaccination with Other Rotavirus Vaccines During the Study: Subjects received other rotavirus vaccines during the study period. Other Exclusion Reasons as Determined by the Investigator: The investigator determines other reasons for exclusion.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hongjun Li
    Phone
    13888918945
    Ext
    +86
    Email
    lihj6912@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yanxia Wang
    Organizational Affiliation
    Henan Center for Disease Control and Prevention
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Phase II Clinical Trial of the Inactivated Rotavirus Vaccine

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