- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04626856
Safety and Preliminary Immunogenicity Study of Inactivated Vaccine for Prevention of Rotavirus Infection
Evaluation of the Safety and Preliminary Immunogenicity of Inactivated Rotavirus Vaccine (Vero Cell) in Healthy Population: a Randomized, Double-blind, Placebo Parallel-controlled Phase I Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
- Biological: Low dosage IRV on a 0- and 28-day schedule
- Biological: Low dosage IRV on a 0- and 28-day schedule
- Biological: Medium dosage IRV on a 0- and 28-day schedule
- Biological: Medium dosage IRV on a 0- and 28-day schedule
- Biological: High dosage IRV on a 0- and 28-day schedule
- Biological: Low dosage IRV on a 0- , 28- and 56-day schedule
- Biological: Medium dosage IRV on a 0- , 28- and 56-day schedule
- Biological: High dosage IRV on a 0- , 28- and 56-day schedule
- Biological: Placebo on day 0, 28
- Biological: Placebo on day 0, 28, 56
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Henan
-
Zhenzhou, Henan, China, 450016
- Henan Provincial Center for Disease Control and Prevention
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
2 months old to 49 years old, healthy resident, excluding the following:
- Congenital malformations, developmental disorders, genetic defects, severe malnutrition and other conditions;
- Have Congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus Erythematosus (SLE) , juvenile Rheumatoid Arthritis, or other autoimmune diseases;
- History of Cerebral Palsy, seizures, mental illness.
- I and/or my guardian voluntarily participate and sign an informed consent form, and can follow the requirements of the clinical trial protocol;
- Have never received oral rotavirus live attenuated vaccine.
Exclusion Criteria:
First dose exclusion criteria:
- Armpit temperature >37.0℃ before vaccination;
- Subjects with history of intussusception or suffering from intussusception;
- Subjects with history of convulsions and convulsions; history of epilepsy, mental illness and their family history;
- Subjects with history of allergy to vaccination;
- Acute attacks of various acute diseases (fever) or chronic diseases within 3 days before receiving the study vaccine;
- Subjects receiving immune enhancement or immunosuppressive therapy within 3 months (continuous oral or infusion for more than 14 days);
- Subjects vaccinated with live attenuated vaccine within 14 days and other vaccines within 7 days before vaccination;
- Subjects with history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease);
- Subjects with primary and secondary immunocompromised (history of thyroid, pancreas, liver, spleen resection, or need for treatment for thyroid disease in the past 12 months);
- Subjects with abnormal blood biochemistry, blood routine, and urine routine related indicators that have clinical significance* before vaccination;
- Subjects who are currently or plan to participate in other clinical studies;
According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Note*: The criterion of no clinical significance is "the laboratory test value between the upper limit (ULN) or lower limit (LLN) of the reference value range and the grade 1 adverse event" as judged by the doctor to have no clinical significance.
- In addition to the general exclusion criteria, specific subjects should also follow the following exclusion criteria.
(1)18-49-year-old women who have plans to become pregnant within the past 2 months or are pregnant or are breastfeeding; (2)Positive pregnancy test of female subjects of childbearing age; (3)18-49-year-old adults with hypertension that cannot be controlled by drugs (on site measurement: systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg); (4)24-month-old infant subjects with a history of dystocia, suffocation rescue, neurological damage; (5)24-month-old baby subjects are born prematurely (delivered after the 37th week of pregnancy), low weight (birth weight for girls <2300g, boys <2500g).
-Exclusion criteria for follow-up needle:
- Subjects with serious adverse reaction after the previous vaccination;
- For the subjects who are newly discovered or newly appeared after the first vaccination that do not meet the selection criteria or meet the first exclusion criteria, the investigator will determine whether the subjects continue to participate the clinical trial;
- Subjects vaccinated with other rotavirus vaccines other than the research vaccine during the study period;
- Other exclusion reasons considered by the researcher.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low dosage in adults
Low dosage Inactivated Rotavirus vaccine (Vero cell) in adults aged 18-49 years old on day 0, 28
|
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0, 28
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28
|
Experimental: Medium dosage in adults
Medium dosage Inactivated Rotavirus vaccine (Vero cell) in adults aged 18-49 years old on day 0, 28
|
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0, 28
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28
|
Experimental: High dosage in adults
High dosage Inactivated Rotavirus vaccine (Vero cell) in adults aged 18-49 years old on day 0, 28
|
Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
|
Experimental: Low dosage in adolescents
Low dosage Inactivated Rotavirus vaccine (Vero cell) in adolescents aged 6-17 years old on day 0, 28
|
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0, 28
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28
|
Experimental: Medium dosage in adolescents
Medium dosage Inactivated Rotavirus vaccine (Vero cell) in adolescents aged 6-17 years old on day 0, 28
|
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0, 28
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28
|
Experimental: High dosage in adolescents
High dosage Inactivated Rotavirus vaccine (Vero cell) in adolescents aged 6-17 years old on day 0, 28
|
Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
|
Experimental: Low dosage in infants (7-71 months old)
Low dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 7-71 months old on day 0, 28
|
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0, 28
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28
|
Experimental: Medium dosage in infants (7-71 months old)
Medium dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 7-71 months old on day 0, 28
|
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0, 28
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28
|
Experimental: High dosage in infants (7-71 months old)
High dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 7-71 months old on day 0, 28
|
Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
|
Experimental: Low dosage in infants (2-6 months old, two-dose)
Low dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28
|
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0, 28
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28
|
Experimental: Medium dosage in infants (2-6 months old, two-dose)
Medium dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28
|
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0, 28
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28
|
Experimental: High dosage in infants (2-6 months old, two-dose)
High dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28
|
Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
|
Experimental: Low dosage in infants (2-6 months old, three-dose)
Low dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28, 56
|
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28,56
|
Experimental: Medium dosage in infants (2-6 months old, three-dose)
Medium dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28, 56
|
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28,56
|
Experimental: High dosage in infants (2-6 months old, three-dose)
High dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28, 56
|
Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28,56
|
Placebo Comparator: Placebo on day 0, 28
Two doses of placebo at the vaccination schedule of day 0,28
|
Two doses of placebo at the vaccination schedule of day 0,28
|
Placebo Comparator: Placebo on day 0, 28, 56
Three doses of placebo at the vaccination schedule of day 0, 28,56
|
Three doses of placebo at the vaccination schedule of day 0, 28,56
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety index-incidence of adverse reactions/events
Time Frame: 0-30 minutes after the first dose vaccination
|
Incidence of adverse reactions/events after the first dose vaccination.
|
0-30 minutes after the first dose vaccination
|
Safety index-incidence of adverse reactions/events
Time Frame: 0-30 minutes after the second dose vaccination
|
Incidence of adverse reactions/events after the second dose vaccination.
|
0-30 minutes after the second dose vaccination
|
Safety index-incidence of adverse reactions/events
Time Frame: 0-30 minutes after the third dose vaccination
|
Incidence of adverse reactions/events after the third dose vaccination.
|
0-30 minutes after the third dose vaccination
|
Safety index-incidence of abnormal blood biochemistry assessment
Time Frame: Day 4 after the first dose vaccination
|
Incidence of abnormal blood biochemistry assessment at Day 4 after the first dose vaccination, except children aged Month 2-71
|
Day 4 after the first dose vaccination
|
Safety index-incidence of abnormal blood routine assessment
Time Frame: Day 4 after the first dose vaccination
|
Incidence of abnormal blood routine assessment at Day 4 after the first dose vaccination, except children aged Month 2-71
|
Day 4 after the first dose vaccination
|
Safety index-incidence of abnormal urine routine assessment
Time Frame: Day 4 after the first dose vaccination
|
Incidence of abnormal urine routine assessment at Day 4 after the first dose vaccination, except children aged Month 2-71
|
Day 4 after the first dose vaccination
|
Safety index-incidence of abnormal blood biochemistry assessment
Time Frame: Day 4 after the second dose vaccination
|
Incidence of abnormal blood biochemistry assessment at Day 4 after the second dose vaccination, except children aged Month 2-71
|
Day 4 after the second dose vaccination
|
Safety index-incidence of abnormal blood routine assessment
Time Frame: Day 4 after the second dose vaccination
|
Incidence of abnormal blood routine assessment at Day 4 after the second dose vaccination, except children aged Month 2-71
|
Day 4 after the second dose vaccination
|
Safety index-incidence of abnormal urine routine assessment
Time Frame: Day 4 after the second dose vaccination
|
Incidence of abnormal urine routine assessment at Day 4 after the second dose vaccination, except children aged Month 2-71
|
Day 4 after the second dose vaccination
|
Safety index-incidence of abnormal blood biochemistry assessment
Time Frame: Day 4 after the third dose vaccination
|
Incidence of abnormal blood biochemistry assessment at Day 4 after the third dose vaccination, except children aged Month 2-71
|
Day 4 after the third dose vaccination
|
Safety index-incidence of abnormal blood routine assessment
Time Frame: Day 4 after the third dose vaccination
|
Incidence of abnormal blood routine assessment at Day 4 after the third dose vaccination, except children aged Month 2-71
|
Day 4 after the third dose vaccination
|
Safety index-incidence of abnormal urine routine assessment
Time Frame: Day 4 after the third dose vaccination
|
Incidence of abnormal urine routine assessment at Day 4 after the third dose vaccination, except children aged Month 2-71
|
Day 4 after the third dose vaccination
|
Safety index-incidence of adverse reactions/events
Time Frame: Day 0 to7 after the first dose vaccination
|
Incidence of adverse reactions/events after the first dose vaccination.
|
Day 0 to7 after the first dose vaccination
|
Safety index-incidence of adverse reactions/events
Time Frame: Day 8 to30 after the first dose vaccination
|
Incidence of adverse reactions/events after the first dose vaccination.
|
Day 8 to30 after the first dose vaccination
|
Safety index-incidence of adverse reactions/events
Time Frame: Day 0 to7 after the second dose vaccination
|
Incidence of adverse reactions/events after the second dose vaccination.
|
Day 0 to7 after the second dose vaccination
|
Safety index-incidence of adverse reactions/events
Time Frame: Day 8 to30 after the second dose vaccination
|
Incidence of adverse reactions/events after the second dose vaccination.
|
Day 8 to30 after the second dose vaccination
|
Safety index-incidence of adverse reactions/events
Time Frame: Day 0 to7 after the third dose vaccination
|
Incidence of adverse reactions/events after the third dose vaccination.
|
Day 0 to7 after the third dose vaccination
|
Safety index-incidence of adverse reactions/events
Time Frame: Day 8 to30 after the third dose vaccination
|
Incidence of adverse reactions/events after the third dose vaccination.
|
Day 8 to30 after the third dose vaccination
|
Safety index-incidence of serious adverse events
Time Frame: From the beginning of the vaccination to 6 months after the last vaccination completed
|
Occurrence of serious adverse reactions/events after vaccination.
|
From the beginning of the vaccination to 6 months after the last vaccination completed
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity index-seroconversion rates of neutralizing antibody
Time Frame: Day 28 after the second dose vaccination
|
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 ≥4-fold increase from baseline.
|
Day 28 after the second dose vaccination
|
Immunogenicity index-seroconversion rates of neutralizing antibody
Time Frame: Day 28 after the third dose vaccination
|
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 ≥4-fold increase from baseline.
|
Day 28 after the third dose vaccination
|
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
Time Frame: Day 28, 90, 180 after the second dose vaccination
|
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
|
Day 28, 90, 180 after the second dose vaccination
|
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
Time Frame: Day 28, 90, 180 after the third dose vaccination
|
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
|
Day 28, 90, 180 after the third dose vaccination
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity index-seroconversion rates of IgA antibody
Time Frame: Day 28 after the second vaccination
|
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 ≥4-fold increase from baseline.
|
Day 28 after the second vaccination
|
Immunogenicity index-seroconversion rates of IgA antibody
Time Frame: Day 28 after the third dose vaccination
|
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 ≥4-fold increase from baseline.
|
Day 28 after the third dose vaccination
|
Immunogenicity index-geometric mean titer (GMT) of IgA antibody
Time Frame: Day 28, 90, 180 after the second dose vaccination
|
IgA antibody assay will be performed using the ELISA method.
|
Day 28, 90, 180 after the second dose vaccination
|
Immunogenicity index-geometric mean titer (GMT) of IgA antibody
Time Frame: Day 28, 90, 180 after the third dose vaccination
|
IgA antibody assay will be performed using the ELISA method.
|
Day 28, 90, 180 after the third dose vaccination
|
Immunogenicity index-seroconversion rates of IgG antibody
Time Frame: Day 28 after the second dose vaccination
|
IgG 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 ≥4-fold increase from baseline.
|
Day 28 after the second dose vaccination
|
Immunogenicity index-seroconversion rates of IgG antibody
Time Frame: Day 28 after the third dose vaccination
|
IgG 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 ≥4-fold increase from baseline.
|
Day 28 after the third dose vaccination
|
Immunogenicity index-geometric mean titer (GMT) of IgG antibody
Time Frame: Day 28, 90, 180 after the second dose vaccination
|
IgG antibody assay will be performed using the ELISA method.
|
Day 28, 90, 180 after the second dose vaccination
|
Immunogenicity index-geometric mean titer (GMT) of IgG antibody
Time Frame: Day 28, 90, 180 after the third dose vaccination
|
IgG antibody assay will be performed using the ELISA method.
|
Day 28, 90, 180 after the third dose vaccination
|
Cellular immune responses of lymphocytes
Time Frame: Day 14 after the second vaccination
|
Lymphocytes (NK cells, B lymphocytes and T lymphocyte) responses of children aged 7-71 months will be measured using Flow cytometry.
|
Day 14 after the second vaccination
|
Cellular immune responses of cytokines
Time Frame: Day 14 after the second vaccination
|
Cytokines (IL-2, IL-4, IL-6, IL-10, TNF - α and IFN - γ) responses of children aged 7-71 months will be measured using ELISA method.
|
Day 14 after the second vaccination
|
Collaborators and Investigators
Investigators
- Study Chair: Hongjun Li, Ph.D, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AF/SC-08/03.0
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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