Rotavirus InfectionPhase 1NCT04626856
Safety and Preliminary Immunogenicity Study of Inactivated Vaccine for Prevention of Rotavirus Infection
A Phase 1 study testing Low dosage IRV on a 0- and 28-day schedule, Medium dosage IRV on a 0- and 28-day schedule and High dosage IRV on a 0- and 28-day schedule in people with Rotavirus Infection, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study is a randomized, double-blinded, placebo-controlled, Phase 1, dose-escalation study to evaluate the safety, reactogenicity and immunogenicity of Inactivated Rotavirus Vaccine (IRV) performed in healthy adult (aged 18-49 years), adolescent (aged 6-17 years) and infant subjects (aged 2-71 months). Read more about this study
- Who is it for?
- Ages 2 months to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Infection
- What is being tested?
- Low dosage IRV on a 0- and 28-day schedule, Medium dosage IRV on a 0- and 28-day schedule and High dosage IRV on a 0- and 28-day schedule
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2020to Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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；
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Henan Provincial Center for Disease Control and Prevention
Zhenzhou, Henan, 450016
About this study
Official title: 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
This study is a randomized, double-blinded, placebo-controlled, Phase 1, dose-escalation study to evaluate the safety, reactogenicity and immunogenicity of Inactivated Rotavirus Vaccine (IRV) performed in healthy adult (aged 18-49 years), adolescent (aged 6-17 years) and infant subjects (aged 2-71 months). Primary objectives of the clinical trial include assessing the safety and tolerability of IRV given at two and three dose levels and comparing the safety and tolerability of IRV after each vaccination, between dosage groups, and by pre-vaccination rotavirus immune status. Secondary objective of the clinical trial is immunogenicity evaluation after each vaccination, between dosage groups, and by pre-vaccination rotavirus immune status.
Read the detailed description
This clinical trial aimed to evaluate safety and immunogenicity effect of IRV（Vero cell）in Chinese healthy adults, adolescents and infants. The subjects were divided into 5 groups. Two dose and three dose levels will be evaluated. Adult (aged 18-49 years), adolescents (aged 6-17 years), infant subjects (aged 7-71 months) and infant subjects (aged 2-6 months) will receive intramuscular (IM) injection on Days 0 and 28. Infant subjects (aged 2-6 months) subjects will receive intramuscular (IM) injection on Days 0 , 28 and 56. Three dose subgroups (low dose, medium dose and high dose were included in each age group. To maintain blindness in the trial, subjects were randomized in a 3:1 ratio to receive different dosages of the vaccine group or placebo group. In the analysis, the placebo subjects of the same age group were combined to ensure that the analysis ratio of the experimental vaccine group to the placebo group is 1:1. Therefore, 24 subjects in the experimental vaccine group and 8 subjects in the placebo group were chose in each dose group. Subjects were randomized to receive different dosages of the vaccine or placebo. Vaccination was performed in the adult group first, then on the adolescents, and on the infants last. Within each age group, dose-escalation with the principle from low to high dosage.
- Conditions
- Rotavirus Infection
- Being tested
- Low dosage IRV on a 0- and 28-day schedule, Medium dosage IRV on a 0- and 28-day schedule, High dosage IRV on a 0- and 28-day schedule, Low dosage IRV on a 0- , 28- and 56-day schedule, Medium dosage IRV on a 0- , 28- and 56-day schedule
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dosage IRV on a 0- and 28-day scheduleBiological
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0, 28
Medium dosage IRV on a 0- and 28-day scheduleBiological
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0, 28
High dosage IRV on a 0- and 28-day scheduleBiological
Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
Low dosage IRV on a 0- and 28-day scheduleBiological
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28
Medium dosage IRV on a 0- and 28-day scheduleBiological
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28
High dosage IRV on a 0- and 28-day scheduleBiological
Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
Low dosage IRV on a 0- and 28-day scheduleBiological
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28
Medium dosage IRV on a 0- and 28-day scheduleBiological
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28
High dosage IRV on a 0- and 28-day scheduleBiological
Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
Low dosage IRV on a 0- and 28-day scheduleBiological
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28
Medium dosage IRV on a 0- and 28-day scheduleBiological
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28
High dosage IRV on a 0- and 28-day scheduleBiological
Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
Low dosage IRV on a 0- , 28- and 56-day scheduleBiological
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28,56
Medium dosage IRV on a 0- , 28- and 56-day scheduleBiological
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28,56
High dosage IRV on a 0- , 28- and 56-day scheduleBiological
Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28,56
Placebo on day 0, 28Biological
Two doses of placebo at the vaccination schedule of day 0,28
Placebo on day 0, 28, 56Biological
Three doses of placebo at the vaccination schedule of day 0, 28,56
| Study group | Role | What they receive |
|---|---|---|
| Low dosage in adults | Experimental | Low dosage Inactivated Rotavirus vaccine (Vero cell) in adults aged 18-49 years old on day 0, 28 Receives: Biological: Low dosage IRV on a 0- and 28-day schedule |
| Medium dosage in adults | Experimental | Medium dosage Inactivated Rotavirus vaccine (Vero cell) in adults aged 18-49 years old on day 0, 28 Receives: Biological: Medium dosage IRV on a 0- and 28-day schedule |
| High dosage in adults | Experimental | High dosage Inactivated Rotavirus vaccine (Vero cell) in adults aged 18-49 years old on day 0, 28 Receives: Biological: High dosage IRV on a 0- and 28-day schedule |
| Low dosage in adolescents | Experimental | Low dosage Inactivated Rotavirus vaccine (Vero cell) in adolescents aged 6-17 years old on day 0, 28 Receives: Biological: Low dosage IRV on a 0- and 28-day schedule |
| Medium dosage in adolescents | Experimental | Medium dosage Inactivated Rotavirus vaccine (Vero cell) in adolescents aged 6-17 years old on day 0, 28 Receives: Biological: Medium dosage IRV on a 0- and 28-day schedule |
| High dosage in adolescents | Experimental | High dosage Inactivated Rotavirus vaccine (Vero cell) in adolescents aged 6-17 years old on day 0, 28 Receives: Biological: High dosage IRV on a 0- and 28-day schedule |
| Low dosage in infants (7-71 months old) | Experimental | Low dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 7-71 months old on day 0, 28 Receives: Biological: Low dosage IRV on a 0- and 28-day schedule |
| Medium dosage in infants (7-71 months old) | Experimental | Medium dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 7-71 months old on day 0, 28 Receives: Biological: Medium dosage IRV on a 0- and 28-day schedule |
| High dosage in infants (7-71 months old) | Experimental | High dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 7-71 months old on day 0, 28 Receives: Biological: High dosage IRV on a 0- and 28-day schedule |
| Low dosage in infants (2-6 months old, two-dose) | Experimental | Low dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28 Receives: Biological: Low dosage IRV on a 0- and 28-day schedule |
| Medium dosage in infants (2-6 months old, two-dose) | Experimental | Medium dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28 Receives: Biological: Medium dosage IRV on a 0- and 28-day schedule |
| High dosage in infants (2-6 months old, two-dose) | Experimental | High dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28 Receives: Biological: High dosage IRV on a 0- and 28-day schedule |
| Low dosage in infants (2-6 months old, three-dose) | Experimental | Low dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28, 56 Receives: Biological: Low dosage IRV on a 0- , 28- and 56-day schedule |
| Medium dosage in infants (2-6 months old, three-dose) | Experimental | Medium dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28, 56 Receives: Biological: Medium dosage IRV on a 0- , 28- and 56-day schedule |
| High dosage in infants (2-6 months old, three-dose) | Experimental | High dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28, 56 Receives: Biological: High dosage IRV on a 0- , 28- and 56-day schedule |
| Placebo on day 0, 28 | Placebo comparator | Two doses of placebo at the vaccination schedule of day 0,28 Receives: Biological: Placebo on day 0, 28 |
| Placebo on day 0, 28, 56 | Placebo comparator | Three doses of placebo at the vaccination schedule of day 0, 28,56 Receives: Biological: Placebo on day 0, 28, 56 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety index-incidence of adverse reactions/events
Incidence of adverse reactions/events after the first dose vaccination.
Measured: 0-30 minutes after the first dose vaccination
Safety index-incidence of adverse reactions/events
Incidence of adverse reactions/events after the second dose vaccination.
Measured: 0-30 minutes after the second dose vaccination
Safety index-incidence of adverse reactions/events
Incidence of adverse reactions/events after the third dose vaccination.
Measured: 0-30 minutes after the third dose vaccination
Safety index-incidence of abnormal blood biochemistry assessment
Incidence of abnormal blood biochemistry assessment at Day 4 after the first dose vaccination, except children aged Month 2-71
Measured: Day 4 after the first dose vaccination
Safety index-incidence of abnormal blood routine assessment
Incidence of abnormal blood routine assessment at Day 4 after the first dose vaccination, except children aged Month 2-71
Measured: Day 4 after the first dose vaccination
Safety index-incidence of abnormal urine routine assessment
Incidence of abnormal urine routine assessment at Day 4 after the first dose vaccination, except children aged Month 2-71
Measured: Day 4 after the first dose vaccination
Safety index-incidence of abnormal blood biochemistry assessment
Incidence of abnormal blood biochemistry assessment at Day 4 after the second dose vaccination, except children aged Month 2-71
Measured: Day 4 after the second dose vaccination
Safety index-incidence of abnormal blood routine assessment
Incidence of abnormal blood routine assessment at Day 4 after the second dose vaccination, except children aged Month 2-71
Measured: Day 4 after the second dose vaccination
Safety index-incidence of abnormal urine routine assessment
Incidence of abnormal urine routine assessment at Day 4 after the second dose vaccination, except children aged Month 2-71
Measured: Day 4 after the second dose vaccination
Safety index-incidence of abnormal blood biochemistry assessment
Incidence of abnormal blood biochemistry assessment at Day 4 after the third dose vaccination, except children aged Month 2-71
Measured: Day 4 after the third dose vaccination
Safety index-incidence of abnormal blood routine assessment
Incidence of abnormal blood routine assessment at Day 4 after the third dose vaccination, except children aged Month 2-71
Measured: Day 4 after the third dose vaccination
Safety index-incidence of abnormal urine routine assessment
Incidence of abnormal urine routine assessment at Day 4 after the third dose vaccination, except children aged Month 2-71
Measured: Day 4 after the third dose vaccination
Safety index-incidence of adverse reactions/events
Incidence of adverse reactions/events after the first dose vaccination.
Measured: Day 0 to7 after the first dose vaccination
Safety index-incidence of adverse reactions/events
Incidence of adverse reactions/events after the first dose vaccination.
Measured: Day 8 to30 after the first dose vaccination
Safety index-incidence of adverse reactions/events
Incidence of adverse reactions/events after the second dose vaccination.
Measured: Day 0 to7 after the second dose vaccination
Safety index-incidence of adverse reactions/events
Incidence of adverse reactions/events after the second dose vaccination.
Measured: Day 8 to30 after the second dose vaccination
Safety index-incidence of adverse reactions/events
Incidence of adverse reactions/events after the third dose vaccination.
Measured: Day 0 to7 after the third dose vaccination
Safety index-incidence of adverse reactions/events
Incidence of adverse reactions/events after the third dose vaccination.
Measured: Day 8 to30 after the third dose vaccination
Safety index-incidence of serious adverse events
Occurrence of serious adverse reactions/events after vaccination.
Measured: From the beginning of the vaccination to 6 months after the last vaccination completed
Secondary outcomes (4)
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 ≥4-fold increase from baseline.
Measured: Day 28 after the second dose vaccination
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 ≥4-fold increase from baseline.
Measured: Day 28 after the third dose vaccination
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Measured: Day 28, 90, 180 after the second dose vaccination
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Measured: Day 28, 90, 180 after the third dose vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start3 Dec 2020
- Primary completionJun 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rotavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Provincal Center for Disease Control and Prevention
- Responsible party
- Principal investigator, Li Hongjun, Chinese Academy of Medical Sciences
- Investigators
- Hongjun Li, Ph.D, Study chair, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626856
- Sponsor's protocol ID
- AF/SC-08/03.0
- Status last verified
- Dec 2020
- First submitted
- 2 Nov 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou Y, Tan J, Liu Y, Pu J, Wu J, Liu X, Yi S, Hu X, Chen R, Ye J, Yin N, Lin X, Gao J, Tong Q, Kuang X, Yang Y, Zhang W, Wang Y, Sun M, Zhang G, Wang Y, Yang J, Hu Z, Li H. Safety and immunogenicity of inactivated human Rotavirus vaccine in young children and infants: a randomized, placebo-controlled, double-blind, phase I clinical trial. Nat Commun. 2026 Aug 14;17(1):9777. doi: 10.1038/s41467-026-76607-z.
PubMed 42733081Wu JY, Zhang W, Pu J, Liu Y, Huang LL, Zhou Y, Gao JM, Tan JB, Liu XL, Yang J, Lin XC, Feng GW, Yin N, Chen R, Hu XQ, Yi S, Ye J, Kuang XJ, Wang Y, Zhang GM, Sun MS, Wang YX, Hu ZY, Yang JS, Li HJ. A randomized, double-blind, placebo-controlled phase I clinical trial of rotavirus inactivated vaccine (Vero cell) in a healthy adult population aged 18-49 years to assess safety and preliminary observation of immunogenicity. Vaccine. 2024 Jul 25;42(19):4030-4039. doi: 10.1016/j.vaccine.2024.05.014. Epub 2024 May 24.
PubMed 38796326
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04626856
- Acronym / sponsor ID
- AF/SC-08/03.0
- Conditions
- Rotavirus Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Henan Provincal Center for Disease Control and Prevention
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, double-blinded, placebo-controlled, Phase 1, dose-escalation study to evaluate the safety, reactogenicity and immunogenicity of Inactivated Rotavirus Vaccine (IRV) performed in healthy adult (aged 18-49 years), adolescent (aged 6-17 years) and infant subjects (aged 2-71 months). Primary objectives of the clinical trial include assessing the safety and tolerability of IRV given at two and three dose levels and comparing the safety and tolerability of IRV after each vaccination, between dosage groups, and by pre-vaccination rotavirus immune status. Secondary objective of the clinical trial is immunogenicity evaluation after each vaccination, between dosage groups, and by pre-vaccination rotavirus immune status.
Detailed description
This clinical trial aimed to evaluate safety and immunogenicity effect of IRV（Vero cell）in Chinese healthy adults, adolescents and infants. The subjects were divided into 5 groups. Two dose and three dose levels will be evaluated. Adult (aged 18-49 years), adolescents (aged 6-17 years), infant subjects (aged 7-71 months) and infant subjects (aged 2-6 months) will receive intramuscular (IM) injection on Days 0 and 28. Infant subjects (aged 2-6 months) subjects will receive intramuscular (IM) injection on Days 0 , 28 and 56. Three dose subgroups (low dose, medium dose and high dose were included in each age group. To maintain blindness in the trial, subjects were randomized in a 3:1 ratio to receive different dosages of the vaccine group or placebo group. In the analysis, the placebo subjects of the same age group were combined to ensure that the analysis ratio of the experimental vaccine group to the placebo group is 1:1. Therefore, 24 subjects in the experimental vaccine group and 8 subjects in the placebo group were chose in each dose group. Subjects were randomized to receive different dosages of the vaccine or placebo. Vaccination was performed in the adult group first, then on the adolescents, and on the infants last. Within each age group, dose-escalation with the principle from low to high dosage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| Low dosage in adults | Experimental | Biological: Low dosage IRV on a 0- and 28-day scheduleLow dosage Inactivated Rotavirus vaccine (Vero cell) in adults aged 18-49 years old on day 0, 28 |
| Medium dosage in adults | Experimental | Biological: Medium dosage IRV on a 0- and 28-day scheduleMedium dosage Inactivated Rotavirus vaccine (Vero cell) in adults aged 18-49 years old on day 0, 28 |
| High dosage in adults | Experimental | Biological: High dosage IRV on a 0- and 28-day scheduleHigh dosage Inactivated Rotavirus vaccine (Vero cell) in adults aged 18-49 years old on day 0, 28 |
| Low dosage in adolescents | Experimental | Biological: Low dosage IRV on a 0- and 28-day scheduleLow dosage Inactivated Rotavirus vaccine (Vero cell) in adolescents aged 6-17 years old on day 0, 28 |
| Medium dosage in adolescents | Experimental | Biological: Medium dosage IRV on a 0- and 28-day scheduleMedium dosage Inactivated Rotavirus vaccine (Vero cell) in adolescents aged 6-17 years old on day 0, 28 |
| High dosage in adolescents | Experimental | Biological: High dosage IRV on a 0- and 28-day scheduleHigh dosage Inactivated Rotavirus vaccine (Vero cell) in adolescents aged 6-17 years old on day 0, 28 |
| Low dosage in infants (7-71 months old) | Experimental | Biological: Low dosage IRV on a 0- and 28-day scheduleLow dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 7-71 months old on day 0, 28 |
| Medium dosage in infants (7-71 months old) | Experimental | Biological: Medium dosage IRV on a 0- and 28-day scheduleMedium dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 7-71 months old on day 0, 28 |
| High dosage in infants (7-71 months old) | Experimental | Biological: High dosage IRV on a 0- and 28-day scheduleHigh dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 7-71 months old on day 0, 28 |
| Low dosage in infants (2-6 months old, two-dose) | Experimental | Biological: Low dosage IRV on a 0- and 28-day scheduleLow dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28 |
| Medium dosage in infants (2-6 months old, two-dose) | Experimental | Biological: Medium dosage IRV on a 0- and 28-day scheduleMedium dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28 |
| High dosage in infants (2-6 months old, two-dose) | Experimental | Biological: High dosage IRV on a 0- and 28-day scheduleHigh dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28 |
| Low dosage in infants (2-6 months old, three-dose) | Experimental | Biological: Low dosage IRV on a 0- , 28- and 56-day scheduleLow dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28, 56 |
| Medium dosage in infants (2-6 months old, three-dose) | Experimental | Biological: Medium dosage IRV on a 0- , 28- and 56-day scheduleMedium dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28, 56 |
| High dosage in infants (2-6 months old, three-dose) | Experimental | Biological: High dosage IRV on a 0- , 28- and 56-day scheduleHigh dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28, 56 |
| Placebo on day 0, 28 | Placebo comparator | Biological: Placebo on day 0, 28Two doses of placebo at the vaccination schedule of day 0,28 |
| Placebo on day 0, 28, 56 | Placebo comparator | Biological: Placebo on day 0, 28, 56Three doses of placebo at the vaccination schedule of day 0, 28,56 |
Who may qualify
- Ages
- 2 months to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 2 months old to 49 years old, healthy resident, excluding the following:
- 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.
Key exclusion criteria (21 listed)
- First dose exclusion criteria:
- 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).
- Subjects with serious adverse reaction after the previous vaccination;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dosage IRV on a 0- and 28-day scheduleInactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0, 28 | Biological | Low dosage in adults |
| Medium dosage IRV on a 0- and 28-day scheduleInactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0, 28 | Biological | Medium dosage in adults |
| High dosage IRV on a 0- and 28-day scheduleInactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28 | Biological | High dosage in adults |
| Low dosage IRV on a 0- and 28-day scheduleInactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28 | Biological | Low dosage in adolescents |
| Medium dosage IRV on a 0- and 28-day scheduleInactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28 | Biological | Medium dosage in adolescents |
| High dosage IRV on a 0- and 28-day scheduleInactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28 | Biological | High dosage in adolescents |
| Low dosage IRV on a 0- and 28-day scheduleInactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28 | Biological | Low dosage in infants (7-71 months old) |
| Medium dosage IRV on a 0- and 28-day scheduleInactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28 | Biological | Medium dosage in infants (7-71 months old) |
| High dosage IRV on a 0- and 28-day scheduleInactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28 | Biological | High dosage in infants (7-71 months old) |
| Low dosage IRV on a 0- and 28-day scheduleInactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28 | Biological | Low dosage in infants (2-6 months old, two-dose) |
| Medium dosage IRV on a 0- and 28-day scheduleInactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28 | Biological | Medium dosage in infants (2-6 months old, two-dose) |
| High dosage IRV on a 0- and 28-day scheduleInactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28 | Biological | High dosage in infants (2-6 months old, two-dose) |
| Low dosage IRV on a 0- , 28- and 56-day scheduleInactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28,56 | Biological | Low dosage in infants (2-6 months old, three-dose) |
| Medium dosage IRV on a 0- , 28- and 56-day scheduleInactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28,56 | Biological | Medium dosage in infants (2-6 months old, three-dose) |
| High dosage IRV on a 0- , 28- and 56-day scheduleInactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28,56 | Biological | High dosage in infants (2-6 months old, three-dose) |
| Placebo on day 0, 28Two doses of placebo at the vaccination schedule of day 0,28 | Biological | Placebo on day 0, 28 |
| Placebo on day 0, 28, 56Three doses of placebo at the vaccination schedule of day 0, 28,56 | Biological | Placebo on day 0, 28, 56 |
Primary outcome
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.
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.
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.
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
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
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
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
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
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
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
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
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
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.
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.
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.
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.
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.
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.
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.
4 secondary outcomes
Immunogenicity index-seroconversion rates of neutralizing antibody
Time frame: Day 28 after the second dose vaccination
Immunogenicity index-seroconversion rates of neutralizing antibody
Time frame: 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
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
Time frame: Day 28, 90, 180 after the third dose vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Derived from this study: PubMed 42733081Zhou Y, Tan J, Liu Y, Pu J, Wu J, Liu X, Yi S, Hu X, Chen R, Ye J, Yin N, Lin X, Gao J, Tong Q, Kuang X, Yang Y, Zhang W, Wang Y, Sun M, Zhang G, Wang Y, Yang J, Hu Z, Li H. Safety and immunogenicity of inactivated human Rotavirus vaccine in young children and infants: a randomized, placebo-controlled, double-blind, phase I clinical trial. Nat Commun. 2026 Aug 14;17(1):9777. doi: 10.1038/s41467-026-76607-z.
- Derived from this study: PubMed 38796326Wu JY, Zhang W, Pu J, Liu Y, Huang LL, Zhou Y, Gao JM, Tan JB, Liu XL, Yang J, Lin XC, Feng GW, Yin N, Chen R, Hu XQ, Yi S, Ye J, Kuang XJ, Wang Y, Zhang GM, Sun MS, Wang YX, Hu ZY, Yang JS, Li HJ. A randomized, double-blind, placebo-controlled phase I clinical trial of rotavirus inactivated vaccine (Vero cell) in a healthy adult population aged 18-49 years to assess safety and preliminary observation of immunogenicity. Vaccine. 2024 Jul 25;42(19):4030-4039. doi: 10.1016/j.vaccine.2024.05.014. Epub 2024 May 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongjun Li, Ph.D study chair
Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low dosage IRV on a 0- and 28-day schedule, Medium dosage IRV on a 0- and 28-day schedule and High dosage IRV on a 0- and 28-day schedule in people with Rotavirus Infection, run by Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Safety index-incidence of adverse reactions/events (time frame: 0-30 minutes after the first dose vaccination). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04626856, which also lists 2 linked publications.
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 10 Dec 2020.