Rotavirus InfectionsPhase 2NCT06080906
Phase II Clinical Trial of the Inactivated Rotavirus Vaccine
A Phase 2 study testing IRV on a 0- and 28-day schedule and IRV on a 0-, 28- and 56-day schedule in people with Rotavirus Infections and Diarrhea, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 to 71 monthsHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Infections, Diarrhea
- What is being tested?
- IRV on a 0- and 28-day schedule and IRV on a 0-, 28- and 56-day schedule
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2023to 17 Jun 2025
- Phase
- Phase 2
- 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 to 71 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongxu Center for Disease Prevention and Control
Kaifeng, Henan
Li Yun, 13598759092 ext. +86, txxxmb@163.com
About this study
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
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.
Read the 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).
- Conditions
- Rotavirus Infections, Diarrhea
- Being tested
- 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
- Keywords
- Rotavirus Infections, Inactivated Rotavirus Vaccine, Diarrhea
- Medical subject headings
- Rotavirus Infections, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRV on a 0- and 28-day scheduleBiological
Inactivated Rotavirus vaccine (Vero Cells) of 320EU/0.5ml on Day 0, 28
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 |
|---|---|---|
| Tolldlers (7-71 months old, two-dose) | Experimental | Inactivated Rotavirus vaccine (Vero cell) in toddlers aged 7-71 months old on Day 0, 28 Receives: Biological: IRV on a 0- and 28-day schedule |
| Infants (2-6 months old, three-dose) | Experimental | Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on Day 0, 28, 56 Receives: Biological: IRV on a 0-, 28- and 56-day schedule |
| Placebo in Tolldlers (7-71 months old, two-dose) | Placebo comparator | Two doses of placebo at the vaccination schedule of Day 0, 28 Receives: Biological: Placebo on Day 0, 28 |
| Placebo in Infants (2-6 months old, three-dose) | 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.
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Measured: Day 28 after the second 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 after the third vaccination
Immunogenicity index-geometric mean increase (GMI) of neutralizing antibody
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Measured: Between baseline and day 28 after the second vaccination
Immunogenicity index-geometric mean increase (GMI) of neutralizing antibody
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Measured: Between baseline and day 28 after the third 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 a ≥4-fold increase from baseline.
Measured: Between baseline and day 28 after the second 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 a ≥4-fold increase from baseline.
Measured: Between baseline and day 28 after the third vaccination
Secondary outcomes (10)
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 solicited adverse reactions/events
Incidence of solicited adverse reactions/events after the first dose vaccination.
Measured: Day 0 to 7 after the first dose vaccination
Safety index-incidence of solicited adverse reactions/events
Incidence of solicited adverse reactions/events after the second dose vaccination.
Measured: Day 0 to 7 after the second dose vaccination
Safety index-incidence of solicited adverse reactions/events
Incidence of solicited adverse reactions/events after the third dose vaccination.
Measured: Day 0 to 7 after the third dose vaccination
Safety index-incidence of unsolicited adverse reactions/events
Incidence of unsolicited adverse reactions/events after the first dose vaccination.
Measured: Day 0 to 28 after the first dose vaccination
Safety index-incidence of unsolicited adverse reactions/events
Incidence of unsolicited adverse reactions/events after the second dose vaccination.
Measured: Day 0 to 28/30 after the second dose vaccination
Safety index-incidence of unsolicited adverse reactions/events
Incidence of unsolicited adverse reactions/events after the third dose vaccination.
Measured: Day 0 to 30 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 up to 6 months after the last vaccination completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start20 Oct 2023
- Primary completion17 Feb 2025 (estimated)
- Study completion17 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotavirus InfectionsStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 300 toddlers (aged 7-71 months) and 300 infants (aged 2-6 months) will be eligible for parallel enrollment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Center for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Yanxia Wang, Principal investigator, Henan Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080906
- Sponsor's protocol ID
- RV-201
- Status last verified
- Jan 2024
- First submitted
- 8 Oct 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06080906
- Acronym / sponsor ID
- RV-201
- Conditions
- Rotavirus Infections, Diarrhea
- Keywords
- Rotavirus Infections, Inactivated Rotavirus Vaccine, Diarrhea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Henan Center for Disease Control and Prevention
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 17 Feb 2025 (estimated)
- Study completion
- 17 Jun 2025 (estimated)
- First posted
- 12 Oct 2023 (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 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 300 toddlers (aged 7-71 months) and 300 infants (aged 2-6 months) will be eligible for parallel enrollment
| Arm | Type | Receives |
|---|---|---|
| Tolldlers (7-71 months old, two-dose) | Experimental | Biological: IRV on a 0- and 28-day scheduleInactivated Rotavirus vaccine (Vero cell) in toddlers aged 7-71 months old on Day 0, 28 |
| Infants (2-6 months old, three-dose) | Experimental | Biological: IRV on a 0-, 28- and 56-day scheduleInactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on Day 0, 28, 56 |
| Placebo in Tolldlers (7-71 months old, two-dose) | Placebo comparator | Biological: Placebo on Day 0, 28Two doses of placebo at the vaccination schedule of Day 0, 28 |
| Placebo in Infants (2-6 months old, three-dose) | 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 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- First Dose Exclusion Criteria
- Subjects meeting any of the following exclusion criteria will be not eligible for enrollment:
- Contraindication of the second and third doses of vaccine
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 |
|---|---|---|
| IRV on a 0- and 28-day scheduleInactivated Rotavirus vaccine (Vero Cells) of 320EU/0.5ml on Day 0, 28 | Biological | Tolldlers (7-71 months old, two-dose) |
| IRV on a 0-, 28- and 56-day scheduleInactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on Day 0, 28, 56 | Biological | 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 in Tolldlers (7-71 months old, two-dose) |
| Placebo on Day 0, 28, 56Three doses of placebo at the vaccination schedule of Day 0, 28, 56 | Biological | Placebo in Infants (2-6 months old, three-dose) |
Primary outcome
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
Time frame: Day 28 after the second vaccination
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
Time frame: Day 28 after the third vaccination
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Immunogenicity index-geometric mean increase (GMI) of neutralizing antibody
Time frame: Between baseline and day 28 after the second vaccination
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Immunogenicity index-geometric mean increase (GMI) of neutralizing antibody
Time frame: Between baseline and day 28 after the third vaccination
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Immunogenicity index-seroconversion rates of neutralizing antibody
Time frame: Between baseline and day 28 after the second 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 a ≥4-fold increase from baseline.
Immunogenicity index-seroconversion rates of neutralizing antibody
Time frame: Between baseline and day 28 after the third 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 a ≥4-fold increase from baseline.
10 secondary outcomes
Safety index-incidence of adverse reactions/events
Time frame: 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
Safety index-incidence of adverse reactions/events
Time frame: 0-30 minutes after the third dose vaccination
Safety index-incidence of solicited adverse reactions/events
Time frame: Day 0 to 7 after the first dose vaccination
Safety index-incidence of solicited adverse reactions/events
Time frame: Day 0 to 7 after the second dose vaccination
Safety index-incidence of solicited adverse reactions/events
Time frame: Day 0 to 7 after the third dose vaccination
Safety index-incidence of unsolicited adverse reactions/events
Time frame: Day 0 to 28 after the first dose vaccination
Safety index-incidence of unsolicited adverse reactions/events
Time frame: Day 0 to 28/30 after the second dose vaccination
Safety index-incidence of unsolicited adverse reactions/events
Time frame: Day 0 to 30 after the third dose vaccination
Safety index-incidence of serious adverse events
Time frame: From the beginning of the vaccination up to 6 months after the last vaccination completed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Rotavirus Infections
Active, not recruitingPhase 1
CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch (MNP) in Healthy Adults
Rotavirus Infections
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
Active, not recruitingPhase 3
The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants
Rotavirus Infection of Children
Recruiting
Artificial Intelligence-driven Virtual Standardized Pediatric Patients Trial
Pneumococcal Pneumonia, Rotavirus Enteritis With Hypovolemic Shock
Active, not recruitingPhase 2
Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers
Rotavirus Infections, Rotavirus Gastroenteritis
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.
Yanxia Wang principal investigator
Henan Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IRV on a 0- and 28-day schedule and IRV on a 0-, 28- and 56-day schedule in people with Rotavirus Infections and Diarrhea, run by Institute of Medical Biology, 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 4 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 3 Jan 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Hongjun Li (13888918945 ext. +86, lihj6912@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody (time frame: Day 28 after the second vaccination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.