RecruitingNCT06080906Updated Jan 3, 2024

Phase II Clinical Trial of the Inactivated Rotavirus Vaccine

A Phase 2 interventional study of IRV on a 0- and 28-day schedule and IRV on a 0-, 28- and 56-day schedule in Rotavirus Infections and Diarrhea, sponsored by Institute of Medical Biology, Chinese Academy of Medical Sciences. Recruiting at 1 site in China. Open to participants aged 2 Months to 71 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-03.

Sponsored by Institute of Medical Biology, Chinese Academy of Medical Sciences · Phase 2, Interventional, and Prevention

From the registry’s dates

Primary completion was expected by Feb 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
Started Oct 2023; still recruiting 3 years later.

Phase: Phase 2
Study type: Interventional
Enrollment: 600
Allocation: Randomized
Ages: 2 Months to 71 Months
Sex: All

Study summary

This study is a randomized, double-blinded, placebo-controlled phase 2 clinical trial to evaluate the immunogenicity and safety of Inactivated Rotavirus Vaccine (IRV) in children (aged 2-71 months). Primary immunogenicity endpoints in two age groups are the anti-RV neutralizing antibody geometric mean titers (GMTs) 28 days after the final dose, anti-RV neutralizing antibody geometric mean increase (GMI), and seroconversion rates between baseline and 28 days after the final dose. The secondary safety endpoints are the number of adverse events/reactions within 30 minutes after each dose, the number of solicited adverse events/reactions within 7 days after each dose, the number of unsolicited adverse events/reactions within 28/30 days after each dose, and the number of serious adverse events (SAE) between the first dose up to 6 months after the final dose. The exploratory endpoints are the anti-RV IgG and IgA antibody GMT 28 days after the final dose, GMI and seroconversion rates of anti-RV IgG and IgA antibody between baseline and 28 days after the final dose, GMT and seropositive rates of anti-RV neutralizing antibody, IgG antibody and IgA antibody 90, 180, and 360 days after the final dose. Besides, as the exploratory endpoint, the GMT, GMI, and seroconversion rates of cross-neutralizing antibodies against G3 and G9 type of RV, gene transcription differences in peripheral blood mononuclear cells on Day 0 and 28 after the final dose will be assessed.

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 studied

Rotavirus Infections
Diarrhea

Browse trials for

Keywords

Rotavirus Infections
Inactivated Rotavirus Vaccine
Diarrhea

In context

Rotavirus Infections

104 studies on the registry are indexed under Rotavirus Infections; 3 are open to participants now.

This study's planned enrollment of 600 is above the median of 403 across 69 interventional studies indexed under Rotavirus Infections.

Browse Rotavirus Infections studies →

Lead sponsor

Institute of Medical Biology, Chinese Academy of Medical Sciences is the lead sponsor of 29 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Months to 71 Months
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age Requirement: Infants and toddlers aged 2 to 71 months at the time of enrollment.
Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.
No Previous Rotavirus Vaccination: Infants and toddlers enrolled in the study should not have received any rotavirus vaccines before enrollment.

Exclusion criteria

Exclusion Criteria:

First Dose Exclusion Criteria
Subjects meeting any of the following exclusion criteria will be not eligible for enrollment:
- Temperature Requirement: Axillary body temperature prior to vaccination is up to 37.3°C or more.
- Allergic History: Subjects have a history of allergies to any component of the 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 or COVID-19 vaccines within 14 days (including the 14th day) prior to vaccination.
- Health Conditions: Subjects have known congenital abnormalities, developmental disorders, genetic defects, or severe malnutrition, among other conditions.
- Immune-Related Diseases: Subjects have compromised primary or secondary immune function, (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other 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.
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.

Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 600 participants (estimated)

Study arms

Experimental
Tolldlers (7-71 months old, two-dose)
Inactivated Rotavirus vaccine (Vero cell) in toddlers aged 7-71 months old on Day 0, 28
Biological: IRV on a 0- and 28-day schedule
Experimental
Infants (2-6 months old, three-dose)
Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on Day 0, 28, 56
Biological: IRV on a 0-, 28- and 56-day schedule
Placebo comparator
Placebo in Tolldlers (7-71 months old, two-dose)
Two doses of placebo at the vaccination schedule of Day 0, 28
Biological: Placebo on Day 0, 28
Placebo comparator
Placebo in Infants (2-6 months old, three-dose)
Three doses of placebo at the vaccination schedule of Day 0, 28, 56
Biological: Placebo on Day 0, 28, 56

Interventions

BiologicalIRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero Cells) of 320EU/0.5ml on Day 0, 28
BiologicalIRV on a 0-, 28- and 56-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on Day 0, 28, 56
BiologicalPlacebo on Day 0, 28
Two doses of placebo at the vaccination schedule of Day 0, 28
BiologicalPlacebo on Day 0, 28, 56
Three doses of placebo at the vaccination schedule of Day 0, 28, 56

What researchers measure

Primary outcomes

Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Between baseline and day 28 after the third vaccination

Secondary outcomes

Safety index-incidence of adverse reactions/events
Incidence of adverse reactions/events after the first dose vaccination.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0 to 30 after the third dose vaccination
Safety index-incidence of serious adverse events
Occurrence of serious adverse reactions/events after vaccination.
Time frame: From the beginning of the vaccination up to 6 months after the last vaccination completed

Other outcomes

Immunogenicity index-geometric mean titer (GMT) of IgG antibody
IgG antibody assay will be performed using the ELISA method.
Time frame: Day 28 after the second vaccination
Immunogenicity index-geometric mean titer (GMT) of IgG antibody
IgG antibody assay will be performed using the ELISA method.
Time frame: Day 28 after the third vaccination
Immunogenicity index-geometric mean increase (GMI) of IgG antibody
IgG antibody assay will be performed using the ELISA method.
Time frame: Between baseline and day 28 after the second vaccination
Immunogenicity index-geometric mean increase (GMI) of IgG antibody
IgG antibody assay will be performed using the ELISA method.
Time frame: Between baseline and day 28 after the third vaccination
Immunogenicity index-seroconversion rates of IgG antibody
IgG antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (≤1:16) to seropositive (\>1:16), or a ≥4-fold increase from baseline.
Time frame: Between baseline and day 28 after the second vaccination
Immunogenicity index-seroconversion rates of IgG antibody
IgG antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (≤1:16) to seropositive (\>1:16), or a ≥4-fold increase from baseline.
Time frame: Between baseline and day 28 after the third vaccination
Immunogenicity index-geometric mean titer (GMT) of IgA antibody
IgA antibody assay will be performed using the ELISA method.
Time frame: Day 28 after the second vaccination
Immunogenicity index-geometric mean titer (GMT) of IgA antibody
IgA antibody assay will be performed using the ELISA method.
Time frame: Day 28 after the third vaccination
Immunogenicity index-geometric mean increase (GMI) of IgA antibody
IgA antibody assay will be performed using the ELISA method.
Time frame: Between baseline and day 28 after the second vaccination
Immunogenicity index-geometric mean increase (GMI) of IgA antibody
IgA antibody assay will be performed using the ELISA method
Time frame: Between baseline and day 28 after the third vaccination
Immunogenicity index-seroconversion rates of IgA antibody
IgA antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (\<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline.
Time frame: Between baseline and day 28 after the second vaccination
Immunogenicity index-seroconversion rates of IgA antibody
IgA antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (\<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline.
Time frame: Between baseline and day 28 after the third vaccination
Immunogenicity index-geometric mean titer (GMT) of IgG antibody
IgG antibody assay will be performed using the ELISA method.
Time frame: Day 90,180 and 360 after the second vaccination
Immunogenicity index-geometric mean titer (GMT) of IgG antibody
IgG antibody assay will be performed using the ELISA method.
Time frame: Day 90,180 and 360 after the third vaccination
Immunogenicity index-seropositive rates of IgG antibody
IgG antibody assay will be performed using the ELISA method. Seropositivity will be defined as the seropositive results (\>1:16).
Time frame: Day 90,180 and 360 after the second vaccination
Immunogenicity index-seropositive rates of IgG antibody
IgG antibody assay will be performed using the ELISA method. Seropositivity will be defined as the seropositive results (\>1:16).
Time frame: Day 90,180 and 360 after the third vaccination
Immunogenicity index-geometric mean titer (GMT) of IgA antibody
IgA antibody assay will be performed using the ELISA method.
Time frame: Day 90,180 and 360 after the second vaccination
Immunogenicity index-geometric mean titer (GMT) of IgA antibody
IgA antibody assay will be performed using the ELISA method.
Time frame: Day 90,180 and 360 after the third vaccination
Immunogenicity index-seropositve rates of IgA antibody
IgA antibody assay will be performed using the ELISA method. Seropositivity will be defined as the seropositive results (≥1:8).
Time frame: Day 90,180 and 360 after the second vaccination
Immunogenicity index-seropositive rates of IgA antibody
IgA antibody assay will be performed using the ELISA method. Seropositivity will be defined as the seropositive results (≥1:8).
Time frame: Day 90,180 and 360 after the third vaccination
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Time frame: Day 90,180 and 360 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.
Time frame: Day 90,180 and 360 after the third vaccination
Immunogenicity index-seropositive rates of neutralizing antibody
Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seropositivity will be defined as the seropositive results (≥1:8).
Time frame: Day 90,180 and 360 after the second vaccination
Immunogenicity index-seroconversion rates of neutralizing antibody
Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seropositivity will be defined as the seropositive results (≥1:8).
Time frame: Day 90,180 and 360 after the third vaccination
Immunogenicity index-geometric mean titer (GMT) of cross- neutralizing antibody
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Time frame: Day 28 after the second vaccination
Immunogenicity index-geometric mean titer (GMT) of cross-neutralizing antibody
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Time frame: Day 28 after the third vaccination
Immunogenicity index-geometric mean increase (GMI) of cross-neutralizing antibody
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Time frame: Between baseline and day 28 after the second vaccination
Immunogenicity index-geometric mean increase (GMI) of cross-neutralizing antibody
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Time frame: Between baseline and day 28 after the thrid vaccination
Immunogenicity index-seroconversion rates of cross-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.
Time frame: Between baseline and day 28 after the second vaccination
Immunogenicity index-seroconversion rates of cross-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.
Time frame: Between baseline and day 28 after the thrid vaccination
mRNA sequencing analysis of peripheral blood monouclear cells（PBMCs）
Differentially expressed genes of infants（2-6 months）between baseline and day 28 after the third vaccination will be measured by mRNA sequencing
Time frame: Between baseline and day 28 after the third vaccination

Study locations

1 of 1 sites recruiting

Tongxu Center for Disease Prevention and Control
Kaifeng, Henan, China
Recruiting
- Li Yun · Contact · txxxmb@163.com · 13598759092
Recruiting

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06080906
Lead sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborators: Henan Center for Disease Control and Prevention
Responsible party: Sponsor
First posted: Oct 12, 2023
Start date: Oct 20, 2023
Primary completion: Feb 17, 2025 (estimated)
Completion: Jun 17, 2025 (estimated)
Last update: Jan 3, 2024

Study contacts

Hongjun Li

Contact

lihj6912@163.com

13888918945 ext. +86

Yanxia Wang

principal investigator · Henan Center for Disease Control and Prevention

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Rotavirus Infections →

Other studies from this sponsor

Institute of Medical Biology, Chinese Academy of Medical Sciences

Start the discussion