Phase II Clinical Trial of the Inactivated Rotavirus Vaccine

• Register: ClinicalTrials.gov
• Last refreshed on: 15 January 2024
• Main ID: NCT06080906
• Date of registration: 08/10/2023
• Prospective Registration: Yes
• Primary sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences
• Public title: Phase II Clinical Trial of the Inactivated Rotavirus Vaccine
• Scientific 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
• Date of first enrolment: October 20, 2023
• Target sample size: 600
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT06080906
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Yanxia Wang
• Affiliation: Henan Center for Disease Control and Prevention

• Name: Li Yun

• Name: Hongjun Li

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age Requirement: Infants and toddlers aged 2 to 71 months at the time of enrollment.

- Provision of Legal Identification: Volunteers and their legal guardians or appointed
representatives must provide valid legal identification documents.

- Informed Consent: Legal guardians or appointed representatives of volunteers must have
the capacity to understand the informed consent document and the research process,
voluntarily participate, sign the informed consent form, and be able to comply with
the requirements in the study as well as complete relevant visits on time.

- No Previous Rotavirus Vaccination: Infants and toddlers enrolled in the study should
not have received any rotavirus vaccines before enrollment.

Exclusion Criteria:

1. First Dose Exclusion Criteria

Subjects meeting any of the following exclusion criteria will be not eligible for
enrollment:

- Temperature Requirement: Axillary body temperature prior to vaccination is up to
37.3°C or more.

- Allergic History: Subjects have a history of allergies to any component of the
investigational vaccine (e.g., aluminum hydroxide), any history of vaccine
allergies, suspected allergies, or any other severe adverse reactions.

- Vaccine History: Subjects received any inactivated vaccines or subunit vaccines
within 7 days (including the 7th day) prior to vaccination with the
investigational vaccine, or any other live attenuated vaccines or COVID-19
vaccines within 14 days (including the 14th day) prior to vaccination.

- Health Conditions: Subjects have known congenital abnormalities, developmental
disorders, genetic defects, or severe malnutrition, among other conditions.

- Immune-Related Diseases: Subjects have compromised primary or secondary immune
function, human immunodeficiency virus (HIV) infection, lymphoma, leukemia,
systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA),
inflammatory bowel disease, or other autoimmune diseases.

- Gastrointestinal Conditions: Subjects have a history of intussusception or
chronic gastrointestinal diseases.

- Neurological and Mental Health: Subjects have a history of seizures, convulsions,
cerebral palsy, epilepsy, mental illness, or a family history of such conditions.

- Acute Illness: Subjects have experienced acute illnesses (e.g., fever) within 3
days prior to vaccination with the investigational vaccine.

- Immune Therapy: Subjects have received immune-enhancing or immune-suppressing
therapy within the last 3 months (continuous oral or intravenous administration
for more than 14 days) prior to vaccination.

- Coagulation Abnormalities: Subjects have a history of coagulation disorders
(e.g., coagulation factor deficiency, coagulation disorders).

- Organ Removal History: Subjects have a history of organ removal (e.g., thyroid,
pancreas, liver, spleen) or have asplenia syndrome.

- Participation in Other Clinical Studies: Subjects are currently or have plans to
participate in other clinical studies before enrollment.

- Special Conditions for Children Aged 24 Months and Below: For such children,
additional exclusion criteria include difficult birth, resuscitation after
suffocation, a history of neurological damage, premature birth (delivery before
the 37th week of gestation), and low birth weight (less than 2500 grams).

- Investigator's Discretion: The final exclusion criterion is the investigator's
discretion to determine whether a subject is suitable for participation in the
study.

2. 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.



Age minimum: 2 Months
Age maximum: 71 Months
Gender: All

Health Condition(s) or Problem(s) studied

Rotavirus Infections

Diarrhea

Intervention(s)

Biological: Placebo on Day 0, 28

Biological: Placebo on Day 0, 28, 56

Biological: IRV on a 0- and 28-day schedule

Biological: IRV on a 0-, 28- and 56-day schedule

Primary Outcome(s)

Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody [Time Frame: Day 28 after the second vaccination]

Immunogenicity index-seroconversion rates of neutralizing antibody [Time Frame: Between baseline and day 28 after the third vaccination]

Immunogenicity index-geometric mean increase (GMI) of neutralizing antibody [Time Frame: Between baseline and day 28 after the second vaccination]

Immunogenicity index-geometric mean increase (GMI) of neutralizing antibody [Time Frame: Between baseline and day 28 after the third vaccination]

Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody [Time Frame: Day 28 after the third vaccination]

Immunogenicity index-seroconversion rates of neutralizing antibody [Time Frame: Between baseline and day 28 after the second vaccination]

Secondary Outcome(s)

Safety index-incidence of serious adverse events [Time Frame: From the beginning of the vaccination up to 6 months after the last vaccination completed]

Safety index-incidence of solicited adverse reactions/events [Time Frame: Day 0 to 7 after the first 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 adverse reactions/events [Time Frame: 0-30 minutes after the first 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 solicited adverse reactions/events [Time Frame: Day 0 to 7 after the second 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]

Secondary ID(s)

RV-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Henan Center for Disease Control and Prevention