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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2 months
Maximum Age: 5
Healthy Volunteers: t
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• 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.

Locations
Other Locations
China
Tongxu Center for Disease Prevention and Control
RECRUITING
Kaifeng
Contact Information
Primary
Hongjun Li
lihj6912@163.com
13888918945
Time Frame
Start Date: 2023-10-20
Estimated Completion Date: 2025-06-17
Participants
Target number of participants: 600
Treatments
Experimental: Tolldlers (7-71 months old, two-dose)
Inactivated Rotavirus vaccine (Vero cell) in toddlers aged 7-71 months old on Day 0, 28
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
Placebo_comparator: Placebo in Tolldlers (7-71 months old, two-dose)
Two doses of placebo at the vaccination schedule of 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
Related Therapeutic Areas
Sponsors
Collaborators: Henan Center for Disease Control and Prevention
Leads: Institute of Medical Biology, Chinese Academy of Medical Sciences

This content was sourced from clinicaltrials.gov