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Phase II Clinical Trial of the Inactivated Rotavirus Vaccine

NCT06080906 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2024-01-03

No results posted yet for this 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.

Conditions

Interventions

BIOLOGICAL

IRV on a 0- and 28-day schedule

Inactivated Rotavirus vaccine (Vero Cells) of 320EU/0.5ml on Day 0, 28

BIOLOGICAL

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

Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on Day 0, 28, 56

BIOLOGICAL

Placebo on Day 0, 28

Two doses of placebo at the vaccination schedule of Day 0, 28

BIOLOGICAL

Placebo on Day 0, 28, 56

Three doses of placebo at the vaccination schedule of Day 0, 28, 56

Sponsors & Collaborators

  • Henan Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Institute of Medical Biology, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Yanxia Wang · Henan Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
71 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-20
Primary Completion
2025-02-17
Completion
2025-06-17

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06080906 on ClinicalTrials.gov