NCT06950645

The Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells)

The Open-label Observation of Oral Hexavalent Reassorted Rotavirus Live Attenuated Vaccine (Vero Cell) in Healthy Adults and Children, as Well as the Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate Safety, Tolerability, and Immunogenicity in Healthy Infants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Sinovac Life Sciences Co., Ltd. · Industry
• Sex: All
• Age: 6 Weeks – 59 Years
• Healthy volunteers: Accepted

Summary

The Phase I clinical trial of the oral hexavalent reassortant rotavirus attenuated live vaccine (Vero Cells) will be conducted in a population ranging from 6 weeks to 59 years of age. The objective of this study is to evaluate the safety of investigational vaccine in healthy adults and children, as well as its safety tolerability, and immunogenicity in healthy infants. The study will be an open-label observation in adults and children, and a randomized, double-blind, placebo-controlled clinical trial in infants.

Detailed description

The Phase I clinical trial is an open-label observation involving healthy adults and children, as well as a randomized, double-blind, placebo-controlled study in healthy infants to evaluate the safety, tolerability, and immunogenicity of the investigaional vaccine. The investigational vaccine is available in both high-dose and low-dose formulations. The placebo is identical to the trial vaccine in all components except for the rotavirus. This study will enroll 100 participants, consisting of 20 adults aged 18-59 years, 20 children aged 2-6 years, and 60 infants aged 6-12 weeks. Participants will be enrolled sequentially, starting with adults, followed by children, and then infants. Enrollment for the subsequent group will begin after a 14-day safety observation period and confirmation of acceptable safety in the preceding group. Adult and child participants will receive the investigational vaccine in an open-label manner. The infants will be enrolled into two cohorts of 30 participants each: a low-dose cohort and a high-dose cohort. Within each cohort, the infants will be randomly assigned to two groups at a ratio of 2:1 and will receive either the investigational vaccine or a placebo in a double-blind manner. The immunization schedule for both the vaccine and placebo consists of three doses administered at 28-day intervals. Adverse events (AE) will be collected for all participants until 42 days after the last dose vaccination. Stool samples will be collected after each vaccination to detect vaccine strain shedding among infant participants. Serious adverse events (SAE) will be observed for 6 months from the last dose for adults and children or 12 months for infants. Blood samples from the infants will be collected at predetermined times to evaluate the immunogenicity of the investigational vaccine.

Conditions

• Rotavirus Gastroenteritis

Interventions

Type	Name	Description
BIOLOGICAL	Oral hexavalent reassortant rotavirus attenuated live vaccine	Oral hexavalent reassortant rotavirus attenuated live vaccine (high-dose) three doses administered orally
BIOLOGICAL	Oral hexavalent reassortant rotavirus attenuated live vaccine	Oral hexavalent reassortant rotavirus attenuated live vaccine (high-dose) three doses administered orally
BIOLOGICAL	Oral hexavalent reassortant rotavirus attenuated live vaccine	Oral hexavalent reassortant rotavirus attenuated live vaccine (low-dose) three doses administered orally
BIOLOGICAL	Placebo	Placebo of experimental vaccine for infants three doses administered orally
BIOLOGICAL	Oral hexavalent reassortant rotavirus attenuated live vaccine	Oral hexavalent reassortant rotavirus attenuated live vaccine (high-dose) three doses administered orally
BIOLOGICAL	Placebo	Placebo of experimental vaccine for infants three doses administered orally

Timeline

• Start date: 2024-03-27
• Primary completion: 2024-12-21
• Completion: 2025-12-18
• First posted: 2025-04-30
• Last updated: 2026-03-20

Locations

1 site across 1 country: China