NCT06967272

PhaseⅡClinical Trial of Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells)

Evaluating the Immunogenicity and Safety of the Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells) in Healthy Infants Via a Randomized, Double-blind, Active-controlled Phase II Clinical Trial.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Sinovac Life Sciences Co., Ltd. · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

The Phase II clinical trial of the oral hexavalent reassortant rotavirus attenuated live vaccine (Vero Cells) will be conducted in infants aged 6 to 12 weeks. This study will evaluate the immunogenicity and safety of the investigational vaccine in healthy infants through a randomized, double-blind, active-controlled trial.

Detailed description

The Phase II clinical trial is a randomized, double-blind, active-controlled study conducted in healthy infants to evaluate the immunogenicity and safety of the investigational vaccine. The investigational vaccine is available in both high-dose and low-dose formulations. The control vaccine is the orally administered pentavalent reassortant rotavirus attenuated live vaccine (Vero Cells) produced by Merck Sharp \& Dohme Corp. This study plans to recruit 400 infants aged 6 to 12 weeks. All participants will be randomly assigned to the low-dose investigational group, high-dose investigational group, and active-controlled group, respectively.The immunization schedule for both the investigational vaccine and controlled vaccine consists of three doses administered at 28-day intervals. Blood samples will be collected at predefined time points to evaluate the immunogenicity of the investigational vaccine. Adverse events (AEs) will be collected for all participants from the first vaccination until 42 days after the last dose, while serious adverse events (SAEs) and adverse events of special interest (AESIs) will be monitored for 12 months. A safety monitoring sub-cohort will be established, with stool samples collected daily for 14 days after each vaccination to assess vaccine virus shedding, duration and patterns of viral shedding, potential reassortment and reversion to virulence of the rotavirus vaccine strains

Conditions

• Rotavirus Gastroenteritis

Interventions

Type	Name	Description
BIOLOGICAL	Oral hexavalent reassortant rotavirus attenuated live vaccine	Oral hexavalent reassortant rotavirus attenuated live vaccine (low-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 pentavalent reassortant rotavirus attenuated live vaccine (controlled)	The controlled vaccine three doses administered orally

Timeline

• Start date: 2025-01-20
• Primary completion: 2026-06-15
• Completion: 2026-11-15
• First posted: 2025-05-13
• Last updated: 2025-08-22

Locations

1 site across 1 country: China