Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

1,512

Participants

Timeline

Start Date

January 8, 2023

Primary Completion Date

April 29, 2023

Study Completion Date

December 31, 2024

Conditions
Rotavirus InfectionsRotavirus Gastroenteritis
Interventions
BIOLOGICAL

Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine

0.5 mL of vaccine containing a total of 60 µg of protein (20 µg of each P type) adjuvanted with 0.5 mg aluminum hydroxide.

BIOLOGICAL

High dose Recombinant Trivalent Subunit Rotavirus Vaccine

0.5 mL of vaccine containing a total of 90 µg of protein (30 µg of each P type) adjuvanted with 0.5 mg aluminum hydroxide.

BIOLOGICAL

Placebo

0.5 mL per dose, containing 0.5 mg aluminium hydroxide adjuvant.

Trial Locations (2)

476000

Shangqiu Liangyuan District Center for Disease Control and Prevention, Shangqiu

476700

Ningling County Center for Disease Control and Prevention, Shangqiu

All Listed Sponsors
collaborator

Henan Center for Disease Control and Prevention

OTHER_GOV

lead

MAXVAX Biotechnology Limited Liability Company

INDUSTRY

NCT05621655 - Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers | Biotech Hunter | Biotech Hunter