NCT06577298 - A Study to Evaluate the Safety and Immunogenicity of VLP-Polio in Infants and Toddlers | Biotech Hunter

Enrollment

480

Participants

Timeline

Start Date

December 19, 2024

Primary Completion Date

October 31, 2026

Study Completion Date

December 31, 2026

Conditions

Poliomyelitis

Interventions

BIOLOGICAL

Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) low adjuvant dose

4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants

BIOLOGICAL

VLP-Polio medium dose

4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants

BIOLOGICAL

VLP-Polio high dose

1 dose of VLP-Polio vaccine (0.5ml) on day 0 for toddlers, 4 doses at 2, 3, 4 months and 12-18 months of age for infants

BIOLOGICAL

Vaccine Poliomyelitis Inactivated (IPV)

1 dose of IPV vaccine (0.5ml) on day 0 for toddlers, 4 doses at 2, 3, 4 months and 12-18 months of age for infants

Trial Locations (1)

RECRUITING

Dr. Cipto Mangunkusumo Hospital, Jakarta