Efficacy/Effectiveness, Safety, and Immunogenicity of LC16m8 Mpox Vaccine in Colombia

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

8,686

Participants

Timeline

Start Date

December 16, 2023

Primary Completion Date

August 20, 2024

Study Completion Date

December 31, 2025

Conditions
Monkeypox
Interventions
BIOLOGICAL

LC16m8

"LC16m8 should be stored at temperatures between -35°C and -20°C. The product should not be stored at temperatures below -35°C, because deterioration or damage of the rubber stopper could occur.~The virus in this product is sensitive to sunlight and is quickly inactivated, so care should be taken to avoid exposure to light, both before or after reconstitution.~Carefully examine the content at the time of reconstitution. Do not use if precipitation, contamination of foreign substances, or other abnormalities are observed.~This product should be dissolving the drug immediately before inoculation. Once dissolved, it should be used immediately. Since this product does not contain thimerosal, once the stopper is removed, any solution remained in the vial must be disposed of.~Do not restore or reuse the remaining solution. Shelf Life: 10 years from the date of passing the national test for lot-release Bottle containing about 250 doses"

Trial Locations (3)

Unknown

Clinica Universitaria Colombia - Centro Medico Teusaquillo, Bogotá

Hospital Universitario San Ignacio, Bogotá

Infecto Clinicos, Bogotá

All Listed Sponsors
collaborator

Ministerio de Salud y Protección Social de Colombia

UNKNOWN

collaborator

Ministry of Health, Labour and Welfare, Japan

OTHER_GOV

collaborator

Japan Agency for Medical Research and Development

OTHER_GOV

collaborator

National Center for Global Health and Medicine, Japan

OTHER_GOV

collaborator

National Institute of Infectious Disease, Japan

UNKNOWN

collaborator

Instituto Nacional de Salud

UNKNOWN

lead

Universidad Nacional de Colombia

OTHER