Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children

PHASE3CompletedINTERVENTIONAL
Enrollment

1,050

Participants

Timeline

Start Date

October 9, 2022

Primary Completion Date

December 31, 2023

Study Completion Date

January 31, 2024

Conditions
Vaccine ReactionVaccine Adverse Reaction
Interventions
BIOLOGICAL

SARS-CoV-2 Protein Subunit Recombinant Vaccine

SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma

BIOLOGICAL

Active Comparator

Covovax

Trial Locations (10)

Unknown

Bali Mandara Hospital, Denpasar

Universitas Udayana Hospital, Denpasar

RSUD Hj. Anna Lasmanah, Banjarnegara

Abdoel Moeloek Hospital, Bandar Lampung

Rumpin Primary Health Care, Bogor

Duren Seribu Primary Health Care, Depok

Pasir Putih Primary Health Care, Depok

Universitas Mataram Hospital, Mataram

M Djamil Hospital, Padang

RS Universitas Andalas, Padang

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Center for Child Health Universitas Gadjah Mada (CCH-PRO UGM

UNKNOWN

collaborator

Cipto Mangunkusumo Hospital/Department of Child Health, Faculty of Medicine, University of Indonesia, Jakarta

UNKNOWN

collaborator

Faculty of Medicine, Andalas University

UNKNOWN

lead

PT Bio Farma

INDUSTRY