Immunogenicity and Safety of IndoVac® as a Heterologous Booster Dose Against COVID-19 in Children 12-17 Years of Age

Tahapan Penelitian : Complete

Sponsor:

Mitra Pelaksana:

Departemen/KSM Ilmu Kesehatan Anak RSHS/FK UNPAD, PT Equilab International (CRO)

No Registry

INA-M05FOH8

Tanggal Input Registry : 14-02-2023

Tracking Information
Tanggal Antisipasi Studi	28-02-2023
Outcome Primer	To evaluate immune response to SARS-CoV-2 neutralizing antibody of IndoVac® before and 14 days after booster dose.
Outcome Skunder	Seropositive rate of neutralizing antibody at baseline (before booster dose), 14 days, 3 months, 6 months, and 12 months after booster vaccination

Descriptive Information
Judul Penelitian Popular	Immunogenicity and Safety of IndoVac® as a Heterologous Booster Dose Against COVID-19 in Children 12-17 Years of Age
Judul Penelitian Ilmiah	Immunogenicity and Safety of IndoVac® as a Heterologous Booster Dose Against COVID-19 in Children 12-17 Years of Age
Jenis Penelitian	Interventional
Intervensi	IndoVac® - SARS-CoV-2 Protein Subunit Recombinant Vaccine Adjuvanted with Alum + CpG 1018
Jumlah Subyek Penelitian	150

Recruitment Information
Eligibility Criteria	Inclusion Criteria: Not Specified Exclusion Criteria: Not Specified

Administrative Information
Nomor Persetujuan Etik	LB.02.01/X.6.5/465/2022
Nomor Persetujuan Material Transfer Agreement	Not applicable
Nomor Persetujuan Pelaksanaan Uji Klinik	PPUK/PPUB number
Other Study ID Numbers	CoV2-Booster-Children-0222
Contact Person	Not Specified