drugset

drugset / Trial / NCT05433285

Immuno-bridging Study of COVID-19 Protein Subunit Recombinant Vaccine

NCT05433285 ↗

Phase 3 Completed 4050 enrolled PT Bio Farma Andalas University · collab Faculty of Medicine Universitas Diponegoro · collab Faculty of Medicine Universitas Hassanudin · collab Fakultas Kedokteran Universitas Indonesia · collab

RandomizedParallel-groupDouble-blindPrevention

Summary

Observer-blind, randomized, active-controlled prospective intervention study

Timeline

Start: 2022-06-07
Primary completion: 2022-08-05
Completion: 2023-08-31

Publications

Nurdin A, Movieta Nency Y, Maddeppungeng M, Sekartini R, Mulia Sari R, Surachman F, Fitry Yani F, Raveinal, Anggrainy F, Hafiz A, Linosefa, Machmud R, Awaliyah Deza P, Rujiana V, Bella Rahimi M, Farhanah N, Gundi Pramudo S, Hapsari R, Tri Anantyo D, Mulyono, Mahati E, Maharani N, Darma S, Husni Esa Darussalam A, Shakinah S, Nasrum Massi M, Soedjatmiko. Immunogenicity and safety of SARS-CoV-2 recombinant protein subunit vaccine (IndoVac) adjuvanted with alum and CpG 1018 in Indonesian adults: A phase 3, randomized, active-controlled, multicenter trial. Vaccine. 2024 Apr 30;42(12):3009-3017. doi: 10.1016/j.vaccine.2024.03.077. Epub 2024 Apr 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Covovax	Vaccine	0.5 ml	—
Subject	IndoVac	Vaccine	0.5 ml	—

Indications