A phase III, observer-blind, randomized, placebo-controlled study of the efficacy, safety, and immunogenicity of SARS-CoV-2 inactivated vaccine in healthy adults aged 18–59 years: An interim analysis in Indonesia

• Published in: Vaccine Vol. 39; no. 44; pp. 6520 - 6528
• Main Authors: Fadlyana, Eddy, Rusmil, Kusnandi, Tarigan, Rodman, Rahmadi, Andri Reza, Prodjosoewojo, Susantina, Sofiatin, Yulia, Khrisna, Citra V., Sari, Rini Mulia, Setyaningsih, Lilis, Surachman, Fikrianti, Bachtiar, Novilia Sjafri, Sukandar, Hadyana, Megantara, Imam, Murad, Chrysanti, Pangesti, Krisna Nur A., Setiawaty, Vivi, Sudigdoadi, Sunarjati, Hu, Yaling, Gao, Qiang, Kartasasmita, Cissy B.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 22.10.2021; Elsevier Limited; The Author(s). Published by Elsevier Ltd
• Subjects: Adult; Adults; Adverse events; Allergy and Immunology; Aluminum; Antibodies; Antibodies, Neutralizing; Antibodies, Viral; Assaying; blood; Chronic illnesses; Clinical trials; Coronaviruses; COVID-19; COVID-19 infection; COVID-19 Vaccines; Deactivation; Dosage; Double-Blind Method; Efficacy; Enzyme-linked immunosorbent assay; Epidemics; Evaluation; Humans; Immunogenicity; Immunogenicity, Vaccine; Immunoglobulin G; Indonesia; Indonesia - epidemiology; Infectious diseases; Influenza; injection site; Laboratories; Life sciences; Neutralization; neutralization tests; pain; pandemic; Pandemics; Placebos; Pneumonia; Safety; SARS-CoV-2; SARS-CoV-2 Inactivated Vaccine; Seroconversion; Severe acute respiratory syndrome coronavirus 2; Surveillance; vaccination; Vaccines; Vaccines, Inactivated - adverse effects; Viral diseases; Viruses; Indonesia; China; COVID-19; Immunogenicity; SARS-CoV-2 Inactivated Vaccine; IgG; Efficacy; SARS; Adults; Safety; ELISA; GMT; rRT-PCR; WHO; World Health Organization; Geometric Mean Titer; Immunoglobulin G; Enzyme Link Immunoassay; Coronavirus Disease 2019; Real-time Reverse Transcriptase-PCR; Severe Acute Respiratory Syndrome

•Most of the adverse reactions were mild in severity with pain at the injection site as the most frequently reported symptom.•The inactivated SARS-CoV-2 vaccine capable of inducing immune response within 14 days after complete dose.•The efficacy of the inactivated SARS-CoV-2 vaccine in preventing sy...