Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-24 @ 1:19 PM
NCT ID:
NCT04672395
Brief Summary:
The purpose of this double-blind, randomized, controlled study is to evaluate the efficacy, immunogenicity, reactogenicity and safety of an adjuvanted recombinant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) trimeric spike (S)-protein subunit vaccine (SCB-2019) for the prevention of SARS-CoV-2-mediated COVID-19 in Participants Aged 12 Years and Older.
Detailed Description:
This study will assess the efficacy against COVID-19, immunogenicity, reactogenicity, and safety of CpG 1018/Alum-adjuvated SCB-2019 vaccine. The COVID-19 pandemic has resulted in high morbidity and mortality, caused major disruption to healthcare systems, and has had significant socioeconomic impacts. Currently, only limited treatment options are available against COVID-19 and accelerated vaccine development is urgently needed. Several COVID-19 vaccines were recently authorized in some countries, but the global supply is insufficient for pandemic control. Additional safe and effective vaccines for COVID-19 prevention would have significant public health impact.
Placebo recipients will be offered two doses of SCB-2019 vaccine at defined points as part of the study.
Adults participants who received SCB-2019 vaccine, will be given a third dose of the SCB-2019 vaccine at least 4 months after the second dose to assess the safety and efficacy of a booster (third) dose.
Study:
NCT04672395
Study Brief:
Protocol Section:
NCT04672395