NCT04922788

Study to Evaluate the Safety, Immunogenicity, and Efficacy of Nanocovax Vaccine Against COVID-19

a Phase 3, Adaptive, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Immunogenicity, and Efficacy of the Nanocovax Vaccine Against COVID-19 in Volunteer Subjects 18 Years of Age and Older.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13,006 (actual)
• Sponsor: Nanogen Pharmaceutical Biotechnology Joint Stock Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, immunogenicity, and efficacy of Nanocovax vaccine in volunteer subjects 18 years of age and older.

Detailed description

This is a phase 3, adaptive, multicenter, randomized, double-blind, placebo control study to evaluate the safety, immunogenicity, and efficacy of the Nanocovax vaccine against COVID-19 in volunteer subjects 18 years of age and older. Age stratified as 18-45, 45-60, and \> 60 years of age. The assessment of immunogenicity will be further expanded in a subset of Phase 3 (1000 participants). Randomly assigned to vaccine or placebo group with a ratio of 2:1 (2 subjects injected with Nanocovax 25 mcg : 1 subject injected with placebo).

Conditions

• SARS-CoV-2 Infection
• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Nanocovax	Recombinant Protein spike (s) SARS-CoV-2 and 0,5 mg Aluminum adjuvant
BIOLOGICAL	Placebo	0,5 mg Aluminum adjuvant

Timeline

• Start date: 2021-06-07
• Primary completion: 2022-07-20
• Completion: 2022-07-20
• First posted: 2021-06-11
• Last updated: 2025-03-27

Locations

1 site across 1 country: Vietnam