NCT05012800

Safety and Immunogenicity of COVID-19 Vaccine Administered in Older Adults

Safety and Immunogenicity of COVID-19 Vaccine Administered in Older Adults: A Multicenter Prospective Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Beijing 302 Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The COVID-19 pandemic is causing unprecedented morbidity and mortality.The safe and effective Novel coronavirus vaccine is an effective means to block the transmission of the virus by building up the immune barrier of the population.Clinical studies have shown that elderly people are at high risk of severe COVID-19 infection and have poor clinical prognosis.Considering the current situation of aging population in China, the elderly people should be given priority to vaccinate to obtain protection and reduce the risk of novel coronavirus infection.However, the current data on vaccines are mostly from young and middle-aged healthy people, while there is little research data on COVID-19 vaccination in the elderly.This study mainly studied the safety and effectiveness of COVID-19 vaccine in the elderly population and explored its potential immune mechanism.

Detailed description

This study is a prospective, multicenter, controlled , open-label and phase I clinical trial. Older adults in the study included healthy people between the ages of 60 and 80 group. Those who is in line with the inclusion criteria and who is not in conformity with the exclusion criteria received two doses of COVID-19 vaccine at 0 days (baseline) and 21 days, respectively, and were followed up at 1, 3, 6, 9 and 12 months after completion of vaccination.

Conditions

• COVID-19 Vaccine
• Older Adults

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 Vaccine	Coronavirus vaccine was inoculated on day 0 and day 21, respectively.

Timeline

• Start date: 2021-07-28
• Primary completion: 2022-08-31
• Completion: 2022-09-30
• First posted: 2021-08-19
• Last updated: 2021-08-19

Locations

1 site across 1 country: China