CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 256 enrolled
Drug / intervention
AZD1222 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04568031
NCT04568031Phase 2Completed
CompareCT.gov

A Phase I/II Randomized, Double-blind, Placebo-controlled Multicentre Study in Participants Aged 18 Years or Older to Determine the Safety and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19

AstraZeneca·interventional·Posted Sep 29, 2020·Updated Mar 1, 2024

In Brief

A Phase 2 clinical trial evaluating AZD1222 and 0.9% (w/v) saline for COVID-19. Completed, enrolled 256 participants across 5 sites.

Detailed Summary

The COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. Currently, there are no licensed preventions available against COVID-19 and accelerated vaccine development is urgently needed. A safe and effective vaccine for COVID 19 prevention would have significant global public health impact.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesJapan
CollaboratorsIQVIA Pty Ltd

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedSep 29, 2020
Enrollment StartAug 23, 2020
Primary CompletionNov 22, 2021
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.8 years ago

Interventions

AZD1222drug

For subjects in part 1 will have that route of Administration as Intramuscular, 5 × 1010 vp (nominal, ± 1.5 × 1010 vp) on V2

0.9% (w/v) salinedrug

For subjects in placebo will have that route of Administration as Intramuscular 0.9% (w/v) saline on V2 and V6.