At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 160 enrolled
Drug / intervention
BNT162b2 +1 morebiological
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.
A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, AND OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY JAPANESE ADULTS
In Brief
A Phase 4 clinical trial evaluating BNT162b2 and Placebo for SARS-CoV-2 Infection and COVID-19. Completed, enrolled 160 participants across 2 sites.
Detailed Summary
This is a Phase 1/2, randomized, placebo-controlled, and observer-blind study in healthy Japanese adults. The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against COVID-19: * As 2 doses, separated by 21 days * At a single dose level * In adults 20 to 85 years of age
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSARS-CoV-2 Infection, COVID-19
CountriesJapan
CollaboratorsPfizer
Timeline
Phase 4CompletedFinished
202120222023202420252026
First PostedOct 2020
Enrollment StartOct 2020
Primary CompletionNov 2021
TodayJul 2026
First PostedOct 19, 2020
Enrollment StartOct 21, 2020
Primary CompletionNov 25, 2021
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.7 years ago
Interventions
BNT162b2biological
BNT162b2 (intramuscular injection)
Placeboother
Placebo (intramuscular injection)