CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 539 enrolled
Drug / intervention
Comirnaty (COVID-19, mRNA vaccine)biological
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/NCT04780659
NCT04780659Phase 4Completed
CompareCT.gov

Immunological Responses After Vaccination for COVID-19 With the Messenger Ribonucleic Acid (mRNA) Vaccine Comirnaty in Immunosuppressed and Immunocompetent Individuals. An Open and Non-randomized, Phase IV Multicenter Study

Karolinska University Hospital·interventional·Posted Mar 3, 2021·Updated Dec 4, 2025

In Brief

A Phase 4 clinical trial evaluating Comirnaty (COVID-19, mRNA vaccine) for Covid19. Completed, enrolled 539 participants across 1 site.

Detailed Summary

The study is designed as an open, non-randomized, phase IV cohort study in which the mRNA vaccine Comirnaty will be given in two doses. Analyses will be performed on blood and saliva, investigating humoral and cellular vaccine responses. Occurence of local or systemic reactogenicity will be evaluated, as well as adverse events. The study will include persons with primary or secondary immunosuppressive disorders, as well as immunocompetent persons, with the aim of investigating if the immune responses after given Comirnaty mRNA vaccine against COVID-19.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesSweden
CollaboratorsKarolinska Institutet

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedMar 3, 2021
Enrollment StartFeb 23, 2021
Primary CompletionOct 15, 2021
Study CompletionMay 8, 2024
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.3 years ago

Interventions

Comirnaty (COVID-19, mRNA vaccine)biological

Comirnaty will be administered two times, one at Day 0 and the second dose at Day 21.