NCT05212610Befejeződött4. fázis
Assessing Safety of Coronavirus Infection (COVID-19) Messenger RNA (mRNA) Vaccine Administration in the Setting of a Previous Adverse Reaction
Assessing Safety of COVID-19 mRNA Vaccine Administration in the Setting of a Previous Adverse Reaction
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. márc. 27.
Rövid összefoglaló (regiszter, angolul)
This study will evaluate the safety of administering an additional dose of an mRNA COVID-19 vaccine or mRNA bivalent COVID-19 booster vaccine to individuals who have had adverse reactions to a previous dose or administering an initial dose of an mRNA COVID-19 vaccine to individuals with a personal history of allergic reaction. In addition, this study will evaluate the safety of administering an initial or additional dose or bivalent booster of an mRNA COVID-19 vaccine to individuals experiencing an adverse reaction to a natural COVID-19 infection ("long COVID"). Eligible participants enrolled in this trial will receive an initial or additional dose of either the Pfizer-BioNTech COVID-19 bivalent vaccine or the Moderna COVID-19 bivalent vaccine. Participants will also be required to have 1-2 in person visits along with phone call follow up visits. We hypothesize that individuals who have had adverse reactions to a previous dose of an mRNA COVID-19 vaccine will tolerate an additional dose of the primary mRNA vaccine or bivalent booster, as indicated, and those with a personal history of allergic reaction will tolerate an initial dose of an mRNA COVID-19 vaccine. We also hypothesize that those individuals experiencing an adverse reaction will tolerate an initial or additional dose of a primary mRNA COVID-19 bivalent vaccine, as indicated. The study hypothesizes that individuals that have had adverse reactions to a dose of an mRNA COVID-19 vaccine will tolerate an additional dose and those with a personal history of allergic reaction will tolerate vaccination with an mRNA COVID-19 vaccine.
- Állapot (regiszter)
- Befejeződött
- Fázis (regiszter)
- 4. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 137 (tényleges)
- Első benyújtás
- 2022. jan. 26.
- Kezdés
- 2022. márc. 21.
- Elsődleges befejezés
- 2025. márc. 7.
- Fő szponzor
- University of Michigan
- Betegségek
- Long COVID és ME/CFS
- NCT-szám
- NCT05212610
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 4. fázis
- Bevont résztvevők: 137
- 2022. márc. 21. és az elsődleges befejezés (2025. márc. 7.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- History of underlying immune disorder.
- Pregnancy
- Immunocompromised
- Persons with primary or acquired immunodeficiency
- Persons on anti-rejection therapy following solid organ transplant or bone marrow transplant
- Persons on biologic therapeutic agents
- Persons with malignancy and ongoing or recent chemotherapy
- Persons receiving systemic immunosuppressive therapy, including corticosteroids equivalent to 20 mg/day of prednisone for 2 weeks
- Persons with chronic kidney disease stage 3 or higher
- Persons with history of significant pulmonary compromise
Más betegség
- Evidence of COVID-19 infection within 21 days of vaccination visit
- History of antibody agent or convalescent plasma for treatment or prevention of COVID-19 within 90 days
- Individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech mRNA COVID-19 vaccination or the Moderna mRNA COVID-19 vaccination.
Életkor
- Under age 18
Egyéb
- Inability or unwillingness of a participant to give written informed consent
Kiket keres a vizsgálat
- Age over 18.
- Participant must be able to understand and provide informed consent
- No evidence of infectious illness (defined as fever >38⁰C, vomiting, diarrhea, new cough, new shortness of breath, new congestion, new runny nose, new headache or sore throat) within 14 days of vaccine administration.
- Subjects must have a history of adverse reaction to either the Pfizer-BioNTech mRNA COVID vaccination or the Moderna mRNA COVID vaccination, a personal history of allergic reaction without prior mRNA COVID vaccination, or a history of adverse reaction to natural COVID infection.
- Females of childbearing potential must have a negative pregnancy test prior to vaccination.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of Michigan | Ann Arbor | Egyesült Államok | Ismeretlen állapot |
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