A multinational, phase 2, randomised, adaptive protocol to assess immune response and side effects of different COVID-19 vaccines given in older adults (75 years and older) already vaccinated against SARS-CoV-2

Phase 1

• Conditions: Prevention of COVID-19 infection; MedDRA version: 23.1Level: LLTClassification code 10084464Term: COVID-19 immunizationSystem Organ Class: 100000004865; MedDRA version: 23.1Level: LLTClassification code 10084465Term: COVID-19 vaccinationSystem Organ Class: 100000004865; MedDRA version: 24.0Level: LLTClassification code 10085559Term: Revaccination with different COVID-19 vaccineSystem Organ Class: 100000004865; MedDRA version: 23.0Level: LLTClassification code 10084462Term: SARS-CoV-2 vaccinationSystem Organ Class: 100000004865; MedDRA version: 23.0Level: LLTClassification code 10084463Term: SARS-CoV-2 immunisationSystem Organ Class: 100000004865; MedDRA version: 23.0Level: LLTClassification code 10084466Term: SARS-CoV-2 immunizationSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2021-004526-29-LT
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-12
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

•Subject is =75 years old.
•For study entry in Part B the subject was vaccinated with one of the following vaccination regimens (1st + 2nd + 3rd dose):
oBNT162b2 + BNT162b2 + BNT162b2
oBNT162b2 + BNT162b2 + mRNA-1273
omRNA-1273 + mRNA-1273 + mRNA-1273
omRNA-1273 + mRNA-1273 + BNT162b2
oChAdOx-1-S + ChAdOx-1-S + BNT162b2
oChAdOx-1-S + ChAdOx-1-S + mRNA-1273

•The last dose of the above vaccinations must have been administered at least 1 month prior to study entry. Vaccination status should be documented in the source data and will be captured in the eCRF.
•No contra-indication against any of the vaccine products in the trial.
•Written informed consent from subject has been obtained.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

Exclusion Criteria

•Prior to study entry the subject got vaccinated with a regimen not included in the above list.
•Last anti-SARS-CoV-2 vaccine dose administered less than one month prior to study entry.
•Vaccination against a disease other than COVID-19 within 2 weeks prior to study entry. Only exception: Influenza vaccination which is allowed at any time.
•Current immunosuppressive therapy, for example continuous glucocorticosteroid treatment equivalent to >10 mg/day prednisolone.
•Subject participates or participated in Part A of this trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified