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| Column | Value |
|---|---|
| Trial registration number | NCT05160766 |
|
Full text link
Last imported at : Dec. 18, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Dec. 18, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
2021-12-16 |
|
Recruitment status
Last imported at : Nov. 16, 2023, midnight Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : Dec. 18, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Dec. 18, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Dec. 18, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Adaptive |
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Masking
Last imported at : Dec. 18, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Dec. 18, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: subject is ≥75 years old). prior to study entry the subject was vaccinated with one of the following vaccination regimens (1st + 2nd + 3rd dose): bnt162b2 + bnt162b2 + bnt162b2 bnt162b2 + bnt162b2 + mrna-1273 mrna-1273 + mrna-1273 + mrna-1273 mrna-1273 + mrna-1273 + bnt162b2 chadox-1-s + chadox-1-s + bnt162b2 chadox-1-s + chadox-1-s + mrna-1273 the last dose of the above listed 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. - written informed consent from subject has been obtained. |
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Exclusion criteria
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
prior to study entry the subject got vaccinated with a regimen not included in the list given above. 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. subjects with any significant or uncontrolled disease posing a risk due to vaccination as judged by the investigator. current immunosuppressive therapy, for example continuous glucocorticosteroid treatment equivalent to >10 mg/day prednisolone. subject simultaneously participates in another clinical trials or has participated in the past 30 days. subjects unable to report solicited adverse events. subject with any contraindications to the vaccines in the trial. a list of contraindications as listed in the summary of medicinal product characteristics (smpc, the fachinformation in germany), if appropriate. |
|
Number of arms
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
6 |
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Funding
Last imported at : Dec. 18, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Oliver Cornely, MD |
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Inclusion age min
Last imported at : Dec. 18, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
75 |
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Inclusion age max
Last imported at : Dec. 18, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
Germany;Ireland;Lithuania;Norway;Spain |
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Type of patients
Last imported at : Dec. 18, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : Dec. 18, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
323 |
|
primary outcome
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
Antibody titre increase 14 days after 4th vaccination dose. |
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Notes
Last imported at : Dec. 18, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Dec. 18, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Single booster shot;Participants are already fully vaccinated with 2x Comirnaty (BNT162b2)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Single booster shot;Participants are already fully vaccinated with 2x Comirnaty (BNT162b2)", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Single booster shot;Participants are already fully vaccinated with 2x Spikevax (mRNA-1273)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Single booster shot;Participants are already fully vaccinated with 2x Spikevax (mRNA-1273)", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Single booster shot;Participants are already fully vaccinated with 2x Vaxzevria (ChAdOx-1-S)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Single booster shot;Participants are already fully vaccinated with 2x Vaxzevria (ChAdOx-1-S)", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}] |