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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-004526-29 | EudraCT Number | ||
| uni-koeln-4602 | Other Identifier | University of Cologne |
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| Name | Class |
|---|---|
| VACCELERATE | UNKNOWN |
| European Commission | OTHER |
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This is a randomised controlled, adaptive, multicentre Phase II protocol evaluating different booster strategies in individuals aged 75 years and older already vaccinated against SARS-CoV-2.
Part A of this trial foresees testing of different vaccines as a 3rd vaccination dose (first booster) for comparative assessment of their immunogenicity and safety against SARS-CoV-2 wild-type and variants in the elderly, a usually neglected population.
Part B of this trial foresees testing of different vaccines as a 4th vaccination dose (second booster) for comparative assessment of their immunogenicity and safety against SARSCoV-2 wild-type and variants in the identical population.
Part A of the present trial in which individuals received a 3rd vaccination (first booster) of either BNT162b2 or mRNA-1273 was closed to further recruitment as of January 13, 2022. This was due to a change in vaccination policies, recommending a 3rd vaccination with either BNT162b2 or mRNA-1273. Therefore, Part A was supplanted by Part B that investigated a 4th COVID-19 vaccination and started on 21 Jan 2022.
The initial study protocol started the trial with Part A in which participants were randomized to a 3rd vaccination (first booster) with either BNT162b2 or mRNA-1273:
Subjects who - prior to study entry - received a vaccination series of either BNT162b2 & BNT162b2 or mRNA-1273 & mRNA-1273 or ChAdOx-1-S & ChAdOx-1-S.
For the reasons mentioned above, the study protocol was amended to continue the trial with Part B in which participants were randomized to a 4th vaccination (second booster) with either BNT162b2 or mRNA-1273:
Subjects who - prior to study entry - received a vaccination series of either BNT162b2 & BNT162b2 & BNT162b2 or BNT162b2 & BNT162b2 & mRNA-1273 or mRNA-1273 & mRNA-1273 & mRNA-1273 or mRNA-1273 & mRNA-1273 & BNT162b2 or ChAdOx-1-S & ChAdOx-1-S & BNT162b2 or ChAdOx-1-S & ChAdOx-1-S & mRNA-1273.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BNT162b2 (Part A) | Active Comparator | vaccination with BNT162b2 as 3rd vaccination |
|
| mRNA-1273 (Part A) | Active Comparator | vaccination with mRNA-1273 as 3rd vaccination |
|
| BNT162b2 (Part B) | Active Comparator | vaccination with BNT162b2 as 4th vaccination |
|
| mRNA-1273 (Part B) | Active Comparator | vaccination with mRNA-1273 as 4th vaccination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comirnaty (BTN162b2) | Biological | Single booster shot (3rd dose in Part A and 4th dose in Part B) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Titre Increase 14 Days After Study Vaccination Dose. | Rate of 2-fold antibody titre increase 14 days after 3rd (Part A) or 4th vaccination dose (Part B) measured by qualitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA) against wildtype virus. | From Day 0 until Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neutralizing Antibody Titre Against Wild-type 14 Days After Study Vaccination Dose | Change in neutralizing antibody titre (Virus Neutralisation Assay) against wild-type 14 days after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only. Microneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients' antibodies neutralizing capacities. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Unsolicited AEs | Number of Participants with Unsolicited AEs until the end of trial | From Day 0 until Month 12 |
| Number of Participants With Solicited AEs | Number of Participants with Solicited AEs for 7 days after study vaccination dose. |
Inclusion Criteria (Part A):
BNT162b2 + BNT162b2
mRNA-1273 + mRNA-1273
ChAdOx-1-S + ChAdOx-1-S
Exclusion Criteria (Part A):
Inclusion Criteria (Part B):
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.
Exclusion Criteria (Part B):
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| Name | Affiliation | Role |
|---|---|---|
| Oliver A Cornely, MD | University of Cologne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Cologne | Cologne | 50931 | Germany | |||
| University Hospital Frankfurt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36209129 | Derived | Neuhann JM, Stemler J, Carcas A, Frias-Iniesta J, Bethe U, Heringer S, Tischmann L, Zarrouk M, Cuppers A, Konig F, Posch M, Cornely OA. A multinational, phase 2, randomised, adaptive protocol to evaluate immunogenicity and reactogenicity of different COVID-19 vaccines in adults >/=75 already vaccinated against SARS-CoV-2 (EU-COVAT-1-AGED): a trial conducted within the VACCELERATE network. Trials. 2022 Oct 8;23(1):865. doi: 10.1186/s13063-022-06791-y. |
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Making de-identified/anonymized data accessible is currently under way. We expect to grant access through a central independent data repository no later than January 2025. Any pertinent information will be updated in due course.
Making de-identified/anonymized data accessible is currently under way. We expect to grant access through a central independent data repository no later than January 2025. Any pertinent information will be updated in due course.
To be announced.
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Due to poor recruitment, Part A of the trial (3rd COVID-19 vaccination) was closed to further enrolment on 13 Jan 2022. Part B (4th COVID-19 vaccination) started on 21 Jan 2022.
In Part A, one randomised subject did not receive the allocated intervention (mRNA-1273) due to an acute onset of SARS-CoV-2 infection.
Both Part A and B belong to one trial and fall under one NCT number.
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| ID | Title | Description |
|---|---|---|
| FG000 | BNT162b2 (Part A) | Part A: Participants were pre-vaccinated with 2 vaccinations when entering the trial, as follows: BNT162b2 + BNT162b2 mRNA-1273 + mRNA-1273 ChAdOx-1-S + ChAdOx-1-S A 3rd dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273). |
| FG001 | mRNA-1273 (Part A) | Part A: Participants were pre-vaccinated with 2 vaccinations when entering the trial, as follows: BNT162b2 + BNT162b2 mRNA-1273 + mRNA-1273 ChAdOx-1-S + ChAdOx-1-S A 3rd dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273). |
| FG002 | BTN162b2 (Part B) | Part B: Participants were pre-vaccinated with 3 vaccinations when entering the trial, as follows: 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 A 4th dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273). |
| FG003 | mRNA-1273 (Part B) | Part B: Participants were pre-vaccinated with 3 vaccinations when entering the trial, as follows: 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 A 4th dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BNT162b2 (Part A) | Part A: Participants were pre-vaccinated with 2 vaccinations when entering the trial, as follows: BNT162b2 + BNT162b2 mRNA-1273 + mRNA-1273 ChAdOx-1-S + ChAdOx-1-S A 3rd dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Antibody Titre Increase 14 Days After Study Vaccination Dose. | Rate of 2-fold antibody titre increase 14 days after 3rd (Part A) or 4th vaccination dose (Part B) measured by qualitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA) against wildtype virus. | All primary analyses were performed on the mITT population set. The primary endpoint was the rate π of 2-fold IgG antibody titre increase following a 3rd (Part A) or 4th dose vaccination (Part B) measured by quantitative enzyme-linked electrochemiluminescent immunoassay (Anti-RBD-ELISA) against wild-type virus at 14 days after study vaccination (versus immediately before vaccination). | Posted | Number | 97.5% Confidence Interval | percentage of participants | From Day 0 until Day 14 |
|
AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BNT162b2 (Part A) | vaccination with BNT162b2 as 3rd vaccination Comirnaty (BTN162b2): Single booster shot (3rd dose) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. med. Oliver A. Cornely | University Hospital Cologne | 0049 221 478 85523 | oliver.cornely@uk-koeln.de |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 27, 2022 | Oct 9, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 2, 2022 | Oct 9, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
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This is a randomised controlled, adaptive, multicentre Phase II protocol evaluating different booster strategies in individuals aged 75 years and older already vaccinated against SARS-CoV-2. This trial foresees testing of different vaccines as a third (first booster, Part A) or fourth vaccine dose (second booster, Part B) for comparative assessment of their immunogenicity and safety against SARS-CoV-2 and SARS-CoV-2 variants in the elderly.
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No blinding is foreseen in this trial.
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| Spikevax (mRNA-1273) | Biological | Single booster shot (3rd dose in Part A and 4th dose in Part B) |
|
| From Day 0 until Day 14 |
| Change in Neutralizing Antibody Titre Against Variants of Concern 14 Days After Study Vaccination Dose | Change in neutralizing antibody titre (Virus Neutralisation Assay) against variants of concern 14 days after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only. Microneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients' antibodies neutralizing capacities. | From Day 0 until Day 14 |
| Antibody Titre Level at 12 Months After a Study Vaccination Dose | Antibody titre level at 12 months after a 3rd (Part A) or 4th vaccination dose (Part B) measured by a quantitative enzyme-linked immunosorbent assay (anti-RBD-ELISA assay). | From Day 0 until Month 12 |
| Neutralizing Antibody Titre Against Wild-type at 12 Months After Study Vaccination Dose | Neutralizing antibody titre (Virus Neutralisation Assay) against wild-type SARS-CoV-2 at 12 months after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only. Microneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients' antibodies neutralizing capacities. | From Day 0 until Month 12 |
| Neutralizing Antibody Titre Against Variants of Concern at 12 Months After Study Vaccination Dose | Neutralizing antibody titre (Virus Neutralisation Assay) against variants of concern at 12 months after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only. Microneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients' antibodies neutralizing capacities. | From Day 0 until Month 12 |
| From Day 0 until Day 7 |
| Number of Participants With Rate of SAEs Grade ≥3 | Number of Participants with Rate of serious adverse events (SAEs) Grade ≥3 according to the National Cancer Institute Common Toxicity Criteria up to three months after study vaccination dose. | From Day 0 until Month 3 |
| Change in Cellular Immune Response Measured by qPCR 14 Days After 4th Vaccination Dose | Change in cellular immune response (CD4+ and CD8+ T cell response) to SARS-CoV-2 measured by fold change of CXCL10 mRNA levels measured by qPCR after 4th vaccination dose, to be determined in a subgroup only. | From Day 0 until Day 14 |
| Neutralizing Antibody Titre Against Newly Emerging Variants in Bio-banked Samples After Study Vaccination Dose | "Neutralizing antibody titre (Virus Neutralisation Assay)" against newly emerging variants in bio-banked samples after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only. Microneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients' antibodies neutralizing capacities. | From Day 0 until Month 12 |
| Frankfurt |
| 60590 |
| Germany |
| Hannover Medical School Hospital | Hanover | 30625 | Germany |
| Vilnius University Hospital Santaros Klinikos | Vilnius | 08661 | Lithuania |
| Helse Bergen HF, Haukeland University Hospital | Bergen | 5021 | Norway |
| Hospital Universitari Germans Trias i Pujol | Badalona | 08916 | Spain |
| Reina Sofia University Hospital | Córdoba | 14004 | Spain |
| La Paz University Hospital | Madrid | 28046 | Spain |
| Biodonostia Health Research Institute | San Sebastián | 20014 | Spain |
| COVID-19 infection |
|
| travel time |
|
| Withdrawal by Subject |
|
| Death |
|
| Lost to Follow-up |
|
| No show |
|
| Physician Decision |
|
| Protocol Violation |
|
| mRNA-1273 (Part A) |
Part A: Participants were pre-vaccinated with 2 vaccinations when entering the trial, as follows: BNT162b2 + BNT162b2 mRNA-1273 + mRNA-1273 ChAdOx-1-S + ChAdOx-1-S A 3rd dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273). |
| BG002 | BNT162b2 (Part B) | Part B: Participants were pre-vaccinated with 3 vaccinations when entering the trial, as follows: 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 A 4th dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273). |
| BG003 | mRNA-1273 (Part B) | Part B: Participants were pre-vaccinated with 3 vaccinations when entering the trial, as follows: 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 A 4th dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273). |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Height | Median | Full Range | cm |
|
| Weight | Median | Full Range | kg |
|
| BMI | Median | Full Range | kg/m2 |
|
| Duration between 1st and 2nd vaccination in days | Median | Full Range | days |
|
| Duration between 2nd and 3rd vaccination in days | Median | Full Range | days |
|
| OG001 | mRNA-1273 (Part A) | vaccination with mRNA-1273 as 3rd vaccination Spikevax (mRNA-1273): Single booster shot (3rd dose) |
| OG002 | BNT162b2 (Part B) | vaccination with BNT162b2 as 4th vaccination Comirnaty (BTN162b2): Single booster shot (4th dose) |
| OG003 | mRNA-1273 (Part B) | vaccination with mRNA-1273 as 4th vaccination Spikevax (mRNA-1273): Single booster shot (4th dose) |
|
|
| Secondary | Change in Neutralizing Antibody Titre Against Wild-type 14 Days After Study Vaccination Dose | Change in neutralizing antibody titre (Virus Neutralisation Assay) against wild-type 14 days after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only. Microneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients' antibodies neutralizing capacities. | Number of subjects for whom the difference of neutralizing activity (Day 14 minus Day 0) could be calculated. | Posted | Mean | Standard Deviation | percentage of inhibition | From Day 0 until Day 14 |
|
|
|
|
| Secondary | Change in Neutralizing Antibody Titre Against Variants of Concern 14 Days After Study Vaccination Dose | Change in neutralizing antibody titre (Virus Neutralisation Assay) against variants of concern 14 days after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only. Microneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients' antibodies neutralizing capacities. | Posted | Mean | Standard Deviation | percentage of inhibition | From Day 0 until Day 14 |
|
|
|
|
| Secondary | Antibody Titre Level at 12 Months After a Study Vaccination Dose | Antibody titre level at 12 months after a 3rd (Part A) or 4th vaccination dose (Part B) measured by a quantitative enzyme-linked immunosorbent assay (anti-RBD-ELISA assay). | Subjects in whom a blood sampling was performed at Month 12. | Posted | Geometric Mean | Standard Deviation | IU/ml | From Day 0 until Month 12 |
|
|
|
| Secondary | Neutralizing Antibody Titre Against Wild-type at 12 Months After Study Vaccination Dose | Neutralizing antibody titre (Virus Neutralisation Assay) against wild-type SARS-CoV-2 at 12 months after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only. Microneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients' antibodies neutralizing capacities. | Titres of neutralizing antibodies were reported as change in neutralization capacity. | Posted | Mean | Standard Deviation | percentage of inhibition | From Day 0 until Month 12 |
|
|
|
| Secondary | Neutralizing Antibody Titre Against Variants of Concern at 12 Months After Study Vaccination Dose | Neutralizing antibody titre (Virus Neutralisation Assay) against variants of concern at 12 months after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only. Microneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients' antibodies neutralizing capacities. | Titres of neutralizing antibodies were reported as change in neutralization capacity. Provided values refer to the variant "B.1.1.7 (alpha)". Besides for B.1.1.7 (alpha), all tests described above were also conducted for the following variants of concern: B.1.351 (beta), P.1 (gamma), BA.1 (omicron), BA.4 (omicron), BA.4.6 (omicron), and BA.5 (omicron). For values of these variants of concern, please see the open-access publication. | Posted | Mean | Standard Deviation | percentage of inhibition | From Day 0 until Month 12 |
|
|
|
|
| Other Pre-specified | Number of Participants With Unsolicited AEs | Number of Participants with Unsolicited AEs until the end of trial | Posted | Count of Participants | Participants | From Day 0 until Month 12 |
|
|
|
| Other Pre-specified | Number of Participants With Solicited AEs | Number of Participants with Solicited AEs for 7 days after study vaccination dose. | Posted | Count of Participants | Participants | From Day 0 until Day 7 |
|
|
|
| Other Pre-specified | Number of Participants With Rate of SAEs Grade ≥3 | Number of Participants with Rate of serious adverse events (SAEs) Grade ≥3 according to the National Cancer Institute Common Toxicity Criteria up to three months after study vaccination dose. | Provided values refer to SAEs related to the IMP. All other trial data is available upon request. | Posted | Count of Participants | Participants | From Day 0 until Month 3 |
|
|
|
| Other Pre-specified | Change in Cellular Immune Response Measured by qPCR 14 Days After 4th Vaccination Dose | Change in cellular immune response (CD4+ and CD8+ T cell response) to SARS-CoV-2 measured by fold change of CXCL10 mRNA levels measured by qPCR after 4th vaccination dose, to be determined in a subgroup only. | Inclusion required completed visits at Day 0 and Day 14 with a sufficient number of aliquots as per CTP. Provided results are absolute values of the cellular immune response on Day 14 of tubes stimulated with peptides from spike (tube A). Samples were also stimulated with peptides from a virus membrane nucleoprotein (tube B) and with peptides from the Omicron variant (tube C). All trial results will be provided upon request. | Posted | Mean | Standard Deviation | Fold change of CXCL10 mRNA levels | From Day 0 until Day 14 |
|
|
|
| Other Pre-specified | Neutralizing Antibody Titre Against Newly Emerging Variants in Bio-banked Samples After Study Vaccination Dose | "Neutralizing antibody titre (Virus Neutralisation Assay)" against newly emerging variants in bio-banked samples after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only. Microneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients' antibodies neutralizing capacities. | Titres of neutralizing antibodies were reported as change in neutralization capacity. Provided values refer to the VoI "XBB.1 (omicron)". | Posted | Mean | Standard Deviation | percentage of inhibition | From Day 0 until Month 12 |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 20 |
| 25 |
| EG001 | mRNA-1273 (Part A) | vaccination with mRNA-1273 as 3rd vaccination Spikevax (mRNA-1273): Single booster shot (3rd dose) | 0 | 27 | 0 | 27 | 25 | 27 |
| EG002 | BNT162b2 (Part B) | vaccination with BNT162b2 as 4th vaccination Comirnaty (BTN162b2): Single booster shot (4th dose) | 2 | 135 | 21 | 135 | 103 | 135 |
| EG003 | mRNA-1273 (Part B) | vaccination with mRNA-1273 as 4th vaccination Spikevax (mRNA-1273): Single booster shot (4th dose) | 5 | 135 | 22 | 135 | 110 | 135 |
| Angina pectoris | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Sinus node dysfunction | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
|
| Amaurosis fugax | Eye disorders | MedDRA 26.1 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 26.1 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 26.1 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Abdominal sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Diarrhoea infectious | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Femoral neck fracture | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Pelvic fracture | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
|
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
|
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
|
| Brain stem stroke | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Obstructive sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Vertebroplasty | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Anaemia megaloblastic | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
|
| Blindness unilateral | Eye disorders | MedDRA 26.1 | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 26.1 | Systematic Assessment |
|
| Eye oedema | Eye disorders | MedDRA 26.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 26.1 | Systematic Assessment |
|
| Myopic chorioretinal degeneration | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Discomfort | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Extensive swelling of vaccinated limb | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Injection site dysaesthesia | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Injection site urticaria | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Injection site vesicles | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Swelling face | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Vaccination site movement impairment | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Acarodermatitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Bronchitis bacterial | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| COVID-19 pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Pulpitis dental | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Heart rate decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Lipids increased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| SARS-CoV-2 test positive | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
|
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
|
| Extranodal marginal zone B-cell lymphoma (MALT type) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Vertigo positional | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Apathy | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
|
| Paraphimosis | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Lens extraction | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
|
| Skin neoplasm excision | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Superficial vein thrombosis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Injection site discomfort | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Injection site movement impairment | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Injection site oedema | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Injection site pain | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
| Male |
|
| ANCOVA |
| 0.0101 |
| Difference of means in percent |
| 4.331 |
| Standard Error of the Mean |
| 1.671 |
| 2-Sided |
| 95 |
| 1.04 |
| 7.621 |
| Other |
This statistical analysis reflects Part A of the study. |
| ANCOVA |
| 0.01744 |
| Difference of means in percent |
| 14.212 |
| Standard Error of the Mean |
| 5.767 |
| 2-Sided |
| 95 |
| 2.61 |
| 25.814 |
| Other |
The above provided values refer to the variant "B.1.351 (beta)". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.02039 | Difference of means in percent | 14.239 | Standard Error of the Mean | 5.932 | 2-Sided | 95 | 2.305 | 26.173 | Other | The above provided values refer to the variant "P.1 (gamma)". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.04989 | Difference of means in percent | 9.331 | Standard Error of the Mean | 4.636 | 2-Sided | 95 | 0.005 | 18.656 | Other | The above provided values refer to the variant "BA.1 (omicron)". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.02259 | Difference of means in percent | 10.312 | Standard Error of the Mean | 4.373 | 2-Sided | 95 | 1.514 | 19.111 | Other | The above provided values refer to the variant "BA.4 (omicron)". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.01583 | Difference of means in percent | 11.601 | Standard Error of the Mean | 4.634 | 2-Sided | 95 | 2.279 | 20.924 | Other | The above provided values refer to the variant "BA.4.6 (omicron)". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.00856 | Difference of means in percent | 11.863 | Standard Error of the Mean | 4.323 | 2-Sided | 95 | 3.166 | 20.56 | Other | The above provided values refer to the variant "BA.5 (omicron)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.00258 | Difference of means in percent | 6.83 | Standard Error of the Mean | 2.244 | 2-Sided | 95 | 2.41 | 11.249 | Other | The above provided values refer to the variant "B.1.1.7 (alpha)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.00748 | Difference of means in percent | 6.048 | Standard Error of the Mean | 2.244 | 2-Sided | 95 | 1.63 | 10.466 | Other | The above provided values refer to the variant "B.1.351 (beta)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.00922 | Difference of means in percent | 7.302 | Standard Error of the Mean | 2.782 | 2-Sided | 95 | 1.821 | 12.782 | Other | The above provided values refer to the variant "P.1 (gamma)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.07136 | Difference of means in percent | 4.791 | Standard Error of the Mean | 2.646 | 2-Sided | 95 | -0.419 | 10.001 | Other | The above provided values refer to the variant "BA.1 (omicron)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.07218 | Difference of means in percent | 3.965 | Standard Error of the Mean | 2.196 | 2-Sided | 95 | -0.36 | 8.29 | Other | The above provided values refer to the variant "BA.4 (omicron)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.02949 | Difference of means in percent | 4.82 | Standard Error of the Mean | 2.202 | 2-Sided | 95 | 0.484 | 9.155 | Other | The above provided values refer to the variant "BA.4.6 (omicron)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.08403 | Difference of means in percent | 3.926 | Standard Error of the Mean | 2.263 | 2-Sided | 95 | -0.531 | 8.382 | Other | The above provided values refer to the variant "BA.5 (omicron)". |
This statistical analysis reflects Part A of the study. |
| ANCOVA |
| 0.73961 |
| Difference of means in percent |
| 3.54 |
| Standard Error of the Mean |
| 10.575 |
| 2-Sided |
| 95 |
| -17.85 |
| 24.929 |
| Other |
The above provided values refer to the variant "B.1.351 (beta)". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.45370 | Difference of means in percent | 8.086 | Standard Error of the Mean | 10.683 | 2-Sided | 95 | -13.524 | 29.695 | Other | The above provided values refer to the variant "P.1 (gamma)". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.87323 | Difference of means in percent | 1.636 | Standard Error of the Mean | 10.187 | 2-Sided | 95 | -18.969 | 22.241 | Other | The above provided values refer to the variant "BA.1 (omicron)". |
| This statistical analysis relfects Part A of the study. | ANCOVA | 0.93489 | Difference of means in percent | 0.81 | Standard Error of the Mean | 9.848 | 2-Sided | 95 | -19.109 | 20.728 | Other | The above provided values refer to the variant "BA.4 (omicron)". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.74784 | Difference of means in percent | 3.511 | Standard Error of the Mean | 10.845 | 2-Sided | 95 | -18.425 | 25.448 | Other | The above provided values refer to the variant "BA.4.6 (omicron)". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.84202 | Difference of means in percent | 2.088 | Standard Error of the Mean | 10.409 | 2-Sided | 95 | -18.966 | 23.143 | Other | The above provided values refer to the variant "BA.5 (omicron)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.15477 | Difference of means in percent | 5.807 | Standard Error of the Mean | 4.068 | 2-Sided | 95 | -2.207 | 13.821 | Other | The above provided values refer to the variant "B.1.1.7 (alpha)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.37773 | Difference of means in percent | 3.52 | Standard Error of the Mean | 3.984 | 2-Sided | 95 | -4.327 | 11.368 | Other | The above provided values refer to the variant "B.1.351 (beta)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.29212 | Difference of means in percent | 4.413 | Standard Error of the Mean | 4.18 | 2-Sided | 95 | -3.821 | 12.647 | Other | The above provided values refer to the variant "P.1 (gamma)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.14140 | Difference of means in percent | 5.961 | Standard Error of the Mean | 4.04 | 2-Sided | 95 | -1.998 | 13.919 | Other | The above provided values refer to the variant "BA.1 (omicron)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.57090 | Difference of means in percent | 2.199 | Standard Error of the Mean | 3.875 | 2-Sided | 95 | -5.434 | 9.832 | Other | The above provided values refer to the variant "BA.4 (omicron)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.11012 | Difference of means in percent | 6.528 | Standard Error of the Mean | 4.071 | 2-Sided | 95 | -1.491 | 14.548 | Other | The above provided values refer to the variant "BA.4.6 (omicron)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.29755 | Difference of means in percent | 4.239 | Standard Error of the Mean | 4.06 | 2-Sided | 95 | -3.759 | 12.237 | Other | The above provided values refer to the variant "BA.5 (omicron)". |
This statistical analysis reflects Part A of the study. |
| ANCOVA |
| 0.42055 |
| Difference of means in percent |
| 8.764 |
| Standard Error of the Mean |
| 10.765 |
| 2-Sided |
| 95 |
| -13.011 |
| 30.539 |
| Other |
The above provided values refer to the variant "B.1.617". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.44391 | Difference of means in percent | 8.472 | Standard Error of the Mean | 10.953 | 2-Sided | 95 | -13.683 | 30.627 | Other | The above provided values refer to the variant "B.1.617.1 (kappa)". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.43775 | Difference of means in percent | 8.483 | Standard Error of the Mean | 10.82 | 2-Sided | 95 | -13.402 | 30.368 | Other | The above provided values refer to the variant "AY.3 (delta)". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.53511 | Difference of means in percent | 6.19 | Standard Error of the Mean | 9.892 | 2-Sided | 95 | -13.819 | 26.2 | Other | The above provided values refer to the variant "AY.4.2 (delta)". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.67576 | Difference of means in percent | 4.552 | Standard Error of the Mean | 10.801 | 2-Sided | 95 | -17.295 | 26.399 | Other | The above provided values refer to the variant "B.1.617.3". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.45443 | Difference of means in percent | 8.438 | Standard Error of the Mean | 11.168 | 2-Sided | 95 | -14.15 | 31.027 | Other | The above provided values refer to the variant "B.1.526.1 (iota)". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.38904 | Difference of means in percent | 8.901 | Standard Error of the Mean | 10.218 | 2-Sided | 95 | -11.768 | 29.569 | Other | The above provided values refer to the variant "BA.2+L452M (omicron)". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.47466 | Difference of means in percent | 7.302 | Standard Error of the Mean | 10.11 | 2-Sided | 95 | -13.147 | 27.751 | Other | The above provided values refer to the variant "BA.2+L452R (omicron)". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.77110 | Difference of means in percent | 2.878 | Standard Error of the Mean | 9.824 | 2-Sided | 95 | -16.993 | 22.749 | Other | The above provided values refer to the variant "BA.2.12.1 (omicron)". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.86646 | Difference of means in percent | 1.753 | 2-Sided | 95 | -19.195 | 22.701 | Other | The above provided values refer to the variant "BA.2.75 (omicron)". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.57972 | Difference of means in percent | 5.42 | Standard Error of the Mean | 9.705 | 2-Sided | 95 | -14.21 | 25.049 | Other | The above provided values refer to the variant "BA.2.75.2 (omicron)". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.90166 | Difference of means in percent | 1.17 | Standard Error of the Mean | 9.408 | 2-Sided | 95 | -17.859 | 20.199 | Other | The above provided values refer to the variant "BA.3 (omicron)". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.92279 | Difference of means in percent | 1.018 | Standard Error of the Mean | 10.44 | 2-Sided | 95 | -20.099 | 22.136 | Other | The above provided values refer to the variant "BF.7 (omicron)". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.71191 | Difference of means in percent | 3.532 | Standard Error of the Mean | 9.496 | 2-Sided | 95 | -15.675 | 22.74 | Other | The above provided values refer to the variant "BQ.1 (omicron)". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.73415 | Difference of means in percent | 2.995 | Standard Error of the Mean | 8.755 | 2-Sided | 95 | -14.714 | 20.703 | Other | The above provided values refer to the variant "BQ.1.1 (omicron)". |
| This statistical analysis reflects Part A of the study. | ANCOVA | 0.45798 | Difference of means in percent | 7.157 | Standard Error of the Mean | 9.548 | 2-Sided | 95 | -12.155 | 26.469 | Other | The above provided values refer to the variant "XBB.1 (omicron)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.23582 | Difference of means in percent | 4.819 | Standard Error of the Mean | 4.055 | 2-Sided | 95 | -3.169 | 12.808 | Other | The above provided values refer to the variant "P.2 (gamma)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.19354 | Difference of means in percent | 5.312 | Standard Error of the Mean | 4.074 | 2-Sided | 95 | -2.713 | 13.337 | Other | The above provided values refer to the variant "B.1.617". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.17033 | Difference of means in percent | 5.714 | Standard Error of the Mean | 4.155 | 2-Sided | 95 | -2.471 | 13.899 | Other | The above provided values refer to the variant "B.1.617.1 (kappa)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.13895 | Difference of means in percent | 5.934 | Standard Error of the Mean | 3.997 | 2-Sided | 95 | -1.94 | 13.808 | Other | The above provided values refer to the variant "AY.3 (delta)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.26924 | Difference of means in percent | 4.222 | Standard Error of the Mean | 3.812 | 2-Sided | 95 | -3.288 | 11.732 | Other | The above provided values refer to the variant "AY.4.2 (delta)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.17080 | Difference of means in percent | 5.49 | Standard Error of the Mean | 3.996 | 2-Sided | 95 | -2.382 | 13.362 | Other | The above provided values refer to the variant "B.1.617.3". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.18502 | Difference of means in percent | 5.567 | Standard Error of the Mean | 4.188 | 2-Sided | 95 | -2.683 | 13.818 | Other | The above provided values refer to the variant "B.1.526.1 (iota)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.38344 | Difference of means in percent | 3.438 | Standard Error of the Mean | 3.938 | 2-Sided | 95 | -4.318 | 11.195 | Other | The above provided values refer to the variant "BA.2+L452M (omicron)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.41100 | Difference of means in percent | 3.279 | Standard Error of the Mean | 3.982 | 2-Sided | 95 | -4.565 | 11.124 | Other | The above provided values refer to the variant "BA.2+L452R (omicron)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.50660 | Difference of means in percent | 2.67 | Standard Error of the Mean | 4.014 | 2-Sided | 95 | -5.237 | 10.577 | Other | The above provided values refer to the variant "BA.2.12.1 (omicron)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.28604 | Difference of means in percent | 4.535 | Standard Error of the Mean | 4.242 | 2-Sided | 95 | -3.82 | 12.891 | Other | The above provided values refer to the variant "BA.2.75 (omicron)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.11715 | Difference of means in percent | 6.259 | Standard Error of the Mean | 3.98 | 2-Sided | 95 | -1.582 | 14.1 | Other | The above provided values refer to the variant "BA.2.75.2 (omicron)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.33567 | Difference of means in percent | 3.818 | Standard Error of the Mean | 3.957 | 2-Sided | 95 | -3.978 | 11.613 | Other | The above provided values refer to the variant "BA.3 (omicron)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.15232 | Difference of means in percent | 5.775 | Standard Error of the Mean | 4.022 | 2-Sided | 95 | -2.147 | 13.697 | Other | The above provided values refer to the variant "BF.7 (omicron)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.21234 | Difference of means in percent | 4.808 | Standard Error of the Mean | 3.845 | 2-Sided | 95 | -2.766 | 12.383 | Other | The above provided values refer to the variant "BQ.1 (omicron)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.22687 | Difference of means in percent | 4.58 | Standard Error of the Mean | 3.78 | 2-Sided | 95 | -2.866 | 12.026 | Other | The above provided values refer to the variant "BQ.1.1 (omicron)". |
| This statistical analysis reflects Part B of the study. | ANCOVA | 0.38832 | Difference of means in percent | 3.498 | Standard Error of the Mean | 4.047 | 2-Sided | 95 | -4.475 | 11.47 | Other | The above provided values refer to the variant "XBB.1 (omicron)". |