A Phase 2 interventional study of Comirnaty (BTN162b2) and Spikevax (mRNA-1273) in Prevention of COVID-19, sponsored by Oliver Cornely, MD. Completed at 9 sites in 4 countries. Open to participants aged 75 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-20.
Sponsored by Oliver Cornely, MD · Phase 2, Interventional, and Prevention
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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 323 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Oliver Cornely, MD is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria (Part B):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
vaccination with BNT162b2 as 3rd vaccination
Biological: Comirnaty (BTN162b2)
vaccination with mRNA-1273 as 3rd vaccination
Biological: Spikevax (mRNA-1273)
vaccination with BNT162b2 as 4th vaccination
Biological: Comirnaty (BTN162b2)
vaccination with mRNA-1273 as 4th vaccination
Biological: Spikevax (mRNA-1273)
Single booster shot (3rd dose in Part A and 4th dose in Part B)
Single booster shot (3rd dose in Part A and 4th dose in Part B)
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.
Time frame: From Day 0 until Day 14
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: From Day 0 until Month 12
Number of Participants With Unsolicited AEs
Number of Participants with Unsolicited AEs until the end of trial
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Day 0 until Month 12
| Milestone | BNT162b2 (Part A) | mRNA-1273 (Part A) | BTN162b2 (Part B) | mRNA-1273 (Part B) |
|---|---|---|---|---|
| Started | 25 | 27 | 135 | 135 |
| Completed | 21 | 20 | 126 | 123 |
| Not completed | 4 | 7 | 9 | 12 |
| Withdrew: Adverse event | 0 | 1 | 0 | 0 |
| Withdrew: Covid-19 infection | 0 | 1 | 0 | 0 |
| Withdrew: Travel time | 1 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 3 | 5 | 4 | 2 |
| Withdrew: Death | 0 | 0 | 2 | 5 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 2 |
| Withdrew: No show | 0 | 0 | 1 | 1 |
| Withdrew: Physician decision | 0 | 0 | 0 | 1 |
| Withdrew: Protocol violation | 0 | 0 | 1 | 0 |
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.
| percentage of participants | BNT162b2 (Part A) | mRNA-1273 (Part A) | BNT162b2 (Part B) | mRNA-1273 (Part B) |
|---|---|---|---|---|
| Antibody Titre Increase 14 Days After Study Vaccination Dose. | 100 (83.9 to 100) | 100 (83.9 to 100) | 78.46 (69.2 to 86) | 87.22 (79.3 to 93) |
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.
| percentage of inhibition | BTN162b2 (Part A) | mRNA-1273 (Part A) | BTN162b2 (Part B) | mRNA-1273 (Part B) |
|---|---|---|---|---|
| Change in Neutralizing Antibody Titre Against Wild-type 14 Days After Study Vaccination Dose | 58.49 ± 16.25 | 65.98 ± 18.32 | 37.33 ± 22.93 | 41.45 ± 24.09 |
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.
| percentage of inhibition | BNT162b2 (Part A) | mRNA-1273 (Part A) | BNT162b2 (Part B) | mRNA-1273 (Part B) |
|---|---|---|---|---|
| Change in Neutralizing Antibody Titre Against Variants of Concern 14 Days After Study Vaccination Dose | 49.86 ± 17.62 | 57.39 ± 19.77 | 38.17 ± 21.74 | 44.04 ± 23.94 |
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).
| IU/ml | BTN162b2 (Part A) | mRNA-1273 (Part A) | BNT162b2 (Part B) | mRNA-1273 (Part B) |
|---|---|---|---|---|
| Antibody Titre Level at 12 Months After a Study Vaccination Dose | 9319.7 ± 25896.27 | 14163.81 ± 46209.35 | 9961.92 ± 26292.23 | 12024.3 ± 29129.18 |
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.
| percentage of inhibition | BNT162b2 (Part A) | mRNA-1273 (Part A) | BNT162b2 (Part B) | mRNA-1273 (Part B) |
|---|---|---|---|---|
| Neutralizing Antibody Titre Against Wild-type at 12 Months After Study Vaccination Dose | 54.5 ± 33.64 | 62.65 ± 33.26 | 12.93 ± 39.29 | 18.15 ± 33.24 |
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.
| percentage of inhibition | BNT162b2 (Part A) | mRNA-1273 (Part A) | BNT162b2 (Part B) | mRNA-1273 (Part B) |
|---|---|---|---|---|
| Neutralizing Antibody Titre Against Variants of Concern at 12 Months After Study Vaccination Dose | 40.59 ± 35.37 | 49 ± 36.37 | 15.76 ± 38.4 | 20.24 ± 37.24 |
Number of Participants with Unsolicited AEs until the end of trial
| Participants | BNT162b2 (Part A) | mRNA-1273 (Part A) | BNT162b2 (Part B) | mRNA-1273 (Part B) |
|---|---|---|---|---|
| Number of Participants With Unsolicited AEs | 22 | 26 | 110 | 112 |
Number of Participants with Solicited AEs for 7 days after study vaccination dose.
| Participants | BNT162b2 (Part A) | mRNA-1273 (Part A) | BNT162b2 (Part B) | mRNA-1273 (Part B) |
|---|---|---|---|---|
| Number of Participants With Solicited AEs | 20 | 25 | 76 | 80 |
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.
| Participants | BNT162b2 (Part A) | mRNA-1273 (Part A) | BNT162b2 (Part B) | mRNA-1273 (Part B) |
|---|---|---|---|---|
| Number of Participants With Rate of SAEs Grade ≥3 | 0 | 0 | 1 | 0 |
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.
| Fold change of CXCL10 mRNA levels | BNT162b2 | mRNA-1273 |
|---|---|---|
| Change in Cellular Immune Response Measured by qPCR 14 Days After 4th Vaccination Dose | 26.63 ± 1.58 | 26.63 ± 1.59 |
"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.
| percentage of inhibition | BNT162b2 (Part A) | mRNA-1273 (Part A) | BNT162b2 (Part B) | mRNA-1273 (Part B) |
|---|---|---|---|---|
| Neutralizing Antibody Titre Against Newly Emerging Variants in Bio-banked Samples After Study Vaccination Dose | 19.28 ± 30.94 | 27.18 ± 28.14 | 16.75 ± 34.24 | 19.03 ± 33.01 |
Collected over AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BNT162b2 (Part A) | 0/25 (0%) | 0/25 (0%) | 20/25 (80%) |
| mRNA-1273 (Part A) | 0/27 (0%) | 0/27 (0%) | 25/27 (92.6%) |
| BNT162b2 (Part B) | 2/135 (1.5%) | 21/135 (15.6%) | 103/135 (76.3%) |
| mRNA-1273 (Part B) | 5/135 (3.7%) | 22/135 (16.3%) | 110/135 (81.5%) |
| Event | BNT162b2 (Part A) | mRNA-1273 (Part A) | BNT162b2 (Part B) | mRNA-1273 (Part B) |
|---|---|---|---|---|
| Atrial fibrillationCardiac disorders | — | — | 1/135 | 3/135 |
| PneumoniaInfections and infestations | — | — | 3/135 | 0/135 |
| Transient ischaemic attackNervous system disorders | — | — | 0/135 | 3/135 |
| Cardiac failureCardiac disorders | — | — | 0/135 | 2/135 |
| Lower respiratory tract infectionInfections and infestations | — | — | 2/135 | 1/135 |
| UrosepsisInfections and infestations | — | — | 2/135 | 0/135 |
| Acute myocardial infarctionCardiac disorders | — | — | 1/135 | 0/135 |
| Angina pectorisCardiac disorders | — | — | 1/135 | 0/135 |
| ArrhythmiaCardiac disorders | — | — | 0/135 | 1/135 |
| Atrioventricular blockCardiac disorders | — | — | 1/135 | 0/135 |
| Event | BNT162b2 (Part A) | mRNA-1273 (Part A) | BNT162b2 (Part B) | mRNA-1273 (Part B) |
|---|---|---|---|---|
| Injection site discomfortGastrointestinal disorders | 8/25 | 15/27 | 0/135 | 0/135 |
| FatigueGeneral disorders | 7/25 | 14/27 | 31/135 | 51/135 |
| Injection site painGeneral disorders | 7/25 | 5/27 | 54/135 | 59/135 |
| Injection site indurationGeneral disorders | 6/25 | 10/27 | 1/135 | 0/135 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 0/25 | 0/27 | 34/135 | 40/135 |
| Injection site swellingGeneral disorders | 2/25 | 7/27 | 10/135 | 15/135 |
| MyalgiaMusculoskeletal and connective tissue disorders | 1/25 | 7/27 | 7/135 | 11/135 |
| COVID-19Infections and infestations | 0/25 | 0/27 | 31/135 | 31/135 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/25 | 6/27 | 6/135 | 8/135 |
| ChillsGeneral disorders | 1/25 | 5/27 | 6/135 | 8/135 |
| Age, Continuous(years) | BNT162b2 (Part A) | mRNA-1273 (Part A) | BNT162b2 (Part B) | mRNA-1273 (Part B) | Total |
|---|---|---|---|---|---|
| Median | 77 (75 to 87) | 78 (75 to 85) | 79 (75 to 99) | 79 (75 to 99) | 79 (75 to 99) |
| Sex: Female, Male(Participants) | BNT162b2 (Part A) | mRNA-1273 (Part A) | BNT162b2 (Part B) | mRNA-1273 (Part B) | Total |
|---|---|---|---|---|---|
| Female | 9 | 11 | 67 | 68 | 155 |
| Male | 16 | 16 | 68 | 67 | 167 |
| Race and Ethnicity Not Collected(Participants) | BNT162b2 (Part A) | mRNA-1273 (Part A) | BNT162b2 (Part B) | mRNA-1273 (Part B) | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Height(cm) | BNT162b2 (Part A) | mRNA-1273 (Part A) | BNT162b2 (Part B) | mRNA-1273 (Part B) | Total |
|---|---|---|---|---|---|
| Median | 171 (155 to 190) | 174 (149 to 198) | 169 (143 to 189) | 169 (145 to 198) | 169 (143 to 198) |
| Weight(kg) | BNT162b2 (Part A) | mRNA-1273 (Part A) | BNT162b2 (Part B) | mRNA-1273 (Part B) | Total |
|---|---|---|---|---|---|
| Median | 75 (53 to 97) | 73 (51 to 100) | 72 (41 to 119) | 75 (41.7 to 110) | 74 (41 to 119) |
| BMI(kg/m2) | BNT162b2 (Part A) | mRNA-1273 (Part A) | BNT162b2 (Part B) | mRNA-1273 (Part B) | Total |
|---|---|---|---|---|---|
| Median | 25.6 (20.3 to 32.8) | 24.1 (16.8 to 32.6) | 25.4 (16.6 to 40.2) | 25.4 (18 to 41.8) | 25.4 (16.6 to 41.8) |
| Duration between 1st and 2nd vaccination in days(days) | BNT162b2 (Part A) | mRNA-1273 (Part A) | BNT162b2 (Part B) | mRNA-1273 (Part B) | Total |
|---|---|---|---|---|---|
| Median | 42 (21 to 84) | 42 (21 to 111) | 22 (20 to 86) | 22 (16 to 114) | 22 (16 to 114) |
| Duration between 2nd and 3rd vaccination in days(days) | BNT162b2 (Part A) | mRNA-1273 (Part A) | BNT162b2 (Part B) | mRNA-1273 (Part B) | Total |
|---|---|---|---|---|---|
| Median | 192 (185 to 255) | 190 (184 to 273) | 207 (124 to 303) | 205 (126 to 313) | 206.5 (124 to 313) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: 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.
Access criteria: To be announced.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: BNT162 Vaccine · 2019-nCoV Vaccine mRNA-1273