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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000063-51 | EudraCT Number |
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This is a 2-part study to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1273.529 and mRNA-1273.214 administered as a booster dose.
In Part 1, participants will be randomized in a 1:1 ratio to receive a single dose of either mRNA-1273.529 or mRNA-1273.
In Part 2, participants will be randomized in a 1:1 ratio to receive a single dose of either mRNA-1273.214 or mRNA-1273.
All participants will have previously received 2 or 3 doses of an authorized/approved COVID-19 vaccine. Participants who previously received 2 doses of a COVID-19 vaccine as a primary series will receive mRNA-1273.529, mRNA-1273.214, or mRNA-1273 as the 3rd dose, and participants who have previously received a primary series and 1 booster dose will receive mRNA-1273.529, mRNA-1273.214, or mRNA-1273 as the 4th dose (a mixed approach is acceptable). Each part will include Phase A (randomized, blinded) and Phase B (open-label, observational).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: mRNA-1273.529 | Experimental | Phase A: Participants will receive 1 intramuscular (IM) dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants may choose to be unblinded and to receive an additional booster outside of the study. |
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| Part 1: mRNA-1273 | Active Comparator | Phase A: Participants will receive 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants may choose to be unblinded and to receive an additional booster outside of the study. |
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| Part 2: mRNA-1273.214 | Experimental | Phase A: Participants will receive 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants may choose to be unblinded and to receive an additional booster outside of the study. |
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| Part 2: mRNA-1273 | Active Comparator | Phase A: Participants will receive 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants may choose to be unblinded and to receive an additional booster outside of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1273.529 | Biological | Sterile liquid for injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Geometric Mean Concentration (GMC) of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain at Day 29 | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. Results are reported as absorbance units/millilitre (AU/mL). The GMC 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation. | Day 29 (post vaccination) |
| Part 1: GMC of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain at Day 85 | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation. | Day 85 (post vaccination) |
| Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against the B1.1.529 Strain at Day 29 | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation. | Day 29 (post vaccination) |
| Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against the B1.1.529 Strain at Day 85 | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: GMC of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain at Day 29 and Day 85 | Blood samples for immunogenicity assessments were collected during protocol specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation. Superiority at Day 29 was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was >1. Superiority at Day 85 was demonstrated if the lower bound of the 96% CI of the Geometric Mean Ratio was >1. |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aberdeen Royal Infirmary - PPDS | Aberdeen | Aberdeenshire | AB25 2ZD | United Kingdom | ||
| Southmead Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37348519 | Derived | Lee IT, Cosgrove CA, Moore P, Bethune C, Nally R, Bula M, Kalra PA, Clark R, Dargan PI, Boffito M, Sheridan R, Moran E, Darton TC, Burns F, Saralaya D, Duncan CJA, Lillie PJ, San Francisco Ramos A, Galiza EP, Heath PT, Girard B, Parker C, Rust D, Mehta S, de Windt E, Sutherland A, Tomassini JE, Dutko FJ, Chalkias S, Deng W, Chen X, Feng J, Tracy L, Zhou H, Miller JM, Das R; Study Investigators. Omicron BA.1-containing mRNA-1273 boosters compared with the original COVID-19 vaccine in the UK: a randomised, observer-blind, active-controlled trial. Lancet Infect Dis. 2023 Sep;23(9):1007-1019. doi: 10.1016/S1473-3099(23)00295-5. Epub 2023 Jun 19. |
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Of the 3779 participants who were screened for Part 1 and Part 2 of the study, 220 participants failed screening and 11 did not receive study vaccine.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: mRNA-1273.529 | Phase A: Participants received 1 intramuscular (IM) dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded and to receive an additional booster outside of the study. |
| FG001 | Part 1: mRNA-1273 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Aug 26, 2022 | Jul 11, 2024 |
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Phase A of this study will be observer-blinded. Phase B of the study will be open-label and blinding is not applicable
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| mRNA-1273 |
| Biological |
Sterile liquid for injection |
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| mRNA-1273.214 | Biological | Sterile liquid for injection |
|
| Day 85 (post vaccination) |
| Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against the Ancestral Strain at Day 29 | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. The ancestral (prototype) strain was Wuhan-Hu-1. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation. | Day 29 (post vaccination) |
| Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against the Ancestral Strain ay Day 85 | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. The ancestral strain was Wuhan-Hu-1. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation. | Day 85 (post vaccination) |
| Parts 1 and 2: Percentage of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) | Reactogenicity refers to the occurrence and intensity of selected signs and symptoms (ARs) occurring after vaccine injection. Participants recorded such occurrences in an electronic diary on the day of study vaccine injection and for the 7 days after the day of dosing. Solicited local ARs were injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of the injection. Solicited systemic ARs were headache, fatigue, myalgia (muscle aches all over the body), arthralgia (joint aches in several joints), nausea/vomiting, chills, and fever (oral temperature). The Investigator determined if a solicited AR was also to be recorded as an adverse event (AE). A summary of all Serious and Non Serious AEs, regardless of causality, is located in the 'Adverse Events' section. | Up to Day 8 (7 days post-vaccination) |
| Parts 1 and 2: Number of Participants With Unsolicited AEs | An AE was any untoward medical occurrence associated with the use of a drug/vaccine, whether or not considered related to the drug/vaccine. An unsolicited AE was any AE reported by the participant that was not specified as a solicited AR in the protocol or was specified as a solicited AR but starts outside the protocol-defined period for reporting solicited ARs (that is, 7 days after vaccination). A summary of all Serious and Non Serious AEs, regardless of causality, is located in the 'Adverse Events' section. | Up to Day 29 (28 days post-vaccination) |
| Parts 1 and 2: Number of Participants With Serious AEs (SAEs) | An AE was considered an SAE if, in the view of either the investigator or Sponsor, it resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization (hospitalization or prolongation of hospitalization in the absence of a precipitating event was not in itself an SAE), resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, was a congenital anomaly/birth defect, or was a medically important event. A summary of all Serious and Non Serious AEs, regardless of causality, is located in the 'Adverse Events' section. | Day 1 to end of study (Day 359) |
| Parts 1 and 2: Number of Participants With Medically Attended AEs (MAAEs) | An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner (HCP). This would include visits to a clinic for unscheduled assessments (for example, rash assessment, abnormal laboratory follow-up, coronavirus disease 2019 [COVID-19]) and visits to HCPs external to the clinic (for example, urgent care, primary care physician). A summary of all Serious and Non Serious AEs, regardless of causality, is located in the 'Adverse Events' section. | Day 1 to end of study (Day 359) |
| Parts 1 and 2: Number of Participants With AEs Leading to Withdrawal | An AE leading to withdrawal was defined as any AE that caused the participant to withdraw from the study, regardless of whether the decision to withdraw from the study was made by the participant or by the Investigator. A summary of all Serious and Non Serious AEs, regardless of causality, is located in the 'Adverse Events' section. | Day 1 to end of study (Day 359) |
| Parts 1 and 2: Number of Participants With AEs of Special Interest (AESIs) | An AESI is an AE (serious or non serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required. Such events may have required further investigation to characterize and understand them. A summary of all Serious and Non Serious AEs, regardless of causality, is located in the 'Adverse Events' section. | Day 1 to end of study (Day 359) |
| Day 29 and Day 85 (post vaccination) |
| Part 1: GMC of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain at Day 179 | Blood samples for immunogenicity assessments were collected during protocol specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation. | Day 179 (post vaccination) |
| Part 1: GMC of mRNA-1273.529 and mRNA-1273 Against the Ancestral Strain at Day 29, Day 85, and Day 179 | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. The ancestral strain was Wuhan-Hu-1. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation. | Day 29, Day 85, Day 179 (post vaccination) |
| Parts 1 and 2: Percentage of Participants With Seroresponse Against SARS-CoV-2 | Seroresponse was defined by an increase of the GMC from pre-study vaccination (booster) below the lower limit of quantitation (LLOQ) to at least 4×LLOQ, or a 4-fold or greater rise if pre-study vaccination was ≥LLOQ. The number of participants analysed from the PPSI-Neg population include those with non-missing data at Baseline and the corresponding timepoint. 95% CI calculated using the Clopper-Pearson method. | Days 29, 85, 179, and 359 |
| Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against Other Variant Strains | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation. Other variant strains include B.1.1.7 Strain, AY.4 Strain, P.1 Strain. | Days 29 and 85 |
| Part 2: Percentage of Participants With Asymptomatic SARS-CoV-2 Infection Measured by Reverse Transcriptase Polymerase-chain Reaction (RT-PCR) | Asymptomatic SARS-CoV-2 infection was defined as a positive RT-PCR test on a respiratory sample in the absence of symptoms or a positive serologic test for antinucleocapsid antibody after a negative test at time of enrollment. | Day 14 through the end of study (Day 359) |
| Part 2: Percentage of Participants With Symptomatic SARS-CoV-2 Infection Measured by RT-PCR | Symptomatic SARS-CoV-2 infection was defined 2 ways: protocol-defined COVID-19 and Center for Disease Control (CDC) COVID-19. Protocol-defined COVID-19 required at least 2 of the following systemic symptoms: fever, chills, myalgia, headache, sore throat, new olfactory and taste disorder(s), or at least 1 of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, or clinical/radiographical evidence of pneumonia, and at least 1 positive nasopharyngeal swab, nasal swab, or saliva sample (RT-PCR). CDC-defined COVID-19 was based on a positive respiratory sample (RT-PCR) and at least 1 of the following systemic or respiratory symptoms: fever, chills, cough, shortness of breath, and/or difficulty breathing, fatigue, muscle and/or body aches, headache, new loss of taste/smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhoea. | Day 1 through the end of study (Day 359) |
| Part 2: Percentage of Participants With Primary Case Definition of COVID-19 | The primary case definition of COVID-19 (protocol-defined COVID-19) required the participant to have experienced at least 2 of the following systemic symptoms: fever, chills, myalgia, headache, sore throat, new olfactory and taste disorder(s), or the participant must have experienced at least 1 of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, or clinical or radiographical evidence of pneumonia, and must have at least 1 nasopharyngeal swab, nasal swab, or saliva sample (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by RT-PCR. | Day 14 through the end of study (Day 359) |
| Part 2: Percentage of Participants With Secondary Case Definition of COVID-19 | The secondary case definition of COVID-19 (CDC case definition) was based on a positive RT-PCR test on a respiratory sample and at least 1 of the following systemic or respiratory symptoms: fever, chills, cough, shortness of breath, and/or difficulty breathing, fatigue, muscle and/or body aches (not related to exercise), headache, new loss of taste/smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhoea. | Day 14 through the end of study (Day 359) |
| Bristol |
| Avon |
| BS10 5NB |
| United Kingdom |
| Wansford and Kingscliffe Practice | Wansford | Cambridgeshire | PE8 6PL | United Kingdom |
| Halton General Hospital | Runcorn | Cheshire | WA7 2DA | United Kingdom |
| The James Cook University Hospital | Middlesbrough | Cleveland | TS4 3BW | United Kingdom |
| Royal Cornwall Hospital | Truro | Cornwall | TR1 3LJ | United Kingdom |
| Royal Devon and Exeter Hospital NHS Trust | Exeter | Devon | EX2 5DW | United Kingdom |
| Royal Bournemouth Hospital | Bournemouth | Dorset | BH7 7DW | United Kingdom |
| Gloucester Royal Hospital | Gloucester | Gloucestershire | GL1 3NN | United Kingdom |
| Portsmouth Research Hub | Portsmouth | Hampshire | PO1 3HN | United Kingdom |
| Fylde Coast Clinical Research | Blackpool | Lancashire | FY3 7EN | United Kingdom |
| Leicester General Hospital | Leicester | Leicestershire | LE5 4PW | United Kingdom |
| Salford Royal Hospital - PPDS | Salford | Manchester | United Kingdom |
| University College London Hospitals Covid-19 Vaccine Centre | London | Middlesex | WC1E 6EB | United Kingdom |
| Castle Hill Hospital | Hull | North Humberside | HU16 5JQ | United Kingdom |
| The Princess Royal Hospital | Telford | Shropshire | TF1 6TF | United Kingdom |
| Royal United Hospital | Bath | Somerset | BA1 3NG | United Kingdom |
| Sheffield/Northern General Hospital | Sheffield | South Yorkshire | S5 7AU | United Kingdom |
| Royal Glamorgan Hospital - PPDS | Pont-y-clun | Wales | CF72 8XR | United Kingdom |
| Bradford Institute for Health Research | Bradford | West Yorkshire | BD9 6RJ | United Kingdom |
| Great Western Hospital | Swindon | Wiltshire | SN3 6BB | United Kingdom |
| Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| Barts Hospital | London | EC1A 7BE | United Kingdom |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| Kings College Hospital | London | SE5 9RS | United Kingdom |
| Chelsea and Westminster Hospital | London | SW10 9NH | United Kingdom |
| St. George's Hospital | London | SW17 0RE | United Kingdom |
| Royal Victoria Infirmary | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded and to receive an additional booster outside of the study. |
| FG002 | Part 2: mRNA-1273.214 | Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and to receive an additional booster outside of the study. |
| FG003 | Part 2: mRNA-1273 | Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and to receive an additional booster outside of the study. |
| Received at Least 1 Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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The Safety Set included all randomized participants who received the study vaccine. Participants were included in the study vaccine arm that they actually received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: mRNA-1273.529 | Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study. |
| BG001 | Part 1: mRNA-1273 | Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study. |
| BG002 | Part 2: mRNA-1273.214 | Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study. |
| BG003 | Part 2: mRNA-1273 | Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Part 1: Geometric Mean Concentration (GMC) of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain at Day 29 | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. Results are reported as absorbance units/millilitre (AU/mL). The GMC 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation. | Per-Protocol Set for Immunogenicity-SARS-CoV-2 negative (PPSI-Neg) included all randomized participants who received the planned dose of study vaccine, had no major protocol deviations with an impact on critical or key study data, and had no serologic or virologic evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection at Baseline and up to the analysis visit. Here, Number of Participants Analysed: those participants who were evaluable for this Outcome Measure. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | Day 29 (post vaccination) |
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| Primary | Part 1: GMC of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain at Day 85 | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation. | PPSI-Neg included all randomized participants who received the planned dose of study vaccine, had no major protocol deviations with an impact on critical or key study data, and had no serologic or virologic evidence of SARS-CoV-2 infection at Baseline and up to the analysis visit. Here, Number of Participants Analysed signifies those participants who were evaluable for this Outcome Measure. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | Day 85 (post vaccination) |
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| Primary | Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against the B1.1.529 Strain at Day 29 | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation. | PPSI-Neg included all randomized participants who received the planned dose of study vaccine, had no major protocol deviations with an impact on critical or key study data, and had no serologic or virologic evidence of SARS-CoV-2 infection at Baseline and up to the analysis visit. Here, Number of Participants Analysed signifies those participants who were evaluable for this Outcome Measure. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | Day 29 (post vaccination) |
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| Primary | Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against the B1.1.529 Strain at Day 85 | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation. | PPSI-Neg included all randomized participants who received the planned dose of study vaccine, had no major protocol deviations with an impact on critical or key study data, and had no serologic or virologic evidence of SARS-CoV-2 infection at Baseline and up to the analysis visit. Here, Number of Participants Analysed signifies those participants who were evaluable for this Outcome Measure. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | Day 85 (post vaccination) |
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| Primary | Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against the Ancestral Strain at Day 29 | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. The ancestral (prototype) strain was Wuhan-Hu-1. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation. | PPSI-Neg included all randomized participants who received the planned dose of study vaccine, had no major protocol deviations with an impact on critical or key study data, and had no serologic or virologic evidence of SARS-CoV-2 infection at Baseline and up to the analysis visit. Here, Number of Participants Analysed signifies those participants who were evaluable for this Outcome Measure. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | Day 29 (post vaccination) |
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| Primary | Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against the Ancestral Strain ay Day 85 | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. The ancestral strain was Wuhan-Hu-1. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation. | PPSI-Neg included all randomized participants who received the planned dose of study vaccine, had no major protocol deviations with an impact on critical or key study data, and had no serologic or virologic evidence of SARS-CoV-2 infection at Baseline and up to the analysis visit. Here, Number of Participants Analysed signifies those participants who were evaluable for this Outcome Measure. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | Day 85 (post vaccination) |
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| Primary | Parts 1 and 2: Percentage of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) | Reactogenicity refers to the occurrence and intensity of selected signs and symptoms (ARs) occurring after vaccine injection. Participants recorded such occurrences in an electronic diary on the day of study vaccine injection and for the 7 days after the day of dosing. Solicited local ARs were injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of the injection. Solicited systemic ARs were headache, fatigue, myalgia (muscle aches all over the body), arthralgia (joint aches in several joints), nausea/vomiting, chills, and fever (oral temperature). The Investigator determined if a solicited AR was also to be recorded as an adverse event (AE). A summary of all Serious and Non Serious AEs, regardless of causality, is located in the 'Adverse Events' section. | The Solicited Safety Set included all randomized participants who received the study vaccine and contributed any solicited AR data within the first 7 days after study vaccine administration. Participants were included in the study vaccine arm that they actually received. Here, Overall number of Participants Analyzed signifies those participants who were evaluable for this Outcome Measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to Day 8 (7 days post-vaccination) |
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| Primary | Parts 1 and 2: Number of Participants With Unsolicited AEs | An AE was any untoward medical occurrence associated with the use of a drug/vaccine, whether or not considered related to the drug/vaccine. An unsolicited AE was any AE reported by the participant that was not specified as a solicited AR in the protocol or was specified as a solicited AR but starts outside the protocol-defined period for reporting solicited ARs (that is, 7 days after vaccination). A summary of all Serious and Non Serious AEs, regardless of causality, is located in the 'Adverse Events' section. | The Safety Set included all randomized participants who received the study vaccine. Participants were included in the study vaccine arm that they actually received. | Posted | Count of Participants | Participants | Up to Day 29 (28 days post-vaccination) |
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| Primary | Parts 1 and 2: Number of Participants With Serious AEs (SAEs) | An AE was considered an SAE if, in the view of either the investigator or Sponsor, it resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization (hospitalization or prolongation of hospitalization in the absence of a precipitating event was not in itself an SAE), resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, was a congenital anomaly/birth defect, or was a medically important event. A summary of all Serious and Non Serious AEs, regardless of causality, is located in the 'Adverse Events' section. | The Safety Set included all randomized participants who received the study vaccine. Participants were included in the study vaccine arm that they actually received. | Posted | Count of Participants | Participants | Day 1 to end of study (Day 359) |
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| Primary | Parts 1 and 2: Number of Participants With Medically Attended AEs (MAAEs) | An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner (HCP). This would include visits to a clinic for unscheduled assessments (for example, rash assessment, abnormal laboratory follow-up, coronavirus disease 2019 [COVID-19]) and visits to HCPs external to the clinic (for example, urgent care, primary care physician). A summary of all Serious and Non Serious AEs, regardless of causality, is located in the 'Adverse Events' section. | The Safety Set included all randomized participants who received the study vaccine. Participants were included in the study vaccine arm that they actually received. | Posted | Count of Participants | Participants | Day 1 to end of study (Day 359) |
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| Primary | Parts 1 and 2: Number of Participants With AEs Leading to Withdrawal | An AE leading to withdrawal was defined as any AE that caused the participant to withdraw from the study, regardless of whether the decision to withdraw from the study was made by the participant or by the Investigator. A summary of all Serious and Non Serious AEs, regardless of causality, is located in the 'Adverse Events' section. | The Safety Set included all randomized participants who received the study vaccine. Participants were included in the study vaccine arm that they actually received. | Posted | Count of Participants | Participants | Day 1 to end of study (Day 359) |
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| Primary | Parts 1 and 2: Number of Participants With AEs of Special Interest (AESIs) | An AESI is an AE (serious or non serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required. Such events may have required further investigation to characterize and understand them. A summary of all Serious and Non Serious AEs, regardless of causality, is located in the 'Adverse Events' section. | The Safety Set included all randomized participants who received the study vaccine. Participants were included in the study vaccine arm that they actually received. | Posted | Count of Participants | Participants | Day 1 to end of study (Day 359) |
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| Secondary | Part 1: GMC of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain at Day 29 and Day 85 | Blood samples for immunogenicity assessments were collected during protocol specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation. Superiority at Day 29 was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was >1. Superiority at Day 85 was demonstrated if the lower bound of the 96% CI of the Geometric Mean Ratio was >1. | PPSI-Neg included all randomized participants who received the planned dose of study vaccine, had no major protocol deviations with an impact on critical or key study data, and had no serologic or virologic evidence of SARS-CoV-2 infection at Baseline and up to the analysis visit. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this Outcome Measure. Number Analyzed signifies those participants who were evaluable at specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | Day 29 and Day 85 (post vaccination) |
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| Secondary | Part 1: GMC of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain at Day 179 | Blood samples for immunogenicity assessments were collected during protocol specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation. | PPSI-Neg included all randomized participants who received the planned dose of study vaccine, had no major protocol deviations with an impact on critical or key study data, and had no serologic or virologic evidence of SARS-CoV-2 infection at Baseline and up to the analysis visit. Here, Number of Participants Analysed signifies those participants who were evaluable for this Outcome Measure. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | Day 179 (post vaccination) |
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| Secondary | Part 1: GMC of mRNA-1273.529 and mRNA-1273 Against the Ancestral Strain at Day 29, Day 85, and Day 179 | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. The ancestral strain was Wuhan-Hu-1. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation. | PPSI-Neg included all randomized participants who received the planned dose of study vaccine, had no major protocol deviations with an impact on critical or key study data, and had no serologic or virologic evidence of SARS-CoV-2 infection at Baseline and up to the analysis visit. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this Outcome Measure. Number Analyzed signifies those participants who were evaluable at specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | Day 29, Day 85, Day 179 (post vaccination) |
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| Secondary | Parts 1 and 2: Percentage of Participants With Seroresponse Against SARS-CoV-2 | Seroresponse was defined by an increase of the GMC from pre-study vaccination (booster) below the lower limit of quantitation (LLOQ) to at least 4×LLOQ, or a 4-fold or greater rise if pre-study vaccination was ≥LLOQ. The number of participants analysed from the PPSI-Neg population include those with non-missing data at Baseline and the corresponding timepoint. 95% CI calculated using the Clopper-Pearson method. | PPSI-Neg included all randomized participants who received the planned dose of study vaccine, had no major protocol deviations with an impact on critical or key study data, and had no serologic or virologic evidence of SARS-CoV-2 infection at Baseline and up to the analysis visit. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this Outcome Measure. Number Analyzed signifies those participants who were evaluable at specified timepoint. | Posted | Number | 95% Confidence Interval | percentage of participants | Days 29, 85, 179, and 359 |
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| Secondary | Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against Other Variant Strains | Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation. Other variant strains include B.1.1.7 Strain, AY.4 Strain, P.1 Strain. | PPSI-Neg included all randomized participants who received the planned dose of study vaccine, had no major protocol deviations with an impact on critical or key study data, and had no serologic or virologic evidence of SARS-CoV-2 infection at Baseline and up to the analysis visit. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this Outcome Measure. Number Analyzed signifies those participants who were evaluable at specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | Days 29 and 85 |
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| Secondary | Part 2: Percentage of Participants With Asymptomatic SARS-CoV-2 Infection Measured by Reverse Transcriptase Polymerase-chain Reaction (RT-PCR) | Asymptomatic SARS-CoV-2 infection was defined as a positive RT-PCR test on a respiratory sample in the absence of symptoms or a positive serologic test for antinucleocapsid antibody after a negative test at time of enrollment. | Per-Protocol Set for Efficacy included all participants with a pre-vaccination/Baseline SARS-CoV-2 negative status who received the planned dose of study vaccination and had no major protocol deviations that had an impact on key or critical data. | Posted | Number | percentage of participants | Day 14 through the end of study (Day 359) |
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| Secondary | Part 2: Percentage of Participants With Symptomatic SARS-CoV-2 Infection Measured by RT-PCR | Symptomatic SARS-CoV-2 infection was defined 2 ways: protocol-defined COVID-19 and Center for Disease Control (CDC) COVID-19. Protocol-defined COVID-19 required at least 2 of the following systemic symptoms: fever, chills, myalgia, headache, sore throat, new olfactory and taste disorder(s), or at least 1 of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, or clinical/radiographical evidence of pneumonia, and at least 1 positive nasopharyngeal swab, nasal swab, or saliva sample (RT-PCR). CDC-defined COVID-19 was based on a positive respiratory sample (RT-PCR) and at least 1 of the following systemic or respiratory symptoms: fever, chills, cough, shortness of breath, and/or difficulty breathing, fatigue, muscle and/or body aches, headache, new loss of taste/smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhoea. | Per-Protocol Set for Efficacy included all participants with a pre-vaccination/Baseline SARS-CoV-2 negative status who received the planned dose of study vaccination and had no major protocol deviations that had an impact on key or critical data. | Posted | Number | percentage of participants | Day 1 through the end of study (Day 359) |
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| Secondary | Part 2: Percentage of Participants With Primary Case Definition of COVID-19 | The primary case definition of COVID-19 (protocol-defined COVID-19) required the participant to have experienced at least 2 of the following systemic symptoms: fever, chills, myalgia, headache, sore throat, new olfactory and taste disorder(s), or the participant must have experienced at least 1 of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, or clinical or radiographical evidence of pneumonia, and must have at least 1 nasopharyngeal swab, nasal swab, or saliva sample (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by RT-PCR. | Per-Protocol Set for Efficacy included all participants with a pre-vaccination/Baseline SARS-CoV-2 negative status who received the planned dose of study vaccination and had no major protocol deviations that had an impact on key or critical data. | Posted | Number | percentage of participants | Day 14 through the end of study (Day 359) |
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| Secondary | Part 2: Percentage of Participants With Secondary Case Definition of COVID-19 | The secondary case definition of COVID-19 (CDC case definition) was based on a positive RT-PCR test on a respiratory sample and at least 1 of the following systemic or respiratory symptoms: fever, chills, cough, shortness of breath, and/or difficulty breathing, fatigue, muscle and/or body aches (not related to exercise), headache, new loss of taste/smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhoea. | Per-Protocol Set for Efficacy included all participants with a pre-vaccination/Baseline SARS-CoV-2 negative status who received the planned dose of study vaccination and had no major protocol deviations that had an impact on key or critical data. | Posted | Number | percentage of participants | Day 14 through the end of study (Day 359) |
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Day 1 to end of study (Day 359)
The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: mRNA-1273.529 | Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study. | 0 | 367 | 20 | 367 | 68 | 367 |
| EG001 | Part 1: mRNA-1273 | Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study. | 1 | 357 | 13 | 357 | 70 | 357 |
| EG002 | Part 2: mRNA-1273.214 | Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study. | 2 | 1,422 | 60 | 1,422 | 207 | 1,422 |
| EG003 | Part 2: mRNA-1273 | Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study. | 4 | 1,402 | 72 | 1,402 | 198 | 1,402 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Corneal dystrophy | Congenital, familial and genetic disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Right aortic arch | Congenital, familial and genetic disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Retinal tear | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Mesenteric panniculitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Richter's hernia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Sudden unexplained death in epilepsy | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Systemic viral infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Delayed recovery from anaesthesia | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Brain neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Colorectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Gastrointestinal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| High-grade B- cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anosmia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Intracranial hypotension | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bicuspid aortic valve | Congenital, familial and genetic disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Incarcerated hernia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Open fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Benign lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Benign ovarian tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Malignant glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Thyroid adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Cauda equina syndrome | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Motor neurone disease | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oromandibular dystonia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Mixed anxiety and depressive disorder | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pelvi-ureteric obstruction | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Idiopathic angioedema | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Poor peripheral circulation | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Asymptomatic COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Moderna Clinical Trials Support Center | ModernaTX, Inc. | 1-877-777-7187 | clinicaltrials@modernatx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 12, 2023 | Jul 11, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| C000722752 | mRNA-1273.214 COVID-19 vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| 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 |
Not provided
Not provided
| >=65 Years |
|
| Male |
|
| Mixed or Multiple Ethnic Groups |
|
| Asian or Asian British |
|
| Black, African, Caribbean, or Black British |
|
| Other Ethnic Group |
|
| Not Reported |
|
| Unknown |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| OG001 | Part 1: mRNA-1273 | Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study. |
| OG002 | Part 2: mRNA-1273.214 | Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study. |
| OG003 | Part 2: mRNA-1273 | Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study. |
|
|
| Part 2: mRNA-1273.214 |
Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study. |
| OG003 | Part 2: mRNA-1273 | Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study. |
|
|
| OG002 | Part 2: mRNA-1273.214 | Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study. |
| OG003 | Part 2: mRNA-1273 | Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study. |
|
|
Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study. |
| OG003 | Part 2: mRNA-1273 | Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study. |
|
|
| OG003 | Part 2: mRNA-1273 | Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study. |
|
|
Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study. |
| OG003 | Part 2: mRNA-1273 | Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study. |
|
|
Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study. |
|
|
|
|
|
|
|
| OG002 | Part 2: mRNA-1273.214 | Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study. |
| OG003 | Part 2: mRNA-1273 | Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study. |
|
|
|
|
| Counts |
|---|
| Participants |
|
|
| Part 2: mRNA-1273 |
Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study. |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|