Trial · NCT04649151
Outcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 7 days post-vaccination | Solicited Safety Set included participants who received at least 1 dose of study drug and contributed any solicited AR data. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Unsolicited AEs | Up to 28 days post-vaccination | Safety Set: participants who received at least 1 dose of study drug. As prespecified in the protocol, Part 1B was not assessed for this outcome measure. 'Overall number of participants analyzed' = participants evaluable for this endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1A Geometric Mean Value of Serum Pseudovirus Neutralizing Antibody (nAb) ID50 Titers From Study P203 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | Day 57 Study P203/Day 57 Study P301 | Part 1A PPIS: randomized participants who were selected for the Immunogenicity Subset, received planned doses of study drug per schedule, complied with immunogenicity testing schedule, and had no major protocol deviations that impacted key or critical data. Participants who were seropositive at baseline were excluded from the PPIS. 'Overall number of participants analyzed' = participants evaluable for this endpoint. | titer | GEOMETRIC_MEAN |
| PRIMARY | Part 1A Seroresponse Rate (SRR) for Serum Pseudovirus nAb ID50 in Study P203 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | Day 57 Study P203/Day 57 Study P301 | Part 1A PPIS: randomized participants who were selected for the Immunogenicity Subset, received planned doses of study drug per schedule, complied with immunogenicity testing schedule, and had no major protocol deviations that impacted key or critical data. Participants who were seropositive at baseline were excluded from the PPIS. 'Overall number of participants analyzed' = participants evaluable for this endpoint. | percentage of participants | NUMBER |
| PRIMARY | Part 1C-1 Geometric Mean Concentration (GMC) of Serum Pseudovirus nAb Against the Original Strain After the BD in Study P203 at BD Day 29 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | BD Day 29 Study P203/Day 57 Study P301 | Part 1C-1 PPIS-Neg: participants were baseline (pre-dose 1 of part 1A) SARS-CoV-2 negative, had BD-Day 1 and BD-Day 29 Ab assessment, had no major protocol deviations, did not receive off-study COVID-19 vaccination prior to BD-Day 29 visit, received 2 doses of mRNA-1273 in the Blinded Phase per schedule, received BD, and were pre-booster SARS-CoV2 negative. 'Overall number of participants analyzed' = participants evaluable for this endpoint. | arbitrary units (AU)/mL | GEOMETRIC_MEAN |
| PRIMARY | Part 1C-1 SRR of Serum Pseudovirus nAb Against the Original Strain After the BD in Study P203 at BD Day 29 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | BD Day 29 Study P203/Day 57 Study P301 | Part 1C-1 PPIS-Neg: participants were baseline (pre-dose 1 of part 1A) SARS-CoV-2 negative, had BD-Day 1 and BD-Day 29 Ab assessment, had no major protocol deviations, did not receive off-study COVID-19 vaccination prior to BD-Day 29 visit, received 2 doses of mRNA-1273 in the Blinded Phase per schedule, received BD, and were pre-booster SARS-CoV2 negative. 'Overall number of participants analyzed' = participants evaluable for this endpoint. | percentage of participants | NUMBER |
| PRIMARY | Part 3 GMC of nAb Post Dose 1 mRNA 1273.222 Against Omicron BA.4/BA.5 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | Day 29 Study P203/Day 57 Study P301 | Part 3 PPIS-Pos: participants received Dose 1 of mRNA-1273.222, had Day 29 antibody assessments, no major protocol deviations, did not receive off-study COVID-19 vaccination prior to Day 29, SARS-CoV-2 positive at Baseline. 'Overall number of participants analyzed' = participants evaluable for the endpoint. | AU/mL | GEOMETRIC_MEAN |
| PRIMARY | Part 1C-2 GMC of Post-booster Pseudovirus nAb Against Ancestral Strain at BD Day 29 | BD Day 29 | Part 1C-2 PPIS: all randomized participants who received BD in Part 1C-2, had BD-Day 29 Ab assessment, had no major protocol deviations that impacted key or critical data, and did not receive off-study COVID-19 vaccination prior to BD-Day 29 visit. 'Overall number of participants analyzed' = participants evaluable for this endpoint. | AU/mL | GEOMETRIC_MEAN |
| PRIMARY | Part 2 GMC of the Pseudovirus nAb Against Ancestral Strain at Day 57 | Day 57 | Part 2 PPIS: all randomized participants who received at least 1 dose of the planned study drug, had Ab assessment for the analysis endpoint, and had no major protocol deviations that could impact key or critical data. | AU/mL | GEOMETRIC_MEAN |
| PRIMARY | Part 3 GMC of nAb Post Dose 1 mRNA 1273.222 Against SARS-CoV-2 Ancestral Strain Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | Day 29 Study P203/Day 57 Study P301 | Part 3 PPIS-Pos: participants received Dose 1 of mRNA-1273.222, had Day 29 antibody assessments, no major protocol deviations, did not receive off-study COVID-19 vaccination prior to Day 29, SARS-CoV-2 positive at Baseline. 'Overall number of participants analyzed' = participants evaluable for the endpoint. | AU/mL | GEOMETRIC_MEAN |
| PRIMARY | Part 2 SRR of Pseudovirus nAb Against Ancestral Strain | Day 57 | Part 2 PPIS: all randomized participants who received at least 1 dose of the planned study drug, had Ab assessment for the analysis endpoint, and had no major protocol deviations that could impact key or critical data. | percentage of participants | NUMBER |
| PRIMARY | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study Discontinuation | Day 1 up to Day 751 | Participants who received at least 1 dose of mRNA-1273 were included in the analysis. 'Overall number of participants analyzed' = participants evaluable for this endpoint. Note: Part 3 is presented for overall study for this assessment (AE section presents AEs separately for 1 dose and second dose). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1A Number of Participants With a SARS-CoV-2 Infection (Symptomatic or Asymptomatic) | Day 43 (14 days after second injection) up to a median follow up of 2.5 months after second injection | Part 1A PP Set for Efficacy: all randomized participants who received planned doses of study drug, had no immunologic or virologic evidence of prior COVID-19, and had no major protocol deviations that impact key or critical efficacy data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1A Number of Participants With Asymptomatic SARS-CoV-2 Infection | Day 43 (14 days after second injection) up to a median follow up of 2.5 months after second injection | Part 1A PP Set for Efficacy: all randomized participants who received planned doses of study drug, had no immunologic or virologic evidence of prior COVID-19, and had no major protocol deviations that impact key or critical efficacy data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1A Number of Participants With a First Occurrence of Symptomatic COVID-19 | Day 43 (14 days after second injection) up to 2.5 months after second injection | Part 1A PP Set for Efficacy: all randomized participants who received planned doses of study drug, had no immunologic or virologic evidence of prior COVID-19, and had no major protocol deviations that impact key or critical efficacy data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1A Number of Participants With Secondary Case Definition of COVID-19 (Center for Disease Control and Prevention [CDC] Case Definition) | Day 43 (14 days after second injection) up to a median follow up of 2.5 months after second injection | Part 1A PP Set for Efficacy: all randomized participants who received planned doses of study drug, had no immunologic or virologic evidence of prior COVID-19, and had no major protocol deviations that impact key or critical efficacy data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1C-1 SRR of the Post-booster Serum Binding Antibody (bAb) Against Variants of Interest (B.1.1.7, B.1.351, B.1.617.2, and P.1) as Measured by MSD | BD Day 29 | Part 1C-1 PPIS: participants were baseline (pre-dose 1 of Part 1A) SARS-CoV-2 negative, had BD-Day 1 and BD-Day 29 Ab assessment, had no major protocol deviations, did not receive off-study COVID-19 vaccination prior to BD-Day 29 visit, received 2 doses of mRNA-1273 in the Blinded Phase per schedule, and received BD. 'Overall number of participants analyzed' = participants evaluable for this endpoint. | Percentage of participants | NUMBER |
| SECONDARY | Part 1C-1 GMC of Post-booster Pseudovirus nAb Against Variant Strain (B.1.1.529) | BD Day 29 | Part 1C-1 PPIS: participants were baseline (pre-dose 1 of Part 1A) SARS-CoV-2 negative, had BD-Day 1 and BD-Day 29 Ab assessment, had no major protocol deviations, did not receive off-study COVID-19 vaccination prior to BD-Day 29 visit, received 2 doses of mRNA-1273 in the Blinded Phase per schedule, and received BD. Overall number of participants analyzed' = participants evaluable for this endpoint. | AU/mL | GEOMETRIC_MEAN |
| SECONDARY | Part 3 SRR of Serum Pseudovirus nAb Post Dose 1 of mRNA-1273.222 Against Omicron BA.4/BA.5 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | Day 29 Study P203/Day 57 Study P301 | Part 3 PPIS-Pos: participants received Dose 1 of mRNA-1273.222, had Day 29 antibody assessments, no major protocol deviations, did not receive off-study COVID-19 vaccination prior to Day 29, SARS-CoV-2 positive at Baseline. 'Overall number of participants analyzed' = participants evaluable for the endpoint. | percentage of participants | NUMBER |
| SECONDARY | Part 3 Pseudovirus nAb SRR of Post Dose 1 of mRNA-1273.222 Against Ancestral Strain Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | Day 29 P203/Day 57 P301 | Part 3 PPIS-Pos: participants who received Dose 1 of mRNA-1273.222, had Day 29 antibody assessments, no major protocol deviations, did not receive off-study COVID-19 vaccination prior to Day 29, and were SARS-CoV-2 positive at baseline. 'Overall number of participants analyzed' = participants evaluable for the endpoint. | percentage of participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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