A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age… (NCT05815498) | Clinical Trial Compass
CompletedPhase 3
A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19
United States13,553 participantsStarted 2023-03-28
Plain-language summary
The purpose of this study (Part 1 and Part 2) is to evaluate the relative vaccine efficacy (rVE), safety, reactogenicity, and immunogenicity of mRNA-1283.222 versus mRNA-1273.222 (Part 1) and mRNA-1283.815 versus mRNA-1273.815 (Part 2).
Who can participate
Age range12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Investigator's assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.
* For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, and agreement to continue adequate contraception or abstinence through 90 days following the vaccine administration.
* Part 1: Has previously received a primary series of an authorized/approved COVID-19 vaccine. For participants ≥18 years of age, at least 1 booster dose must have also been received. Proof of prior vaccination is required. A heterologous vaccine regimen is acceptable.
Part 2: No prior vaccination is required. For participants who have been previously vaccinated, proof of vaccination is required.
Key Exclusion Criteria:
* Has had close contact, as defined by the Centers for Disease Control and Prevention (CDC), with someone who had a SARS-CoV-2 infection in the past 14 days, or COVID-19 in the past 10 days.
* Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) 72 hours prior to or at the Screening Visit or Day 1.
* Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the investigator, might pose additional risk due to partici…
What they're measuring
1
Part 1: Geometric Mean (GM) of Omicron BA.4/5 at Day 29
Timeframe: Day 29
2
Part 1: Seroresponse Rate (SRR) Omicron BA.4/5 at Day 29
Timeframe: Day 29
3
Part 1: GM of the Ancestral Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) D614G at Day 29
Timeframe: Day 29
4
Part 1: SRR of Ancestral SARS-CoV-2 D641G at Day 29
Timeframe: Day 29
5
Part 1: Number of Participants With First Event of Centers for Disease Control and Prevention (CDC)-Defined COVID-19
Timeframe: From 14 days after injection up to Day 365
6
Part 1: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Timeframe: Up to Day 7 (7-day follow-up after vaccination)
7
Part 3: Number of Participants With Solicited Local and Systemic ARs
Timeframe: Up to Day 7 (7-day follow-up after vaccination)
8
Part 1: Number of Participants With Unsolicited Adverse Events (AEs)
Timeframe: Up to Day 28 (28-day follow-up after vaccination)
9
Part 3: Number of Participants With Unsolicited AEs
Timeframe: Up to Day 28 (28-day follow-up after vaccination)
10
Part 1: Number of Participants With Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study, and AEs of Special Interest (AESIs)
Timeframe: Day 1 up to Day 365
11
Part 3: Number of Participants With Any SAEs, MAAEs, AEs Leading to Withdrawal From Study, and AESIs