Phase 3
N=4,328
A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19
SARS-CoV-2
Bottom Line
View on ClinicalTrials.gov: NCT04649151 ↗Enrolled (actual)
4,328
Serious AEs
0.9%
Results posted
Sep 2025
Primary outcome: Primary: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) — 586; 585; 627; 42 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- mRNA-1273 (Biological); Placebo (Biological); mRNA-1273.222 (Biological)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- ModernaTX, Inc.
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) |
586; 585; 627; 42; 25; 18 | — |
| PRIMARY Number of Participants With Unsolicited AEs |
582; 237; 209; 19; 10; 2 | — |
| 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 |
1401.670; 1299.855 | — |
| 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 |
98.8; 99.0 | — |
| 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 |
7102.0; 1400.4 | — |
| 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 |
100.0; 99.3 | — |
| 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 |
2727.8; 56.6 | — |
| PRIMARY Part 1C-2 GMC of Post-booster Pseudovirus nAb Against Ancestral Strain at BD Day 29 |
9433.4 | — |
| PRIMARY Part 2 GMC of the Pseudovirus nAb Against Ancestral Strain at Day 57 |
7351.5 | — |
| 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 |
7603.9; 1692.3 | — |
| PRIMARY Part 2 SRR of Pseudovirus nAb Against Ancestral Strain |
91.3 | — |
| PRIMARY Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study Discontinuation |
21; 2; 9; 3; 0; 0 | — |
| SECONDARY Part 1A Number of Participants With a SARS-CoV-2 Infection (Symptomatic or Asymptomatic) |
22; 25 | — |
| SECONDARY Part 1A Number of Participants With Asymptomatic SARS-CoV-2 Infection |
20; 16 | — |
| SECONDARY Part 1A Number of Participants With a First Occurrence of Symptomatic COVID-19 |
0; 6 | — |
| SECONDARY Part 1A Number of Participants With Secondary Case Definition of COVID-19 (Center for Disease Control and Prevention [CDC] Case Definition) |
2; 9 | — |
| 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 |
100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Part 1C-1 GMC of Post-booster Pseudovirus nAb Against Variant Strain (B.1.1.529) |
943.4 | — |
| 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 |
95.4; 0.0 | — |
| 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 |
94.9; 99.3 | — |
| SECONDARY Part 3 GM Value of Post Dose 1 (Day 29) of mRNA-1273.222 bAb Against Other Variants of Interest |
282734.2; 557963.4; 434879.0; 431476.5; 189826.0; 471868.9 | — |
| SECONDARY Part 1C-2 GM Value of mRNA-1273 Booster Against Variants of Interest at Day 29 |
— | — |
| SECONDARY Part 1A GM Level of SARS-CoV-2 Spike Protein-specific bAb at Days 1, 57, 209, 394 |
65.848; 346830.736; 79624.290; 58647.246 | — |
| SECONDARY Part 1A GM Value of SARS-CoV-2-Specific nAb at Days 1, 57, 209, 394 |
11.249; 1868.363; 625.363; 550.262 | — |
| SECONDARY Part 1C-1 GM Value of Post-booster Dose Serum bAb Against Variants of Interest (B.1.1.7, B.1.351, B.1.617.2, and P.1) as Measured by MSD |
581097.8; 431569.2; 456423.3; 417277.2 | — |
Summary
The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the safety, reactogenicity, and effectiveness of mRNA-1273 vaccine administered as primary series and a booster dose (BD) to an adolescent population. The study will also evaluate the safety and immunogenicity of an mRNA-1273.222 vaccine against the SARS-CoV- 2 omicron variant as a primary series.
Eligibility Criteria
Inclusion Criteria
For Part 1A, Part 2 and Part 3:
- Participants 12 to 14 days in total within 6 months prior to the day of enrollment (for corticosteroids, ≥20 mg/day prednisone equivalent). Topical tacrolimus is allowed if not used within 14 days prior to the day of enrollment. Participants may have visits rescheduled for enrollment if they no longer meet this criterion within the Screening Visit window. Inhaled, nasal, and topical steroids are allowed.
- Intravenous blood products (red cells, platelets, immunoglobulins) within 3 months prior to enrollment
- Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit (Day 0) or plans to donate blood products during the study
- Participated in an interventional clinical study within 28 days prior to the Screening Visit (Day 0) or plans to do so while participating in this study
- Is an immediate family member or has a household contact who is an employee of the research center or otherwise involved with the conduct of the study
For Part 1C-1 and Part 1C-2:
- Pregnant or breastfeeding.
- Is acutely ill or febrile 24 hours prior to or at the Screening Visit (Day 0). Fever is defined as a body temperature ≥ 38.0°C/≥ 100.4°F. Participants who meet this criterion may have visits rescheduled within the relevant study visit windows. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
- Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment.
- History of a diagnosis or condition (after enrolment in Part 1A) that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety:
- Suspected active hepatitis
- Has a bleeding disorder that is considered a contraindication to IM injection or phlebotomy
- Dermatologic conditions that could affect local solicited AR assessments
- History of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine
- Diagnosis of malignancy (excluding nonmelanoma skin cancer)
- Receipt of:
- Any authorized or licensed vaccine within 28 days before the first dose of IP or plans for receipt of any licensed vaccine through 28 days following the last dose of IP or any seasonal influenza vaccine within 14 days before the first dose of IP or plans for receipt of any seasonal influenza vaccine 14 days following the last dose of IP.
- Participated in an interventional clinical study, other than mRNA-1273-P203 study, within 28 days prior to the Screening Visit (Day 0 [for Part 1C-1], BD-Day 0 [for Part 1C-2]) or plans to do so while participating in this study.
Part 1C-2 Heterologous Booster Dose:
- Has a known history of SARS-CoV-2 infection within 2 weeks prior to administration of IP or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID 19 within 2 weeks prior to administration of IP.
Data sourced from ClinicalTrials.gov (NCT04649151). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.