A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19

NCT04649151 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: mRNA-1273-P2032023-000382-14
• Study Type: interventional
• Target: 4,328
• Locations: 2 countries
• Sites: 53

Brief 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.

Conditions

SARS-CoV-2

Keywords

mRNA-1273; mRNA-1273 vaccine; SARS-CoV-2; SARS-CoV-2 Vaccine; mRNA-1273.222 vaccine; SARS-CoV-2 VOC; SARS-CoV-2 VOC vaccine; Omicron; Variant; Coronavirus; Virus Diseases; Messenger RNA; COVID-19; COVID-19 Vaccine; Moderna

Outcome Measures

Primary Outcomes (12)

• Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)

  Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Solicited ARs considered causally related to injection were graded 1-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicated lower severity, and higher score indicated greater severity. Investigator reviewed if the solicited AR was recorded as an adverse event (AE) as detailed in the AE section. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the AE section.

  7 days post-vaccination

• Number of Participants With Unsolicited AEs

  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 started outside the protocol-defined period for reporting solicited ARs (onset after Day 7 of dosing). An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result or other safety assessment, including one that worsened from baseline and was considered clinically significant by the Investigator was recorded as an AE. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part1/2 but were considered clinical events for efficacy in Part 3 and not AEs. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the AE section.

  Up to 28 days post-vaccination

• 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

  Pseudovirus nAb ID50 titers were measured using pseudovirus neutralization assay (PsVNA) assay. Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5\*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ if actual values were not available (LLOQ: 18.5 arbitrary units (AU)/milliliter (mL), ULOQ: 45118 AU/mL). Antibody levels were analyzed using an analysis of covariance (ANCOVA) model with the group variable (adolescents in P203 and young adults in P301) as fixed effect. PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria were used for comparison assessments of immune response.

  Day 57 Study P203/Day 57 Study P301

• 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

  Percentage of participants with seroresponse for pseudovirus nAb ID50 measured using PsVNA assay are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4\*LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ (LLOQ: 18.5 AU/mL), ULOQ: 45118 AU/mL). PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria were used for comparison assessments of immune response.

  Day 57 Study P203/Day 57 Study P301

• 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

  Pseudovirus nAb were measured using PsVNA assay. Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available (LLOQ: 10, ULOQ: 281600). PPIS P301: randomly selected participants from study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison assessments of immune response.

  BD Day 29 Study P203/Day 57 Study P301

• 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

  Percentage of participants with seroresponse for pseudovirus nAb measured using PsVNA assay are reported. Seroresponse relative to pre-Dose 1 (baseline) at a participant level was defined as a change from below the LLOQ to equal or above 4 \* LLOQ, or at least a 4-fold-rise if baseline was equal to or above LLOQ (LLOQ: 10 AU/mL, ULOQ: 281600 AU/mL). PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison assessments of immune response.

  BD Day 29 Study P203/Day 57 Study P301

• 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

  Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available (LLOQ: 103 AU/mL, ULOQ: 28571 AU/mL). ANCOVA model with the group variable (adolescents in P203 and young adults in P301) as fixed effect. PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison of immune response.

  Day 29 Study P203/Day 57 Study P301

• Part 1C-2 GMC of Post-booster Pseudovirus nAb Against Ancestral Strain at BD Day 29

  Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available (LLOQ: 10 AU/mL, ULOQ: 111433 AU/mL).

  BD Day 29

• Part 2 GMC of the Pseudovirus nAb Against Ancestral Strain at Day 57

  Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available (LLOQ: 10 AU/mL, ULOQ: 111433 AU/mL).

  Day 57

• 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

  Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available (LLOQ: 10 AU/mL, ULOQ: 111433 AU/mL). ANCOVA model with the group variable (adolescents in P203 and young adults in P301) as fixed effect. PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison of immune response.

  Day 29 Study P203/Day 57 Study P301

• Part 2 SRR of Pseudovirus nAb Against Ancestral Strain

  Percentage of participants with seroresponse for pseudovirus nAb measured using PsVNA assay are reported. Seroresponse relative to pre-Dose 1 (baseline) at a participant level was defined as a change from below the LLOQ to equal or above 4 \* LLOQ, or at least a 4-fold-rise if baseline was equal to or above the LLOQ (LLOQ: 10 AU/mL, ULOQ: 111433 AU/mL).

  Day 57

• Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study Discontinuation

  SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs were identified based upon medical concepts that may be related to COVID-19 or were of interest in COVID-19 vaccine safety surveillance. MAAE was an AE that led to an unscheduled visit to a healthcare practitioner, included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and visits to healthcare practitioners external to the study site \[for example, urgent care, primary care physician\]). Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were defined as AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.

  Day 1 up to Day 751

Secondary Outcomes (13)

• 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 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 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 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 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

Other Outcomes (1)

• Number of Deaths Related to Study Drug

  Day 1 up to Day 751

Study Arms (4)

mRNA-1273

EXPERIMENTAL

Part 1A (Blinded Phase): Participants will receive 2 intramuscular (IM) injections of mRNA-1273 (100 microgram \[ug\] each), 28 days apart, on Day 1 and Day 29. Part 1B (Open-Label Phase): Participants who cross over from placebo in Part 1A to Part 1B will receive 2 IM injections of mRNA-1273 (100 ug each), 28 days apart on Open Label Day 1 and Open Label Day 29. Part 2 (Open-Label): Participants will receive 2 IM injections of mRNA-1273 (50 ug each), 28 days apart, on Day 1 and Day 29 and may receive a booster dose on Day 149.

Biological: mRNA-1273

Placebo

PLACEBO COMPARATOR

Part 1A (Blinded Phase): Participants will receive 2 IM injections of mRNA-1273 matching placebo, 28 days apart, on Day 1 and Day 29.

Biological: Placebo

mRNA-1273 BD

EXPERIMENTAL

Part 1C-1 (BD Phase): Participants will receive 1 IM injection of mRNA-1273 (50 ug) on BD-Day 1, 5 months after the last dose of Part 1A and 1B. Part 1C-2 (BD Phase): Participants will receive 1 IM injection of mRNA-1273 (50 ug) on BD-Day 1, at least 3 months post-last dose.

Biological: mRNA-1273

mRNA-1273.222

EXPERIMENTAL

Part 3 (Open-Label): Participants will receive up to 2 IM injections of mRNA-1273.222 (50 ug each), 6 months apart, on Day 1 and Day 181.

Biological: mRNA-1273.222

Interventions

mRNA-1273 BIOLOGICAL

Sterile liquid for injection

mRNA-1273; mRNA-1273 BD

Placebo BIOLOGICAL

0.9% sodium chloride (normal saline) injection

Placebo

mRNA-1273.222 BIOLOGICAL

Sterile solution for injection

mRNA-1273.222

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• For Part 1A, Part 2 and Part 3:
• Participants 12 to \<18 years of age at the time of consent (Screening Visit, Day 0) who, in the opinion of the Investigator, are in good general health based on review of medical history and screening physical examination.
• Investigator assessment that the participant, in the case of an emancipated minor, or parent(s)/legally acceptable representative(s) (LAR\[s\]) understand and is willing and physically able to comply with protocol-mandated follow up, including all procedures and provides written informed consent/assent.
• Body mass index (BMI) at or above the third percentile according to World Health Organization (WHO) Child Growth Standards at the Screening Visit (Day 0)
• Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as premenarche or surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy).
• Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test at Screening (Day 0), on the day of the first injection (Day 1), on the day of the second injection (Day 29 in Parts 1A and Part 2, and Day 181 in Part 3); has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (Day 1); and has agreed to continue adequate contraception or abstinence through 3 months following the second injection (Day 29 in Part 1A and Part 2, and Day 181 in Part 3).
• For Part 1B:
• Participants must have been previously enrolled in mRNA-1273-P203 study.
• Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test on the day of the first injection (Open-Label-Day 1) and on the day of the second injection (Open-Label-Day 29).
• For Part 1C-1 Homologous Booster Dose:
• Participants must have been previously enrolled in the mRNA-1273-P203 study, are actively participating in Part 1A or Part 1B and are least 5 months from the last dose.
• Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test on the day of the first injection (BD-Day 1).
• Part 1C-2 Heterologous Booster Dose:
• Male or female, 12 to \< 18 years of age at the time of consent who, in the opinion of the investigator, is in good general health based on review of medical history and screening physical examination AND has completed non-Moderna primary COVID-19 vaccination series under EUA (for example, Pfizer) at least 3 months from consent.

You may not qualify if:

• For Part 1A, Part 2, and Part 3:
• Has a known history of SARS-CoV-2 infection within 2 weeks prior to administration of investigational product (IP) or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection of COVID-19 within 2 weeks prior to administration of IP (Part 2 participants only). For Part 3 participants, known history of SARS-CoV-2 infection within 90 days prior to administration of IP or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 90 days prior to administration of IP.
• Travel outside of the United States or home country (Part 2 and Part 3 only) in the 28 days prior to the Screening Visit (Day 0).
• 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°Celsius (C)/≥100.4°Farenheit (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.
• Prior administration of an investigational coronavirus (for example, SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome \[MERS-CoV\]) vaccine
• Current treatment with investigational agents for prophylaxis against COVID-19
• 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
• Current use of any inhaled substance (for example, tobacco or cannabis smoke, nicotine vapors)
• History of chronic smoking (≥1 cigarette a day) within 1 year of the Screening Visit (Day 0)
• History of a diagnosis or condition that, in the judgment of the Investigator, may affect study endpoint assessment or compromise participant safety, specifically:
• Congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection
• 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

Sponsors & Collaborators

• ModernaTX, Inc.: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (53)

Velocity Clinical Research - Banning

Banning, California, 92220, United States

Location

Paradigm Clinical Research

La Mesa, California, 91942, United States

Location

Altus Research - Hunt - PPDS

Lake Worth, Florida, 33461, United States

Location

Accel Research Sites - Nona Pediatric Center - ERN - PPDS

Orlando, Florida, 32829, United States

Location

Tekton Research - Georgia - PPDS

Chamblee, Georgia, 30341, United States

Location

IACT Health - Roswell - IACT - HyperCore - PPDS

Columbus, Georgia, 31904, United States

Location

Meridian Clinical Research - (Macon Georgia) - Platinum - PPDS

Macon, Georgia, 31210, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Velocity Clinical Research - Boise - PPDS

Meridian, Idaho, 83642, United States

Location

Olivo Medical and Wellness Center

Chicago, Illinois, 60618, United States

Location

Velocity Clinical Research - Valparaiso

Valparaiso, Indiana, 46383, United States

Location

Meridian Clinical Research (Sioux City - Iowa)

Sioux City, Iowa, 51106, United States

Location

Alliance for Multispecialty Research -El Dorado

El Dorado, Kansas, 67042, United States

Location

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

Velocity Clinical Research - Metairie - PPDS

Metairie, Louisiana, 70006, United States

Location

University of Massachusetts Medical School, Molecu

Worcester, Massachusetts, 01655, United States

Location

Clinical Research Institute, Inc - CRN - PPDS

Minneapolis, Minnesota, 55402, United States

Location

Velocity Clinical Research - Gulfport - PPDS

Gulfport, Mississippi, 39503, United States

Location

Sundance Clinical Research - Platinum - PPDS

St Louis, Missouri, 63141, United States

Location

Meridian Clinical Research (Hastings-Nebraska) - Platinum - PPDS

Hastings, Nebraska, 68901, United States

Location

Quality Clinical Research - HyperCore - PPDS

Omaha, Nebraska, 68114, United States

Location

Meridian Clinical Research (Omaha-Nebraska) - Platinum - PPDS

Omaha, Nebraska, 68134, United States

Location

Velocity Clinical Research - Albuquerque - PPDS

Albuquerque, New Mexico, 87102, United States

Location

Child Healthcare Associates - East Syracuse

East Syracuse, New York, 13210, United States

Location

Meridian Clinical Research (Endwell-New York) - Platinum - PPDS

Endwell, New York, 13901, United States

Location

Velocity Clinical Research - Cincinnati - PPDS

Cincinnati, Ohio, 45242, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Vital Prospects Clinical Research Institute PC - CRN - PPDS

Tulsa, Oklahoma, 74136, United States

Location

Cyn3rgy Research - ClinEdge - PPDS

Gresham, Oregon, 97030, United States

Location

Velocity Clinical Research - Providence - PPDS

East Greenwich, Rhode Island, 02818, United States

Location

Coastal Pediatric Associates

Charleston, South Carolina, 29414, United States

Location

Meridian Clinical Research - Charleston, SC

Charleston, South Carolina, 29414, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Benchmark Research

Austin, Texas, 78705, United States

Location

Coastal Bend Research Center

Corpus Christi, Texas, 78404, United States

Location

ACRC Trials

Frisco, Texas, 75033, United States

Location

DM Clinical Research - Kool Kids Pediatrics - ERN - PPDS

Houston, Texas, 77064, United States

Location

Clinical Trials of Texas, Inc. - PPDS

San Antonio, Texas, 78229, United States

Location

Tekton Research

San Antonio, Texas, 78229, United States

Location

Tekton Research

San Antonio, Texas, 78244, United States

Location

Cope Family Medicine - Ogden Clinic - CCT

Bountiful, Utah, 84010, United States

Location

Wee Care Pediatrics - Kaysville

Kaysville, Utah, 84037, United States

Location

Cottonwood Pediatrics

Murray, Utah, 84107, United States

Location

South Ogden Family Medicine/Ogden Clinic - CCT Research

South Ogden, Utah, 84405, United States

Location

Alliance for Multispecialty Research

Syracuse, Utah, 84075, United States

Location

Advanced Clinical Research - Jordan Valley - ERN - PPDS

West Jordan, Utah, 84088, United States

Location

Meridian Clinical Research (Norfolk, Virginia)

Norfolk, Virginia, 68701, United States

Location

Meridian Clinical Research - Family Practice Ports - Portsmouth - Platinum - PPDS

Portsmouth, Virginia, 23703, United States

Location

Caimed Dominicana S.A.S

Santo Domingo, Nacional, Dominican Republic

Location

Hospital General Regional Dr. Marcelino Velez Santana

Santo Domingo, Nacional, Dominican Republic

Location

Hospital Materno Infantil San Lorenzo de Los Mina

Santo Domingo, Nacional, Dominican Republic

Location

Instituto Dermatologico y Cirugia de la Piel Dr. H Sede San Cristóbal

Santo Domingo, Nacional, Dominican Republic

Location

Instituto Dominicano de Estudios Virologicos IDEV

Santo Domingo, Nacional, Dominican Republic

Location

Related Publications (2)

• Figueroa AL, Torres D, Reyes-Acuna C, Matherne P, Yeakey A, Deng W, Xu W, Sigal Y, Chambers G, Olsen M, Girard B, Miller JM, Das R, Priddy F. Safety and immunogenicity of a single-dose omicron-containing COVID-19 vaccination in adolescents: an open-label, single-arm, phase 2/3 trial. Lancet Infect Dis. 2025 Feb;25(2):208-217. doi: 10.1016/S1473-3099(24)00501-2. Epub 2024 Sep 24.

  PMID: 39332418 DERIVED

• Ali K, Berman G, Zhou H, Deng W, Faughnan V, Coronado-Voges M, Ding B, Dooley J, Girard B, Hillebrand W, Pajon R, Miller JM, Leav B, McPhee R. Evaluation of mRNA-1273 SARS-CoV-2 Vaccine in Adolescents. N Engl J Med. 2021 Dec 9;385(24):2241-2251. doi: 10.1056/NEJMoa2109522. Epub 2021 Aug 11.

  PMID: 34379915 DERIVED

Related Links

• Click here to access the website, http://TeenCoveStudy.com, for additional information for the study, such as Study Overview, Participation, Site Locations, along with contact numbers for each location for the study.

MeSH Terms

Conditions

Coronavirus Infections; Virus Diseases; COVID-19

Interventions

2019-nCoV Vaccine mRNA-1273

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Limitations and Caveats

Part 1C-2 enrollment discontinued before planned number of participants. Part 2 discontinued early due to availability of updated variant vaccine (mRNA-1273.222); no hypothesis testing done for primary endpoint/other endpoints not assessed.

Results Point of Contact

• Title: Moderna WeCare Team
• Organization: ModernaTX, Inc.

WeCareClinicalTrials@modernatx.com

+1-866-663-3762

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part 1A is observer-blind. Participants will remain blinded until the initiation of Part 1B.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 2, 2020
• Study Start: December 9, 2020
• Primary Completion: June 14, 2024
• Study Completion: June 14, 2024
• Last Updated: September 15, 2025
• Results First Posted: September 15, 2025

Record last verified: 2025-08

Locations

DO (5); US (48)