ClinicalTrials.gov record
A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age
ClinicalTrials.gov ID: NCT04796896
Public ClinicalTrials.gov record NCT04796896. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2/3, Three-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children as intramuscular (IM) injection in 2 doses (in Parts 1 and 2) and 3 doses (in Part 3), and a third dose or an optional booster dose (BD) (in Parts 1 and 2).
Study identification
- NCT ID
- NCT04796896
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 11,942 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Months to 11 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 14, 2021
- Primary completion
- Mar 14, 2024
- Completion
- Mar 14, 2024
- Last update posted
- Jun 12, 2025
2021 – 2024
United States locations
- U.S. sites
- 83
- U.S. states
- 32
- U.S. cities
- 71
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's of Alabama | Birmingham | Alabama | 35233-1711 | — |
| MedPharmics, LLC | Phoenix | Arizona | 85015-1105 | — |
| Emmaus Research Center Inc | Anaheim | California | 92804-1866 | — |
| Velocity Clinical Research - Banning - ERN- PPDS | Banning | California | 92220-3082 | — |
| SeraCollection Research Services LLC | El Monte | California | 91731 | — |
| UCSD Altman Clinical and Translational Research Institute Building | La Jolla | California | 92037 | — |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | — |
| Center for Clinical Trials, LLC | Paramount | California | 90723-5459 | — |
| Rady Childrens Hospital San Diego - PIN | San Diego | California | 92123 | — |
| Carey Chronis MD Pediatric, Infant and Adolescent Medicine - FOMAT | Ventura | California | 93003-5369 | — |
| Children's Hospital Colorado - (CRS) | Aurora | Colorado | 80045-7144 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06519-1712 | — |
| Prohealth Research Center | Doral | Florida | 33166 | — |
| University of Florida Jacksonville | Jacksonville | Florida | 32209-6511 | — |
| Kissimmee Clinical Research (KCR) | Kissimmee | Florida | 34743 | — |
| Allied Biomedical Research Institute | Miami | Florida | 33155-4630 | — |
| Pensacola Research Consultants Inc. d/b/a Avanza Medical Research Center | Pensacola | Florida | 32503 | — |
| University of South Florida | Tampa | Florida | 33613-3946 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30322-1014 | — |
| Iresearch Atlanta, LLC | Decatur | Georgia | 30030-3438 | — |
| iresearch Savannah | Savannah | Georgia | 31405 | — |
| Velocity Clinical Research - Boise - ERN - PPDS | Meridian | Idaho | 83642-6246 | — |
| Ann and Robert H Lurie Childrens Hospital of Chicago | Chicago | Illinois | 60611-2991 | — |
| Alliance for Multispecialty Research -El Dorado | El Dorado | Kansas | 67042-2187 | — |
| University of Kentucky | Lexington | Kentucky | 40504-3516 | — |
| Michael W Simon, MD PSC | Lexington | Kentucky | 40517-8366 | — |
| Our Lady of the Lake Regional Medical Center | Baton Rouge | Louisiana | 70809 | — |
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70809 | — |
| MedPharmics - Platinum | Metairie | Louisiana | 70006-4152 | — |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | — |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201-1519 | — |
| Javara Inc. | Chevy Chase | Maryland | 20815 | — |
| The Pediatric Centre of Frederick | Frederick | Maryland | 21702-4747 | — |
| Tufts University - Boston - PPDS | Boston | Massachusetts | 02111-1552 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114-2621 | — |
| Pediatric Associates of Fall River | Fall River | Massachusetts | 02721-1778 | — |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | — |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | — |
| Henry Ford Health System | Detroit | Michigan | 48202-2608 | — |
| Clinical Research Institute, Inc - CRN - PPDS | Minneapolis | Minnesota | 55402-2700 | — |
| University of Minnesota Masonic Children's Hospital | Minneapolis | Minnesota | 55454 | — |
| MediSync Clinical Research Hattiesburg Clinic | Petal | Mississippi | 39465 | — |
| University of Missouri Health Care System | Columbia | Missouri | 65212-1000 | — |
| Washington University in St. Louis | St Louis | Missouri | 63110-1010 | — |
| Meridian Clinical Research (Hastings, Nebraska) | Hastings | Nebraska | 68901 | — |
| Meridian Clinical Research (Norfolk-Nebraska) - Platinum - PPDS | Norfolk | Nebraska | 68701-2669 | — |
| Quality Clinical Research - PPDS | Omaha | Nebraska | 68114-3723 | — |
| MedPharmics, LLC | Albuquerque | New Mexico | 87102 | — |
| University of New Mexico | Albuquerque | New Mexico | 87106-2719 | — |
| Meridian Clinical Research (Endwell-New York) - Platinum - PPDS | Binghamton | New York | 13901-1046 | — |
| Certified Research Associates | Cortland | New York | 13045-9398 | — |
| Child Healthcare Associates - East Syracuse | East Syracuse | New York | 13057 | — |
| University of Rochester Medical Center | Rochester | New York | 14642-0001 | — |
| Stony Brook University Medical Center | Stony Brook | New York | 11794-0001 | — |
| OnSite Clinical Solutions, LLC | Charlotte | North Carolina | 28208 | — |
| Javara Inc. - Winston-Salem | Winston-Salem | North Carolina | 27101-4263 | — |
| Cincinnati Children's Hospital Medical Center - PIN | Cincinnati | Ohio | 45229-3026 | — |
| Lynn Health Science Institute - ERN - PPDS | Oklahoma City | Oklahoma | 73112-4703 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104-4319 | — |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15213-1481 | — |
| Velocity Clinical Research - Providence - ERN - PPDS | Warwick | Rhode Island | 02886-1617 | — |
| Coastal Pediatric Associates | Charleston | South Carolina | 29414-5834 | — |
| Medical University of South Carolina- PPDS | Charleston | South Carolina | 29425-8903 | — |
| Palmetto Pediatrics | North Charleston | South Carolina | 29406-9170 | — |
| Meharry Medical College - Clinical and Translational Research Center & Meharry Medical College - Pediatric Department | Nashville | Tennessee | 37208-3501 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-0011 | — |
| Tekton Research - Texas - Platinum - PPDS | Austin | Texas | 78745 | — |
| BRCR Global Texas | Edinburg | Texas | 78539-8462 | — |
| Pininos Pediatric Services | El Paso | Texas | 79902-1139 | — |
| Ventavia Research Group - Platinum - PPDS | Houston | Texas | 77008-1398 | — |
| Baylor College of Medicine | Houston | Texas | 77030-3411 | — |
| West Houston Clinical Research - Hunt | Houston | Texas | 77055-1626 | — |
| Texas Center for Drug Development, Inc | Houston | Texas | 77081 | — |
| Cyfair Clinical Research Center - ERN- PPDS | Houston | Texas | 77375-6579 | — |
| Village Health Partners - HUNT | Plano | Texas | 75024 | — |
| Victoria Clinical Research | Port Lavaca | Texas | 77901-5531 | — |
| Javara, Inc. | The Woodlands | Texas | 77382 | — |
| Crossroads Clinical Research (Victoria) | Victoria | Texas | 77901 | — |
| Tanner Clinic | Layton | Utah | 84041 | — |
| Advanced Clinical Research/Velocity Clinical Research | West Jordan | Utah | 84088 | — |
| PI-Coor Clinical Research, LLC | Burke | Virginia | 22015-1635 | — |
| Clinical Research Partners, LLC | Richmond | Virginia | 23226 | — |
| University of Wisconsin - Madison | Madison | Wisconsin | 53792-0001 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04796896, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 12, 2025 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04796896 live on ClinicalTrials.gov.