A Study to Evaluate the Safety and Immunogenicity of the mRNA COVID-19 Vaccines in Healthy Children Between 6 Months to Less Than 6 Years of Age
Public ClinicalTrials.gov record NCT05436834. 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
An Open-Label, Phase 3 Study to Evaluate the Safety and Immunogenicity of mRNA Vaccines for SARS-CoV-2 Variants in Participants Aged 6 Months to < 6 Years
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the safety and immunogenicity of the mRNA-1273.214 vaccine for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant of concerns (VOCs) in participants aged 6 months to \<6 years, when administered as a primary series in SARS-CoV-2 vaccine-naïve participants (Part 1) and a single booster dose (BD) given to participants who previously received 2 doses of the mRNA-1273 vaccine as a primary series (Part 2); and will evaluate the safety and immunogenicity of the mRNA-1273.815 vaccine, when administered as a BD in participants aged 6 months to \<6 years (Part 3) and when administered to SARS-CoV-2 vaccine-naïve participants aged 2 years to \<5 years of age (Part 4).
Study identification
- NCT ID
- NCT05436834
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,807 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Months to 5 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
- Jun 21, 2022 (Actual)
- Primary completion
- Oct 20, 2025 (Actual)
- Completion
- Oct 20, 2025 (Actual)
- Last update posted
- Nov 26, 2025
2022 – 2025
United States locations
- U.S. sites
- 48
- U.S. states
- 22
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Trinity Clinical Research, LLC | Bessemer | Alabama | 34020 | — |
| Velcocity Clinical Research | Banning | California | 92220 | — |
| Sera Collection Research Services | Montebello | California | 90640 | — |
| Center For Clinical Trials LLC -Paramount | Paramount | California | 90723 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| Meridian Clinical Research | Washington D.C. | District of Columbia | 20016 | — |
| Prohealth Research Center | Doral | Florida | 33166 | — |
| University of Florida Jacksonville | Jacksonville | Florida | 32209 | — |
| Kissimmee Clinical Research | Kissimmee | Florida | 34741 | — |
| Med-Care Research | Miami | Florida | 33125 | — |
| University of South Florida | Tampa | Florida | 33612 | — |
| IResearch | Decatur | Georgia | 30030 | — |
| Meridian Clinical Research | Macon | Georgia | 31210 | — |
| Velcocity Clinical Research | Meridian | Idaho | 83642 | — |
| Lurie Childrens Hospital | Chicago | Illinois | 60611 | — |
| Meridian Clinical Research | Overland Park | Kansas | 66210 | — |
| Michael W. Simon MD, PSC | Lexington | Kentucky | 40517 | — |
| University of Kentucky | Lexington | Kentucky | 40536 | — |
| Velocity Clinical Research - Lafayette - PPDS | Lafayette | Louisiana | 70508 | — |
| MedPharmics | Metairie | Louisiana | 70006 | — |
| Velocity Clinical Research - Covington - PPDS | Metairie | Louisiana | 70006 | — |
| Clinical Research Institute | Minneapolis | Minnesota | 55402 | — |
| University of Missouri Health Care | Columbia | Missouri | 65212 | — |
| Meridian Clinical Research | Hastings | Nebraska | 68901 | — |
| Meridian Clinical Research | Lincoln | Nebraska | 68510 | — |
| Be Well Clinical Studies, LLC - Lincoln - ERN - PPDS | Lincoln | Nebraska | 68516 | — |
| Quality Clinical Research | Omaha | Nebraska | 68114 | — |
| Velocity Clinical Research | Albuquerque | New Mexico | 87102 | — |
| Meridian Clinical Research | Binghamton | New York | 13901 | — |
| WellNow Urgent Care Clinical Research | East Amherst | New York | 14051 | — |
| Child Healthcare Associates - East Syracuse | East Syracuse | New York | 13057 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| Velcocity Clinical Research | East Greenwich | Rhode Island | 02818 | — |
| Coastal Pediatric Associates | Charleston | South Carolina | 29414 | — |
| Meridian Clinical Research | Charleston | South Carolina | 29414 | — |
| MUSC | Charleston | South Carolina | 29425 | — |
| Le Bonheur Childrens Hospital | Memphis | Tennessee | 38105 | — |
| Velocity Clinical Research Austin | Austin | Texas | 78759 | — |
| REX Clinical Trials, LLC Beaumont | Beaumont | Texas | 77701-3739 | — |
| Velcocity Clinical Research | Cedar Park | Texas | 78613 | — |
| BRCR Global Texas | Edinburg | Texas | 78539 | — |
| Village Health Partners - Frisco Medical Village | Frisco | Texas | 75033 | — |
| Ventavia Research Group | Houston | Texas | 77008 | — |
| Cyfair Clinical Reseach Center | Houston | Texas | 77065 | — |
| Texas Center for Drug Development | Houston | Texas | 77081 | — |
| Victoria Clinical Research Group | Victoria | Texas | 77901 | — |
| PI Coor Clinical Research LLC | Burke | Virginia | 22015 | — |
| Clinical Research Partners | Richmond | Virginia | 23226 | — |
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 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05436834, 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 Nov 26, 2025 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05436834 live on ClinicalTrials.gov.