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NCT05436834 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by ModernaTX.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,807
- Enrollment target
NCT05436834 is a Phase 3 study that has completed, run by ModernaTX. The registered enrollment target is 1,807 participants.
The verdict
NCT05436834, a Phase 3 study, has completed, sponsored by ModernaTX.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,807 participants
- Enrollment target
Study Summary
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).
Interventions
- BIOLOGICAL mRNA-1273.815
- BIOLOGICAL mRNA-1273.214
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,807 participants |
| Start Date | 2022-06-21 |
| Est. Completion | 2025-10-20 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05436834
The ClinicalTrials.gov registry entry for NCT05436834 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,807 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ModernaTX, which has 90 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which mRNA-1273.815 is the first listed.
NCT05436834 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05436834 about?
NCT05436834 is a clinical study titled "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". 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 (...
What is the current status of trial NCT05436834?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,807 participants. The study started on 2022-06-21. Estimated completion is 2025-10-20.
What interventions are being tested in trial NCT05436834?
The interventions under investigation include: mRNA-1273.815 (BIOLOGICAL), mRNA-1273.214 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05436834?
This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.
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