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NCT04952402 · ClinicalTrials.gov registry record · Phase 4
SARS-CoV-2 Immune Responses After COVID-19 Therapy and Subsequent Vaccine
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 4
- Development phase
- 43
- Enrollment target
NCT04952402: Completed Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04952402 is a Phase 4 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 43 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04952402, a Phase 4 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 43 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of mRNA COVID-19 vaccines in: • People with prior COVID-19 (SARS-CoV-2 infection) who were in the ACTIV-2/A5401 study. And • People who have never had COVID-19 (SARS-CoV-2 infection).
Primary Outcome
NAb level was measured by using both 50% neutralizing dilution titers (ND50) and 80% neutralizing titers (ND80). A higher NAb level corresponds to a stronger immune response. For ND50 values less than lower limit of quantification (LLQ), we impute with 10 (which is ½ LLQ of 20). For ND50 values exceeding the upper limit of quantification (ULQ), we impute with 20,000 (a value suggested by the immunology lab, which is 2 times the ULQ of 10,000). For ND80, we impute similarly with 10 and 20,000. We
Interventions
- BIOLOGICAL Study-provided Moderna mRNA-1273 COVID-19 vaccine
- BIOLOGICAL Community-provided Moderna mRNA-1273 COVID-19 Vaccine
- BIOLOGICAL Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2021-07-09 |
| Est. Completion | 2023-01-10 |
| Phase | Phase 4 |
What the finished NCT04952402 record still lists
NCT04952402 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Study-provided Moderna mRNA-1273 COVID-19 vaccine is the first listed.
NCT04952402 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04952402 about?
NCT04952402 is a clinical study titled "SARS-CoV-2 Immune Responses After COVID-19 Therapy and Subsequent Vaccine". The purpose of this study is to evaluate the safety and efficacy of mRNA COVID-19 vaccines in: • People with prior COVID-19 (SARS-CoV-2 infection) who were in the ACTIV-2/A5401 study. And • People who have never had COVID-19 (SARS-CoV-2 infection).
What is the current status of trial NCT04952402?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 43 participants. The study started on 2021-07-09. Estimated completion is 2023-01-10.
What interventions are being tested in trial NCT04952402?
The interventions under investigation include: Study-provided Moderna mRNA-1273 COVID-19 vaccine (BIOLOGICAL), Community-provided Moderna mRNA-1273 COVID-19 Vaccine (BIOLOGICAL), Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04952402?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04952402's enrollment target sits among peer trials
43 1371st of 2000 higher than 621 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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