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NCT04969250 · ClinicalTrials.gov registry record · Phase 4
Vaccination for Recovered Inpatients With COVID-19 (VATICO)
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 4
- Development phase
- 66
- Enrollment target
NCT04969250: Completed Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04969250 is a Phase 4 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 66 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04969250, a Phase 4 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 66 participants
- Enrollment target
Study Summary
In this Phase 4, open-label trial, participants of the ACTIV-3/TICO clinical trial at selected sites who received certain pre-specified blinded investigational agents or placebo as part of that trial, and who have since achieved sustained recovery, and who are still \[TICO assignment\] blinded and who are still within 28 to 90 days after initial TICO randomization, will be randomized in this 2x2 factorial design to one of four groups: (i) immediate versus 12 week deferral of first dose administration and also (ii) one dose only, versus two doses to be given 4 weeks apart of the Moderna mRNA-1273 or the Pfizer BNT162b2 vaccine (mRNA vaccines). Choice of Moderna or Pfizer vaccine is determined based on availability at the site. The choice is individual, although participants vaccinated twice should receive the same type of vaccine for both injections. The primary objectives of this 2x2 factorial design are (i) to estimate the difference in neutralizing antibody (NAb) response to the mRNA vaccine from baseline to Week 48 among participants vaccinated early versus deferred, and (ii) to estimate the difference in NAb response to this vaccine among participants vaccinated once versus twice. The primary analyses will be carried out in participants randomized to placebo in TICO. Analyses will also be carried out for those who receive the investigational agent(s) studied in TICO. A key secondary objective is to ascertain the effect, if any, of SARS-CoV-2 monoclonal antibodies, and other interventions that have been studied in hospitalized COVID-19 subjects, on natural and vaccine-induced immunity. Participants will remain blinded to the interventions received in the ACTIV-3/TICO study, however allocation to the timing of vaccination and to one or two vaccinations in this (VATICO) study is not blinded.
Primary Outcome
Change in antibody level as measured by ratio of follow-up to baseline level
Interventions
- BIOLOGICAL Moderna mRNA-1273 COVID-19 vaccine
- BIOLOGICAL Pfizer BNT162b2 COVID-19 vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2021-08-25 |
| Est. Completion | 2022-12-21 |
| Phase | Phase 4 |
What the finished NCT04969250 record still lists
NCT04969250 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Moderna mRNA-1273 COVID-19 vaccine is the first listed.
NCT04969250 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04969250 about?
NCT04969250 is a clinical study titled "Vaccination for Recovered Inpatients With COVID-19 (VATICO)". In this Phase 4, open-label trial, participants of the ACTIV-3/TICO clinical trial at selected sites who received certain pre-specified blinded investigational agents or placebo as part of that trial, and who have since achieved sustained recovery, and who are still \[TICO assignment\] blinded and w...
What is the current status of trial NCT04969250?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 66 participants. The study started on 2021-08-25. Estimated completion is 2022-12-21.
What interventions are being tested in trial NCT04969250?
The interventions under investigation include: Moderna mRNA-1273 COVID-19 vaccine (BIOLOGICAL), Pfizer BNT162b2 COVID-19 vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04969250?
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 NCT04969250's enrollment target sits among peer trials
66 1083rd of 2000 higher than 910 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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