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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04969250
The ClinicalTrials.gov registry entry for NCT04969250 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Moderna mRNA-1273 COVID-19 vaccine is the first listed.
NCT04969250 reports 0 study locations.
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.
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