Trials / Completed
CompletedNCT05303402
A Phase IIb/III Clinical Trial to Assess Safety and Immunogenicity of a COVID-19 Vaccine Booster Dose in Immunosupressed Adults.
A Phase IIb/III, Open Label, Single Arm, Multi-centre, Trial to Assess the Immunogenicity and Safety of an Additional Dose Vaccination With a Recombinant Protein RBD Fusion Heterodimer Candidate (PHH-1V) Against SARS-CoV-2, in Adults With Pre-existing Immunosuppressive Conditions Vaccinated Against COVID-19
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 241 (actual)
- Sponsor
- Hipra Scientific, S.L.U · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A phase IIb/III, open label, single arm, multi-centre, trial to assess the immunogenicity and safety of an additional dose vaccination with a recombinant protein RBD fusion heterodimer candidate (PHH-1V) against SARS-CoV-2, in adults with pre-existing immunosuppressive conditions vaccinated against COVID-19
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PHH-1V | COVID-19 Vaccine HIPRA, 40 mcg/dose |
Timeline
- Start date
- 2022-05-12
- Primary completion
- 2023-07-29
- Completion
- 2023-12-01
- First posted
- 2022-03-31
- Last updated
- 2025-09-16
Locations
6 sites across 2 countries: Spain, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT05303402. Inclusion in this directory is not an endorsement.