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Clinical trial

A Phase IIb, Double-blind, Randomised, Active-controlled, Multi-centre, Non-inferiority Trial Followed by a Phase III, Single-arm, Open-label Trial, to Assess Immunogenicity and Safety of a Booster Vaccination With a Recombinant Protein RBD Fusion Dimer Candidate (PHH-1V) Against the Virus That Cause COVID-19, Know as Severe Acute Respiratoy Syndrome Coronavirus 2 (SARS-CoV-2)SARS-CoV-2, in Adults Fully Vaccinated Against COVID-19 Followed by an Extension Period to Study a Fourth Dose Administration of PHH-1V.

NCT05142553 is registered in ClinicalTrials.gov with Hipra Scientific, S.L.U as lead sponsor.

NCT NCT05142553
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase IIb, Double-blind, Randomised, Active-controlled, Multi-centre, Non-inferiority Trial Followed by a Phase III, Single-arm, Open-label Trial, to Assess Immunogenicity and Safety of a Booster Vaccination With a Recombinant Protein RBD Fusion Dimer Candidate (PHH-1V) Against the Virus That Cause COVID-19, Know as Severe Acute Respiratoy Syndrome Coronavirus 2 (SARS-CoV-2)SARS-CoV-2, in Adults Fully Vaccinated Against COVID-19 Followed by an Extension Period to Study a Fourth Dose Administration of PHH-1V.
Lead sponsor
Hipra Scientific, S.L.U
Phase
Phase 2
Overall status
Completed
Start date
November 16, 2021
Completion date
May 29, 2023
Enrollment
887 (actual)
Sites
10

Conditions

As the registry lists them; a condition with its own page is linked.

covid-19, sars-cov-2 acute respiratory disease