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A Phase III Trial to Assess the Safety and Immunogenicity of a HIPRA's Candidate Booster Vaccination Against COVID-19.

NCT05246137 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2646

Last updated 2023-03-15

No results posted yet for this study

Summary

This is a phase III clinical study to assess the safety, tolerability and immunogenicity of PHH-1V as a booster dose in healthy adult subjects vaccinated against COVID-19 with the Comirnaty, Spikevax, Vaxevria or Janssen vaccine.

Conditions

  • COVID-19
  • SARS-CoV-2 Acute Respiratory Disease

Interventions

BIOLOGICAL

COVID-19 Vaccine 40 ug/dose

Intramuscular injection of 0,5 ml with 40 ug of recombinant PHH-1V

Sponsors & Collaborators

  • Hipra Scientific, S.L.U

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-03
Primary Completion
2022-03-03
Completion
2023-03-03

Countries

  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05246137 on ClinicalTrials.gov