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Safety and Immunogenicity of a Booster Vaccination With an Adapted Vaccine

NCT06181292 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 913

Last updated 2026-03-12

No results posted yet for this study

Summary

This is a phase IIb/III, double-blind, randomised, active-controlled, multi-centre, non-inferiority clinical trial that aims to determine safety, tolerability and immunogenicity of a booster vaccination with a recombinant protein receptor binding domain (RBD) fusion homodimer of XBB.1.16 adapted candidate against SARS-CoV-2 developed by HIPRA (PHH-1V81).

Conditions

  • SARS-CoV2 Infection

Interventions

BIOLOGICAL

PHH-1V81

booster of PHH-1V81

BIOLOGICAL

Comirnaty Omicron XBB1.5

booster of Comirnaty Omicron XBB1.5

Sponsors & Collaborators

  • Hipra Scientific, S.L.U

    lead INDUSTRY

Principal Investigators

  • Teresa Prat · Hipra Scientific, S.L.U

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-15
Primary Completion
2024-06-17
Completion
2024-06-17

Countries

  • Spain

Study Locations

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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 NCT06181292 on ClinicalTrials.gov