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Safety and Immunogenicity of Recombinant Protein RBD Fusion Dimer Vaccine Against the Virus That Cause COVID-19, Known as Severe Acute Respiratoy Syndrome Coronavirus 2 (SARS-CoV-2)

NCT05142514 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 629

Last updated 2024-02-26

No results posted yet for this study

Summary

This is a Phase IIb, randomized, controlled, observer-blinded, clinical trial to evaluate safety and immunogenicity of COVID-19 Vaccine HIPRA in adult healthy volunteers in Vietnam

Conditions

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

Interventions

BIOLOGICAL

COVID-19 Vaccine HIPRA

Subjects will receive 2 injections of COVID-19 vaccine HIPRA administered 21 days apart

BIOLOGICAL

Cominarty (Pfizer-BioNtech)

Subjects will receive 2 injections of Cominarty administered 21 days apart

Sponsors & Collaborators

  • Laboratorios Hipra, S.A.

    collaborator INDUSTRY

  • National Institute of Hygiene and Epidemiology, Vietnam

    collaborator OTHER

  • Hipra Scientific, S.L.U

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-11
Primary Completion
2021-12-27
Completion
2022-05-06

Countries

  • Vietnam

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 NCT05142514 on ClinicalTrials.gov