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A Phase II/III Study of PIKA Recombinant SARS-CoV-2 Vaccine as a Booster Dose.

NCT05463419 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 5860

Last updated 2024-07-23

No results posted yet for this study

Summary

This is a Phase II/III, randomized, double-blinded study in adults ≥ 18 years old who received 2 or more doses of inactivated COVID-19 vaccine to evaluate the efficacy, safety and immunogenicity of a booster dose of PIKA COVID-19 vaccine compared to the comparator inactivated COVID-19 vaccine. Phase II/III will be a competitive enrollment process in all participating countries. Once the target number of subjects is reached, the enrollment in all participating countries in the particular phase will be stopped.

Conditions

  • Covid-19 Vaccine

Interventions

BIOLOGICAL

PIKA COVID-19 vaccine

SARS-CoV-2 spike subunit protein (Also called "Recombinant SARS-CoV-2 S-trimer protein"), PIKA adjuvant.

BIOLOGICAL

Inactivated Covid-19 vaccine

Inactivated SARS-CoV-2 virus

Sponsors & Collaborators

  • Yisheng Biopharma (Singapore) Pte. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-03
Primary Completion
2023-12-28
Completion
2024-04-11

Countries

  • Philippines
  • United Arab Emirates

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 NCT05463419 on ClinicalTrials.gov