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UNAIR Inactivated COVID-19 Vaccine as Homologue Booster (Immunobridging Study)

NCT06259578 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2024-02-14

No results posted yet for this study

Summary

The goal of this open-label clinical trial is to evaluate the safety and immunogenicity of INAVAC (Vaksin Merah Putih - UNAIR SARS-CoV-2 (Vero Cell Inactivated)) Vaccine as Homologue Booster in Adult Subjects in Indonesia. The main question it aims to answer is: "To evaluate the humoral immunogenicity profile at 28 days following vaccination with INAVAC vaccine as homolog booster administered intramuscularly in healthy adults age 18 years and above". Participants will be administered one dose of vaccination for the third dose (booster vaccination) intramuscularly.

Conditions

  • COVID-19 Pandemic
  • COVID-19 Vaccines
  • COVID-19 Virus Disease

Interventions

BIOLOGICAL

INAVAC (Vaksin Merah Putih - UA- SARS CoV-2 (Vero Cell Inactivated) 5 μg

1 dose of 0.5 ml containing inactivated SARS-CoV-2 virus (5 μg ), Tween 80, histidine, Polysorbate 80, Aluminium hydroxide gel, and sodium chloride

Sponsors & Collaborators

  • Universitas Airlangga

    collaborator OTHER

  • Bioxis Pharmaceuticalls

    collaborator INDUSTRY

  • Indonesia-MoH

    collaborator OTHER_GOV

  • Dr. Soetomo General Hospital

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-29
Primary Completion
2024-08-29
Completion
2024-12-29

Countries

  • Indonesia

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 NCT06259578 on ClinicalTrials.gov