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UNAIR Inactivated COVID-19 Vaccine INAVAC as Heterologue Booster (Immunobridging Study) in Adolescent Subjects

NCT06272253 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2024-02-22

No results posted yet for this study

Summary

This is an open label trial. There will only be 1 group in the study. All subjects will receive INAVAC vaccine and be followed for 6 months.

The vaccine will be administered intramuscularly. This study will be started after the interim analysis of the phase III INAVAC trial in adolescent. This study will have two interim and one full analysis reports.

Conditions

  • COVID-19 Pandemic
  • COVID-19 Vaccines

Interventions

BIOLOGICAL

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

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

Sponsors & Collaborators

  • Indonesia-MoH

    collaborator OTHER_GOV

  • Universitas Airlangga

    collaborator OTHER

  • PT Biotis Pharmaceuticals, Indonesia

    collaborator UNKNOWN

  • Dr. Soetomo General Hospital

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-19
Primary Completion
2024-03-19
Completion
2024-07-19

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 NCT06272253 on ClinicalTrials.gov