Clinical Trials Logo
  1. Home
  2. Vaccine Reaction
  3. NCT05546502

Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children

Vaccine Reaction Clinical Trial

Official title:
A Phase III, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children Aged 12-17 Years in Indonesia

Clinical Trial Summary

A Phase III, Observer-blind, randomized, active-controlled prospective intervention study

Clinical Trial Description

This trial is randomized, prospective intervention study. A total of 1,050 subjects aged 12-17 years (COVID-19 vaccine naive) who are willing to participate in the study by signing the consent form, will be involved in this trial. The subjects will be divided into twostudy subsets, namely Main Study and Exploratory Study. Main Study for immunogenicity and safety evaluation. Exploratory Study for cellular immunity evaluation, ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05546502
Study type Interventional
Source PT Bio Farma
Contact Rini Mulia Sari, MD
Phone 0222033755
Email rini.mulia@biofarma.co.id
Status Recruiting
Phase Phase 3
Start date October 9, 2022
Completion date January 31, 2024
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06091410 - Immunogenicity of Concomitant Administration of COVID-19 Vaccines With Influenza Vaccines Phase 4
Completed NCT05057910 - SARS-CoV-2 (Covid-19) RBD Antibody in My Duc Hospital Healthcare Workers
Completed NCT06385821 - A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus Phase 3
Recruiting NCT05028257 - Allergy and COVID-19 Vaccines Phase 3
Active, not recruiting NCT06286488 - Effectiveness and Tolerability of Influenza Vaccine in Patients at Risk for Severe and Complicated Influenza Phase 4
Completed NCT05869201 - Tolerability, Safety and Immunogenicity Trial of the Flu-M Quadro, Tetravalent Inactivated Split Influenza Vaccine Phase 2/Phase 3
Completed NCT04798677 - Efficacy and Tolerability of ABBC1 in Volunteers Receiving the Influenza or Covid-19 Vaccine N/A
Recruiting NCT05598372 - Infant Pain During Vaccination and Maternal Anxiety N/A
Active, not recruiting NCT06002503 - Safety, Reactogenicity and Immunogenicity of a Venezuelan Equine Encephalitis DNA Vaccine Candidate Administered by Jet Injection Phase 1
Completed NCT05098600 - The Epidemiology, Management and Comorbidities in Alopecia Areata in Czech Republic
Completed NCT03600428 - Safety of LAIV4 in Children With Asthma Phase 4
Completed NCT03400878 - Comparing Morbidity and Mortality Effects of Two Different Strains of BCG Phase 4
Completed NCT05116748 - COVID19 Vaccine in SOT Adult Recipients
Completed NCT05069714 - One or Two Week Methotrexate Discontinuation on Efficacy of Influenza Vaccination in Rheumatoid Arthritis. Phase 3
Completed NCT04576910 - Immunogenicity and Safety of the Booster Dose of Polio Vaccine With Different Primary Sequential Schedules in China Phase 4
Not yet recruiting NCT05094635 - Immunogenicity Against SARS-CoV-2 in COVID-19 Close Contacts
Recruiting NCT05493917 - A Real-world Study to Evaluate the Safety and Immunogenicity of a Third-dose Booster After Two Doses of an Inactivated COVID-19 Vaccine
Not yet recruiting NCT05171946 - Phase-I Study to Evaluate the Safety and Immunogenicity of a Prophylactic pDNA Vaccine Candidate Against COVID-19 in Healthy Adults Phase 1
Completed NCT05154383 - Effect of High-Dose Quadrivalent Influenza Vaccine (Efluelda®) Versus Standard-Dose (QIV-SD), in Subjects 65 Years of Age and Older on Innate Immunity, Including Gene Expression Phase 4
Recruiting NCT05128721 - Evaluation of Inactivated Vaccine in Healthy Adults Against Coronavirus Disease of 2019 (COVID-19) Phase 1