Clinical Trials Logo
  1. Home
  2. Influenza, Human
  3. NCT02621164

Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents

Influenza, Human Clinical Trial

Official title:
A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess the Immunogenicity and Safety of 'NBP607-QIV(Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine)' in Children and Adolescents Aged 6 Months ~ 18 Years

Clinical Trial Summary

This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of the study is to describe the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects.

Clinical Trial Description

Subjects are randomly assigned in a 4:1 ratio to NBP607-QIV versus Agrippal S1. To assess the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at pre-vaccination and 28 days post-vaccination. To assess the safety, solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination are assessed and reported. The serious adverse events are collected during 6 months post-vaccination. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02621164
Study type Interventional
Source SK Chemicals Co.,Ltd.
Contact
Status Completed
Phase Phase 3
Start date September 2014
Completion date June 2015
View Details
See also
  Status Clinical Trial Phase
Completed NCT03275389 - A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years Phase 1
Completed NCT03442582 - Afluria Pregnancy Registry
Completed NCT05981846 - A Phase II Trial to Evaluate the Safety and Immunogenicity of BIMERVAX® When Coadministered With Seasonal Influenza Vaccine (SIIV) in Adults Older Than 65 Years of Age Fully Vaccinated Against COVID-19 Phase 2
Completed NCT05044195 - A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age Phase 3
Completed NCT02914275 - A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age. Phase 3
Completed NCT04590066 - Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates at a Large Retail Pharmacy N/A
Recruiting NCT03778203 - Development of Childhood Anti-influenza Immunity Phase 4
Completed NCT04527614 - Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection N/A
Terminated NCT03658629 - Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults Phase 2
Completed NCT05269290 - Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute Respiratory Viral Infections Phase 3
Completed NCT06385821 - A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus Phase 3
Completed NCT02998996 - Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU Phase 1/Phase 2
Completed NCT02984280 - Specific Respiratory Infections as Triggers of Acute Medical Events N/A
Completed NCT02867358 - A Clinical Trial of KT07 Capsule in the U.S.A Phase 2
Withdrawn NCT02883972 - Childhood Influenza Immunisation Invitation Trial in Schools N/A
Completed NCT02545543 - A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age Phase 3
Completed NCT02243774 - Mail Outreach To Increase Vaccination Acceptance Through Engagement N/A
Completed NCT02212106 - A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years Phase 4
Completed NCT02344134 - Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects Phase 3
Completed NCT01674205 - Study of Immune Responses in Healthy Adults Receiving Live Influenza Virus Vaccines Phase 1