Clinical Trials Logo
  1. Home
  2. Influenza, Human
  3. NCT02344134

Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects

Influenza, Human Clinical Trial

Official title:
A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess the Immunogenicity and Safety of NBP607 (Trivalent Inactivated Cell Culture-derived Influenza Vaccine) in Healthy Adults and Elderly Subjects

Clinical Trial Summary

The purpose of this study is to describe the immunogenicity and safety of the cell culture-derived influenza vaccine compared with the egg-derived influenza vaccine among subjects.

To describe the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained pre-vaccination and 21 days post-vaccination.

To describe the safety, the time of onset and duration of local and systemic solicited adverse events are assessed and reported. Unsolicited adverse events and serious adverse events are collected and categorized throughout the study period.

Clinical Trial Description

This is a multi-center, randomized, double-blind study in healthy adult and elderly subjects. Subjects receive a single dose of one of the influenza vaccine formulations and provide blood samples for immunogenicity assessment. ;

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 NCT02344134
Study type Interventional
Source SK Chemicals Co.,Ltd.
Contact
Status Completed
Phase Phase 3
Start date September 2013
Completion date May 2014
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
Withdrawn NCT02883972 - Childhood Influenza Immunisation Invitation Trial in Schools N/A
Completed NCT02984280 - Specific Respiratory Infections as Triggers of Acute Medical Events N/A
Completed NCT02998996 - Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU Phase 1/Phase 2
Completed NCT02867358 - A Clinical Trial of KT07 Capsule in the U.S.A Phase 2
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 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 NCT02243774 - Mail Outreach To Increase Vaccination Acceptance Through Engagement N/A
Completed NCT02621164 - Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents Phase 3
Completed NCT01674205 - Study of Immune Responses in Healthy Adults Receiving Live Influenza Virus Vaccines Phase 1