Clinical Trials Logo
  1. Home
  2. Influenza, Human
  3. NCT03165617

Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of QIVc in Subjects ≥2 to <18 Years of Age

Influenza, Human Clinical Trial

Official title:
A Phase III/IV, Stratified, Randomized, Observer Blind, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of a Cell-Based Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Influenza Comparator Vaccine in Subjects ≥2 to <18 Years of Age

Clinical Trial Summary

This Phase 3/4, randomized, observer-blind, multi-center study, stratified study evaluated the immune (antibody) response, efficacy and safety of a cell-derived quadrivalent subunit influenza virus vaccine (Seqirus QIVc) in comparison with a non-influenza comparator, meningococcal serogroup A, C, W-135, and Y (Menveo®, GlaxoSmithKline Biologicals, S.A.) in healthy pediatric subjects ≥2 Years to <18 Years of Age

Clinical Trial Description

This Phase 3/4, randomized, observer-blind, multi-center, stratified study evaluated the efficacy, safety, and immunogenicity of a cell-derived quadrivalent subunit influenza virus vaccine (Seqirus QIVc) compared to a non-influenza comparator vaccine in healthy male and female participants between 2 to <18 years of age. A total of 4514 children/teens were randomized, receiving either QIVc or the non-influenza comparator vaccine. The comparator was (meningococcal [Groups A, C, W-135, and Y] oligosaccharide diphtheria CRM197 conjugate vaccine [Men ACWY]). Randomized enrollment was stratified in a 1:1 ratio via an Interactive Response Technology (IRT) system which assigned the participants into two age cohorts: 2 to <9 years of age and 9 to <18 years of age. Subjects between 2 to <9 years of age were further stratified by previous influenza vaccine status ("previously vaccinated" or "not previously vaccinated"). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03165617
Study type Interventional
Source Seqirus
Contact
Status Completed
Phase Phase 3
Start date May 25, 2017
Completion date September 30, 2019
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 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
Withdrawn NCT02883972 - Childhood Influenza Immunisation Invitation Trial in Schools N/A
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 NCT02621164 - Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents 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 NCT02344134 - Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects Phase 3