NCT03165617

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,514 (actual)
• Sponsor: Seqirus · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Accepted

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

Detailed 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").

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	QIVc	Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains
BIOLOGICAL	Non-influenza Comparator Vaccine	Non-influenza comparator vaccine for intramuscular use

Timeline

• Start date: 2017-05-25
• Primary completion: 2019-09-30
• Completion: 2019-09-30
• First posted: 2017-05-24
• Last updated: 2020-10-22
• Results posted: 2020-10-22

Locations

40 sites across 8 countries: Australia, Estonia, Finland, Lithuania, Philippines, Poland, Spain, Thailand

Regulatory

• FDA-regulated drug study