NCT03932682

Efficacy Study With QIVc in Pediatric Subjects

A Phase 3, Randomized, Observer-blind, Multicenter Study to Evaluate the Efficacy, Immunogenicity and Safety of Seqirus' Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) Compared to a Non-Influenza Vaccine When Administrated in Healthy Subjects Aged 6 Months Through 47 Months

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,723 (actual)
• Sponsor: Seqirus · Industry
• Sex: All
• Age: 6 Months – 47 Months
• Healthy volunteers: Accepted

Summary

This phase 3 clinical study is a randomized, observer-blind, multicenter study of QIVc versus a non-influenza vaccine in subjects 6 months though 47 months of age. The purpose of this study is to evaluate efficacy of QIVc in the prevention of laboratory confirmed influenza A or B disease in children 6 through 47 months of age, compared to a non-influenza vaccine.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	QIVc	QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
BIOLOGICAL	Comparator	Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)

Timeline

• Start date: 2019-05-13
• Primary completion: 2023-11-30
• Completion: 2024-02-13
• First posted: 2019-05-01
• Last updated: 2025-03-04
• Results posted: 2025-03-04

Locations

74 sites across 15 countries: Bangladesh, Bulgaria, Czechia, Estonia, Honduras, Latvia, Malaysia, New Zealand, Pakistan, Philippines, Poland, Romania, South Africa, Thailand, Ukraine

Regulatory

• FDA-regulated drug study