NCT04074928

Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects

A Phase 3, Randomized, Observer-Blind, Multicenter, Noninferiority Study to Evaluate Safety and Immunogenicity of a Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) and a United States Licensed Quadrivalent Influenza Virus Vaccine (QIV) in Healthy Subjects 6 Months Through 47 Months

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,414 (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, comparator-controlled, multicenter study of QIVc versus a US-licensed comparator QIV in children 6 months through 47 months of age. The purpose of this study is to demonstrate that vaccination with QIVc elicits an immune response that is noninferior to that of a US-licensed comparator QIV containing the same virus strains, in children 6 months through 47 months of age.

Conditions

• Influenza
• Human
• Virus Diseases

Interventions

Type	Name	Description
BIOLOGICAL	QIVc	Previously vaccinated subjects received a 0.5 mL intramuscular dose of QIVc on Day 1; not previously vaccinated subjects received a 0.5 mL intramuscular dose of QIVc on Day 1 and Day 29.
BIOLOGICAL	Comparator QIV	Previously vaccinated subjects received a dose of Comparator QIV on Day 1; not previously vaccinated subjects received a dose of Comparator QIV on Day 1 and Day 29. Subjects 6 months through 35 months of age received a 0.25 mL intramuscular dose of Comparator QIV; subjects 36 months through 47 months of age received a 0.5 mL intramuscular dose of Comparator QIV.

Timeline

• Start date: 2019-09-06
• Primary completion: 2020-09-03
• Completion: 2020-09-03
• First posted: 2019-08-30
• Last updated: 2022-01-12
• Results posted: 2022-01-12

Locations

47 sites across 1 country: United States

Regulatory

• FDA-regulated drug study