NCT04669691

A Dose-ranging Pediatric Study of an Adjuvanted Pandemic Influenza Vaccine

A Phase 2, Randomized, Observer-Blind, Multicenter Study to Evaluate the Immunogenicity and Safety of Several Doses of Antigen and MF59 Adjuvant Content in a Monovalent H5N1 Pandemic Influenza Vaccine in Healthy Pediatric Subjects 6 Months to < 9 Years of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: Seqirus · Industry
• Sex: All
• Age: 6 Months – 8 Years
• Healthy volunteers: Accepted

Summary

This study is a pediatric dose-ranging study to evaluate the safety and immunogenicity of vaccination with different MF59-adjuvanted H5N1 vaccine formulations.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	H5N1 antigen combined with MF59 adjuvant	Eligible subjects will be stratified by age at the time of enrollment into one of 2 age cohorts and within each age cohort will be randomly assigned (equally) to 1 of 6 study vaccine groups. Subjects in each study vaccine group will be scheduled to receive 2 injections of aH5N1 vaccine 3 weeks apart

Timeline

• Start date: 2020-12-19
• Primary completion: 2022-04-15
• Completion: 2022-04-15
• First posted: 2020-12-17
• Last updated: 2024-03-13
• Results posted: 2024-01-16

Locations

7 sites across 2 countries: Estonia, Philippines