Study design
BLIND, INFLUENZA
This was an experimental, randomized, double blind, four arm parallel group bridging study to assess immune response and safety after one dose of quadrivalent and trivalent influenza HA vaccine in subjects 9–40 years old in clinically health children and adults aged 9–40 years. The study was a collaboration between the Department of Child Health, Faculty of Medicine, Universitas Padjadjaran, and PT Bio Farma (Persero), Indonesia. This study was approved by the Research Ethics Committee of the Faculty of Medicine, Universitas Padjadjaran, and conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. Written informed consent was obtained from the participants or their parents before performing any study-specific procedure.