Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V

Phase 3 Completed 205 enrolled Crucell Holland BV

RandomizedParallel-groupOpen-labelPrevention

Summary

The study aims to evaluate the immunogenicity of a single full (0.5 mL) dose and a 0.25 mL 2-dose regime of Inflexal V in unprimed children aged 6 - \<36 months, using the EMA guideline for the re-registration of the seasonal influenza vaccine in adults (aged ≥18 ≤60 years) as reference.

Timeline

Start: 2010-10
Primary completion: 2010-11
Completion: 2010-11

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Inflexal V	Vaccine	0.25 ml	—
Subject	Inflexal V	Vaccine	0.5 ml	—

Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V

Summary

Timeline

Drugs

Indications