NCT01229397

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

A Phase III Open, Randomized, Parallel, Multi-center Study in Children Aged 6 - 35 Months to Compare the Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V Administered According to a 0/4 Week Schedule

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Crucell Holland BV · Industry
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Inflexal V	vaccination with Inflexal V 0.25 mL administered twice, 4 weeks apart
BIOLOGICAL	Inflexal V	Inflexal V 0.5 mL administrated once only

Timeline

• Start date: 2010-10-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-10-27
• Last updated: 2014-02-06
• Results posted: 2013-05-20

Locations

2 sites across 1 country: Italy