NCT01100294

Tolerability and Safety Study of FLUVAL P Monovalent Influenza Vaccine in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Fluart Innovative Vaccine Ltd, Hungary · Industry
• Sex: All
• Age: 6 Months – 36 Months
• Healthy volunteers: Accepted

Summary

To determine the tolerability and safety of FLUVAL P monovalent influenza vaccine in children.

Detailed description

This is an open, uncontrolled study to assess safety and tolerability of Fluval P monovalent influenza vaccine (whole virus, inactivated, adjuvanted with alumn phosphate gel) containing 6 mcgHA per 0.5mL active ingredient in children of 6-36 months of age. The vaccination is not repeated. Tolerability and safety (incidence of adverse events) of the study drug is assessed after Day 28 then after Day 180-210 following the vaccination.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Vaccination with FLUVAL P	Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant. Dose: 0.25 ml (total 3 μg HA), single dose.

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-04-01
• Completion: 2010-05-01
• First posted: 2010-04-08
• Last updated: 2012-05-21

Locations

1 site across 1 country: Hungary