NCT01147081

Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2010/2011

A Phase III, Multicenter, Uncontrolled, Open-label Study to Evaluate Safety and Immunogenicity of Begrivac®, Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2010/2011 When Administered to Adult and Elderly Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Annual trial for registration influenza vaccine Begrivac with strain composition for season 2010/2011.

Detailed description

At enrolment, subjects were stratified into two age strata (18 to 60 years, over 60 years). Total duration of the study is three weeks. Vaccinations were to be administered on day 1. Blood samples were collected at day 1 (baseline, before the vaccination) and at day 22 (three weeks after the vaccination). Sera were tested by Hemagglutination Inhibition (HI) assay. Safety was assessed until 3 weeks after the vaccination.

Conditions

• Seasonal Influenza

Interventions

Type	Name	Description
BIOLOGICAL	BEGRIVAC	126 healthy subjects enrolled to receive, in open-label manner, one dose of Begrivax (influenza vaccine)

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2010-06-22
• Last updated: 2012-01-05

Locations

3 sites across 1 country: Germany