NCT01633749

Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2012/2013 Season

Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Northern Hemisphere Season 2012/2013. An Open-label, Baseline-controlled Study in Two Age Groups: Adult Subjects ≥ 18 and ≤ 60 Years and Elderly Subjects ≥ 61 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Abbott Biologicals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Annual study to investigate influenza vaccine (flu vaccine) developed for the 2012/2013 season for the prevention of influenza infection. The immunizing effect is being investigated, as well as its tolerability and safety.

Detailed description

An open, baseline-controlled study in two age groups: adults and elderly. The subjects will be screened within 14 days prior to or at Visit 1 (Day 1). At Visit 1 (Day 1) subjects will be vaccinated after blood sampling for baseline serum antihemagglutinin antibody titration. Subjects will be asked to record local and systemic reactions daily on a diary at home for 72 hours after vaccination. One week later (Visit 2, Day 8) the subjects will return to the study site to hand in the diary and for the assessment of safety and tolerability (reactogenicity and overall inconvenience). Three weeks after vaccination (Visit 3, Day 22) the subjects will return to the study site for blood sampling to assess immunogenicity and for the assessment of safety and tolerability.

Conditions

• Prophylaxis of Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Trivalent influenza subunit vaccine Influvac	3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1

Timeline

• Start date: 2012-07-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-07-04
• Last updated: 2012-08-06

Locations

1 site across 1 country: Germany