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

Phase 3

Completed

• Conditions: Prophylaxis of Influenza
• Interventions: Biological: Trivalent influenza subunit vaccine Influvac

• Registration Number: NCT01633749
• Lead Sponsor: Abbott Biologicals

Brief 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.

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Study First Submitted: 2012-07-02
• Study First Submitted QC: 2012-07-02
• Study First Posted: 2012-07-04
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-03
• Last Update Posted: 2012-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Antihemagglutinin antibody titers and the derived parameters seroprotection, seroconversion and mean fold increase	3 weeks	Standard parameters to quantify antibody levels. Recommended in the CHMP guideline.
Solicited local and systemic reactions, overall inconvenience	3 days	Reactogenicity and inconvenience
Unsolicited adverse events	3 weeks	Other adverse events

Trial Locations

Locations (1)

Site Reference ID/Investigator# 74593; 🇩🇪 Hamburg, Germany