Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the Southern Hemisphere 2015 Season

Phase 3

Completed

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

• Registration Number: NCT02381418
• Lead Sponsor: Abbott

Brief Summary

Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. The current study is a phase III A clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. The objective of this study is to investigate the immunogenicity and safety and tolerability of the changed influenza vaccine virus composition in two groups of subjects in good health: subjects aged \>= 18 and \<= 60 years and subjects \>= 61 years of age (elderly).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Study First Submitted: 2015-03-03
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-06
• Results First Submitted: 2016-03-11
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-31
• Last Update Submitted: 2016-10-31
• Results First Posted: 2016-12-22
• Last Update Posted: 2016-12-22

Recruitment & Eligibility

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

Inclusion Criteria

• Willing and able to give informed consent and able to adhere to all protocol required study procedures.
• Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination.
• Being in good health as judged by medical history, physical examination (if needed) and clinical judgment of the Investigator

Exclusion Criteria

• Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
• A serious adverse reaction after a previous (influenza) vaccination.
• Presence of any significant condition that may prohibit inclusion as determined by the investigator.
• Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period.
• A history of Guillain-Barré syndrome or active neurological disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Trivalent influenza subunit vaccine Influvac	Trivalent influenza subunit vaccine Influvac. "3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 "

Primary Outcome Measures

Name	Time	Method
the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.	3 weeks post vaccination	Mean fold increase in HI antibody titer 3 weeks After Vaccination in non-elderly adults and elderly adults.

Secondary Outcome Measures

Name	Time	Method
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.	up to 3 weeks post vaccination

Trial Locations

Locations (1)

Research Facility ID ORG-001075; 🇦🇺 Maroubra, Australia