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

Influenza Clinical Trial

Official title:

Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Southern Hemisphere Season 2015. An Open-Label, Baseline-Controlled Study in Two Age Groups: Adult Subjects ≥ 18 and ≤ 60 Years and Elderly Subjects ≥ 61 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02381418
• Other study ID #: INFL3014
• Status: Completed
• Phase: Phase 3
• First received: March 3, 2015
• Last updated: March 26, 2015
• Start date: March 2015
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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 IIIa 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Trivalent influenza subunit vaccine Influvac
"3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "

Locations

Country	Name	City	State
Australia	Research Facility ID ORG-001075	Maroubra

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the serum antihemagglutinin antibody titers and the derived parameters defined in the CHMP Note for Guidance on Harmonization of Requirements for Influenza Vaccines (CPMP/BWP/214/96) for influenza vaccines.		3 weeks post vaccination	No
Secondary	Safety (unsolicited adverse events) and tolerability (reactogenicity and overall inconvenience) of Influvac®.		up to 3 weeks post vaccination	Yes