Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2013/2014 Seaso

Phase 1

• Conditions: Prophylaxis of Influenza; MedDRA version: 14.1Level: HLTClassification code 10022005Term: Influenza viral infectionsSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-000881-12-BE
• Lead Sponsor: Abbott Biologicals B.V

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-28
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

1. Willing and able to give informed consent and able to adhere to all protocol required study procedures.
2. Men and women aged = 18 and = 60 years or = 61 years of age at the day of study vaccination.
3. Being in good health as judged by medical history, physical examination (if needed) and clinical judgment of the Investigator.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

1. Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
2. A serious adverse reaction after a previous (influenza) vaccination.
3. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
4. 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.
5. Having any condition which suppresses the immune system and autoimmune disorders.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified