Adult Safety Study of 2009/2010 Seasonal Influenza Vaccine

Ology Bioservices

Status and phase

Completed

Phase 3

Conditions

Influenza

Treatments

Biological: Seasonal influenza vaccine (split virion, inactivated, prepared in Vero Cell cultures)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01063088

2009-017781-23 (EudraCT Number)

720903

Details and patient eligibility

About

The purpose of the study is to verify the safety and immunogenicity of a trivalent seasonal influenza vaccine with strain composition according to World Health Organization (WHO)/European Union (EU) recommendation for the 2009/2010 season.

Enrollment

211 patients

Sex

All

Ages

18 to 59 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subject is 18 to 59 years of age, inclusive, at the time of screening
Subject has given written informed consent prior to study entry
Subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination, such that the investigator would not hesitate to provide routine influenza immunization to the subject in the course of routine medical practice
Subject agrees to keep a daily record of symptoms for the duration of the study
If female of childbearing potential, subject presents with a negative urine pregnancy test immediately prior to vaccination on Study Day 1 and agrees to employ adequate birth control measures for the duration of the study
Subject is willing and able to comply with the requirements of the protocol

Exclusion criteria

Subject has a history of severe allergic reaction or anaphylaxis
Subject has an oral temperature of >= 37.5°C on the day of vaccination in this study Subject has a dermatologic condition or tattoos, which may interfere with injection site reaction rating
Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of study entry
Subject has been vaccinated with seasonal influenza vaccine for the 2009/2010 season
Subject currently has or had a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
Subject has any inherited or acquired immunodeficiency
Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (> 800 μg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs.
Subject has a functional or surgical asplenia
Subject has a known or suspected problem with alcohol or drug abuse
Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie., children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study.
If female, subject is pregnant or lactating at the time of study enrollment
Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study