Adult Safety Study of 2009/2010 Seasonal Influenza Vaccine

NCT01063088 | Completed Phase 3

• 2 other identifiers: 7209032009-017781-23
• Study Type: interventional
• Target: 211
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Influenza

Keywords

Prophylaxis of seasonal influenza in adults

Outcome Measures

Primary Outcomes (1)

• To assess the safety of a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2009/2010 season in an adult population through the first seven post vaccination days

  7 days

Study Arms (1)

Vaccination

EXPERIMENTAL

Single 0.5 mL intramuscular injection of PreFluCel 2009/2010

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

Interventions

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

Single 0.5 mL intramuscular injection

Also known as: PreFluCel 2009/2010

Vaccination

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alachua Government Services, Inc.: lead

Study Sites (2)

Sanatorium Leech

Graz, 8010, Austria

Location

ZU Gent, Centrum voor vaccinologie

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Gerald Aichinger, MD

  Baxter Healthcare Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 5, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 9, 2015

Record last verified: 2010-07

Locations

BE (1); AU (1)