NCT00161811

Brief Summary

The objectives of the study are to assess the immunogenicity and safety among three different lots of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_2

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
Last Updated

October 9, 2015

Status Verified

October 1, 2006

First QC Date

September 8, 2005

Last Update Submit

October 7, 2015

Conditions

Influenza

Interventions

Vero Cell-derived Influenza VaccineBIOLOGICAL
Egg cell-derived Influenza VaccineBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects will be eligible for participation in this study if they:
  • are \>= 18 and \<= 60 years old on the day of screening (for Stratum A only);
  • are \> 60 years old on the day of screening (for Stratum B only);
  • are clinically healthy (in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical study);
  • will reliably keep a daily record of symptoms;
  • understand the nature of the study, agree to its provisions, and give written informed consent;
  • if female and capable of bearing children - have a negative pregnancy test (urine) result at study entry and agree to employ adequate birth control measures for the duration of the study.

You may not qualify if:

  • Subjects will be excluded from participation in this study if they:
  • have received any influenza vaccine for the 2003/2004 season and/or for the 2004/2005 season;
  • suffer from any kind of immunodeficiency;
  • suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence the normal immunologic functions;
  • have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis);
  • have received a blood transfusion or immunoglobulins within 30 days of study entry;
  • have donated blood or plasma within 30 days of study entry;
  • have a history of any vaccine-related contraindicating event (e.g. anaphylaxis or other known contraindications);
  • have a rash or dermatological condition which may interfere with injection site reaction rating;
  • have a known or suspected problem with drug or alcohol abuse;
  • are unable to lead an independent life either physically or mentally;
  • were administered an investigational drug within six weeks prior to study entry;
  • are concurrently participating in a clinical study including the administration of an investigational product;
  • if female, are pregnant or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Vienna General Hospital (AKH), Department of Clinical Pharmacology

Vienna, Vienna, 1090, Austria

Location

Neuendorfstr. 20

Henningsdorf, 16761, Germany

Location

Münstererstr. 1a

Mainz, 55116, Germany

Location

Mainz University Children´s Clinic

Mainz, D-55101, Germany

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Markus Müller, MD

    Vienna General Hospital (AKH), Department of Clinical Pharmacology

    PRINCIPAL INVESTIGATOR

  • Pirmin Habermehl, MD

    Mainz University Children´s Clinic, Center for Clinical Studies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 13, 2005

Study Start

November 1, 2004

Study Completion

July 1, 2005

Last Updated

October 9, 2015

Record last verified: 2006-10

Locations

DE(3)AU(1)