NCT00289510

Brief Summary

The objective of this study is to assess the safety and immunogenicity of inactivated influenza vaccine (whole virion, Vero cell derived). Subjects will be randomly assigned to receive a single injection of whole virion, Vero cell derived or egg derived influenza vaccine on Day 0. Subjects will return to the study site for safety evaluation at predetermined intervals for 180 days after vaccination. Subjects will also have blood drawn at predetermined intervals to measure their immunologic response to vaccination.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
423

participants targeted

Target at P75+ for phase_1

Geographic Reach
2 countries

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2006

Completed
Last Updated

October 9, 2015

Status Verified

October 1, 2007

First QC Date

February 9, 2006

Last Update Submit

October 7, 2015

Conditions

Influenza

Interventions

Inactivated influenza vaccine (whole virion, Vero cell-derived)BIOLOGICAL
Inactivated influenza vaccine (egg derived) [licensed control vaccine]BIOLOGICAL

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female subjects who
  • are 18 to 45 years of age, inclusive, on the day of screening;
  • have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry;
  • 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);
  • agree to keep a daily record of symptoms;
  • if female and capable of bearing children - have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study.

You may not qualify if:

  • Subjects who
  • have received any influenza vaccination for the 2005/2006 influenza season and/or the 2004/2005 influenza season;
  • have received any vaccination within 2 weeks prior to vaccination in this study;
  • 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) that can be expected to influence immune response;
  • 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, allergy to eggs, allergy to components of the test or comparator vaccine, other known contraindications);
  • have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating;
  • have a known or suspected problem with alcohol or drug abuse;
  • are unable to lead an independent life as a result of either physical or mental handicap;
  • were administered an investigational drug within six weeks prior to study entry;
  • are concurrently participating in a clinical study that includes the administration of an investigational product;
  • if female, are pregnant or lactating;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Allgemeines Krankenhaus Wien (General Hospital Vienna)

Vienna, 1090, Austria

Location

Klinikum Westend, Haus 18

Berlin, 14050, Germany

Location

Internistische Gemeinschaftspraxis Dr. Regner & Dr. Schmitt (Group practice for internal medicine)

Mainz, 55116, Germany

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Markus Müller, MD

    Allgemeines Krankenhaus Wien (General Hospital Vienna)

    PRINCIPAL INVESTIGATOR

  • Kasra Shakeri-Nejad, MD

    Klinikum Westend, Berlin

    PRINCIPAL INVESTIGATOR

  • Bernhard Schmitt, MD

    Internistische Gemeinschaftspraxis (Group practice for internal medicine) Dr. Regner & Dr. Schmitt, Mainz

    PRINCIPAL INVESTIGATOR

  • Alen Jambrecina, MD

    MDS Pharma Services Germany GmbH, Hamburg

    PRINCIPAL INVESTIGATOR

  • Stephan De la Motte, MD

    Harrison Clinical Research / Clinical Unit, Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 9, 2006

First Posted

February 10, 2006

Study Start

January 1, 2006

Last Updated

October 9, 2015

Record last verified: 2007-10

Locations

AU(1)DE(2)