NCT00354016

Brief Summary

Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly and elderly subjects (CPMP/BWP/214/96).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

2 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

July 1, 2006

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2006

Completed
Last Updated

March 13, 2007

Status Verified

March 1, 2007

First QC Date

July 18, 2006

Last Update Submit

March 12, 2007

Conditions

Influenza

Keywords

influenzavaccine

Outcome Measures

Primary Outcomes (1)

  • antibody titers to each influenza strain measured by hemagglutination inhibition (HI) test on Day 0 and on Day 21

Secondary Outcomes (1)

  • safety of a single IM dose of the split influenza vaccine using solicited local and systemic reactions and adverse event reporting

Interventions

preservative free inactivated split influenza vaccine using the strain composition 2006/2007BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

  • Healthy adults aged \>18 years

You may not qualify if:

  • serious chronic diseases or significant acute infections requiring systemic antibiotic treatment
  • history of any anaphylaxis, serious vaccine reactions
  • hypersensitivity against vaccine components
  • history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
  • known or suspected impairment/alteration of immune function
  • more than one injection of influenza vaccine received or laboratory confirmed influenza disease
  • within last 6 months: influenza vaccination received

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Werksarztzentrum Herborn, Westerwaldstr 36,

Herborn, 35745, Germany

Location

Betriebsarztlicher Dienst, Universitat Marburg, Robert-Koch-Str, 5,

Marburg, 35037, Germany

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Novartis Vaccines - Drug Information Services

    Novartis Vaccines & Diagnostics

    STUDY CHAIR

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

July 18, 2006

First Posted

July 19, 2006

Study Start

July 1, 2006

Last Updated

March 13, 2007

Record last verified: 2007-03

Locations

DE(2)