NCT00342940

Brief Summary

The present study aims to evaluate safety and immunogenicity of one dose of a commercially available Surface Antigen, Inactivated Influenza Vaccine, Formulation 2006-2007, in non-elderly adult and elderly subjects.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

June 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

First QC Date

June 20, 2006

Last Update Submit

April 19, 2017

Conditions

Influenza

Keywords

influenzainfluenza vaccinefluvaccinationimmunogenicity

Outcome Measures

Primary Outcomes (1)

  • CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination

Secondary Outcomes (3)

  • Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.

  • Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.

  • Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).

Interventions

influenza surface antigen inactivated vaccineBIOLOGICAL

Eligibility Criteria

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

You may qualify if:

  • Male and female subjects 18 years of age or older

You may not qualify if:

  • any auto-immune disease or other serious acute, chronic or progressive disease
  • hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine
  • known or suspected (or high risk of developing) impairment/alteration of immune function
  • within the past 7 days any acute disease or infections requiring systemic antibiotic or antiviral therapy
  • history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chiltern International Limited , Chiltern Place, Upton Road

Slough, SL1 2AD, United Kingdom

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

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 20, 2006

First Posted

June 21, 2006

Study Start

October 1, 2006

Last Updated

April 20, 2017

Record last verified: 2017-04

Locations

GB(1)