NCT00329927

Brief Summary

To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over

Trial Health

80
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2006

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
Last Updated

September 14, 2006

Status Verified

September 1, 2006

First QC Date

May 23, 2006

Last Update Submit

September 13, 2006

Conditions

Influenza

Keywords

Adjuvanted Influenza Vaccine

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

Surface Antigen, Inactivated, (Adjuvanted with MF59C.1), form. 2006-07BIOLOGICAL

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)

You may qualify if:

  • years of age or older

You may not qualify if:

  • any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time
  • hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine - - history of neurological symptoms or signs, or anaphylactic shock following administration of any 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 fever within the past 3 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio

Via Dei Vestini, Chieti, 66100, Italy

Location

Ufficio Igiene e Sanità Pubblica di Lanciano, Via S. Spaventa, 37

Lanciano, Italy

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Antigens, Surface

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AntigensBiological Factors

Study Officials

  • Novartis Vaccines - Drug Information Services

    Novartis Vaccines & Diagnostics

    STUDY CHAIR

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

May 23, 2006

First Posted

May 25, 2006

Study Start

June 1, 2006

Last Updated

September 14, 2006

Record last verified: 2006-09

Locations

IT(2)