NCT00316615

Brief Summary

The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular (IM) injection of a Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2005-2006, when Administered to Non-Elderly Adults and Elderly Subjects

Trial Health

80
On Track

Trial Health Score

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

Enrollment
100

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2006

Completed
Last Updated

September 14, 2006

Status Verified

September 1, 2006

First QC Date

April 19, 2006

Last Update Submit

September 13, 2006

Conditions

Influenza Disease

Keywords

influenzanon elderly adult and elderlyvaccine

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 vaccineBIOLOGICAL

Eligibility Criteria

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

You may qualify if:

  • subjects 18 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

G. D'Annunzio University

Chieti, 66100, Italy

Location

Office of Hygiene and Public Health, ASL Lanciano

Lanciano, Italy

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Novartis Vaccines - Drug Information Services

    Novartis

    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

April 19, 2006

First Posted

April 21, 2006

Study Start

June 1, 2005

Last Updated

September 14, 2006

Record last verified: 2006-09

Locations

IT(2)