CClinicalTrials.gg
Sign In
CompletedNCT00329927Updated Sep 14, 2006

Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Elderly Subjects

A Phase 2 interventional study of Surface Antigen, Inactivated, (Adjuvanted with MF59C.1), form. 2006-07 in Influenza, sponsored by Novartis. Completed at 2 sites in Italy. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2006-09-14.

Sponsored by Novartis · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
65 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Influenza

Browse trials for

Keywords

  • Adjuvanted Influenza Vaccine
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 60 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All

Inclusion criteria

  • 65 years of age or older

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants

Interventions

  • BiologicalSurface Antigen, Inactivated, (Adjuvanted with MF59C.1), form. 2006-07
06

What researchers measure

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

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

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

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

07

Study locations

2 sites
  • Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio
    Via dei Vestini, Chieti 66100, Italy
  • Ufficio Igiene e Sanità Pubblica di Lanciano, Via S. Spaventa, 37
    Lanciano, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00329927
Lead sponsor
Novartis
Collaborators
Novartis Vaccines
First posted
May 25, 2006
Start date
Jun 2006
Last update
Sep 14, 2006

Study contacts

Novartis Vaccines - Drug Information Services
study chair · Novartis Vaccines & Diagnostics
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2006. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Influenza, Human→

Other studies from this sponsor

Novartis

Start the discussion