NCT00519064

Brief Summary

This phase III is designed to confirm the previous trial results evaluating the safety, clinical tolerability and immunogenicity of the 2006-2007 formulation of Novartis Vaccines' adjuvanted influenza vaccine and subunit influenza vaccine in adults with underlying chronic diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
361

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

November 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2007

Completed
Last Updated

December 1, 2016

Status Verified

February 1, 2012

Enrollment Period

1 month

First QC Date

August 20, 2007

Last Update Submit

November 30, 2016

Conditions

Influenza Disease

Keywords

influenzainfluenza vaccineadjuvanted influenza vaccineH5N1 influenza antigen

Outcome Measures

Primary Outcomes (1)

  • Compare immunogenicity of a single IM inj. of an adj. inactivated subunit flu vaccine vs. inactivated subunit virus flu vaccine, with regards to A/H3N2 antigen, when administered to adults with underlying chronic disease, as measured by HI test at day 22

Secondary Outcomes (3)

  • Compare immunogenicity of an IM injection of an adj. inactivated subunit flu vaccine vs. inactivated subunit virus flu vaccine, with regards to B antigen, when administered to adults with underlying chronic disease, as measured by HI test at day 22

  • Evaluate immunog. of a single IM inj. of an adj. inactivated subunit flu vaccine vs. inactivated subunit virus flu vaccine, with regards to A/H1N1 antigen, when administered to adults with underlying chronic disease, as measured by HI test at day 22

  • To evaluate the safety of a single IM injection of the two influenza vaccines, when administered to adult subjects with underlying chronic disease(s).

Study Arms (2)

Arm 1

ACTIVE COMPARATOR
Biological: Adjuvanted influenza vaccine

Arm 2

ACTIVE COMPARATOR
Biological: Adjuvanted influenza vaccine

Interventions

Adjuvanted influenza vaccineBIOLOGICAL
Arm 1Arm 2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • to 60 years of age adult volunteers, mentally competent, willing and able to give written informed consent prior to study entry, suffering from at least one of these chronic diseases:moderate to severe hypertension, moderate to severe congestive heart failure, chronic obstructive pulmonary disease (COPD) or moderate to severe asthma, moderate to severe hepatic or renal insufficiency, arteriosclerotic disease or insulin dependent diabetes mellitus

You may not qualify if:

  • Hypersensitivity to ovalbumin, 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 impairment/ alteration of immune function;
  • Any condition which might interfere with the evaluation of the study objectives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda ULSS 13 di Mirano

Mira, Via Nazionale 48, Venezia, 30034, Italy

Location

Related Publications (1)

  • Black S, Della Cioppa G, Malfroot A, Nacci P, Nicolay U, Pellegrini M, Sokal E, Vertruyen A. Safety of MF59-adjuvanted versus non-adjuvanted influenza vaccines in children and adolescents: an integrated analysis. Vaccine. 2010 Oct 21;28(45):7331-6. doi: 10.1016/j.vaccine.2010.08.075. Epub 2010 Sep 15.

    PMID: 20813217RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Novartis Vaccines

    Novartis Vaccines

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2007

First Posted

August 21, 2007

Study Start

November 1, 2006

Primary Completion

December 1, 2006

Study Completion

May 1, 2007

Last Updated

December 1, 2016

Record last verified: 2012-02

Locations

IT(1)