NCT00735020

Brief Summary

This trial is designed to evaluate safety, tolerability and immunogenicity of a bedside mixing formulation of adjuvanted influenza vaccines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_1

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

June 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
Last Updated

January 24, 2014

Status Verified

January 1, 2014

Enrollment Period

2 months

First QC Date

August 13, 2008

Last Update Submit

January 23, 2014

Conditions

Influenza

Keywords

influenzavaccineadjuvantsflu

Outcome Measures

Primary Outcomes (1)

  • Safety as measured through local and systemic reactions and efficacy (immunogenicity) as measured by antibody titers.

    36 Days

Secondary Outcomes (1)

  • To evaluate immunogenicity of a single IM injection of adjuvanted Influenza vaccine

    36 Days

Study Arms (2)

1

EXPERIMENTAL
Biological: Adjuvanted Influenza Vaccine

2

ACTIVE COMPARATOR
Biological: Influenza Vaccine

Interventions

Adjuvanted Influenza VaccineBIOLOGICAL

1 dose of Adjuvanted Influenza Vaccine

1
Influenza VaccineBIOLOGICAL

1 dose of Influenza Vaccine

2

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy 18 to 39 year old males and females who are in good health and have provided informed consent prior to enrollment

You may not qualify if:

  • serious medical conditions
  • allergies to vaccine components, including but not limited to egg/chicken products
  • reduced immune function
  • recent use of immunosuppressive therapy
  • recent use of influenza vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

I.P.A.S.

Ligornetto, 36 6853, Switzerland

Location

Related Publications (1)

  • Della Cioppa G, Vesikari T, Sokal E, Lindert K, Nicolay U. Trivalent and quadrivalent MF59((R))-adjuvanted influenza vaccine in young children: a dose- and schedule-finding study. Vaccine. 2011 Nov 3;29(47):8696-704. doi: 10.1016/j.vaccine.2011.08.111. Epub 2011 Sep 9.

    PMID: 21906647RESULT

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

    Novartis Vaccines

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 14, 2008

Study Start

June 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

January 24, 2014

Record last verified: 2014-01

Locations

CH(1)