NCT00945438

Brief Summary

This study is in support of the annual application for the variation of the vaccine strains for a marketing authorisation. Objectives:

  • To evaluate compliance, in terms of immunogenicity, of the corresponding strength of the intradermal (ID) influenza vaccine Northern Hemisphere (NH) 2009-2010 formulation.
  • To describe the safety of the corresponding strength of the ID influenza vaccine, NH 2009-2010 formulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2009

Shorter than P25 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

May 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
Last Updated

January 14, 2014

Status Verified

January 1, 2014

Enrollment Period

1 month

First QC Date

July 22, 2009

Last Update Submit

January 10, 2014

Conditions

Influenza

Keywords

InfluenzaInfluenza virus vaccineSplit virionIntradermal

Outcome Measures

Primary Outcomes (2)

  • To provide information concerning the immunogenicity of Intradermal (ID) Influenza vaccine (split virion, inactivated), NH 2009-2010 formulation.

    21 days post-vaccination

  • To provide information concerning the safety of Intradermal (ID) Influenza vaccine (split virion, inactivated), NH 2009-2010 formulation.

    21 days post-vaccination and entire study duration

Study Arms (2)

Group 1

EXPERIMENTAL

Participants aged 18 to 59 years at enrollment.

Biological: Influenza virus vaccine 2009-2010 formulation

Group 2

EXPERIMENTAL

Participants aged 60 years or older at enrollment.

Biological: Influenza virus vaccine 2009-2010 formulation

Interventions

Influenza virus vaccine 2009-2010 formulationBIOLOGICAL

0.1 mL, Intradermal

Group 1

Eligibility Criteria

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

You may qualify if:

  • Provision of a signed informed consent
  • Able to attend all scheduled visits and comply with all trial procedures
  • For a woman of child-bearing potential: avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 3 weeks after vaccination
  • Entitled to national social security

You may not qualify if:

  • For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test at Visit 1
  • Febrile illness (temperature ≥ 38 °C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
  • Breast-feeding woman
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
  • Known systemic hypersensitivity to eggs, chicken proteins, neomycin, formaldehyde and octoxynol-9, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing any of the same substances
  • Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
  • Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
  • Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination
  • Planned receipt of any vaccine in the 3 weeks following the trial vaccination
  • Previous vaccination against influenza in the previous 6 months
  • Known human immunodeficiency virus (HIV), Hepatitis B surface (HBs) antigen or Hepatitis C seropositivity
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Angers, 49000, France

Location

Unknown Facility

Tiercé, 49125, France

Location

Related Links

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Medical Monitor

    Sanofi Pasteur Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2009

First Posted

July 24, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2009

Study Completion

July 1, 2009

Last Updated

January 14, 2014

Record last verified: 2014-01

Locations

FR(2)