NCT00343681

Brief Summary

This study is designed to generate clinical data as outlined in the Note for Guidance on harmonization requirements for influenza vaccine marketing authorization by the European Medicines Agency. The objectives of the trial are:

  • To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine Northern Hemisphere 2006-2007 formulation with the requirements of the European Medicines Agency
  • To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere 2006-2007 formulation.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_2

Geographic Reach
2 countries

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

First Submitted

Initial submission to the registry

June 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2006

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

January 17, 2014

Status Verified

January 1, 2014

Enrollment Period

1.1 years

First QC Date

June 21, 2006

Last Update Submit

January 16, 2014

Conditions

InfluenzaOrthomyxoviridae Infections

Keywords

InfluenzaOrthomyxoviridae InfectionsOrthomyxovirusesSplit-virion influenza vaccine

Outcome Measures

Primary Outcomes (1)

  • To provide information concerning the immunogenicity of inactivated influenza vaccine (split virion)

    21 Days post-vaccination

Study Arms (1)

1

EXPERIMENTAL
Biological: Inactivated influenza vaccine (split virion)

Interventions

Inactivated influenza vaccine (split virion)BIOLOGICAL

0.5 mL, Intramuscular

1

Eligibility Criteria

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

You may qualify if:

  • Informed consent form signed
  • Able to attend all scheduled visits and to comply with all trial procedures
  • For a woman, inability to bear a child or negative urine pregnancy test at Visit 1
  • For a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least four weeks prior to vaccination and at least three weeks after vaccination.

You may not qualify if:

  • Febrile illness (oral temperature \>=37.5°C) on the day of vaccination
  • Breast-feeding
  • Participation in another clinical trial in the four weeks preceding the trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months, or long-term systemic corticosteroids therapy
  • Systemic hypersensitivity to egg proteins, chick proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
  • Chronic illness at a stage that could interfere with trial conduct or completion
  • Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures
  • Blood or blood-derived products received in the past three months
  • Any vaccination in the four weeks preceding the trial vaccination
  • Vaccination planned in the three weeks following the trial vaccination
  • Vaccination against influenza in the previous six months
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Allschwil, Switzerland

Location

Unknown Facility

Edinburgh, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Influenza, HumanOrthomyxoviridae Infections

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Medical Monitor

    Sanofi Pasteur Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2006

First Posted

June 23, 2006

Study Start

July 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

January 17, 2014

Record last verified: 2014-01

Locations

GB(1)CH(1)