NCT00457509

Brief Summary

The purpose of this study is to test different adjuvanted vaccine formulations as a two-dose schedule in immunologically naïve adults against one vaccine formulation without adjuvant in terms of tolerance and immunogenicity Primary Objective: To describe the safety profile and immunogenicity following each injection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
251

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2007

Typical duration for phase_1

Geographic Reach
1 country

3 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

January 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

January 14, 2014

Status Verified

January 1, 2014

Enrollment Period

2.8 years

First QC Date

April 5, 2007

Last Update Submit

January 10, 2014

Conditions

Pandemic InfluenzaInfluenza A Virus InfectionOrthomyxoviridae Infections

Keywords

Pandemic influenzaAvian influenzaOrthomyxoviridae InfectionsA/H5N1

Outcome Measures

Primary Outcomes (1)

  • To provide information concerning the safety of A/H5N1 Inactivated split influenza virus vaccine

    Entire study period

Study Arms (5)

Group 1

EXPERIMENTAL

Dose 1 with Adjuvant

Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant

Group 2

EXPERIMENTAL

Dose 2 with adjuvant

Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant

Group 3

EXPERIMENTAL

Dose 3 with adjuvant

Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant

Group 4

EXPERIMENTAL

Dose 4 with adjuvant

Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant

Group 5

ACTIVE COMPARATOR

Control

Biological: A/H5N1 inactivated, split-virion influenza vaccine

Interventions

A/H5N1 inactivated, split-virion influenza vaccine+AdjuvantBIOLOGICAL

0.5 mL, Intramuscular

Group 1
A/H5N1 inactivated, split-virion influenza vaccineBIOLOGICAL

0.5 mL, Intramuscular

Group 5

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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.

You may not qualify if:

  • Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Previous participation in a clinical trial involving an investigational flu pandemic vaccine.
  • Vaccination with an influenza vaccine during the past 6 months
  • Any vaccination in the 4 weeks preceding the first trial vaccination
  • Vaccination planned in the 4 weeks following any trial vaccination
  • Breast-feeding.
  • For a woman of child-bearing potential, the absence of an effective method of contraception or abstinence non observed for at least 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination.
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
  • Known human immunodeficiency virus (HIV), hepatitis B (AgHBs) or hepatitis C seropositivity.
  • Known 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.
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
  • 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.
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Related Publications (1)

  • Levie K, Leroux-Roels I, Hoppenbrouwers K, Kervyn AD, Vandermeulen C, Forgus S, Leroux-Roels G, Pichon S, Kusters I. An adjuvanted, low-dose, pandemic influenza A (H5N1) vaccine candidate is safe, immunogenic, and induces cross-reactive immune responses in healthy adults. J Infect Dis. 2008 Sep 1;198(5):642-9. doi: 10.1086/590913.

    PMID: 18576945DERIVED

Related Links

MeSH Terms

Conditions

Orthomyxoviridae InfectionsInfluenza in Birds

Condition Hierarchy (Ancestors)

RNA Virus InfectionsVirus DiseasesInfectionsBird DiseasesAnimal Diseases

Study Officials

  • Medical Monitor

    Sanofi Pasteur Inc

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 5, 2007

First Posted

April 6, 2007

Study Start

January 1, 2007

Primary Completion

November 1, 2009

Study Completion

September 1, 2010

Last Updated

January 14, 2014

Record last verified: 2014-01

Locations

BE(3)