NCT00415129

Brief Summary

Based on the results from a previous formulation/dosage ranging trial, this phase II multicenter, open trial was designed to determine the safety and immunogenicity of two vaccine formulation/dosages with and without adjuvant 21 days after each vaccination in adults (18 to 60 years and in the elderly (\> 60 years) as required by the European Medicines Agency (EMEA) guideline. The antibody persistence until the booster vaccination at 6 or 12 months will also be evaluated.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2006

Geographic Reach
2 countries

4 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

June 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

January 14, 2014

Status Verified

January 1, 2014

Enrollment Period

2.5 years

First QC Date

December 21, 2006

Last Update Submit

January 10, 2014

Conditions

InfluenzaOrthomyxoviridae Infections

Keywords

InfluenzaOrthomyxoviridae InfectionsInfluenza PandemicsA/H5N1 strain

Outcome Measures

Primary Outcomes (1)

  • To provide information concerning the safety of an A/H5N1 inactivated, split-virion influenza virus vaccine

    21 Days post-vaccination

Study Arms (2)

Study Group 1

EXPERIMENTAL

Vaccine with adjuvant

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

Study Group 2

EXPERIMENTAL

Vaccine without adjuvant

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

Interventions

A/H5N1 inactivated, split-virion influenza virusBIOLOGICAL

0.5mL, Intramuscular

Study Group 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
  • For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior and at least 4 weeks after to each vaccination.

You may not qualify if:

  • Systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances
  • Breast-feeding
  • Previous vaccination with an avian flu vaccine
  • Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination
  • Planned participation in another clinical trial during the present trial period
  • Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy
  • Chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders)
  • Current alcohol or drug abuse that may interfere with the subject's ability to comply with trial procedures
  • Receipt of blood or blood-derived products within the past 3 months
  • Any vaccination within 4 weeks prior to the first trial vaccination
  • Vaccination planned within 4 weeks after any trial vaccination
  • 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 (4)

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Wilrijk, Belgium

Location

Unknown Facility

Oxford, United Kingdom

Location

Related Publications (2)

  • Lazarus R, Kelly S, Snape MD, Vandermeulen C, Voysey M, Hoppenbrouwers K, Hens A, Van Damme P, Pepin S, Leroux-Roels I, Leroux-Roels G, Pollard AJ. Antibody Persistence and Booster Responses to Split-Virion H5N1 Avian Influenza Vaccine in Young and Elderly Adults. PLoS One. 2016 Nov 4;11(11):e0165384. doi: 10.1371/journal.pone.0165384. eCollection 2016.

    PMID: 27814377DERIVED

  • Leroux-Roels I, Van der Wielen M, Kafeja F, Vandermeulen C, Lazarus R, Snape MD, John T, Carre C, Nougarede N, Pepin S, Leroux-Roels G, Hoppenbrouwers K, Pollard AJ, Van Damme P. Humoral and cellular immune responses to split-virion H5N1 influenza vaccine in young and elderly adults. Vaccine. 2009 Nov 16;27(49):6918-25. doi: 10.1016/j.vaccine.2009.08.110. Epub 2009 Sep 15.

    PMID: 19761837DERIVED

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
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2006

First Posted

December 22, 2006

Study Start

June 1, 2006

Primary Completion

December 1, 2008

Study Completion

March 1, 2009

Last Updated

January 14, 2014

Record last verified: 2014-01

Locations

BE(3)GB(1)