Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Children
1 other identifier
interventional
350
1 country
13
Brief Summary
This study is part of an effort to develop an effective vaccination program in children in the event of a pandemic. Study objectives:
- To describe the safety profiles in the periods following each vaccination in subjects receiving different vaccination schedule.
- To describe the immune response after each vaccination in subjects receiving study vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2009
Shorter than P25 for phase_2
13 active sites
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
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 16, 2009
CompletedFirst Posted
Study publicly available on registry
April 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJanuary 14, 2014
January 1, 2014
11 months
April 16, 2009
January 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To provide information concerning the safety of the Split Virion Pandemic Influenza vaccine.
21 days post-vaccination and entire study
Secondary Outcomes (1)
To provide information concerning the immunogenicity of Split Virion Pandemic Influenza vaccine.
21 days post-vaccination
Study Arms (3)
Group 1
EXPERIMENTALParticipants on vaccination schedule 1 (Day 0 and Day 21)
Group 2
EXPERIMENTALParticipants on vaccination schedule 2 (Day 0 and Day 14)
Group 3
EXPERIMENTALParticipants on vaccination schedule 3 (Day 0 and Day 42)
Interventions
0.5 mL, Intramuscular
Eligibility Criteria
You may qualify if:
- All Subjects
- Subject and parent(s)/legal representative able to attend all scheduled visits and to comply with all trial procedures.
- Completion of vaccination according to the national immunization schedule
- Subjects Aged ≥ 2 Years to \< 18 Years:
- Provision of Informed Consent Form signed by the subject's the parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 8 to 11 years, and of Informed Consent Form signed by subjects ≥ 12 years.
- For a female of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to each vaccination, until at least 4 weeks after each vaccination.
- Subjects Aged ≥ 6 Months to \< 2 Years:
- Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg.
- Provision of Informed Consent Form signed by the parent(s) or other legal representative (and by an independent witness if required by local regulations).
You may not qualify if:
- All subjects
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding 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 any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to 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 trial vaccination
- Planned receipt of any vaccine in the 4 weeks following any trial vaccination
- (Known) Human Immunodeficiency Virus (HIV), Hepatitis B surface (HBs) antigen or Hepatitis C seropositivity
- Previous vaccination against avian influenza with either the trial vaccine or another vaccine
- Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw
- Subjects Aged ≥2 Years to \<18 Years:
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Unknown Facility
Espoo, FIN-02100, Finland
Unknown Facility
Helsinki, FIN-00100, Finland
Unknown Facility
Helsinki, FIN-00930, Finland
Unknown Facility
Jarvenpaa, FIN-04400, Finland
Unknown Facility
Kuopio, FIN-70100, Finland
Unknown Facility
Lahti, FIN-15140, Finland
Unknown Facility
Oulu, FIN-90220, Finland
Unknown Facility
Pori, FIN-28100, Finland
Unknown Facility
Tampere, FIN-33014, Finland
Unknown Facility
Tampere, FIN-33100, Finland
Unknown Facility
Turku, FIN-20520, Finland
Unknown Facility
Vantaa, FIN-01300, Finland
Unknown Facility
Vantaa, FIN-01600, Finland
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Sanofi Pasteur Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2009
First Posted
April 20, 2009
Study Start
April 1, 2009
Primary Completion
March 1, 2010
Study Completion
June 1, 2010
Last Updated
January 14, 2014
Record last verified: 2014-01