Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Children

NCT ID: NCT00884182

Last Updated: 2014-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-06-30

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.

Detailed Description

Study participants will receive two administrations of the investigational vaccine at one of 3 vaccination schedules.

Conditions

Influenza; Orthomyxoviridae Infections; Orthomyxovirus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1

Participants on vaccination schedule 1 (Day 0 and Day 21)

Group Type: EXPERIMENTAL

A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Group 2

Participants on vaccination schedule 2 (Day 0 and Day 14)

Group Type: EXPERIMENTAL

A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Group 3

Participants on vaccination schedule 3 (Day 0 and Day 42)

Group Type: EXPERIMENTAL

A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Interventions

A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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:

• Aged ≥ 2 years to < 18 years on the day of inclusion.
• 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:

• Aged ≥ 6 months to < 2 years on the day of inclusion.
• 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).

Exclusion Criteria

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
• Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
• 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:

• For a female of child-bearing potential, known pregnancy or positive urine pregnancy test
• Breast-feeding female
• Febrile illness (temperature ≥ 37.5 °C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment

Subjects Aged ≥ 6 Months to < 2 Years:

• History of seizures
• Febrile illness (temperature ≥ 38 °C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

Espoo, , Finland

Helsinki, , Finland

Helsinki, , Finland

Järvenpää, , Finland

Kuopio, , Finland

Lahti, , Finland

Oulu, , Finland

Pori, , Finland

Tampere, , Finland

Tampere, , Finland

Turku, , Finland

Vantaa, , Finland

Vantaa, , Finland

Countries

Finland

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

GPA12

Identifier Type: -

Identifier Source: org_study_id