A clinical study to assess safety of and immune response to a whole virus H5N1 bird flu vaccine in children aged 6 months to 17 years

• Conditions: Prophylaxis of influenza infection caused by a pandemic influenza virus (H5N1); MedDRA version: 13.1Level: LLTClassification code 10059430Term: Influenza immunizationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2009-013105-34-FI
• Lead Sponsor: Baxter Innovations GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-28
• Last Update Posted: 10 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 670

Inclusion Criteria

Male and female subjects will be eligible for participation in this study if:
• They are 9 to 17ii years of age on the day of screening (for Stratum A only);
• They are 3 to 8iii years of age on the day of screening (for Stratum B onl
• They are 6 to 35iv months of age on the day of screening (for Stratum C only);
• They were born at full term of pregnancy (= 37 weeks) with a birth weight = 2 kg (for Stratum C only);
• They and/or their parents/legal guardians understand the nature and procedures of the study and agree to its provisions;
• Their parents/legal guardians provide written consent for participation according to national law. In case the parents/legal guardians are illiterate, the informed consent is also to be signed by an independent witness;
• They provide written assent according to their age and capacity of understanding;
• They are generally healthy, as determined by the investigator’s clinical judgment through collection of medical history and performance of a physical examination;
• They are physically and mentally capable of participating in the study and follow its procedures;
• They and/or their parents/legal guardians agree to keep a daily record of symptoms for the duration of the study;
• If female of childbearing potential – have a negative urine pregnancy test result within 24 hours prior to the scheduled first vaccination and agree to employ adequate birth control measures for the duration of the study.

ii From the 9th birthday to the last day before the 18th birthday
iii From the 3rd birthday to the last day before the 9th birthday
iv From 6 months of age to the last day before the 3rd birthday
Are the trial subjects under 18? yes
Number of subjects for this age range: 670
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects will be excluded from participation in this study if:
• They have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza vaccine;
• They are at high risk of contracting H5N1 influenza infection (e.g. contact with poultry);
• They currently have or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorderv;
• They have any inherited or acquired immunodeficiency;
• They have a disease or are currently undergoing a form of treatment or were undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs;
• They have a history of severe allergic reactions or anaphylaxis;
• They have a rash, dermatological condition or tattoos which may interfere with injection site reaction rating;
• They have received a blood transfusion or immunoglobulins or other derivatives within 90 days prior to study entry;
• They have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study;
• They have a functional or surgical asplenia;
• They have a known or suspected problem with alcohol or drug abuse;
• They were administered an investigational drug within 6 weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product;
• They are in a dependent relationship with the study site personnel. Dependent relationships include close relatives (i.e., children, siblings);
• If female: are pregnant or lactating.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified