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

Recruitment & Eligibility

Status: A

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

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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