Prophylaxis of influenza infection caused by a pandemic influenza virus (H5N1) MedDRA version: 13.1 Level: LLT Classification code 10059430 Term: Influenza immunization System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine
Product Code: H5N1 Influenza Vaccine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Whole virion non-adjuvanted inf
Sponsors
Baxter Innovations GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess safety: Frequency and severity of systemic reactions until 7 days after the first vaccination. To assess immunogenicity: Rate of subjects with antibody response to the vaccine strain associated with protection 21 days after the second vaccination defined as titer measured by Microneutralization (MN) test >= 1:20. ;Secondary Objective: To assess the safety and tolerability of a non-adjuvanted H5N1 influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years; Rate of subjects with antibody response 21 days after the first and second vaccination ; Fold increase of antibody response 21 days after the first and second vaccination as compared to baseline; Rate of subjects with seroconversion 21 days after the first, second and booster vaccination; Rate of subjects with antibody response associated with protection 360 days after the first vaccination and 21 days after the booster vaccination; Antibody response 360 days after the first vaccination and 21 days after the booster vaccination; Fold increase of antibody response 21 days after the booster vaccination as compared to before the booster; ;Primary end point(s): Safety: • Frequency and severity of systemic reactions until 7 days after the first and second vaccination. Immunogenicity: • Rate of subjects with antibody response to the vaccine strain associated with protection 21 days after the second vaccination defined as titer measured by Microneutralization (MN) test = 1:20. In addition, a separate immunogenicity analysis within each age stratum may be performed on subjects who have versus those who have not received an H1N1 pandemic influenza vaccine between 7 days after the first* and 21 days after the second vaccination. *Administration of an H1N1 pandemic influenza vaccine is prohibited in the period from study start until Day 7 after the first vaccination (see also section 10.11 of the clinical study protocol). ;Timepoint(s) of evaluation of this end point | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety: • Frequency and severity of systemic reactions until 21 days after the first, second and booster vaccination; • Frequency and severity of injection site reactions until 21 days after the first, second and booster vaccination; • Rate of subjects with fever, malaise or shivering (in children and adolescents aged 3 to 17 years) and fever and irritability (in infants and young children aged 6 to 35 months) with onset within 7 days after the first, second and booster vaccination; • Frequency and severity of adverse events (AEs) observed during the entire study period. Immunogenicity: • Rate of subjects with antibody response associated with protection 21 days after the first and second vaccination defined as Hemagglutination Inhibition Antibody (HIA) titer = 1:40 or Single Radial Hemolysis (SRH) area =25 mm2; • Rate of subjects with antibody response associated with protection 21 days after the first vaccination defined as titer measured by MN test = 1:20; • Antibody response 21 days after the first and second vaccination as measured by MN, HI and SRH assay; • Fold increase of antibody response 21 days after the first and second vaccination as compared to baseline as measured by MN, HI and SRH assay; • Rate of subjects with seroconversion (defined as a minimum four fold titer increase as compared to baseline [for MN and HI assay] or as either a = 25 mm2 hemolysis area after the vaccination in case of a negative prevaccination sample [= 4 mm2] or a =50% increase in hemolysis area if the pre-vaccination sample is > 4 mm2 [for SRH assay]) 21 days after the first and second vaccination as measured by MN, HI and SRH assay; • Rate of subjects with antibody response associated with protection 360 days after the first vaccination and 21 days after the booster vaccination as measured by MN, HI and SRH assay; • Antibody response 360 days after the first vaccination and 21 days after the booster vaccination as measured by MN, HI and | — |
Countries
Australia, Finland, Singapore, Spain
Contacts
Public ContactClinical Development and Medical Se
Dr Guido Wuerth
Outcome results
None listed