Safety and Immunogenicity Study of a H5N1 Influenza Vaccine (Vero Cell-Derived, Whole Virus) in Healthy Infants, Children and Adolescents
- Conditions
- Influenza, Avian
- Interventions
- Biological: H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation
- Registration Number
- NCT01052402
- Lead Sponsor
- Resilience Government Services, Inc.
- Brief Summary
The purpose of this study is to assess the safety and immunogenicity (i.e. primary immune response, immunogenicity of two different doses, antibody persistence 360 days after the first vaccination, immune response to a heterologous booster given on Day 360) of a Vero cell-derived whole virus H5N1 influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 684
- 9 to 17 years of age on the day of screening (for Stratum A only)
- 3 to 8 years of age on the day of screening (for Stratum B only)
- 6 to 35 months of age on the day of screening (for Stratum C only)
- Subject who were born at full term of pregnancy (>= 37 weeks) with a birth weight >= 2 kg (for Stratum C only)
- Subjects and/or their parents/legal guardians understand the nature and procedures of the study and agree to its provisions
- Subjects´ 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
- Written assent according to subjects´ age and capacity of understanding
- Subjects who are generally healthy, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination
- Subjects who are physically and mentally capable of participating in the study and follow its procedures
- Subjects and/or their parents/legal guardians agree to keep a daily record of symptoms for the duration of the study
- If subjects are 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
- History of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza vaccine
- High risk of contracting H5N1 influenza infection (e.g. contact with poultry);
- Subjects who currently have or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
- Inherited or acquired immunodeficiency
- Subjects who 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.
- History of severe allergic reactions or anaphylaxis
- Rash, dermatological condition or tattoos which may interfere with injection site reaction rating
- Subjects who have received a blood transfusion or immunoglobulins within 90 days prior to study entry
- Subjects who have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study
- Functional or surgical asplenia
- Subjects with a known or suspected problem with alcohol or drug abuse
- Subjects who were administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product
- Dependent relationship with the study site personnel. Dependent relationships include close relatives (i.e., children, siblings).
- If female: subjects wo are pregnant or lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose A H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation Two intramuscular injections (21 days apart, i.e. Days 0 and 21) of H5N1 Influenza Vaccine (Dose A) followed by a heterologous booster vaccination (Dose A) on Day 360 Dose B H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation Two intramuscular injections (21 days apart, i.e. Days 0 and 21) of H5N1 Influenza Vaccine (Dose B) followed by a heterologous booster vaccination (Dose B) on Day 360
- Primary Outcome Measures
Name Time Method Frequency and severity of systemic reactions until 7 days after the first vaccination 7 days 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 test >= 1:20. 42 days
- Secondary Outcome Measures
Name Time Method Seroconversion 21 days after the first and second vaccination and at 21 days after the booster vaccination Day 21, 42 and 381 Measured by MN, HI and SRH assay
Frequency and severity of systemic and injection site reactions until 21 days after the first, second and booster vaccination Day 21, 42 and 381 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 Day 21, 42 and 381 Adverse events observed during the entire study period Throughout entire study period Antibody response associated with protection 21 days after the first and second vaccination, and again at 360 days after the first vaccination and 21 days after the booster vaccination Day 21, 42, 360 and 381 Antibody response defined as Hemagglutination Inhibition Antibody (HIA) titer \>= 1:40 or Single Radial Hemolysis (SRH) area \>= 25 mm2, and as measured by Microneutralization (MN) test \>= 1:20
Fold increase of antibody response 21 days after first and second vaccination as compared to baseline, and again at 21 days after the booster vaccination as compared to before the booster vaccination Day 21, 42, 360 and 381 Measured by MN, HI and SRH assay
Trial Locations
- Locations (20)
Mount Elizabeth Medical Centre, The Child and Allergy Clinic
🇸🇬Singapore, Singapore
Centro de Salud de Paiporta
🇪🇸Paiporta, Spain
Instituto Hispalense de Pediatria, Pediatría - IHP1
🇪🇸Sevilla, Spain
Porin Vaccine Research Clinic
🇫🇮Pori, Finland
University of Tampere, Seinäjoki Vaccine Research Clinic (Tampereen Yliopisto, Seinajoen Rokotetutkimusklinikka)
🇫🇮Seinäjoki, Finland
Tampere Vacine Research Clinic (Tampereen Rokotetutkimusklinikka)
🇫🇮Tampere, Finland
Tampere University, Espoo Vaccine Research (Tampereen Yliopisto, Espoon Rokotetutkimus)
🇫🇮Espoo, Finland
Turku Vaccine Research Clinic (Turun Rokotetutkimusklinikka)
🇫🇮Turku, Finland
The Children´s Medical Institute
🇸🇬Singapore, Singapore
Kokkola Vaccine Research Clinic (Kokkolan Rokotetutkimusklinikka)
🇫🇮Kokkola, Finland
Kuopion Vaccine Research Clinic
🇫🇮Kuopio, Finland
Oulu Vacine Research Clinic (Oulun Rokotetutkimusklinikka)
🇫🇮Oulu, Finland
South Helsinki Vaccine Research Clinic (Etelä-Helsingin Rokotetutkimusklinikka)
🇫🇮Helsinki, Finland
Centro de Salud Malvarrosa
🇪🇸Valencia, Spain
Centro de Salud Serreria II
🇪🇸Valencia, Spain
Centro de Salud Quart de Poblet
🇪🇸Valencia, Spain
Centro de Salud Trafalgar
🇪🇸Valencia, Spain
Centro de Salud de Catarroja
🇪🇸Valencia, Spain
University of Tampere, Vantaa East Vaccine Research Clinic (Itä Vantaan Rokotetutkimusklinikka)
🇫🇮Vantaa, Finland
Princess Margaret Hospital for Children
🇦🇺Subiaco, Australia