Clinical trial NCT01052402: Safety and Immunogenicity Study of a H5N1 Influenza Vaccine (Vero Cell-Derived, Whole Virus) in Healthy Infants, Children and Adolescents
Official title: A Phase 1/2 Study to Assess the Safety and Immunogenicity of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in Healthy Infants, Children and Adolescents Aged 6 Months to 17 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza, Avian
Lead sponsor: Resilience Government Services, Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-20
Enrollment: 684
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Frequency and severity of systemic reactions until 7 days after the first vaccination
timeFrame: 7 days
measure: 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.
timeFrame: 42 days
Secondary outcomes:
measure: Frequency and severity of systemic and injection site reactions until 21 days after the first, second and booster vaccination
timeFrame: Day 21, 42 and 381
measure: 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
timeFrame: Day 21, 42 and 381
measure: Adverse events observed during the entire study period
timeFrame: Throughout entire study period
measure: 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
timeFrame: Day 21, 42, 360 and 381
measure: 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
timeFrame: Day 21, 42, 360 and 381
measure: Seroconversion 21 days after the first and second vaccination and at 21 days after the booster vaccination
timeFrame: Day 21, 42 and 381
Other outcomes:
Locations:
city: Subiaco
country: Australia
facility: Princess Margaret Hospital for Children
city: Espoo
country: Finland
facility: Tampere University, Espoo Vaccine Research (Tampereen Yliopisto, Espoon Rokotetutkimus)
city: Helsinki
country: Finland
facility: South Helsinki Vaccine Research Clinic (Etelä-Helsingin Rokotetutkimusklinikka)
city: Kokkola
country: Finland
facility: Kokkola Vaccine Research Clinic (Kokkolan Rokotetutkimusklinikka)
city: Kuopio
country: Finland
facility: Kuopion Vaccine Research Clinic
city: Oulu
country: Finland
facility: Oulu Vacine Research Clinic (Oulun Rokotetutkimusklinikka)
city: Pori
country: Finland
facility: Porin Vaccine Research Clinic
city: Seinäjoki
country: Finland
facility: University of Tampere, Seinäjoki Vaccine Research Clinic (Tampereen Yliopisto, Seinajoen Rokotetutkimusklinikka)
city: Tampere
country: Finland
facility: Tampere Vacine Research Clinic (Tampereen Rokotetutkimusklinikka)
city: Turku
country: Finland
facility: Turku Vaccine Research Clinic (Turun Rokotetutkimusklinikka)
city: Vantaa
country: Finland
facility: University of Tampere, Vantaa East Vaccine Research Clinic (Itä Vantaan Rokotetutkimusklinikka)
city: Singapore
country: Singapore
facility: The Children´s Medical Institute
city: Singapore
country: Singapore
facility: Mount Elizabeth Medical Centre, The Child and Allergy Clinic
city: Paiporta
country: Spain
facility: Centro de Salud de Paiporta
city: Sevilla
country: Spain
facility: Instituto Hispalense de Pediatria, Pediatría - IHP1
city: Valencia
country: Spain
facility: Centro de Salud Malvarrosa
city: Valencia
country: Spain
facility: Centro de Salud Serreria II
city: Valencia
country: Spain
facility: Centro de Salud Trafalgar
city: Valencia
country: Spain
facility: Centro de Salud de Catarroja
city: Valencia
country: Spain
facility: Centro de Salud Quart de Poblet
Study officials:
affiliation: Baxter Innovations GmbH
name: BioScience Investigator, MD
role: STUDY_DIRECTOR
References:
citation: van der Velden MV, Fritz R, Pollabauer EM, Portsmouth D, Howard MK, Kreil TR, Dvorak T, Fritsch S, Vesikari T, Diez-Domingo J, Richmond P, Lee BW, Kistner O, Ehrlich HJ, Barrett PN, Aichinger G. Safety and immunogenicity of a vero cell culture-derived whole-virus influenza A(H5N1) vaccine in a pediatric population. J Infect Dis. 2014 Jan 1;209(1):12-23. doi: 10.1093/infdis/jit498. Epub 2013 Sep 16.