Safety and Immunogenicity Study of a H5N1 Influenza Vaccine (Vero Cell-Derived, Whole Virus) in Healthy Infants, Children and Adolescents

Influenza, Avian Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01052402
• Other study ID #: 810706
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 18, 2010
• Last updated: October 7, 2015
• Start date: December 2009
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Nanotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ministry of Social Affairs and HealthSpain: Agencia Española de Medicamentos y Productos SanitariosAustralia: Department of Health and Ageing Therapeutic Goods AdministrationSingapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 684
• Est. completion date: November 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza, Avian
• Influenza, Human

Intervention

Biological:
• H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation
Two vaccinations, 21 days apart, followed by a heterologous booster vaccination on Day 360

Locations

Country	Name	City	State
Australia	Princess Margaret Hospital for Children	Subiaco
Finland	Tampere University, Espoo Vaccine Research (Tampereen Yliopisto, Espoon Rokotetutkimus)	Espoo
Finland	South Helsinki Vaccine Research Clinic (Etelä-Helsingin Rokotetutkimusklinikka)	Helsinki
Finland	Kokkola Vaccine Research Clinic (Kokkolan Rokotetutkimusklinikka)	Kokkola
Finland	Kuopion Vaccine Research Clinic	Kuopio
Finland	Oulu Vacine Research Clinic (Oulun Rokotetutkimusklinikka)	Oulu
Finland	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	Turku Vaccine Research Clinic (Turun Rokotetutkimusklinikka)	Turku
Finland	University of Tampere, Vantaa East Vaccine Research Clinic (Itä Vantaan Rokotetutkimusklinikka)	Vantaa
Singapore	Mount Elizabeth Medical Centre, The Child and Allergy Clinic	Singapore
Singapore	The Children´s Medical Institute	Singapore
Spain	Centro de Salud de Paiporta	Paiporta
Spain	Instituto Hispalense de Pediatria, Pediatría - IHP1	Sevilla
Spain	Centro de Salud de Catarroja	Valencia
Spain	Centro de Salud Malvarrosa	Valencia
Spain	Centro de Salud Quart de Poblet	Valencia
Spain	Centro de Salud Serreria II	Valencia
Spain	Centro de Salud Trafalgar	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Nanotherapeutics, Inc.

Countries where clinical trial is conducted

Australia,  Finland,  Singapore,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and severity of systemic reactions until 7 days after the first vaccination		7 days	Yes
Primary	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	No
Secondary	Frequency and severity of systemic and injection site reactions until 21 days after the first, second and booster vaccination		Day 21, 42 and 381	Yes
Secondary	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	Yes
Secondary	Adverse events observed during the entire study period		Throughout entire study period	Yes
Secondary	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	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	Day 21, 42, 360 and 381	No
Secondary	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	Measured by MN, HI and SRH assay	Day 21, 42, 360 and 381	No
Secondary	Seroconversion 21 days after the first and second vaccination and at 21 days after the booster vaccination	Measured by MN, HI and SRH assay	Day 21, 42 and 381	No