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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01052402
First received: January 18, 2010
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Influenza, Avian
Biological: H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Frequency and severity of systemic reactions until 7 days after the first vaccination [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency and severity of systemic and injection site reactions until 21 days after the first, second and booster vaccination [ Time Frame: Day 21, 42 and 381 ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: Day 21, 42 and 381 ] [ Designated as safety issue: Yes ]
  • Adverse events observed during the entire study period [ Time Frame: Throughout entire study period ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: Day 21, 42, 360 and 381 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 21, 42, 360 and 381 ] [ Designated as safety issue: No ]
    Measured by MN, HI and SRH assay

  • Seroconversion 21 days after the first and second vaccination and at 21 days after the booster vaccination [ Time Frame: Day 21, 42 and 381 ] [ Designated as safety issue: No ]
    Measured by MN, HI and SRH assay


Enrollment: 684
Study Start Date: December 2009
Study Completion Date: November 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose A
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
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
Experimental: Dose B
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
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

  Eligibility

Ages Eligible for Study:   6 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052402

Locations
Australia
Princess Margaret Hospital for Children
Subiaco, Australia, 6008
Finland
Tampere University, Espoo Vaccine Research (Tampereen Yliopisto, Espoon Rokotetutkimus)
Espoo, Finland, 02100
South Helsinki Vaccine Research Clinic (Etelä-Helsingin Rokotetutkimusklinikka)
Helsinki, Finland, 00100
Kokkola Vaccine Research Clinic (Kokkolan Rokotetutkimusklinikka)
Kokkola, Finland, 67100
Kuopion Vaccine Research Clinic
Kuopio, Finland, 70210
Oulu Vacine Research Clinic (Oulun Rokotetutkimusklinikka)
Oulu, Finland, 90220
Porin Vaccine Research Clinic
Pori, Finland, 28100
University of Tampere, Seinäjoki Vaccine Research Clinic (Tampereen Yliopisto, Seinajoen Rokotetutkimusklinikka)
Seinäjoki, Finland, 60100
Tampere Vacine Research Clinic (Tampereen Rokotetutkimusklinikka)
Tampere, Finland, 33100
Turku Vaccine Research Clinic (Turun Rokotetutkimusklinikka)
Turku, Finland, 20520
University of Tampere, Vantaa East Vaccine Research Clinic (Itä Vantaan Rokotetutkimusklinikka)
Vantaa, Finland, 01300
Singapore
Mount Elizabeth Medical Centre, The Child and Allergy Clinic
Singapore, Singapore, 228510
The Children´s Medical Institute
Singapore, Singapore, 119074
Spain
Centro de Salud de Paiporta
Paiporta, Spain, 46200
Instituto Hispalense de Pediatria, Pediatría - IHP1
Sevilla, Spain, 41013
Centro de Salud Trafalgar
Valencia, Spain, 46023
Centro de Salud Malvarrosa
Valencia, Spain, 46011
Centro de Salud de Catarroja
Valencia, Spain, 46470
Centro de Salud Quart de Poblet
Valencia, Spain, 46930
Centro de Salud Serreria II
Valencia, Spain, 46022
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: BioScience Investigator, MD Baxter Innovations GmbH
  More Information

No publications provided by Baxter Healthcare Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01052402     History of Changes
Other Study ID Numbers: 810706
Study First Received: January 18, 2010
Last Updated: November 28, 2012
Health Authority: Finland: Ministry of Social Affairs and Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Australia: Department of Health and Ageing Therapeutic Goods Administration
Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Influenza in Birds
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 14, 2014