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

Primary Purpose

Influenza, Avian

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation

About this trial

This is an interventional prevention trial for Influenza, Avian

Eligibility Criteria

6 Months - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Dose A

Dose B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Frequency and severity of systemic reactions until 7 days after the first vaccination

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.

Secondary Outcome Measures

Frequency and severity of systemic and injection site reactions until 21 days after the first, second and booster vaccination

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

Adverse events observed during the 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

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

Measured by MN, HI and SRH assay

Seroconversion 21 days after the first and second vaccination and at 21 days after the booster vaccination

Measured by MN, HI and SRH assay

Full Information

NCT ID

NCT01052402

First Posted

January 18, 2010

Last Updated

October 7, 2015

Sponsor

Ology Bioservices

1. Study Identification

Unique Protocol Identification Number

NCT01052402

Brief Title

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

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ology Bioservices

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Avian

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

684 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose A

Arm Type

Experimental

Arm Description

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

Arm Title

Dose B

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation

Intervention Description

Two vaccinations, 21 days apart, followed by a heterologous booster vaccination on Day 360

Primary Outcome Measure Information:

Title

Frequency and severity of systemic reactions until 7 days after the first vaccination

Time Frame

7 days

Title

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

Secondary Outcome Measure Information:

Title

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

Title

Time Frame

Day 21, 42 and 381

Title

Adverse events observed during the entire study period

Time Frame

Throughout entire study period

Title

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

Description

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

Time Frame

Day 21, 42, 360 and 381

Title

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

Description

Measured by MN, HI and SRH assay

Time Frame

Day 21, 42, 360 and 381

Title

Seroconversion 21 days after the first and second vaccination and at 21 days after the booster vaccination

Description

Measured by MN, HI and SRH assay

Time Frame

Day 21, 42 and 381

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

BioScience Investigator, MD

Organizational Affiliation

Baxter Innovations GmbH

Official's Role

Study Director

Facility Information:

Facility Name

Princess Margaret Hospital for Children

City

Subiaco

ZIP/Postal Code

6008

Country

Australia

Facility Name

Tampere University, Espoo Vaccine Research (Tampereen Yliopisto, Espoon Rokotetutkimus)

City

Espoo

ZIP/Postal Code

02100

Country

Finland

Facility Name

South Helsinki Vaccine Research Clinic (Etelä-Helsingin Rokotetutkimusklinikka)

City

Helsinki

ZIP/Postal Code

00100

Country

Finland

Facility Name

Kokkola Vaccine Research Clinic (Kokkolan Rokotetutkimusklinikka)

City

Kokkola

ZIP/Postal Code

67100

Country

Finland

Facility Name

Kuopion Vaccine Research Clinic

City

Kuopio

ZIP/Postal Code

70210

Country

Finland

Facility Name

Oulu Vacine Research Clinic (Oulun Rokotetutkimusklinikka)

City

Oulu

ZIP/Postal Code

90220

Country

Finland

Facility Name

Porin Vaccine Research Clinic

City

Pori

ZIP/Postal Code

28100

Country

Finland

Facility Name

University of Tampere, Seinäjoki Vaccine Research Clinic (Tampereen Yliopisto, Seinajoen Rokotetutkimusklinikka)

City

Seinäjoki

ZIP/Postal Code

60100

Country

Finland

Facility Name

Tampere Vacine Research Clinic (Tampereen Rokotetutkimusklinikka)

City

Tampere

ZIP/Postal Code

33100

Country

Finland

Facility Name

Turku Vaccine Research Clinic (Turun Rokotetutkimusklinikka)

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

University of Tampere, Vantaa East Vaccine Research Clinic (Itä Vantaan Rokotetutkimusklinikka)

City

Vantaa

ZIP/Postal Code

01300

Country

Finland

Facility Name

The Children´s Medical Institute

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Facility Name

Mount Elizabeth Medical Centre, The Child and Allergy Clinic

City

Singapore

ZIP/Postal Code

228510

Country

Singapore

Facility Name

Centro de Salud de Paiporta

City

Paiporta

ZIP/Postal Code

46200

Country

Spain

Facility Name

Instituto Hispalense de Pediatria, Pediatría - IHP1

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Centro de Salud Malvarrosa

City

Valencia

ZIP/Postal Code

46011

Country

Spain

Facility Name

Centro de Salud Serreria II

City

Valencia

ZIP/Postal Code

46022

Country

Spain

Facility Name

Centro de Salud Trafalgar

City

Valencia

ZIP/Postal Code

46023

Country

Spain

Facility Name

Centro de Salud de Catarroja

City

Valencia

ZIP/Postal Code

46470

Country

Spain

Facility Name

Centro de Salud Quart de Poblet

City

Valencia

ZIP/Postal Code

46930

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

24041789

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.

Results Reference

derived

Learn more about this trial

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

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