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Japanese Pediatric H5N1 Vaccine Study

Primary Purpose

Influenza

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

H5N1 (Pre-)Pandemic Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated)

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

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

Inclusion Criteria:

Participant is 6 months to 17 years old at time of screening.
Participant is born at full term of pregnancy (≥37 weeks) with a birth weight ≥2 kg (for participants aged 6 to 35 months only).
Participant is generally healthy, as determined by investigator's clinical judgment through collection of medical history and a physical examination.
If female of childbearing potential, participant has a negative pregnancy test within 24 hours prior to first scheduled vaccination and agrees to employ adequate birth control measures for study duration.
Participant and/or their parents/legal guardians is/are willing and able to comply with protocol requirements.

Exclusion Criteria:

Participant has a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza vaccine.
Participant is at high risk of contracting H5N1 influenza infection (e.g. contact with poultry).
Participant currently has or has a history of a significant cardiovascular (including hypertension), respiratory (including asthma), metabolic, neurological (including Guillain-Barré Syndrome and acute disseminated encephalomyelitis), hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder.
Participant has any inherited or acquired immunodeficiency
Participant has a disease or is currently undergoing a form of treatment or was 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 inhaled corticosteroids
- radiation treatment
- or other immunosuppressive or cytotoxic drugs.
Participant has a history of severe allergic reactions or anaphylaxis.
Participant has a rash, dermatological condition or tattoos which may interfere with injection site reaction rating.
Participant has received a blood transfusion, immunoglobulins or other blood derivatives within 90 days prior to study entry.
Participant has donated blood or plasma within 30 days prior to study entry.
Participant has received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study.
Participant has a functional or surgical asplenia.
Participant has a known or suspected problem with alcohol or drug abuse.
Participant has been exposed to an investigational product (IP) within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
Participant is a family member or employee of the investigator.
Participant is pregnant or lactating at the time of enrollment.
Participant has any other condition that disqualifies his/her participation in the study in the opinion of the investigator.

Sites / Locations

Minami Clinic
Shibahara Tahara Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Influenza Vaccine

Arm Description

One dose of the vaccine will be administered at a volume of 0.5 mL by intramuscular injection on Day 1 and 22

Outcomes

Primary Outcome Measures

Co-Primary Evaluation of Immunogenicity by Single Radial Hemolysis (SRH) Assay: Number of participants with antibody response to vaccine strain (A/Indonesia/05/2005)

Associated with protection 21 days after second vaccination defined as hemolysis area measured by SRH assay ≥25mm^2

Co-Primary Evaluation of Immunogenicity by SRH Assay: Number of participants demonstrating seroconversion 21 days after the second vaccination

'Seroconversion' is defined as either a ≥25mm^2 hemolysis area after the vaccination in case of a negative prevaccination sample (≤4mm^2) or a ≥50% increase in hemolysis area if the prevaccination sample is >4mm^2.

Co-Primary Evaluation of Immunogenicity by SRH Assay: Fold increase of antibody response 21 days after the second vaccination as compared to baseline

Secondary Outcome Measures

Evaluation of Immunogenicity by SRH Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)

Associated with protection 21 days after the first and 180 days after the second vaccination defined as SRH area ≥25mm^2

Evaluation of Immunogenicity by SRH Assay: Number of participants demonstrating seroconversion 21 days after the first and 180 days after the second vaccination

'Seroconversion' is defined as either a ≥25mm^2 hemolysis area after the vaccination in case of a negative prevaccination sample [≤4mm^2] or a ≥50% increase in hemolysis area if the prevaccination sample is >4mm^2.

Evaluation of Immunogenicity by SRH Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination

Evaluation of Immunogenicity by SRH Assay: Fold increase of antibody response 21 days after the first and 180 days after the second vaccination as compared to baseline

Evaluation of Immunogenicity by Microneutralization (MN) Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)

Associated with protection 21 days after the first and 21 and 180 days after the second vaccination defined as MN titer ≥ 1:20

Evaluation of Immunogenicity by MN Assay: Number of participants demonstrating seroconversion 21 days after the first and 21 and 180 days after the second vaccination

'Seroconversion' is defined as a four-fold or greater increase in titer as compared to baseline.

Evaluation of Immunogenicity by MN Assay: Number of participants demonstrating either ≥4-fold titer increase compared to baseline if above detection limit OR a ≥ 20 titer after vaccination if baseline titer is below detection limit

Evaluation of Immunogenicity by MN Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination

Evaluation of Immunogenicity by MN Assay: Fold increase of antibody response 21 days after the first and 21 and 180 days after the second vaccination as compared to baseline

Evaluation of Immunogenicity by Hemagglutination Inhibition (HI) Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)

Associated with protection 21 days after the first and 21 and 180 days after second vaccination defined as HI titer ≥ 1:40

Evaluation of Immunogenicity by HI Assay: Number of participants demonstrating seroconversion 21 days after the first and 21 and 180 days after the second vaccination

'Seroconversion' is defined as a 4-fold or greater increase in HI titer as compared to baseline

Evaluation of Immunogenicity by HI Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination

Evaluation of Immunogenicity by HI Assay: Fold increase of antibody response 21 days after the first and 21 and 180 days after the second vaccination as compared to baseline

Frequency and severity of injection site and systemic reactions until 21 days after the first and second vaccinations

Number of participants with 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 and second vaccinations.

Frequency and severity of all adverse events (AEs) observed during the entire study period

Full Information

NCT ID

NCT01911754

First Posted

July 26, 2013

Last Updated

October 7, 2015

Sponsor

Ology Bioservices

Collaborators

Baxter Innovations GmbH

1. Study Identification

Unique Protocol Identification Number

NCT01911754

Brief Title

Japanese Pediatric H5N1 Vaccine Study

Official Title

An Open-Label Phase 3 Study to Assess Immunogenicity and Safety of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in a Japanese Pediatric Population Aged 6 Months to 17 Years

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ology Bioservices

Collaborators

Baxter Innovations GmbH

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to obtain immunogenicity and safety data of an H5N1 pandemic influenza vaccine in a Japanese pediatric population 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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Influenza Vaccine

Arm Type

Experimental

Arm Description

One dose of the vaccine will be administered at a volume of 0.5 mL by intramuscular injection on Day 1 and 22

Intervention Type

Biological

Intervention Name(s)

H5N1 (Pre-)Pandemic Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated)

Primary Outcome Measure Information:

Title

Co-Primary Evaluation of Immunogenicity by Single Radial Hemolysis (SRH) Assay: Number of participants with antibody response to vaccine strain (A/Indonesia/05/2005)

Description

Associated with protection 21 days after second vaccination defined as hemolysis area measured by SRH assay ≥25mm^2

Time Frame

Day 43

Title

Co-Primary Evaluation of Immunogenicity by SRH Assay: Number of participants demonstrating seroconversion 21 days after the second vaccination

Description

Time Frame

Day 43

Title

Co-Primary Evaluation of Immunogenicity by SRH Assay: Fold increase of antibody response 21 days after the second vaccination as compared to baseline

Time Frame

Day 43

Secondary Outcome Measure Information:

Title

Evaluation of Immunogenicity by SRH Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)

Description

Associated with protection 21 days after the first and 180 days after the second vaccination defined as SRH area ≥25mm^2

Time Frame

Days 22 and 202

Title

Evaluation of Immunogenicity by SRH Assay: Number of participants demonstrating seroconversion 21 days after the first and 180 days after the second vaccination

Description

Time Frame

Days 22 and 202

Title

Evaluation of Immunogenicity by SRH Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination

Time Frame

Days 22, 43 and 202

Title

Evaluation of Immunogenicity by SRH Assay: Fold increase of antibody response 21 days after the first and 180 days after the second vaccination as compared to baseline

Time Frame

Days 22 and 202

Title

Evaluation of Immunogenicity by Microneutralization (MN) Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)

Description

Associated with protection 21 days after the first and 21 and 180 days after the second vaccination defined as MN titer ≥ 1:20

Time Frame

Days 22, 43 and 202

Title

Evaluation of Immunogenicity by MN Assay: Number of participants demonstrating seroconversion 21 days after the first and 21 and 180 days after the second vaccination

Description

'Seroconversion' is defined as a four-fold or greater increase in titer as compared to baseline.

Time Frame

Days 22, 43 and 202

Title

Time Frame

Days 22, 43 and 202

Title

Evaluation of Immunogenicity by MN Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination

Time Frame

Days 22, 43 and 202

Title

Evaluation of Immunogenicity by MN Assay: Fold increase of antibody response 21 days after the first and 21 and 180 days after the second vaccination as compared to baseline

Time Frame

Days 22, 43 and 202

Title

Evaluation of Immunogenicity by Hemagglutination Inhibition (HI) Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)

Description

Associated with protection 21 days after the first and 21 and 180 days after second vaccination defined as HI titer ≥ 1:40

Time Frame

Days 22, 43 and 202

Title

Evaluation of Immunogenicity by HI Assay: Number of participants demonstrating seroconversion 21 days after the first and 21 and 180 days after the second vaccination

Description

'Seroconversion' is defined as a 4-fold or greater increase in HI titer as compared to baseline

Time Frame

Days 22, 43 and 202

Title

Evaluation of Immunogenicity by HI Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination

Time Frame

Days 22, 43 and 202

Title

Evaluation of Immunogenicity by HI Assay: Fold increase of antibody response 21 days after the first and 21 and 180 days after the second vaccination as compared to baseline

Time Frame

Days 22, 43 and 202

Title

Frequency and severity of injection site and systemic reactions until 21 days after the first and second vaccinations

Time Frame

Through study day 43

Title

Time Frame

Days 1-7 and days 22-28

Title

Frequency and severity of all adverse events (AEs) observed during the entire study period

Time Frame

Through day 202

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: Participant is 6 months to 17 years old at time of screening. Participant is born at full term of pregnancy (≥37 weeks) with a birth weight ≥2 kg (for participants aged 6 to 35 months only). Participant is generally healthy, as determined by investigator's clinical judgment through collection of medical history and a physical examination. If female of childbearing potential, participant has a negative pregnancy test within 24 hours prior to first scheduled vaccination and agrees to employ adequate birth control measures for study duration. Participant and/or their parents/legal guardians is/are willing and able to comply with protocol requirements. Exclusion Criteria: Participant has a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza vaccine. Participant is at high risk of contracting H5N1 influenza infection (e.g. contact with poultry). Participant currently has or has a history of a significant cardiovascular (including hypertension), respiratory (including asthma), metabolic, neurological (including Guillain-Barré Syndrome and acute disseminated encephalomyelitis), hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder. Participant has any inherited or acquired immunodeficiency Participant has a disease or is currently undergoing a form of treatment or was 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 inhaled corticosteroids radiation treatment or other immunosuppressive or cytotoxic drugs. Participant has a history of severe allergic reactions or anaphylaxis. Participant has a rash, dermatological condition or tattoos which may interfere with injection site reaction rating. Participant has received a blood transfusion, immunoglobulins or other blood derivatives within 90 days prior to study entry. Participant has donated blood or plasma within 30 days prior to study entry. Participant has received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study. Participant has a functional or surgical asplenia. Participant has a known or suspected problem with alcohol or drug abuse. Participant has been exposed to an investigational product (IP) within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study. Participant is a family member or employee of the investigator. Participant is pregnant or lactating at the time of enrollment. Participant has any other condition that disqualifies his/her participation in the study in the opinion of the investigator.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nirjhar Chatterjee, MD

Organizational Affiliation

Baxter Innovations GmbH

Official's Role

Study Director

Facility Information:

Facility Name

Minami Clinic

City

Kagoshima-shi

State/Province

Kagoshima-ken

ZIP/Postal Code

890-0063

Country

Japan

Facility Name

Shibahara Tahara Hospital

City

Kagoshima-shi

State/Province

Kagoshima-ken

ZIP/Postal Code

890-0082

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

Japanese Pediatric H5N1 Vaccine Study

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