Japanese Pediatric H5N1 Vaccine Study

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01911754
• Other study ID #: 811202
• Status: Completed
• Phase: Phase 3
• First received: July 26, 2013
• Last updated: October 7, 2015
• Start date: August 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Nanotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 17 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza

Intervention

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

Locations

Country	Name	City	State
Japan	Minami Clinic	Kagoshima-shi	Kagoshima-ken
Japan	Shibahara Tahara Hospital	Kagoshima-shi	Kagoshima-ken

Sponsors (2)

Lead Sponsor	Collaborator
Nanotherapeutics, Inc.	Baxter Innovations GmbH

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 43	No
Primary	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.	Day 43	No
Primary	Co-Primary Evaluation of Immunogenicity by SRH Assay: Fold increase of antibody response 21 days after the second vaccination as compared to baseline		Day 43	No
Secondary	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	Days 22 and 202	No
Secondary	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.	Days 22 and 202	No
Secondary	Evaluation of Immunogenicity by SRH Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination		Days 22, 43 and 202	No
Secondary	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		Days 22 and 202	No
Secondary	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	Days 22, 43 and 202	No
Secondary	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.	Days 22, 43 and 202	No
Secondary	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		Days 22, 43 and 202	No
Secondary	Evaluation of Immunogenicity by MN Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination		Days 22, 43 and 202	No
Secondary	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		Days 22, 43 and 202	No
Secondary	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	Days 22, 43 and 202	No
Secondary	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	Days 22, 43 and 202	No
Secondary	Evaluation of Immunogenicity by HI Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination		Days 22, 43 and 202	No
Secondary	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		Days 22, 43 and 202	No
Secondary	Frequency and severity of injection site and systemic reactions until 21 days after the first and second vaccinations		Through study day 43	Yes
Secondary	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.		Days 1-7 and days 22-28	Yes
Secondary	Frequency and severity of all adverse events (AEs) observed during the entire study period		Through day 202	Yes