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Completed

NCT Number: NCT01774032

H5N1 Vaccine Study in Japanese Elderly Population Aged 65 Years and Older

The purpose of this study is to obtain immunogenicity and safety data of an H5N1 pandemic influenza vaccine in a Japanese elderly population aged 65 years and older.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

PS Clinic, Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant is 65 years or older at the time of screening.
  • Participant is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination.
  • Participant is physically and mentally capable of participating in the study.
  • Participant is willing and able to comply with the requirements of the protocol.

Exclusion criteria

  • Participant has a history of infection with H5N1 virus or a history of vaccination with an H5N1 influenza vaccine.
  • Participant is at high risk of contracting H5N1 influenza infection (e.g., poultry workers).
  • 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, dermatologic condition or tattoos which may interfere with injection site reaction rating.
  • Participant has received a blood transfusion or immunoglobulins within 90 days prior to study entry.
  • Participant has donated blood or plasma within 30 days prior to study entry.
  • Participant has received any influenza or any live vaccine within 4 weeks or any other 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 has any other condition that disqualifies his/her participation in the study in the opinion of the investigator.

Treatment and study plan

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

Biological

Primary outcomes

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

    Time frame: Day 43 (42 days after first vaccination, 21 days after second vaccination)

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

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

    Time frame: Day 43 (42 days after first vaccination, 21 days after 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.

  3. 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 (42 days after first vaccination, 21 days after second vaccination)

Secondary outcomes

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

    Time frame: Days 22 and 202

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

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

    Time frame: Days 22 and 202

    '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.

  3. 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

  4. 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

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

    Time frame: Days 22, 43 and 202

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

  6. 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

    Time frame: Days 22, 43 and 202

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

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

    Time frame: Days 22, 43 and 202

  8. 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

  9. 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

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

    Time frame: Days 22, 43 and 202

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

  11. 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

    Time frame: Days 22, 43 and 202

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

  12. 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

  13. 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

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

    Time frame: Through study day 43

  15. Number of participants with fever, malaise or shivering with onset within 7 days after the first and second vaccinations

    Time frame: Days 1-8 and days 22-29

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

    Time frame: Throughout the study period- 8 months

Sponsors and collaborators

Lead sponsor

Alachua Government Services, Inc.

Industry

Registry information

Official study 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 Elderly Population Aged 65 Years and Older

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 23, 2013
Registry last updated
Oct 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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