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Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Elderly Subjects

Primary Purpose

Pandemic H5N1 Influenza

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Adjuvanted H5N1 pandemic influenza vaccine
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pandemic H5N1 Influenza focused on measuring Influenza, Pandemic, H5N1, Elderly adults

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy elderly subjects ≥65 years,
  2. Individuals willing to provide written informed consent,
  3. Individuals in good health,
  4. Individuals willing to allow for their serum samples to be stored beyond the study period.

Exclusion Criteria:

  1. Individuals not able to understand and follow study procedures,
  2. History of any significant illness,
  3. History of any serious chronic medical condition or progressive disease,
  4. Presence of medically significant cancer,
  5. Known or suspected impairment/alteration of immune function,
  6. Presence of any progressive or severe neurologic disorder,
  7. Presence of any bleeding disorders or conditions that prolongs bleeding time,
  8. History of allergy to vaccine components,
  9. Receipt of any other investigational product within 30 days prior to entry into the study,
  10. History of previous H5N1 vaccination,
  11. Receipt of any other type of seasonal vaccination within 2 months prior to entry into the study,
  12. Receipt of any other vaccine within 2 weeks prior to entry into the study
  13. Body temperature ≥38°C.0 (≥100.4° F) and/or acute illness within 3 days of intended study vaccination,
  14. Body mass index (BMI) ≥ 35 kg/m2,
  15. History of drug or alcohol abuse,
  16. Any planned surgery during study period,
  17. Individuals conducting the study and their immediate family members,
  18. Individuals with behavioral or cognitive impairment or psychiatric diseases.

Sites / Locations

  • 1 Tatum Highlands Med Ass PLLC
  • 5 Broward Research Group Pembroke Pines
  • 7 Heartland Rsrch Ass LLC
  • 9 Heartland Research Associates
  • 2 Mercy Health Research
  • 3 Saint Louis University
  • 6 Regional Clinical Research Endwell,
  • 4 Benchmark Medical Research
  • 12 Tekton Research
  • 8 J. Lewis Research Inc.
  • 10 Foothill Family Clinic
  • 11 Jordan River Family Medicine
  • 42 Hunter Clinical Research
  • 44 Wesley Research Institute Clinical Trials Center
  • 40 CMAX
  • 41 Linear Clinical Research
  • 45 Childrens Clin Rsrch Facility
  • 50 Southern Clinical Trials
  • 51 Riccarton Clinic
  • 72 Faculty of Medicine, Chulalongkorn University - Queen Saovabha Memorial Institute
  • 71 Phramongkutklao Hospital
  • 73 Siriraj Clinical Research Ctr
  • 74 Chiang Mai Uni Hospital Clinical Trial Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

aH5N1c - High dose

aH5N1c - Low dose

Arm Description

Outcomes

Primary Outcome Measures

The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain.
The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion. The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 60%.
The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.
Immunogenicity was measured in terms of the percentages of subjects achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criterion. Seroconversion is defined as, a postvaccination titer ≥40 in subjects with a prevaccination HI titer <10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 30%.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination.
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with aH5N1c vaccine

Secondary Outcome Measures

Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.
Immunogenicity was measured as the GMR. The ratio of postvaccination to prevaccination HI geometric mean titers (GMTs) is reported. The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criterion if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.0 for subjects >60 years of age.
Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain
Immunogenicity was assessed in terms of percentage of subjects achieving HI titers >40, three weeks after second vaccination with aH5N1c according to the CHMP criterion. The European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >60%.
The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain
Immunogenicity was assessed in terms of percentages of subjects achieving seroconversion in HI titers, three weeks after receiving two injections of either low dose or high dose aH5N1c vaccine according to the CHMP criterion. Seroconversion is defined as a postvaccination titer ≥40 in subjects with a prevaccination HI titer <10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion is >30%.

Full Information

First Posted
January 10, 2013
Last Updated
January 14, 2019
Sponsor
Novartis Vaccines
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT01766921
Brief Title
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Elderly Subjects
Official Title
A Phase II, Randomized, Observer-Blind, Multi-Center, Study to Evaluate Safety, Tolerability and Immunogenicity of an Adjuvanted Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine at Two Different Formulations in Healthy Elderly Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
Collaborators
Department of Health and Human Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in elderly subjects

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pandemic H5N1 Influenza
Keywords
Influenza, Pandemic, H5N1, Elderly adults

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1393 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aH5N1c - High dose
Arm Type
Experimental
Arm Title
aH5N1c - Low dose
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Adjuvanted H5N1 pandemic influenza vaccine
Intervention Description
Comparison of two doses of aH5N1c vaccine
Primary Outcome Measure Information:
Title
The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain.
Description
The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion. The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 60%.
Time Frame
Baseline (day 1) and Three weeks after 2nd vaccination (day 43)
Title
The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.
Description
Immunogenicity was measured in terms of the percentages of subjects achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criterion. Seroconversion is defined as, a postvaccination titer ≥40 in subjects with a prevaccination HI titer <10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 30%.
Time Frame
Three weeks after 2nd vaccination (day 43)
Title
Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination.
Description
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.
Time Frame
From day 1 through day 7 after any vaccination.
Title
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
Description
Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with aH5N1c vaccine
Time Frame
Day 1 through day 387 after any vaccination
Secondary Outcome Measure Information:
Title
Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.
Description
Immunogenicity was measured as the GMR. The ratio of postvaccination to prevaccination HI geometric mean titers (GMTs) is reported. The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criterion if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.0 for subjects >60 years of age.
Time Frame
Day 1; day 22; day 43 and day 387
Title
Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain
Description
Immunogenicity was assessed in terms of percentage of subjects achieving HI titers >40, three weeks after second vaccination with aH5N1c according to the CHMP criterion. The European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >60%.
Time Frame
Day 1, day 22, day 43 and day 387.
Title
The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain
Description
Immunogenicity was assessed in terms of percentages of subjects achieving seroconversion in HI titers, three weeks after receiving two injections of either low dose or high dose aH5N1c vaccine according to the CHMP criterion. Seroconversion is defined as a postvaccination titer ≥40 in subjects with a prevaccination HI titer <10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion is >30%.
Time Frame
Day 22, day 43 and day 387

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy elderly subjects ≥65 years, Individuals willing to provide written informed consent, Individuals in good health, Individuals willing to allow for their serum samples to be stored beyond the study period. Exclusion Criteria: Individuals not able to understand and follow study procedures, History of any significant illness, History of any serious chronic medical condition or progressive disease, Presence of medically significant cancer, Known or suspected impairment/alteration of immune function, Presence of any progressive or severe neurologic disorder, Presence of any bleeding disorders or conditions that prolongs bleeding time, History of allergy to vaccine components, Receipt of any other investigational product within 30 days prior to entry into the study, History of previous H5N1 vaccination, Receipt of any other type of seasonal vaccination within 2 months prior to entry into the study, Receipt of any other vaccine within 2 weeks prior to entry into the study Body temperature ≥38°C.0 (≥100.4° F) and/or acute illness within 3 days of intended study vaccination, Body mass index (BMI) ≥ 35 kg/m2, History of drug or alcohol abuse, Any planned surgery during study period, Individuals conducting the study and their immediate family members, Individuals with behavioral or cognitive impairment or psychiatric diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis vaccines and Diagnostics
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
1 Tatum Highlands Med Ass PLLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
Facility Name
5 Broward Research Group Pembroke Pines
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
7 Heartland Rsrch Ass LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
9 Heartland Research Associates
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
2 Mercy Health Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
3 Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
6 Regional Clinical Research Endwell,
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
4 Benchmark Medical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
12 Tekton Research
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
8 J. Lewis Research Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
10 Foothill Family Clinic
City
South Cottonwood Heights
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
11 Jordan River Family Medicine
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
42 Hunter Clinical Research
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2292
Country
Australia
Facility Name
44 Wesley Research Institute Clinical Trials Center
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
40 CMAX
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
41 Linear Clinical Research
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
45 Childrens Clin Rsrch Facility
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6872
Country
Australia
Facility Name
50 Southern Clinical Trials
City
Beckenham
State/Province
Christchurch
ZIP/Postal Code
8244
Country
New Zealand
Facility Name
51 Riccarton Clinic
City
Riccarton
State/Province
Christchurch
ZIP/Postal Code
8041
Country
New Zealand
Facility Name
72 Faculty of Medicine, Chulalongkorn University - Queen Saovabha Memorial Institute
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
71 Phramongkutklao Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
73 Siriraj Clinical Research Ctr
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
74 Chiang Mai Uni Hospital Clinical Trial Center
City
Bangkok
ZIP/Postal Code
50200
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
30968056
Citation
Frey SE, Shakib S, Chanthavanich P, Richmond P, Smith T, Tantawichien T, Kittel C, Jaehnig P, Mojares Z, Verma B, Kanesa-Thasan N, Hohenboken M. Safety and Immunogenicity of MF59-Adjuvanted Cell Culture-Derived A/H5N1 Subunit Influenza Virus Vaccine: Dose-Finding Clinical Trials in Adults and the Elderly. Open Forum Infect Dis. 2019 Mar 1;6(4):ofz107. doi: 10.1093/ofid/ofz107. eCollection 2019 Apr.
Results Reference
derived

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Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Elderly Subjects

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