Back to resultsDose-finding Study of Four Dosage Levels of an H7N9 Influenza Vaccine in Adults Between Ages of 18 Years and 65 Years
Primary Purpose
H7N9 Influenza
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
H7N9c low dose with adjuvant
H7N9c medium dose with adjuvant
H7N9c high dose with adjuvant
H7N9c high dose without adjuvant
Sponsored by
About this trial
This is an interventional prevention trial for H7N9 Influenza focused on measuring Influenza, H7N9, Vaccine
Eligibility Criteria
Inclusion Criteria:
- Healthy adult subject ages 18-64 years.
- Individuals willing to provide written informed consent
- Individuals in good health.
- Individuals who can comply with study procedures and follow-up.
Exclusion Criteria:
- Individuals with history of cognitive or behavioral impairment or psychiatric disease,
- Individuals unable to understand and follow study procedures,
- History of significant illness,
- History of chronic medical condition or progressive disease,
- Allergy to any vaccine component or adverse event related to a vaccine component,
- Impairment/alteration of the immune system,
- Presence of progressive or severe neurological disorder,
- Pregnant or breast-feeding,
- Female of Child-bearing potential unwilling to use acceptable method of birth control,
- Presence of medically significant cancer,
- Receipt of investigational product within 30 day prior to entry into the study,
- History of previous or suspected illness from avian flu caused by H7N9 virus,
- History of H7 vaccination,
- Body temperature of greater than or equal to 38.0°C (100.4◦F) and/or acute illness within 3 days of intended study vaccination,
- Receipt of any flu vaccination 2 weeks before study entry or 4 weeks after study vaccination,
- Receipt of any vaccination 2 weeks before study entry or 4 weeks after study vaccination,
- History of drug or alcohol abuse within the past 2 years,
- Body Mass Index (BMI) greater than or equal to 35kg/m2,
- Individuals conducting the study or their immediate family members.
Sites / Locations
- Site 04: Accelovance
- Site 01: Accelovance
- Site 02: Accelovance
- Site 03: Accelovance
- Site 05: Janet Lewis
- Site 06: Janet Lewis
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Group A
Group B
Group C
Group D
Arm Description
H7N9c low dose with adjuvant
H7N9c medium dose with adjuvant
H7N9c high dose with adjuvant
H7N9c high dose without adjuvant
Outcomes
Primary Outcome Measures
Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43)
Immunogenicity was measured by Hemagglutination Inhibition (HI) assay and summarized through the geometric mean titers (GMTs) at baseline (day 1) and three weeks after the second (day 43) vaccination
Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43)
Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after second (day 43) vaccination.
Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)
Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after second (day 43) vaccination.
Seroconversion is defined as postvaccination HI titer> 40 for subjects with baseline (day 1); HI titer <1:10 or a minimum 4-fold increase in titer for subjects with baseline titer >1:10.
Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)
Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after second (Day 43) vaccination.
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Safety was assessed as the number of subjects who reported any AEs, and at least possibly related AEs are collected from day 1 to day 43 following vaccination with adjuvanted and unadjuvanted formulations of H7N9c vaccine.
Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
The number of subjects reporting unsolicited adverse events after receiving adjuvanted and unadjuvanted formulations of H7N9c vaccine was reported. Safety was assessed as the number of subjects who reported SAEs, at least possibly related SAEs, new onset of chronic diseases (NOCDs), medically attended AEs, AEs of Special Interest (AESIs), AEs leading to withdrawal from the study were collected from day 1 to day 366 following vaccination with adjuvanted and unadjuvanted formulations of H7N9 vaccine.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 to day 7 of vaccination of adjuvanted and unadjuvanted formulations of H7N9c vaccine.
Secondary Outcome Measures
Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22)
Immunogenicity was measured by HI assay and summarized through the GMTs at baseline (day 1) and three weeks after the first (day 22) vaccination.
Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22)
GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after first (day 22) vaccination.
Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)
Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after first (day 22) vaccination.
Seroconversion is defined as postvaccination HI titer> 40 for subjects with baseline (day 1); HI titer <1:10 or a minimum 4-fold increase in titer for subjects with baseline titer >1:10.
Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)
Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after first (Day 22) vaccination.
Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)
The immunogenicity was measured as GMTs in subjects as persistence at six months (day 183) and one year (day 366) after the first vaccination as measured by Hemagglutination Inhibition (HI) Assay.
Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)
GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs six months (day 183) and one year (day 366) after the first vaccination.
Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)
Percentage of subjects with HI seroconversion was measured as HI titer persistence at six months (day 183) and one year (day 366) after the first vaccination.
Seroconversion is defined as postvaccination HI titer>40 for subjects with baseline (day 1); HI titer <1:10 or a minimum four-fold increase in titer for subjects with baseline titer>1:10.
Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)
Percentages of subjects who achieved HI titers≥1:40 was measured at six months (day 183) and one year (day 366) after the first vaccination of a cell-culture derived H7N9 vaccine.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01928472
Brief Title
Dose-finding Study of Four Dosage Levels of an H7N9 Influenza Vaccine in Adults Between Ages of 18 Years and 65 Years
Official Title
Phase I Multi-center, Observer-Blind, Randomized Dose-Ranging Study of Adjuvanted and Non-Adjuvanted Cell Culture-Derived, Inactivated A/H7N9 Monovalent Subunit Influenza Virus Vaccine (H7N9c) in Adults 18 to <65 Years
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the safety and immunogenicity of four different doses of H7N9 vaccination in adults between the ages of 18 years and 65 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
H7N9 Influenza
Keywords
Influenza, H7N9, Vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
402 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
H7N9c low dose with adjuvant
Arm Title
Group B
Arm Type
Experimental
Arm Description
H7N9c medium dose with adjuvant
Arm Title
Group C
Arm Type
Experimental
Arm Description
H7N9c high dose with adjuvant
Arm Title
Group D
Arm Type
Experimental
Arm Description
H7N9c high dose without adjuvant
Intervention Type
Biological
Intervention Name(s)
H7N9c low dose with adjuvant
Intervention Type
Biological
Intervention Name(s)
H7N9c medium dose with adjuvant
Intervention Type
Biological
Intervention Name(s)
H7N9c high dose with adjuvant
Intervention Type
Biological
Intervention Name(s)
H7N9c high dose without adjuvant
Primary Outcome Measure Information:
Title
Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43)
Description
Immunogenicity was measured by Hemagglutination Inhibition (HI) assay and summarized through the geometric mean titers (GMTs) at baseline (day 1) and three weeks after the second (day 43) vaccination
Time Frame
Day 1 and 43
Title
Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43)
Description
Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after second (day 43) vaccination.
Time Frame
Day 43
Title
Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)
Description
Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after second (day 43) vaccination.
Seroconversion is defined as postvaccination HI titer> 40 for subjects with baseline (day 1); HI titer <1:10 or a minimum 4-fold increase in titer for subjects with baseline titer >1:10.
Time Frame
Day 43
Title
Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)
Description
Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after second (Day 43) vaccination.
Time Frame
Day 1 and 43
Title
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Description
Safety was assessed as the number of subjects who reported any AEs, and at least possibly related AEs are collected from day 1 to day 43 following vaccination with adjuvanted and unadjuvanted formulations of H7N9c vaccine.
Time Frame
Day 1 to Day 43
Title
Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Description
The number of subjects reporting unsolicited adverse events after receiving adjuvanted and unadjuvanted formulations of H7N9c vaccine was reported. Safety was assessed as the number of subjects who reported SAEs, at least possibly related SAEs, new onset of chronic diseases (NOCDs), medically attended AEs, AEs of Special Interest (AESIs), AEs leading to withdrawal from the study were collected from day 1 to day 366 following vaccination with adjuvanted and unadjuvanted formulations of H7N9 vaccine.
Time Frame
Day 1 to Day 366.
Title
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Description
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 to day 7 of vaccination of adjuvanted and unadjuvanted formulations of H7N9c vaccine.
Time Frame
Day 1 through Day 7 after each vaccination.
Secondary Outcome Measure Information:
Title
Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22)
Description
Immunogenicity was measured by HI assay and summarized through the GMTs at baseline (day 1) and three weeks after the first (day 22) vaccination.
Time Frame
Day 1 and 22
Title
Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22)
Description
GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after first (day 22) vaccination.
Time Frame
Day 22
Title
Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)
Description
Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after first (day 22) vaccination.
Seroconversion is defined as postvaccination HI titer> 40 for subjects with baseline (day 1); HI titer <1:10 or a minimum 4-fold increase in titer for subjects with baseline titer >1:10.
Time Frame
Day 22
Title
Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)
Description
Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after first (Day 22) vaccination.
Time Frame
Day 1 and 22.
Title
Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)
Description
The immunogenicity was measured as GMTs in subjects as persistence at six months (day 183) and one year (day 366) after the first vaccination as measured by Hemagglutination Inhibition (HI) Assay.
Time Frame
Day 183 and 366.
Title
Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)
Description
GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs six months (day 183) and one year (day 366) after the first vaccination.
Time Frame
Day 183 and 366
Title
Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)
Description
Percentage of subjects with HI seroconversion was measured as HI titer persistence at six months (day 183) and one year (day 366) after the first vaccination.
Seroconversion is defined as postvaccination HI titer>40 for subjects with baseline (day 1); HI titer <1:10 or a minimum four-fold increase in titer for subjects with baseline titer>1:10.
Time Frame
Day 183 and 366
Title
Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)
Description
Percentages of subjects who achieved HI titers≥1:40 was measured at six months (day 183) and one year (day 366) after the first vaccination of a cell-culture derived H7N9 vaccine.
Time Frame
Day 183 and 366
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adult subject ages 18-64 years.
Individuals willing to provide written informed consent
Individuals in good health.
Individuals who can comply with study procedures and follow-up.
Exclusion Criteria:
Individuals with history of cognitive or behavioral impairment or psychiatric disease,
Individuals unable to understand and follow study procedures,
History of significant illness,
History of chronic medical condition or progressive disease,
Allergy to any vaccine component or adverse event related to a vaccine component,
Impairment/alteration of the immune system,
Presence of progressive or severe neurological disorder,
Pregnant or breast-feeding,
Female of Child-bearing potential unwilling to use acceptable method of birth control,
Presence of medically significant cancer,
Receipt of investigational product within 30 day prior to entry into the study,
History of previous or suspected illness from avian flu caused by H7N9 virus,
History of H7 vaccination,
Body temperature of greater than or equal to 38.0°C (100.4◦F) and/or acute illness within 3 days of intended study vaccination,
Receipt of any flu vaccination 2 weeks before study entry or 4 weeks after study vaccination,
Receipt of any vaccination 2 weeks before study entry or 4 weeks after study vaccination,
History of drug or alcohol abuse within the past 2 years,
Body Mass Index (BMI) greater than or equal to 35kg/m2,
Individuals conducting the study or their immediate family members.
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
Site 04: Accelovance
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Site 01: Accelovance
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
Facility Name
Site 02: Accelovance
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Site 03: Accelovance
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Site 05: Janet Lewis
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
Site 06: Janet Lewis
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dose-finding Study of Four Dosage Levels of an H7N9 Influenza Vaccine in Adults Between Ages of 18 Years and 65 Years
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