Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vacc... | NCT00973349 | Trialant
NCT00973349
Sponsor
Novartis
Status
Completed
Last Update Posted
Dec 7, 2015Estimated
Enrollment
2,719Actual
Phase
Phase 2Phase 3
Conditions
Influenza
Interventions
MF59-eH1N1_f
Countries
United States
Mexico
Protocol Section
Identification Module
NCT ID
NCT00973349
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V112_01
Secondary IDs
Not provided
Brief Title
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults
Official Title
A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Adult Subjects 18 or More Years of Age
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Oct 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2009
Primary Completion Date
Nov 2009Actual
Completion Date
Dec 2010Actual
First Submitted Date
Sep 2, 2009
First Submission Date that Met QC Criteria
Sep 7, 2009
First Posted Date
Sep 9, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 7, 2010
Results First Submitted that Met QC Criteria
Apr 21, 2011
Results First Posted Date
May 25, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 29, 2015
Last Update Posted Date
Dec 7, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
NovartisINDUSTRY
Collaborators
Name
Class
Novartis Vaccines
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.
Detailed Description
Not provided
Conditions Module
Conditions
Influenza
Keywords
Swine Flu
Flu
Vaccine
Adults
Elderly
Non-Elderly
Adjuvant
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
2,719Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
3.75_(50)MF59
Experimental
50% of MF59 with 3.75 µg A/H1N1 antigen
Biological: MF59-eH1N1_f
7.5 w/o MF59
Experimental
0% of MF59 with 7.5 µg A/H1N1 antigen
Biological: MF59-eH1N1_f
7.5_(50)MF59
Experimental
50% of MF59 with 7.5 µg A/H1N1 antigen
Biological: MF59-eH1N1_f
7.5_(100)MF59
Experimental
100% of MF59 with 7.5 µg A/H1N1 antigen
Biological: MF59-eH1N1_f
15 w/o MF59
Experimental
0% of MF59 with 15 µg A/H1N1 antigen
Biological: MF59-eH1N1_f
15_(50)MF59
Experimental
50% of MF59 with 15 µg A/H1N1 antigen
Biological: MF59-eH1N1_f
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MF59-eH1N1_f
Biological
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
15 w/o MF59
15_(100)MF59
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.
21 days after each vaccination
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age
Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.
21 days after each vaccination
Secondary Outcomes
Measure
Description
Time Frame
Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age
Geometric mean hemagglutinin inhibition (HI) titer = GMT
21 days after each vaccination
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Adults 18 years of age and older in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.
Exclusion Criteria:
History of serious disease.
History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
Known or suspected impairment/alteration of immune function.
Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
Sexually active women of childbearing potential must use acceptable birth control during the treatment phase of the study.
For additional entry criteria, please refer to protocol.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Novartis Vaccine and Diagnostics
Novartis
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Miami Research Associates
Miami
Florida
33143
United States
Johnson County Clin-Trials
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Participants were enrolled at 21 sites in the US.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
3.75_(50)MF59 (18-64 Years)
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
FG001
7.5 w/o MF59 (18-64 Years)
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Single
Masking Description
Not provided
Who Masked
Participant
15_(100)MF59
Experimental
100% of MF59 with 15 µg A/H1N1 antigen
Biological: MF59-eH1N1_f
30 w/o MF59
Experimental
0% of MF59 with 30 µg A/H1N1 antigen
Biological: MF59-eH1N1_f
15_(50)MF59
3.75_(50)MF59
30 w/o MF59
7.5 w/o MF59
7.5_(100)MF59
7.5_(50)MF59
Immunogenicity evaluation after each vaccination by vaccine group according to CHMP (Committee for Medicinal Products for Human Use) criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.
21 days after each vaccination
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age
Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.
21 days after each vaccination
Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age
Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Geometric Mean Ratio (GMR) of the hemagglutinin inhibition (HI)titers.
21 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
7 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
7 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
7 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
7 days after vaccination
Lenexa
Kansas
66219
United States
Meridien Clinical Research
Omaha
Nebraska
68134
United States
Regional Clinical Research
Endwell
New York
13760
United States
Rochester Clinical Research, Inc
Rochester
New York
14609
United States
Triangle Medical Research Associates
Cary
North Carolina
27518
United States
Triangle Medical Research Associates
Raleigh
North Carolina
27609
United States
Carolina Medical Trials
Winston-Salem
North Carolina
27103
United States
Prestige Clinical Research
Franklin
Ohio
45005
United States
IPS Research
Oklahoma City
Oklahoma
73103
United States
West Ridge Family Practice (adult)
Erie
Pennsylvania
16506
United States
Primary Physicians Research Inc. (adult)
Jefferson Hills
Pennsylvania
15025
United States
Omega Clinical Research
Warwick
Rhode Island
02886
United States
Research Across America
Dallas
Texas
75234
United States
West Houston Clinical Research Service
Houston
Texas
77055
United States
J.Lewis Research, Inc./Foothill Family Clinic
Salt Lake City
Utah
84109
United States
J. Lewis Research, Inc./Foothill Family Clinic South
Salt Lake City
Utah
84121
United States
PI-Coor Clinical Research
Burke
Virginia
22015
United States
PI Coor Clinical Research
Fairfax
Virginia
22030
United States
Virginia Commonwealth University
Richmond
Virginia
23219
United States
Instituto Nacional de Ciencias
Tlalpan
14000
Mexico
FG002
7.5_(50)MF59 (18-64 Years)
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
FG003
7.5_(100)MF59 (18-64 Years)
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
FG004
15 w/o MF59 (18-64 Years)
1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
FG005
15_(50)MF59 (18-64 Years)
50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
FG006
15_(100)MF59 (18-64 Years)
100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
FG007
30 w/o MF59(18-64 Years)
1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
FG008
3.75_(50)MF59 (≥ 65 Years)
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
FG009
7.5 w/o MF59 (≥ 65 Years)
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
FG010
7.5_(50)MF59 (≥ 65 Years)
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
FG011
7.5_(100)MF59 (≥ 65 Years)
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
FG012
15 w/o MF59 (≥ 65 Years)
1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
FG013
15_(50)MF59 (≥ 65 Years)
50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
FG014
15_(100)MF59 (≥ 65 Years)
100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
FG015
30 w/o MF59(≥ 65 Years)
1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
FG000170 subjects
FG001168 subjects
FG002171 subjects
FG003168 subjects
FG004170 subjects
FG005169 subjects
FG006174 subjects
FG007169 subjects
FG008171 subjects
FG009169 subjects
FG010174 subjects
FG011169 subjects
FG012169 subjects
FG013171 subjects
FG014170 subjects
FG015167 subjects
COMPLETED
FG000166 subjects
FG001165 subjects
FG002166 subjects
FG003163 subjects
FG004165 subjects
FG005165 subjects
FG006172 subjects
FG007166 subjects
FG008167 subjects
FG009163 subjects
FG010174 subjects
FG011167 subjects
FG012168 subjects
FG013171 subjects
FG014168 subjects
FG015165 subjects
NOT COMPLETED
FG0004 subjects
FG0013 subjects
FG0025 subjects
FG0035 subjects
FG0045 subjects
FG0054 subjects
FG0062 subjects
FG0073 subjects
FG0084 subjects
FG0096 subjects
FG0100 subjects
FG0112 subjects
FG0121 subjects
FG0130 subjects
FG0142 subjects
FG0152 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0141 subjects
FG0150 subjects
Withdrawal by Subject
FG0001 subjects
FG0012 subjects
FG0022 subjects
FG0033 subjects
FG004
Lost to Follow-up
FG0003 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG004
Inappropriate enrolment
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Unable to classify
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
ITT population for immunology assessments. Participants from one center excluded for GCP issues.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
3.75_(50)MF59 (18 to 64)
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen in subjects 18 to 64 years of age
BG001
7.5 w/o MF59 (18 to 64)
1 dose of 7.5 µg A/H1N1 in subjects 18 to 64 years of age
BG002
7.5_(50)MF59 (18 to 64)
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects 18 to 64 years of age
BG003
7.5_(100)MF59 (18 to 64)
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects 18 to 64 years of age
BG004
15 w/o MF59 (18 to 64)
1 dose of 15 µg A/H1N1 in subjects 18 to 64 years of age
BG005
15_(50)MF59 (18 to 64)
50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects 18 to 64 years of age
BG006
15_(100)MF59 (18 to 64)
100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen
BG007
30 w/o MF59 (18 to 64)
1 dose of 30 µg A/H1N1 in subjects 18 to 64 years of age
BG008
3.75_(50)MF59 (≥ 65 )
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen in subjects ≥ 65 years of age
BG009
7.5 w/o MF59 (≥ 65)
1 dose of 7.5 µg A/H1N1 in subjects ≥ 65 years of age
BG010
7.5_(50)MF59 (≥ 65)
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects ≥ 65 years of age
BG011
7.5_(100)MF59 (≥ 65)
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects ≥ 65 years of age
BG012
15 w/o MF59 (≥ 65)
1 dose of 15 µg A/H1N1 in subjects ≥ 65 years of age
BG013
15_(50)MF59 (≥ 65)
50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects ≥ 65 years of age
BG014
15_(100)MF59 (≥ 65)
100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects ≥ 65 years of age
BG015
30 w/o MF59 (≥ 65)
1 dose of 30 µg A/H1N1 in subjects ≥ 65 years of age
BG016
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000155
BG001153
BG002157
BG003153
BG004155
BG005154
BG006159
BG007154
BG008170
BG009168
BG010172
BG011168
BG012168
BG013171
BG014169
BG015166
BG0162592
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00040.3± 12.8
BG00139.8± 12.9
BG00239.1± 13.5
BG003
Sex/Gender, Customized
Number
participants
Title
Denominators
Categories
Male(18 to 64 or ≥65 years)
Title
Measurements
BG00061
BG00162
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.
The analysis was based on the per protocol population.
Posted
Number
Participants
21 days after each vaccination
ID
Title
Description
OG000
3.75_(50)MF59
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
OG001
7.5 w/o MF59
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
OG002
7.5_(50)MF59
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
OG003
7.5_(100)MF59
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
OG004
15 w/o MF59
1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
OG005
15_(50)MF59
50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
OG006
15_(100)MF59
100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
OG007
30 w/o MF59
1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
Units
Counts
Participants
OG000146
OG001142
OG002142
OG003
Title
Denominators
Categories
Seroprotection Day 22
Title
Measurements
OG000129
OG001126
OG002135
OG003
Secondary
Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age
Geometric mean hemagglutinin inhibition (HI) titer = GMT
The analysis was on the per protocol set. For this analysis, total subjects enrolled were stratified and randomized in two age groups, according to the CBER criteria, 18 to 64 years and over 64 years of age.
Posted
Geometric Mean
95% Confidence Interval
Geometric Mean Titer
21 days after each vaccination
ID
Title
Description
OG000
3.75_(50)MF59
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
OG001
7.5 w/o MF59
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
OG002
7.5_(50)MF59
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
OG003
7.5_(100)MF59
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
Secondary
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age
Immunogenicity evaluation after each vaccination by vaccine group according to CHMP (Committee for Medicinal Products for Human Use) criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.
The analysis was on the per protocol set.
Posted
Number
Participants
21 days after each vaccination
ID
Title
Description
OG000
3.75_(50)MF59
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
OG001
7.5 w/o MF59
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
OG002
7.5_(50)MF59
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
OG003
7.5_(100)MF59
Primary
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age
Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.
The analysis was on the per protocol set.
Posted
Number
Participants
21 days after each vaccination
ID
Title
Description
OG000
3.75_(50)MF59
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
OG001
7.5 w/o MF59
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
OG002
7.5_(50)MF59
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
OG003
7.5_(100)MF59
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
Secondary
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age
Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.
The analysis was on the per protocol set.
Posted
Number
Participants
21 days after each vaccination
ID
Title
Description
OG000
3.75_(50)MF59
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
OG001
7.5 w/o MF59
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
OG002
7.5_(50)MF59
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
OG003
7.5_(100)MF59
Secondary
Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age
Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Geometric Mean Ratio (GMR) of the hemagglutinin inhibition (HI)titers.
The analysis was on the per protocol set. For this analysis, total subjects enrolled were stratified and randomized in two age groups, according to the CHMP criteria, 18 to 60 years and over 60 years of age.
Posted
Geometric Mean
95% Confidence Interval
Geometric Mean Ratio
21 days after vaccination
ID
Title
Description
OG000
3.75_(50)MF59
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
OG001
7.5 w/o MF59
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
OG002
7.5_(50)MF59
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
OG003
7.5_(100)MF59
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
Secondary
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
The population used in analysis was the safety set
Posted
Number
Participants
7 days after vaccination
ID
Title
Description
OG000
3.75_(50)MF59
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
OG001
7.5 w/o MF59
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
OG002
7.5_(50)MF59
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
OG003
7.5_(100)MF59
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
OG004
Secondary
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
The analysis was on the safety set.
Posted
Number
Participants
7 days after vaccination
ID
Title
Description
OG000
3.75_(50)MF59
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
OG001
7.5 w/o MF59
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
OG002
7.5_(50)MF59
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
OG003
7.5_(100)MF59
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
OG004
Secondary
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
The analysis was on the safety set.
Posted
Number
Participants
7 days after vaccination
ID
Title
Description
OG000
3.75_(50)MF59
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
OG001
7.5 w/o MF59
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
OG002
7.5_(50)MF59
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
OG003
7.5_(100)MF59
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
OG004
Secondary
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
The analysis was on the safety set.
Posted
Number
Participants
7 days after vaccination
ID
Title
Description
OG000
3.75_(50)MF59
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
OG001
7.5 w/o MF59
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
OG002
7.5_(50)MF59
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
OG003
7.5_(100)MF59
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
OG004
Time Frame
All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
Description
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
3.75_(50)MF59
50% of MF59 with the lowest amount of A/H1N1 antigen
5
170
125
170
EG001
7.5 w/o MF59
1 dose of 7.5 µg A/H1N1
5
168
108
168
EG002
7.5_(50)MF59
50% of MF59 with 7.5 µg A/H1N1 antigen
5
171
121
171
EG003
7.5_(100)MF59
100% of MF59 with 7.5 µg A/H1N1 antigen
5
165
128
165
EG004
15 w/o MF59
1 dose of 15 µg A/H1N1
6
170
113
170
EG005
15_(50)MF59
50% of MF59 with 15 µg A/H1N1 antigen
6
169
122
169
EG006
15_(100)MF59
100% of MF59 with 15 µg A/H1N1 antigen
5
174
130
174
EG007
30 w/o MF59
1 dose of 30 µg A/H1N1
7
168
110
168
EG008
3.75_(50)MF59 (Above 65 Yrs)
50% of MF59 with the lowest amount of A/H1N1 antigen
9
170
102
170
EG009
7.5 w/o MF59 (≥65 Yrs)
1 dose of 7.5 µg A/H1N1
16
166
88
166
EG010
7.5_(50)MF59 (≥65 Yrs)
50% of MF59 with 7.5 µg A/H1N1 antigen
18
173
101
173
EG011
7.5_(100)MF59 (≥65 Yrs)
100% of MF59 with 7.5 µg A/H1N1 antigen
11
169
118
169
EG012
15 w/o MF59 (≥ 65 Yrs)
1 dose of 15 µg A/H1N1
12
169
104
169
EG013
15_(50)MF59 (≥65 Yrs)
50% of MF59 with 15 µg A/H1N1 antigen
20
171
109
171
EG014
15_(100)MF59 (≥65 Yrs)
100% of MF59 with 15 µg A/H1N1 antigen
14
169
97
169
EG015
30 w/o MF59 (≥65 Yrs)
1 dose of 30 µg A/H1N1
10
167
99
167
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abortion Spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0011 affected168 at risk
EG0021 affected171 at risk
EG0030 affected165 at risk
EG004
Ankle Fracture
Injury, poisoning and procedural complications
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0021 affected171 at risk
EG003
Cerebral Infarction
Nervous system disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Dehydration
General disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Depression
Psychiatric disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0011 affected168 at risk
EG0020 affected171 at risk
EG003
Diabetes Mellitus
Endocrine disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Influenza
Infections and infestations
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Malaise
General disorders
MedDRA (10.0)
Systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Pyrexia
General disorders
MedDRA (10.0)
Systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Retinal Detachment
Eye disorders
MedDRA (10.0)
Non-systematic Assessment
EG0001 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Road Traffic Accident
Injury, poisoning and procedural complications
MedDRA (10.0)
Non-systematic Assessment
EG0001 affected170 at risk
EG0010 affected168 at risk
EG0022 affected171 at risk
EG003
Suicide Attempt
General disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Syncope
Nervous system disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Cardiac Arrest
Cardiac disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0021 affected171 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDRA (10.0)
Non-systematic Assessment
EG0001 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Colitis Ischaemic
Gastrointestinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Colitis Ulcerative
Gastrointestinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Gallbladder non-functioning
Hepatobiliary disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Lobar Pneumonia
Infections and infestations
MedDRA (10.0)
Non-systematic Assessment
EG0001 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Incisional Hernia
Injury, poisoning and procedural complications
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Splenic Rupture
Injury, poisoning and procedural complications
MedDRA (10.0)
Non-systematic Assessment
EG0001 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Traumatic Lung Injury
Injury, poisoning and procedural complications
MedDRA (10.0)
Non-systematic Assessment
EG0001 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Blood Pressure Increased
Investigations
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Arthritis Reactive
Musculoskeletal and connective tissue disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Intervertebral Disc Degeneration
Musculoskeletal and connective tissue disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0011 affected168 at risk
EG0020 affected171 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Acoustic Neuroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
B-Cell Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Colon Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Gallbladder Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Penis Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Prostate Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0011 affected168 at risk
EG0020 affected171 at risk
EG003
Migraine
Nervous system disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Viith Nerve Paralysis
Nervous system disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Abortion Spontaneus Complete
Pregnancy, puerperium and perinatal conditions
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0021 affected171 at risk
EG003
Eclampsia
Pregnancy, puerperium and perinatal conditions
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0021 affected171 at risk
EG003
Psychotic Disorder
Psychiatric disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Suicidal Ideation
Psychiatric disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Menstruation Irregular
Reproductive system and breast disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Tonsillar Hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG0001 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Intestinal Resection
Surgical and medical procedures
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Intra-abdominal Haemorrhage
Vascular disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0021 affected171 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Angina Pectoris
Cardiac disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Aortic Valve imcompetence
Cardiac disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Cardiac Failure Congestive
Cardiac disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Coronary artery occlusion
Cardiac disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA (10.0)
Systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Gastric Ulcer
Gastrointestinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Intestinal Mass
Gastrointestinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Intestinal Obstructuction
Gastrointestinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Small Intestinal Obstruction
Gastrointestinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG0001 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Upper Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Chest Pain
General disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Hernia
General disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Biliary Colic
Hepatobiliary disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0011 affected168 at risk
EG0020 affected171 at risk
EG003
Cholecystitis Acute
Hepatobiliary disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0011 affected168 at risk
EG0020 affected171 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Gallbladder Disorder
Hepatobiliary disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Cholecystitis Infective
Infections and infestations
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Cytomegalovirus Infection
Infections and infestations
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Labyrinthitis
Infections and infestations
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Sepsis
Infections and infestations
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Staphylococcal Infection
Infections and infestations
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Arthropod Bite
Injury, poisoning and procedural complications
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Head Injury
Injury, poisoning and procedural complications
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Rib Fracture
Injury, poisoning and procedural complications
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Scapula Fracture
Injury, poisoning and procedural complications
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Traumatic Brain Injury
Injury, poisoning and procedural complications
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Urinary Retention Postoperative
Injury, poisoning and procedural complications
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Transaminases Increased
Investigations
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Glucose Tolerance Impaired
Metabolism and nutrition disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Intervertebral Disc Protrusion
Musculoskeletal and connective tissue disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Lumbar Spinal Stenosis
Musculoskeletal and connective tissue disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Spinal Column Stenosis
Musculoskeletal and connective tissue disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Synovial Cyst
Musculoskeletal and connective tissue disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Breast Cancer Stage I
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Cholesteatoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Lung Carcinoma Cell Type Unspecified Stage I
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Malignant Melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Parathyroid Tumour Benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Thyroid Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Uterine Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Carotid Artery Occlusion
Nervous system disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Cerebral Haemorrhage
Nervous system disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Convulsion
Nervous system disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Dementia
Nervous system disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Grand Mal Convulsion
Nervous system disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Subarachnoid Haemorrhage
Nervous system disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Renal Failure
Renal and urinary disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Renal Failure Acute
Renal and urinary disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Urinary Retention
Renal and urinary disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Benign Prostatic Hyperplasia
Reproductive system and breast disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Prostatic Obstruction
Reproductive system and breast disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Pulmonary Oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Ankle Operation
Surgical and medical procedures
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Knee Arthroplasty
Surgical and medical procedures
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Aneurysm
Vascular disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Aortic Stenosis
Vascular disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Arterial Occlusive Disease
Vascular disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Haematoma
Vascular disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Hypertensive Emergency
Vascular disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
H1N1 Influenza
Infections and infestations
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected170 at risk
EG0010 affected168 at risk
EG0020 affected171 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Headache
Nervous system disorders
MedDRA (10.0)
Systematic Assessment
EG00056 affected170 at risk
EG00149 affected168 at risk
EG00251 affected171 at risk
EG00342 affected165 at risk
EG00460 affected170 at risk
EG00555 affected169 at risk
EG00650 affected174 at risk
EG00743 affected168 at risk
EG00833 affected170 at risk
EG00929 affected166 at risk
EG01033 affected173 at risk
EG01130 affected169 at risk
EG01228 affected169 at risk
EG01329 affected171 at risk
EG01425 affected169 at risk
EG01524 affected167 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (10.0)
Systematic Assessment
EG00011 affected170 at risk
EG00110 affected168 at risk
EG0028 affected171 at risk
EG003
Injection site pain
General disorders
MedDRA (10.0)
Systematic Assessment
EG00097 affected170 at risk
EG00168 affected168 at risk
EG00290 affected171 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (10.0)
Systematic Assessment
EG00040 affected170 at risk
EG00134 affected168 at risk
EG00232 affected171 at risk
EG003
Fatigue
General disorders
MedDRA (10.0)
Systematic Assessment
EG00033 affected170 at risk
EG00133 affected168 at risk
EG00235 affected171 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (10.0)
Systematic Assessment
EG00020 affected170 at risk
EG00118 affected168 at risk
EG00225 affected171 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (10.0)
Systematic Assessment
EG00017 affected170 at risk
EG00118 affected168 at risk
EG00224 affected171 at risk
EG003
Injection site erythema
General disorders
MedDRA (10.0)
Systematic Assessment
EG00023 affected170 at risk
EG00115 affected168 at risk
EG00221 affected171 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (10.0)
Systematic Assessment
EG00020 affected170 at risk
EG00117 affected168 at risk
EG00222 affected171 at risk
EG003
Injection site induration
General disorders
MedDRA (10.0)
Systematic Assessment
EG00015 affected170 at risk
EG0019 affected168 at risk
EG00215 affected171 at risk
EG003
Injection site swelling
General disorders
MedDRA (10.0)
Systematic Assessment
EG00016 affected170 at risk
EG0019 affected168 at risk
EG00210 affected171 at risk
EG003
Chills
General disorders
MedDRA (10.0)
Systematic Assessment
EG00015 affected170 at risk
EG00113 affected168 at risk
EG00215 affected171 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG00012 affected170 at risk
EG0018 affected168 at risk
EG0027 affected171 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (10.0)
Non-systematic Assessment
EG0009 affected170 at risk
EG0018 affected168 at risk
EG0028 affected171 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (10.0)
Non-systematic Assessment
EG0008 affected170 at risk
EG0016 affected168 at risk
EG00219 affected171 at risk
EG003
Upper Respiratory Tract infection
Infections and infestations
MedDRA (10.0)
Non-systematic Assessment
EG0004 affected170 at risk
EG00114 affected168 at risk
EG0029 affected171 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA (10.0)
Non-systematic Assessment
EG0004 affected170 at risk
EG0011 affected168 at risk
EG0022 affected171 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (10.0)
Non-systematic Assessment
EG0003 affected170 at risk
EG00110 affected168 at risk
EG0024 affected171 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Posting Director
Novartis Vaccines and Diagnostics
RegContactVacUS.nvdit@Novartis.com
ID
Term
D007251
Influenza, Human
D009976
Orthomyxoviridae Infections
Ancestor Terms
ID
Term
D012141
Respiratory Tract Infections
D007239
Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D012140
Respiratory Tract Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
FG0050 subjects
FG0062 subjects
FG0072 subjects
FG0080 subjects
FG0092 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
1 subjects
FG0053 subjects
FG0060 subjects
FG0071 subjects
FG0082 subjects
FG0091 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0151 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0092 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
FG0141 subjects
FG0151 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
1 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
40.6
± 12.2
BG00441.8± 12.9
BG00539.7± 13.1
BG00638.8± 11.9
BG00740.8± 13.0
BG00870.8± 5.1
BG00971.8± 5.6
BG01071.4± 5.6
BG01170.7± 5.1
BG01271.0± 5.0
BG01370.4± 4.9
BG01471.3± 5.2
BG01570.8± 5.3
BG01639.6± 12.8
57
BG00359
BG00457
BG00569
BG00671
BG00763
BG00854
BG00988
BG01071
BG01170
BG01268
BG01374
BG01479
BG01576
BG0161079
Female(18 to 64 or ≥65 yrs)
Title
Measurements
BG00094
BG00191
BG002100
BG00394
BG00498
BG00585
BG00688
BG00791
BG008116
BG00980
BG010101
BG01198
BG012100
BG01397
BG01490
BG01590
BG0161513
141
OG004141
OG005138
OG006149
OG007144
134
OG004133
OG005135
OG006147
OG007141
Seroconversion Day 22
Title
Measurements
OG000113
OG001100
OG002123
OG003126
OG004127
OG005124
OG006135
OG007130
Seroprotection Day 43
Title
Measurements
OG000138
OG001133
OG002136
OG003137
OG004135
OG005137
OG006145
OG007142
Seroconversion Day 43
Title
Measurements
OG000118
OG001104
OG002123
OG003129
OG004126
OG005125
OG006139
OG007132
Seroprotection Day 202 (N=79,65,78,80,73,74,74,76)
Title
Measurements
OG00068
OG00151
OG00267
OG00370
OG00456
OG00559
OG00665
OG00769
Seroconversion Day 202 (N=79,65,78,80,73,74,74,76)
Title
Measurements
OG00050
OG00132
OG00248
OG00353
OG00449
OG00549
OG00651
OG00755
Seroprotection Day 387(N=105,95,88,84,91,91,106,84