A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CS... | NCT00958126 | Trialant
NCT00958126
Sponsor
Seqirus
Status
Completed
Last Update Posted
Nov 21, 2017Actual
Enrollment
1,313Actual
Phase
Phase 2
Conditions
Influenza
Interventions
CSL425
CSL425
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00958126
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CSLCT-CAL-09-61
Secondary IDs
Not provided
Brief Title
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults in the USA
Official Title
A Phase II, Multicenter, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults Aged 18 Years and Older
Acronym
Not provided
Organization
SeqirusINDUSTRY
Status Module
Record Verification Date
Oct 2017
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
Aug 2009
Primary Completion Date
Nov 2009Actual
Completion Date
Apr 2010Actual
First Submitted Date
Aug 12, 2009
First Submission Date that Met QC Criteria
Aug 12, 2009
First Posted Date
Aug 13, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 5, 2012
Results First Submitted that Met QC Criteria
Aug 31, 2012
Results First Posted Date
Oct 3, 2012Estimated
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 18, 2017
Last Update Posted Date
Nov 21, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
SeqirusINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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
The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults
Detailed Description
Not provided
Conditions Module
Conditions
Influenza
Keywords
Not provided
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,313Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
CSL425 (7.5 mcg)
Experimental
7.5 mcg of hemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
Biological: CSL425
CSL425 (15 mcg)
Experimental
15 mcg of hemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
Biological: CSL425
CSL425 (30 mcg)
Experimental
30 mcg of hemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
Biological: CSL425
Placebo
Placebo Comparator
Vaccine diluent. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
Seroconversion Rate 21 Days After the First Vaccination
Seroconversion rate: the proportion of participants achieving seroconversion in hemagglutination inhibition (HI) antibody titer. Seroconversion is defined as participants with a baseline titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a baseline HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
21 days after the first vaccination
Seroconversion Rate 21 Days After the Second Vaccination
Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
21 days after the second vaccination
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination
21 days after the first vaccination
Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination
21 days after the second vaccination
Secondary Outcomes
Measure
Description
Time Frame
Frequency and Intensity of Solicited Adverse Events After the First Vaccination
Grade 3 solicited adverse event (AE) definitions: Prevented normal daily activities; Size > 100 mm for injection site redness or induration/swelling; Temperature 102.2°F (39.0°C) or more for fevers.
During the 7 days after the first vaccination
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female aged 18 and older, inclusive, at the time of providing informed consent.
Females of child bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child bearing potential must return a negative urine pregnancy test result at enrolment and prior to each study vaccination.
Exclusion Criteria:
Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thimerosal, neomycin, polymyxin, or any components of the Study Vaccine.
Talaat KR, Greenberg ME, Lai MH, Hartel GF, Wichems CH, Rockman S, Jeanfreau RJ, Ghosh MR, Kabongo ML, Gittleson C, Karron RA. A single dose of unadjuvanted novel 2009 H1N1 vaccine is immunogenic and well tolerated in young and elderly adults. J Infect Dis. 2010 Nov 1;202(9):1327-37. doi: 10.1086/656601.
See Also Links
Not provided
Available IPD Information
Not provided
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
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo, Adults
Vaccine diluent; Adults aged 18 to 64 years
FG001
CSL425 (7.5 mcg), Adults
7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
Duration of Solicited Local Adverse Events After the First Vaccination
During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI)
A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).
Up to 180 days after the last vaccination
Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination
Unsolicited adverse event (UAE) grading:
Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.
Grade 2 (moderate): Enough discomfort to cause some interference with daily activities.
Grade 3 (severe): Symptoms that prevented normal, everyday activities.
Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI
San Diego
California
92108
United States
Study Site
Melbourne
Florida
32935
United States
Study Site
Peoria
Illinois
61602
United States
Study Site
South Bend
Indiana
46601
United States
Study Site
Metairie
Louisiana
70006
United States
Study Site
Baltimore
Maryland
21205
United States
Study Site
Rockville
Maryland
20850
United States
Study Site
Austin
Texas
78705
United States
Study Site
Fort Worth
Texas
76135
United States
Study Site
Salt Lake City
Utah
84124
United States
FG002
CSL425 (15 Mcg), Adults
15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
FG003
CSL425 (30 Mcg), Adults
30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
FG004
Placebo, Older Adults
Vaccine diluent; Older adults aged 65 years or older
FG005
CSL425 (7.5 Mcg), Older Adults
7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
FG006
CSL425 (15 Mcg), Older Adults
15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
FG007
CSL425 (30 Mcg), Older Adults
30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
FG00049 subjects
FG001205 subjects
FG002201 subjects
FG003203 subjects
FG00450 subjects
FG005203 subjects
FG006200 subjects
FG007202 subjects
COMPLETED
FG00048 subjects
FG001196 subjects
FG002191 subjects
FG003192 subjects
FG00450 subjects
FG005202 subjects
FG006199 subjects
FG007202 subjects
NOT COMPLETED
FG0001 subjects
FG0019 subjects
FG00210 subjects
FG00311 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
Type
Comment
Reasons
Serious Adverse Event
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
Withdrawal by Subject
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Moved away from study area
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0015 subjects
FG0029 subjects
FG0038 subjects
FG004
Sponsor/Investigator decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Other Reason
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo, Adults
Vaccine diluent; Adults aged 18 to 64 years
BG001
CSL425 (7.5 mcg), Adults
7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
BG002
CSL425 (15 Mcg), Adults
15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
BG003
CSL425 (30 Mcg), Adults
30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
BG004
Placebo, Older Adults
Vaccine diluent; Older adults aged 65 years or older
BG005
CSL425 (7.5 Mcg), Older Adults
7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
BG006
CSL425 (15 Mcg), Older Adults
15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
BG007
CSL425 (30 Mcg), Older Adults
30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00049
BG001205
BG002201
BG003203
BG00450
BG005203
BG006200
BG007202
BG0081313
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
participants
Title
Denominators
Categories
>= 18 years to 64 years
Title
Measurements
BG00049
BG001205
BG002201
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00031
BG001123
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
Seroconversion Rate 21 Days After the First Vaccination
Seroconversion rate: the proportion of participants achieving seroconversion in hemagglutination inhibition (HI) antibody titer. Seroconversion is defined as participants with a baseline titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a baseline HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
Posted
Number
95% Confidence Interval
percentage of participants
21 days after the first vaccination
ID
Title
Description
OG000
Placebo, Adults
Vaccine diluent; Adults aged 18 to 64 years
OG001
CSL425 (7.5 mcg), Adults
7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
OG002
CSL425 (15 Mcg), Adults
15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
OG003
CSL425 (30 Mcg), Adults
30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
OG004
Placebo, Older Adults
Vaccine diluent; Older adults aged 65 years or older
OG005
CSL425 (7.5 Mcg), Older Adults
7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
OG006
CSL425 (15 Mcg), Older Adults
15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
OG007
CSL425 (30 Mcg), Older Adults
30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
Units
Counts
Participants
OG00048
OG001200
OG002195
OG003
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 7.4)
OG00182(76.0 to 87.1)
OG00288.2(82.8 to 92.4)
OG003
Secondary
Frequency and Intensity of Solicited Adverse Events After the First Vaccination
Grade 3 solicited adverse event (AE) definitions: Prevented normal daily activities; Size > 100 mm for injection site redness or induration/swelling; Temperature 102.2°F (39.0°C) or more for fevers.
The Safety Population (first vaccination) comprised all randomized participants who received the first vaccination and provided follow-up safety data.
Posted
Number
percentage of participants
During the 7 days after the first vaccination
ID
Title
Description
OG000
Placebo, Adults
Vaccine diluent; Adults aged 18 to 64 years
OG001
CSL425 (7.5 mcg), Adults
7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
OG002
CSL425 (15 Mcg), Adults
15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
OG003
CSL425 (30 Mcg), Adults
30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
Secondary
Duration of Solicited Local Adverse Events After the First Vaccination
The Safety Population (first vaccination) comprised all randomized participants who received the first vaccination and provided follow-up safety data.
Posted
Mean
Standard Deviation
days
During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs
ID
Title
Description
OG000
Placebo, Adults
Vaccine diluent; Adults aged 18 to 64 years
OG001
CSL425 (7.5 mcg), Adults
7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
OG002
CSL425 (15 Mcg), Adults
15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
OG003
CSL425 (30 Mcg), Adults
30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
OG004
Placebo, Older Adults
Primary
Seroconversion Rate 21 Days After the Second Vaccination
Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
Posted
Number
95% Confidence Interval
percentage of participants
21 days after the second vaccination
ID
Title
Description
OG000
Placebo, Adults
Vaccine diluent; Adults aged 18 to 64 years
OG001
CSL425 (7.5 mcg), Adults
7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
OG002
CSL425 (15 Mcg), Adults
15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
Primary
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination
The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
Posted
Number
95% Confidence Interval
percentage of participants
21 days after the first vaccination
ID
Title
Description
OG000
Placebo, Adults
Vaccine diluent; Adults aged 18 to 64 years
OG001
CSL425 (7.5 mcg), Adults
7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
OG002
CSL425 (15 Mcg), Adults
15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
OG003
CSL425 (30 Mcg), Adults
30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
Primary
Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination
The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
Posted
Number
95% Confidence Interval
percentage of participants
21 days after the second vaccination
ID
Title
Description
OG000
Placebo, Adults
Vaccine diluent; Adults aged 18 to 64 years
OG001
CSL425 (7.5 mcg), Adults
7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
OG002
CSL425 (15 Mcg), Adults
15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
OG003
CSL425 (30 Mcg), Adults
30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
Secondary
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI)
A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).
The Safety Population comprised all randomized participants who received at least one dose of study vaccine and provided follow-up safety data.
Posted
Number
percentage of participants
Up to 180 days after the last vaccination
ID
Title
Description
OG000
Placebo, Adults
Vaccine diluent; Adults aged 18 to 64 years
OG001
CSL425 (7.5 mcg), Adults
7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
OG002
CSL425 (15 Mcg), Adults
15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
OG003
CSL425 (30 Mcg), Adults
30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
Secondary
Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination
Unsolicited adverse event (UAE) grading:
Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.
Grade 2 (moderate): Enough discomfort to cause some interference with daily activities.
Grade 3 (severe): Symptoms that prevented normal, everyday activities.
The Safety Population comprised all randomized participants who received at least one dose of study vaccine and provided follow-up safety data.
Posted
Number
percentage of participants
Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI
ID
Title
Description
OG000
Placebo, Age Cohorts Combined
Vaccine diluent
OG001
CSL425 (7.5 mcg), Age Cohorts Combined
7.5 mcg of hemagglutinin antigen per dose
OG002
CSL425 (15 Mcg), Age Cohorts Combined
15 mcg of hemagglutinin antigen per dose
OG003
CSL425 (30 Mcg), Age Cohorts Combined
Time Frame
For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI).
Description
Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination.
The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last 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
Placebo, Adults
Vaccine diluent; Adults aged 18 to 64 years
0
49
12
49
EG001
CSL425 (7.5 mcg), Adults
7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
6
204
27
204
EG002
CSL425 (15 Mcg), Adults
15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
4
201
25
201
EG003
CSL425 (30 Mcg), Adults
30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
3
203
27
203
EG004
Placebo, Older Adults
Vaccine diluent; Older adults aged 65 years or older
3
50
5
50
EG005
CSL425 (7.5 Mcg), Older Adults
7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
9
203
20
203
EG006
CSL425 (15 Mcg), Older Adults
15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
6
200
23
200
EG007
CSL425 (30 Mcg), Older Adults
30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
9
202
18
202
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pneumonia
Infections and infestations
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected204 at risk
EG0021 events1 affected201 at risk
EG0030 events0 affected203 at risk
EG0041 events1 affected50 at risk
EG0051 events1 affected203 at risk
EG0060 events0 affected200 at risk
EG0070 events0 affected202 at risk
Appendicitis
Infections and infestations
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Viral infection
Infections and infestations
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0021 events1 affected201 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0021 events1 affected201 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0021 events1 affected201 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Umbilical hernia, obstructive
Gastrointestinal disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Atrial septal defect
Congenital, familial and genetic disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Fibrous dysplasia of bone
Congenital, familial and genetic disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0021 events1 affected201 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Viral myocarditis
Infections and infestations
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Lip and/or oral cavity cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Lung metastatic cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Tonsil cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Ventricular fibrillation
Cardiac disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Athralgia
Musculoskeletal and connective tissue disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Torticollis
Musculoskeletal and connective tissue disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Urinary bladder haemorrhage
Renal and urinary disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Prostatic obstruction
Reproductive system and breast disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Acetabulum fracture
Injury, poisoning and procedural complications
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Arterial injury
Injury, poisoning and procedural complications
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDRA (13.0)
Systematic Assessment
EG0002 events2 affected49 at risk
EG0014 events4 affected204 at risk
EG0025 events4 affected201 at risk
EG0033 events3 affected203 at risk
EG0040 events0 affected50 at risk
EG0051 events1 affected203 at risk
EG0061 events1 affected200 at risk
EG0072 events2 affected202 at risk
Oral herpes
Infections and infestations
MedDRA (13.0)
Systematic Assessment
EG0001 events1 affected49 at risk
EG0012 events2 affected204 at risk
EG0021 events1 affected201 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (13.0)
Systematic Assessment
EG0001 events1 affected49 at risk
EG0011 events1 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (13.0)
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (13.0)
Systematic Assessment
EG0001 events1 affected49 at risk
EG0011 events1 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (13.0)
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (13.0)
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Depression
Psychiatric disorders
MedDRA (13.0)
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Headache
Nervous system disorders
MedDRA (13.0)
Systematic Assessment
EG0004 events2 affected49 at risk
EG0018 events8 affected204 at risk
EG0027 events5 affected201 at risk
EG003
Hypertension
Vascular disorders
MedDRA (13.0)
Systematic Assessment
EG0002 events2 affected49 at risk
EG0010 events0 affected204 at risk
EG0021 events1 affected201 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (13.0)
Systematic Assessment
EG0001 events1 affected49 at risk
EG0016 events6 affected204 at risk
EG0028 events8 affected201 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (13.0)
Systematic Assessment
EG0001 events1 affected49 at risk
EG0015 events5 affected204 at risk
EG0027 events7 affected201 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0012 events2 affected204 at risk
EG0022 events2 affected201 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (13.0)
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected204 at risk
EG0021 events1 affected201 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (13.0)
Systematic Assessment
EG0001 events1 affected49 at risk
EG0014 events4 affected204 at risk
EG0022 events1 affected201 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (13.0)
Systematic Assessment
EG0001 events1 affected49 at risk
EG0011 events1 affected204 at risk
EG0022 events1 affected201 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (13.0)
Systematic Assessment
EG0001 events1 affected49 at risk
EG0011 events1 affected204 at risk
EG0022 events1 affected201 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (13.0)
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected204 at risk
EG0022 events2 affected201 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (13.0)
Systematic Assessment
EG0001 events1 affected49 at risk
EG0011 events1 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (13.0)
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Pyrexia
General disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0012 events2 affected204 at risk
EG0025 events5 affected201 at risk
EG003
Malaise
General disorders
MedDRA (13.0)
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0012 events2 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0021 events1 affected201 at risk
EG003
Pelvic prolapse
Reproductive system and breast disorders
MedDRA (13.0)
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected204 at risk
EG0020 events0 affected201 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
Clinical Trials Disclosure Manager
Seqirus
Seqirus.ClinicalTrials@Seqirus.com
ID
Term
D007251
Influenza, Human
Ancestor Terms
ID
Term
D012141
Respiratory Tract Infections
D007239
Infections
D009976
Orthomyxoviridae Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D012140
Respiratory Tract Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
203
BG0040
BG0050
BG0060
BG0070
BG008658
>=65 years
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG00450
BG005203
BG006200
BG007202
BG008655
113
BG003113
BG00429
BG005120
BG006108
BG007112
BG008749
Male
BG00018
BG00182
BG00288
BG00390
BG00421
BG00583
BG00692
BG00790
BG008564
199
OG00448
OG005201
OG006197
OG007200
94.5
(90.3 to 97.2)
OG0042.1(0.1 to 11.1)
OG00551.2(44.1 to 58.3)
OG00658.9(51.7 to 65.8)
OG00773.0(66.3 to 79.0)
OG004
Placebo, Older Adults
Vaccine diluent; Older adults aged 65 years or older
OG005
CSL425 (7.5 Mcg), Older Adults
7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
OG006
CSL425 (15 Mcg), Older Adults
15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
OG007
CSL425 (30 Mcg), Older Adults
30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
Units
Counts
Participants
OG00049
OG001204
OG002201
OG003203
OG00450
OG005203
OG006200
OG007202
Title
Denominators
Categories
Any local solicited adverse event
Title
Measurements
OG00022.4(11.8 to 36.6)
OG00128.9(22.8 to 35.7)
OG00235.8(29.2 to 42.9)
OG00352.7(45.6 to 59.7)
OG0044.0
OG00513.3
OG00623.5
OG00721.8
Any pain at injection site
Title
Measurements
OG00014.3(5.9 to 27.2)
OG00114.7(10.1 to 20.3)
OG00217.4(12.4 to 23.4)
OG003
Grade 3 pain at injection site
Title
Measurements
OG0000
OG0010
OG0020
OG003
Any redness at injection site
Title
Measurements
OG0000
OG0011.0
OG0020.5
OG003
Grade 3 redness at injection site
Title
Measurements
OG0000
OG0010
OG0020
OG003
Any swelling/induration at injection site
Title
Measurements
OG0000
OG0013.9
OG0022.5
OG003
Grade 3 swelling/induration at injection site
Title
Measurements
OG0000
OG0010
OG0020
OG003
Any tenderness at injection site
Title
Measurements
OG00018.4
OG00123.5
OG00232.8
OG003
Grade 3 tenderness at injection site
Title
Measurements
OG0000
OG0010
OG0020
OG003
Any bruising at injection site
Title
Measurements
OG0000
OG0014.4
OG0024.0
OG003
Grade 3 bruising at injection site
Title
Measurements
OG0000
OG0010
OG0020
OG003
Any solicited systemic adverse event
Title
Measurements
OG00028.6
OG00135.3
OG00234.8
OG003
Any headache
Title
Measurements
OG00016.3
OG00119.6
OG00221.4
OG003
Grade 3 headache
Title
Measurements
OG0000
OG0011.0
OG0021.0
OG003
Any malaise
Title
Measurements
OG0008.2
OG00110.8
OG00216.4
OG003
Grade 3 malaise
Title
Measurements
OG0000
OG0011.0
OG0021.0
OG003
Any myalgia
Title
Measurements
OG0004.1
OG00114.7
OG00215.9
OG003
Grade 3 myalgia
Title
Measurements
OG0000
OG0010.5
OG0020.5
OG003
Any nausea
Title
Measurements
OG0004.1
OG0016.4
OG0028.0
OG003
Grade 3 nausea
Title
Measurements
OG0000
OG0010.5
OG0020
OG003
Any chills
Title
Measurements
OG0002.0
OG0013.9
OG0025.0
OG003
Grade 3 chills
Title
Measurements
OG0000
OG0010.5
OG0020.5
OG003
Any vomiting
Title
Measurements
OG0000
OG0012.9
OG0021.0
OG003
Grade 3 vomiting
Title
Measurements
OG0000
OG0010.5
OG0020
OG003
Any fever
Title
Measurements
OG0002.0
OG0013.4
OG0023.0
OG003
Grade 3 fever
Title
Measurements
OG0000
OG0010.5
OG0021.0
OG003
Vaccine diluent; Older adults aged 65 years or older
OG005
CSL425 (7.5 Mcg), Older Adults
7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
OG006
CSL425 (15 Mcg), Older Adults
15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
OG007
CSL425 (30 Mcg), Older Adults
30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
Units
Counts
Participants
OG00049
OG001204
OG002201
OG003203
OG00450
OG005203
OG006200
OG007202
Title
Denominators
Categories
Pain at injection site
Title
Measurements
OG0001.14± 0.378
OG0011.87± 2.705
OG0021.71± 0.926
OG0031.91± 1.237
OG0041.00± NAn = 1
OG0051.75± 0.957
OG0061.75± 0.886
OG0071.27± 0.594
Redness at injection site
Title
Measurements
OG000NA± NAn = 0
OG0011.00± 0.000
OG0021.00± NAn = 1
OG003
Swelling/induration at injection site
Title
Measurements
OG000NA± NAn = 0
OG0011.56± 0.726
OG0021.2± 0.447
OG003
Tenderness at injection site
Title
Measurements
OG0002.1± 1.912
OG0012.04± 2.813
OG0021.85± 0.966
OG003
Bruising at injection site
Title
Measurements
OG000NA± NAn = 0
OG0013.00± 2.539
OG0022.25± 1.669
OG003
OG003
CSL425 (30 Mcg), Adults
30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
OG004
Placebo, Older Adults
Vaccine diluent; Older adults aged 65 years or older
OG005
CSL425 (7.5 Mcg), Older Adults
7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
OG006
CSL425 (15 Mcg), Older Adults
15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
OG007
CSL425 (30 Mcg), Older Adults
30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
Units
Counts
Participants
OG00048
OG001196
OG002191
OG003193
OG00448
OG005200
OG006196
OG007198
Title
Denominators
Categories
Title
Measurements
OG0006.3(1.3 to 17.2)
OG00183.2(77.2 to 88.1)
OG00291.1(86.1 to 94.7)
OG00395.9(92.0 to 98.2)
OG0048.3(2.3 to 20.0)
OG00559.5(52.3 to 66.4)
OG00667.3(60.3 to 73.9)
OG00775.3(68.6 to 81.1)
OG004
Placebo, Older Adults
Vaccine diluent; Older adults aged 65 years or older
OG005
CSL425 (7.5 Mcg), Older Adults
7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
OG006
CSL425 (15 Mcg), Older Adults
15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
OG007
CSL425 (30 Mcg), Older Adults
30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
Units
Counts
Participants
OG00048
OG001200
OG002195
OG003199
OG00448
OG005201
OG006197
OG007200
Title
Denominators
Categories
Title
Measurements
OG00022.9(12.0 to 37.3)
OG00197.0(93.6 to 98.9)
OG00296.4(92.7 to 98.5)
OG00399.5(97.2 to 100.0)
OG00439.6(25.8 to 54.7)
OG00592.0(87.4 to 95.4)
OG00690.9(85.9 to 94.5)
OG00794.0(89.8 to 96.9)
OG004
Placebo, Older Adults
Vaccine diluent; Older adults aged 65 years or older
OG005
CSL425 (7.5 Mcg), Older Adults
7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
OG006
CSL425 (15 Mcg), Older Adults
15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
OG007
CSL425 (30 Mcg), Older Adults
30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
Units
Counts
Participants
OG00048
OG001196
OG002191
OG003193
OG00448
OG005200
OG006196
OG007198
Title
Denominators
Categories
Title
Measurements
OG00029.2(17.0 to 44.1)
OG00198.5(95.6 to 99.7)
OG00299.5(97.1 to 100.0)
OG00399.5(97.1 to 100.0)
OG00435.4(22.2 to 50.5)
OG00596.0(92.3 to 98.3)
OG00693.4(88.9 to 96.4)
OG00794.9(90.9 to 97.6)
OG004
Placebo, Older Adults
Vaccine diluent; Older adults aged 65 years or older
OG005
CSL425 (7.5 Mcg), Older Adults
7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
OG006
CSL425 (15 Mcg), Older Adults
15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
OG007
CSL425 (30 Mcg), Older Adults
30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older