A Study to Determine the Immunogenicity and Safety Profil... | NCT00959049 | Trialant
NCT00959049
Sponsor
Seqirus
Status
Completed
Last Update Posted
May 16, 2017Actual
Enrollment
1,474Actual
Phase
Phase 3
Conditions
Influenza
Interventions
CSL's Influenza Virus Vaccine (Afluria)
Influenza Virus Vaccine (Fluzone)
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00959049
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CSLCT-USF-07-36
Secondary IDs
Not provided
Brief Title
A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine in a Pediatric Population
Official Title
A Phase III, Randomized, Observer-blind, Multi-center, Noninferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Trivalent Inactivated Split-Virion Influenza Vaccine in a Pediatric Population Aged Greater Than or Equal to 6 Months to Less Than 18 Years.
Acronym
Not provided
Organization
SeqirusINDUSTRY
Status Module
Record Verification Date
Apr 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
Sep 2009
Primary Completion Date
Dec 2009Actual
Completion Date
May 2010Actual
First Submitted Date
Aug 12, 2009
First Submission Date that Met QC Criteria
Aug 13, 2009
First Posted Date
Aug 14, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 3, 2011
Results First Submitted that Met QC Criteria
Jul 3, 2011
Results First Posted Date
Jul 29, 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
Apr 16, 2017
Last Update Posted Date
May 16, 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 the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18 years.
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Afluria Cohort A
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Geometric Mean Titer 30 Days After the Last Study Vaccination
30 days after the last study vaccination
Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination
Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.
30 days after the last study vaccination
Secondary Outcomes
Measure
Description
Time Frame
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
7 days after each vaccination
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
7 days after each vaccination
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy male or non-pregnant female participants aged ≥ 6 calendar months to < 18 years at the time of the first study vaccination.
For participants aged ≥ 6 months to < 9 years, born after a normal gestation period (between 36 and 42 weeks).
Females of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for at least 2 months after vaccination. Females aged ≥ 9 years must also return a negative urine pregnancy test at enrollment.
Exclusion Criteria:
Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine.
Brady RC, Hu W, Houchin VG, Eder FS, Jackson KC, Hartel GF, Sawlwin DC, Albano FR, Greenberg M. Randomized trial to compare the safety and immunogenicity of CSL Limited's 2009 trivalent inactivated influenza vaccine to an established vaccine in United States children. Vaccine. 2014 Dec 12;32(52):7141-7. doi: 10.1016/j.vaccine.2014.10.024. Epub 2014 Oct 29.
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
A total of 1474 participants were enrolled, vaccinated and analyzed.
Recruitment Details
Participants were enrolled into this study during the autumn of 2009 at 23 sites in the US.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Afluria Cohort A
Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
FG001
Afluria Cohort B
Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Fluzone Cohort A
Fluzone Cohort B
Fluzone Cohort C
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
7 days after vaccination
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
UAE stands for Unsolicited Adverse Events
30 days after each vaccination
New Onset of Chronic Illnesses (NOCIs)
New onset of chronic illness after any vaccine dose. A new onset of chronic illness was defined as the diagnosis of a new medical condition which was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).
6 months after last study vaccination
Serious Adverse Events (SAEs)
6 months after last study vaccination
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
7 days after each vaccination
Duration of Local and Systemic Solicited Symptoms, Cohort B
7 days after each vaccination
Duration of Local and Systemic Solicited Symptoms, Cohort C
7 days after vaccination
Harrisburg
Arkansas
72432
United States
Jonesboro
Arkansas
72401
United States
Little Rock
Arkansas
72205
United States
Mountain Home
Arkansas
72653
United States
Melbourne
Florida
32935
United States
Bardstown
Kentucky
40004
United States
Omaha
Nebraska
68134
United States
Binghamton
New York
13901
United States
Elmira
New York
14901
United States
Cincinnati Children's Hospital Medical Center- Division of Infectious Disease
Cincinnati
Ohio
45229
United States
Warr Acres
Oklahoma
73132
United States
UPMC / Community Medicine Inc
Greenville
Pennsylvania
16125
United States
Pediatric Associates of Latrobe
Latrobe
Pennsylvania
15650
United States
Pediatric Alliance Greentree Division
Pittsburgh
Pennsylvania
15220
United States
South Hills Pediatrics
Pittsburgh
Pennsylvania
15227
United States
Pittsburgh
Pennsylvania
15241
United States
Salt Lake City
Utah
84109
United States
Salt Lake City
Utah
84121
United States
Salt Lake City
Utah
84124
United States
South Jordan
Utah
84095
United States
Burke
Virginia
22015
United States
Vienna
Virginia
22180
United States
FG002
Afluria Cohort C
Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
FG003
Fluzone Cohort A
Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
FG004
Fluzone Cohort B
Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
FG005
Fluzone Cohort C
Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
FG000231 subjects
FG001254 subjects
FG002254 subjects
FG003228 subjects
FG004257 subjects
FG005250 subjects
COMPLETED
FG000213 subjects
FG001247 subjects
FG002253 subjects
FG003217 subjects
FG004248 subjects
FG005249 subjects
NOT COMPLETED
FG00018 subjects
FG0017 subjects
FG0021 subjects
FG00311 subjects
FG0049 subjects
FG0051 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Lost to Follow-up
FG00017 subjects
FG0015 subjects
FG0021 subjects
FG00310 subjects
FG004
Contraindicated medication
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Afluria Cohort A
Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
BG001
Afluria Cohort B
Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
BG002
Afluria Cohort C
Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
BG003
Fluzone Cohort A
Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
BG004
Fluzone Cohort B
Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
BG005
Fluzone Cohort C
Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000231
BG001254
BG002254
BG003228
BG004257
BG005250
BG0061474
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG000231
BG001254
BG002254
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG0001.94± 0.667
BG0015.93± 1.725
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000119
BG001140
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG000231
BG001254
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
Secondary
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Safety population; Afluria Cohort A receiving 2 doses N=96, Fluzone Cohort A receiving 2 doses N=110
Posted
Number
Participants
7 days after each vaccination
ID
Title
Description
OG000
Afluria Cohort A
Age 6 months to < 3 years
OG001
Fluzone Cohort A
Age 6 months to < 3 years
Units
Counts
Participants
OG000229
OG001228
Title
Denominators
Categories
Any local solicited symptom post-dose 1
Title
Measurements
OG000116
OG001100
Any pain (post dose 1)
Title
Measurements
OG000
Secondary
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Safety population; Afluria cohort B receiving 2 doses N=68, Fluzone cohort B receiving 2 doses N=78
Posted
Number
Participants
7 days after each vaccination
ID
Title
Description
OG000
Afluria Cohort B
Age 3 to < 9 years
OG001
Fluzone Cohort B
Age 3 to < 9 years
Units
Counts
Participants
OG000
Secondary
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Safety population
Posted
Number
Participants
7 days after vaccination
ID
Title
Description
OG000
Afluria Cohort C
Age 9 to < 18 years
OG001
Fluzone Cohort C
Age 9 to < 18 years
Units
Counts
Participants
OG000254
Primary
Geometric Mean Titer 30 Days After the Last Study Vaccination
Per-protocol population
Posted
Jul 2011
Geometric Mean
95% Confidence Interval
Titers
30 days after the last study vaccination
ID
Title
Description
OG000
Afluria Cohort A
Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
OG001
Afluria Cohort B
Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
OG002
Afluria Cohort C
Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
OG003
Fluzone Cohort A
Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
OG004
Fluzone Cohort B
Primary
Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination
Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.
Per-Protocol Population
Posted
Jul 2011
Number
95% Confidence Interval
Percentage of participants
30 days after the last study vaccination
ID
Title
Description
OG000
Afluria Cohort A
Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
OG001
Afluria Cohort B
Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
OG002
Afluria Cohort C
Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
OG003
Fluzone Cohort A
Secondary
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
UAE stands for Unsolicited Adverse Events
Safety population
Posted
Number
Participants
30 days after each vaccination
ID
Title
Description
OG000
Afluria Cohort A
Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
OG001
Afluria Cohort B
Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
OG002
Afluria Cohort C
Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
OG003
Fluzone Cohort A
Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
OG004
Secondary
New Onset of Chronic Illnesses (NOCIs)
New onset of chronic illness after any vaccine dose. A new onset of chronic illness was defined as the diagnosis of a new medical condition which was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).
Safety population
Posted
Number
Participants
6 months after last study vaccination
ID
Title
Description
OG000
Afluria Cohort A
Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
OG001
Afluria Cohort B
Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
OG002
Afluria Cohort C
Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
OG003
Fluzone Cohort A
Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
Secondary
Serious Adverse Events (SAEs)
Safety Population
Posted
Number
Participants
6 months after last study vaccination
ID
Title
Description
OG000
Afluria Cohort A
Age 6 months to < 3 years
OG001
Afluria Cohort B
Age 3 to < 9 years
OG002
Afluria Cohort C
Age 9 to < 18 years
OG003
Fluzone Cohort A
Age 6 months to < 3 years
OG004
Fluzone Cohort B
Age 3 to < 9 years
OG005
Fluzone Cohort C
Age 3 to < 9 years
Secondary
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Safety population
Posted
Mean
Standard Deviation
Days
7 days after each vaccination
ID
Title
Description
OG000
Afluria Cohort A
Age 6 months to < 3 years
OG001
Fluzone Cohort A
Age 6 months to < 3 years
Units
Counts
Participants
OG000229
Secondary
Duration of Local and Systemic Solicited Symptoms, Cohort B
Safety population
Posted
Mean
Standard Deviation
Days
7 days after each vaccination
ID
Title
Description
OG000
Afluria Cohort B
Age 3 to < 9 years
OG001
Fluzone Cohort B
Age 3 to < 9 years
Units
Counts
Participants
OG000252
Secondary
Duration of Local and Systemic Solicited Symptoms, Cohort C
Safety population
Posted
Mean
Standard Deviation
Days
7 days after vaccination
ID
Title
Description
OG000
Afluria Cohort C
Age 9 to < 18 years
OG001
Fluzone Cohort C
Age 9 to < 18 years
Units
Counts
Participants
OG000254
Time Frame
Adverse event data were collected for 180 days after the last study vaccination.
Description
Not provided
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
Afluria Cohort A
Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
4
229
210
231
EG001
Afluria Cohort B
Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
3
252
216
254
EG002
Afluria Cohort C
Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
2
254
214
254
EG003
Fluzone Cohort A
Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
4
228
187
228
EG004
Fluzone Cohort B
Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
0
255
202
257
EG005
Fluzone Cohort C
Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
0
250
202
250
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Gastroenteritis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 events1 affected229 at risk
EG0010 events0 affected252 at risk
EG0020 events0 affected254 at risk
EG0030 events0 affected228 at risk
EG0040 events0 affected255 at risk
EG0050 events0 affected250 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 events1 affected229 at risk
EG0010 events0 affected252 at risk
EG0020 events0 affected254 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 events1 affected229 at risk
EG0011 events1 affected252 at risk
EG0020 events0 affected254 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 events1 affected229 at risk
EG0010 events0 affected252 at risk
EG0020 events0 affected254 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 events0 affected229 at risk
EG0011 events1 affected252 at risk
EG0020 events0 affected254 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 events0 affected229 at risk
EG0011 events1 affected252 at risk
EG0020 events0 affected254 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 events0 affected229 at risk
EG0010 events0 affected252 at risk
EG0021 events1 affected254 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 events0 affected229 at risk
EG0010 events0 affected252 at risk
EG0021 events1 affected254 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 events0 affected229 at risk
EG0010 events0 affected252 at risk
EG0020 events0 affected254 at risk
EG003
Furuncle
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 events0 affected229 at risk
EG0010 events0 affected252 at risk
EG0020 events0 affected254 at risk
EG003
Respiratory syncitial virus bronchiolitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 events0 affected229 at risk
EG0010 events0 affected252 at risk
EG0020 events0 affected254 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pain at the injection site
General disorders
MedDRA 13.0
Systematic Assessment
EG000107 affected229 at risk
EG001157 affected252 at risk
EG002167 affected254 at risk
EG00389 affected228 at risk
EG004134 affected255 at risk
EG005151 affected250 at risk
Redness at the injection site
General disorders
MedDRA 13.0
Systematic Assessment
EG00060 affected229 at risk
EG00162 affected252 at risk
EG00243 affected254 at risk
EG003
Swelling at the injection site
General disorders
MedDRA 13.0
Systematic Assessment
EG00034 affected229 at risk
EG00138 affected252 at risk
EG00239 affected254 at risk
EG003
Fever
General disorders
MedDRA 13.0
Systematic Assessment
EG00091 affected229 at risk
EG00158 affected252 at risk
EG00216 affected254 at risk
EG003
Nausea/vomiting
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG00031 affected229 at risk
EG00135 affected252 at risk
EG00223 affected254 at risk
EG003
Diarrhea
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG00069 affected229 at risk
EG00122 affected252 at risk
EG00220 affected254 at risk
EG003
Loss of appetite
General disorders
MedDRA 13.0
Systematic Assessment
EG00079 affected229 at risk
EG0010 affected252 at risk
EG0020 affected254 at risk
EG003
Irritability
General disorders
MedDRA 13.0
Systematic Assessment
EG000142 affected229 at risk
EG0010 affected252 at risk
EG0020 affected254 at risk
EG003
Malaise
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected229 at risk
EG00174 affected252 at risk
EG00255 affected254 at risk
EG003
Headache
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected229 at risk
EG00158 affected252 at risk
EG00269 affected254 at risk
EG003
Myalgia
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 affected229 at risk
EG00187 affected252 at risk
EG002101 affected254 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0009 affected229 at risk
EG0016 affected252 at risk
EG0024 affected254 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG00039 affected229 at risk
EG00140 affected252 at risk
EG00219 affected254 at risk
EG003
Rhinorrhea
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG00025 affected229 at risk
EG00114 affected252 at risk
EG0025 affected254 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG00014 affected229 at risk
EG0018 affected252 at risk
EG00216 affected254 at risk
EG003
Diarrhea
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG00010 affected229 at risk
EG0013 affected252 at risk
EG0024 affected254 at risk
EG003
Pyrexia
General disorders
MedDRA 13.0
Non-systematic Assessment
EG00032 affected229 at risk
EG00124 affected252 at risk
EG00212 affected254 at risk
EG003
Headache
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0006 affected229 at risk
EG0016 affected252 at risk
EG00217 affected254 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0004 affected229 at risk
EG0017 affected252 at risk
EG00219 affected254 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
LTE60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Clinical Program Director
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
ID
Term
C000613428
Afluria
D007252
Influenza Vaccines
Ancestor Terms
ID
Term
D014765
Viral Vaccines
D014612
Vaccines
D001688
Biological Products
D045424
Complex Mixtures
Browse Leaves
Not provided
Browse Branches
Not provided
9 subjects
FG0051 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
228
BG004257
BG005250
BG0061474
Between 18 and 65 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
>=65 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
12.98
± 2.388
BG0031.96± 0.673
BG0045.82± 1.748
BG00512.86± 2.474
BG0067.06± 4.855
121
BG003101
BG004127
BG005120
BG006728
Male
BG000112
BG001114
BG002133
BG003127
BG004130
BG005130
BG006746
254
BG003228
BG004257
BG005250
BG0061474
98
OG00178
Grade 3 pain (post dose 1)
Title
Measurements
OG0001
OG0010
Any redness (> 0 mm) (post dose 1)
Title
Measurements
OG00053
OG00153
Grade 3 redness (> 30 mm) (post dose 1)
Title
Measurements
OG0000
OG0011
Any swelling (> 0 mm) (post dose 1)
Title
Measurements
OG00030
OG00126
Grade 3 swelling (> 30 mm) (post dose 1)
Title
Measurements
OG0001
OG0010
Any local solicited symptom post-dose 2
Title
Measurements
OG00030
OG00132
Any pain (post dose 2)
Title
Measurements
OG00028
OG00122
Grade 3 pain (post dose 2)
Title
Measurements
OG0000
OG0010
Any redness (> 0 mm) (post dose 2)
Title
Measurements
OG00015
OG00122
Grade 3 redness (> 30 mm) (post dose 2)
Title
Measurements
OG0001
OG0010
Any swelling (> 0 mm) (post dose 2)
Title
Measurements
OG0009
OG0017
Grade 3 swelling (> 30 mm) (post dose 2)
Title
Measurements
OG0000
OG0010
Any systemic solicited symptom, post dose 1
Title
Measurements
OG000171
OG001121
Any fever ≥ 99.5°F ax or≥ 100.4°F oral, dose1