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A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults (CSL's IVV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00562484
Recruitment Status : Completed
First Posted : November 22, 2007
Results First Posted : September 12, 2011
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Seqirus

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: CSL Limited Influenza Vaccine
Biological: Placebo
Enrollment 7500
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CSL's IVV Placebo
Hide Arm/Group Description Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
Period Title: Overall Study
Started 10033 5011
Completed 9827 4907
Not Completed 206 104
Reason Not Completed
Adverse Event             6             1
Protocol Violation             11             2
Withdrawal by Subject             12             9
Moved away from the study area             20             9
Lost to Follow-up             132             71
Reason not provided or not specified             25             12
Arm/Group Title CSL's IVV Placebo Total
Hide Arm/Group Description Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season Total of all reporting groups
Overall Number of Baseline Participants 10033 5011 15044
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10033 participants 5011 participants 15044 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10033
 100.0%
5011
 100.0%
15044
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10033 participants 5011 participants 15044 participants
35.5  (14.69) 35.4  (14.69) 35.5  (14.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10033 participants 5011 participants 15044 participants
Female
5523
  55.0%
2667
  53.2%
8190
  54.4%
Male
4510
  45.0%
2344
  46.8%
6854
  45.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10033 participants 5011 participants 15044 participants
Australia 8201 4090 12291
New Zealand 1832 921 2753
1.Primary Outcome
Title CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection
Hide Description

Incidence of Laboratory Confirmed Influenza A/B infection was assessed per the study population in the 2008 and 2009 Southern Hemisphere influenza seasons.

Vaccine efficacy = 100 x (1 - ratio of incidence rate). Ratio of incidence rate = active Study Vaccine recipient infection rate / placebo recipient infection rate.

Time Frame 2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
Arm/Group Title CSL's IVV Placebo
Hide Arm/Group Description:
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
Overall Number of Participants Analyzed 9889 4960
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Ratio
2.24
(1.97 to 2.57)
3.87
(3.37 to 4.44)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CSL's IVV, Placebo
Comments Vaccine efficacy = 100 x (1 - ratio of incidence rate)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 42
Confidence Interval (2-Sided) 95%
30 to 52
Estimation Comments [Not Specified]
2.Secondary Outcome
Title CSL's IVV Vaccine Efficacy Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection Due to Strains Matched to Vaccine Strains
Hide Description

Incidence of laboratory confirmed influenza A/B infection due to strains matched to vaccine strains was assessed per the study population in the 2008 and 2009 Southern Hemisphere influenza seasons.

Vaccine efficacy = 100 x (1 - ratio of incidence rate). Ratio of incidence rate = active Study Vaccine recipient infection rate / Placebo recipient infection rate.

Time Frame 2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
Arm/Group Title CSL's IVV Placebo
Hide Arm/Group Description:
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
Overall Number of Participants Analyzed 9889 4960
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Ratio
0.59
(0.45 to 0.76)
1.47
(1.17 to 1.85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CSL's IVV, Placebo
Comments Vaccine efficacy = 100 x (1 - ratio of incidence rate)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy
Estimated Value 60
Confidence Interval (2-Sided) 95%
44 to 72
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Incidence of Influenza-like Illness (ILI)
Hide Description

The criteria for the protocol defined ILI were as follows:

  • At least one respiratory symptom:
  • cough, sore throat or nasal congestion
  • And at least one systemic symptom:
  • fever (as defined by oral temperature ≥ 37.8°C (100.0°F), or feverishness (as defined by participant's subjective feeling of fever), chills or body aches.

The CDC ILI case definition was the occurrence of fever (100°F [37.8°C] or higher) in conjunction with either cough or sore throat.

Time Frame 2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
Arm/Group Title CSL's IVV Placebo
Hide Arm/Group Description:
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
Overall Number of Participants Analyzed 9889 4960
Measure Type: Number
Unit of Measure: Percentage of participants
Reported ILI (protocol definition) 11.9 13.5
Culture-confirmed ILI 1.5 2.4
Reported ILI (CDC definition) 2.6 3.6
Laboratory-confirmed ILI (CDC definition) 0.9 1.7
4.Secondary Outcome
Title Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008
Hide Description [Not Specified]
Time Frame 21 days after study vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
Arm/Group Title CSL's IVV Placebo
Hide Arm/Group Description:
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
Overall Number of Participants Analyzed 303 147
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
H1N1 (A/Solomon Islands/3/2006)
99
(97 to 100)
42
(34 to 51)
H3N2 (A/Brisbane/10/2007)
97
(94 to 98)
35
(27 to 43)
B (B/Brisbane/3/2007)
77
(72 to 82)
13
(8 to 19)
5.Secondary Outcome
Title Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009
Hide Description [Not Specified]
Time Frame 21 days after study vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
Arm/Group Title CSL's IVV Placebo
Hide Arm/Group Description:
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
Overall Number of Participants Analyzed 291 149
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
H1N1 (A/Brisbane/59/2007)
94
(90 to 96)
36
(28 to 44)
H3N2 (A/Uruguay/2007)
94
(90 to 96)
43
(35 to 51)
B (B/Florida/4/2006)
89
(85 to 93)
30
(23 to 38)
6.Secondary Outcome
Title Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008
Hide Description Seroconversion rate: defined as the percentage of participants with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
Time Frame 21 days after study vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
Arm/Group Title CSL's IVV Placebo
Hide Arm/Group Description:
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
Overall Number of Participants Analyzed 303 147
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
H1N1 (A/Solomon Islands/3/2006)
81
(76 to 85)
1
(0 to 4)
H3N2 (A/Brisbane/10/2007)
87
(82 to 90)
1
(0 to 4)
B (B/Brisbane/3/2007)
63
(57 to 69)
1
(0 to 4)
7.Secondary Outcome
Title Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009
Hide Description Seroconversion rate: defined as the percentage of participants with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
Time Frame 21 days after study vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
Arm/Group Title CSL's IVV Placebo
Hide Arm/Group Description:
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
Overall Number of Participants Analyzed 291 149
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
H1N1 (A/Brisbane/59/2007)
78
(72 to 82)
1
(0 to 4)
H3N2 (A/Uruguay/2007)
81
(76 to 85)
1
(0 to 5)
B (B/Florida/4/2006)
61
(55 to 67)
0
(0 to 0)
8.Secondary Outcome
Title Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008
Hide Description Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.
Time Frame 21 days after study vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
Arm/Group Title CSL's IVV Placebo
Hide Arm/Group Description:
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
Overall Number of Participants Analyzed 303 147
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Fold increase
H1N1 (A/Solomon Islands/3/2006)
21
(17 to 26)
1
(1 to 1)
H3N2 (A/Brisbane/10/2007)
18
(15 to 21)
1
(1 to 1)
B (B/Brisbane/3/2007)
8
(7 to 10)
1
(1 to 1)
9.Secondary Outcome
Title Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009
Hide Description Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.
Time Frame 21 days after study vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
Arm/Group Title CSL's IVV Placebo
Hide Arm/Group Description:
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
Overall Number of Participants Analyzed 291 149
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Fold increase
H1N1 (A/Brisbane/59/2007)
13
(11 to 16)
1
(1 to 1)
H3N2 (A/Uruguay/2007)
15
(13 to 18)
1
(1 to 1)
B (B/Florida/4/2006)
6
(5 to 7)
1
(1 to 1)
10.Secondary Outcome
Title Frequency and Intensity of Local and Systemic Solicited Symptoms
Hide Description

Adverse event grading:

Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.

Grade 2 (moderate): Discomfort was enough to cause some interference with daily activities.

Grade 3 (severe): Symptoms that prevented normal, everyday activities.

Fever Grade 1: ≥ 37.7°C - < 38.0°C (≥ 99.9 - < 100.4°F) Grade 2: ≥ 38.0°C - < 39.0°C (≥ 100.4 - < 102.2°F) Grade 3: ≥ 39.0°C (> 102.2°F)

Time Frame 5 days after study vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.
Arm/Group Title CSL's IVV Placebo
Hide Arm/Group Description:
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
Overall Number of Participants Analyzed 10015 5005
Measure Type: Number
Unit of Measure: Participants
Any local solicited symptom 7474 1021
Any pain 4850 539
Grade 3 pain 19 0
Any tenderness 6956 874
Grade 3 tenderness 30 2
Any redness 362 18
Grade 3 redness 3 0
Any swelling / induration 433 20
Grade 3 swelling / induration 6 0
Any bruising 135 29
Grade 3 bruising 1 0
Any systemic solicited symptom 4670 1955
Any fever 258 93
Grade 3 fever 8 2
Any headache 2553 1176
Grade 3 headache 43 19
Any malaise 2916 1277
Grade 3 malaise 67 24
Any myalgia 2150 609
Grade 3 myalgia 33 5
Any chills 509 187
Grade 3 chills 17 3
Any nausea 678 287
Grade 3 nausea 22 16
Any vomiting 83 38
Grade 3 vomiting 10 4
11.Secondary Outcome
Title Frequency and Intensity of Unsolicited Adverse Events (UAEs)
Hide Description

UAE grading:

Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.

Grade 2 (moderate): Discomfort was enough to cause some interference with daily activities.

Grade 3 (severe): Symptoms that prevented normal, everyday activities.

Time Frame 21 days after study vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.
Arm/Group Title CSL's IVV Placebo
Hide Arm/Group Description:
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
Overall Number of Participants Analyzed 9889 4960
Measure Type: Number
Unit of Measure: Participants
Number of participants with at least one UAE 3519 1698
Number of participants reported Grade 1 UAE 1604 750
Number of participants reported Grade 2 UAE 1536 784
Number of participants reported Grade 3 UAE 378 162
12.Secondary Outcome
Title Serious Adverse Events (SAEs)
Hide Description

An SAE was any untoward medical occurrence that at any dose:

  • Resulted in death;
  • Was life-threatening;
  • Required an unexpected in-participant hospitalization or prolongation of existing hospitalization;
  • Resulted in persistent or significant disability / incapacity;
  • Was a congenital anomaly / birth defect; and / or
  • Was medically significant (defined as an event that did not necessarily meet any of the SAE criteria, but was judged by the treating physician to potentially jeopardize the participant or require medical intervention to prevent one of the out
Time Frame 180 days after study vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.
Arm/Group Title CSL's IVV Placebo
Hide Arm/Group Description:
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
Overall Number of Participants Analyzed 9889 4960
Measure Type: Number
Unit of Measure: Participants
Number of participants with at least one SAE 100 44
Number rof participants with related SAE 0 0
13.Secondary Outcome
Title New Onsets of Chronic Illness (NOCI)
Hide Description An NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension).
Time Frame 180 days after study vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.
Arm/Group Title CSL's IVV Placebo
Hide Arm/Group Description:
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
Overall Number of Participants Analyzed 9889 4960
Measure Type: Number
Unit of Measure: Participants
Number of participants with at least one NOCI 80 46
Number of participants with related NOCI 3 0
Time Frame 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Adverse Event Reporting Description Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
 
Arm/Group Title CSL's IVV Placebo
Hide Arm/Group Description Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
All-Cause Mortality
CSL's IVV Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
CSL's IVV Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   100/10015 (1.00%)      44/5005 (0.88%)    
Cardiac disorders     
Acute myocardial infarction * 1  1/10015 (0.01%)  1 1/5005 (0.02%)  1
Myocardial infarction * 1  2/10015 (0.02%)  2 0/5005 (0.00%)  0
Angina unstable * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Aortic valve incompetence * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Atrial fibrillation * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Cardiac arrest * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Coronary artery disease * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Pericarditis * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Sick sinus syndrome * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Myocardial ischaemia * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  2
Congenital, familial and genetic disorders     
Bicuspid aortic valve * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Heart disease congenital * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Trisomy 21 * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Gastrointestinal disorders     
Pancreatitis * 1  1/10015 (0.01%)  1 2/5005 (0.04%)  2
Crohn's disease * 1  1/10015 (0.01%)  1 1/5005 (0.02%)  1
Abdominal hernia obstructive * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Abdominal pain lower * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Diverticular perforation * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Gastritis * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Gastrooesophageal reflux disease * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Haemorrhoids * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Ileitis * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Inguinal hernia * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Intussusception * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Irritable bowel syndrome * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Pancreatitis relapsing * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Reflux oesophagitis * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Umbilical hernia obstructive * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Uvulitis * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis acute * 1  2/10015 (0.02%)  2 0/5005 (0.00%)  0
Cholecystitis * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Cholecystitis chronic * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Cholelithiasis * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Immune system disorders     
Amyloidosis * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Drug hypersensitivity * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Infections and infestations     
Appendicitis * 1  8/10015 (0.08%)  8 2/5005 (0.04%)  2
Cellulitis * 1  4/10015 (0.04%)  4 2/5005 (0.04%)  2
Pneumonia * 1  2/10015 (0.02%)  2 2/5005 (0.04%)  2
Vestibular neuronitis * 1  2/10015 (0.02%)  2 0/5005 (0.00%)  0
Viral infection * 1  1/10015 (0.01%)  1 1/5005 (0.02%)  1
Bacterial pyelonephritis * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Bartholin's abscess * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Cellulitis of male external genital organ * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Gastroenteritis * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Gastroenteritis viral * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Haemophilus infection * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Herpes simplex hepatitis * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Liver abscess * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Measles * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Peritonsillar abscess * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Pyomyositis * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Tonsillitis * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Urosepsis * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Uterine leiomyoma * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Injury, poisoning and procedural complications     
Lower limb fracture * 1  1/10015 (0.01%)  1 2/5005 (0.04%)  2
Ankle fracture * 1  1/10015 (0.01%)  1 1/5005 (0.02%)  1
Humerus fracture * 1  2/10015 (0.02%)  2 0/5005 (0.00%)  0
Ligament rupture * 1  1/10015 (0.01%)  1 1/5005 (0.02%)  1
Anaesthetic complication pulmonary * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Cervical vertebral fracture * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Facial bones fracture * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Fibula fracture * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Foot fracture * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Hand fracture * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Head injury * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Incisional hernia * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Jaw fracture * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Multiple injuries * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Pubic rami fracture * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Rib fracture * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Road traffic accident * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Subdural haemorrhage * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Heart injury * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Fracture nonunion * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Osteoarthritis * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Rotator cuff syndrome * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Spondylolisthesis * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Tendonitis * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer * 1  4/10015 (0.04%)  4 1/5005 (0.02%)  1
B precursor type acute leukaemia * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Breast cancer in situ * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Breast cancer metastatic * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Colon cancer stage II * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Leiomyosarcoma metastatic * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Malignant pleural effusion * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Non-Hodgkin's lymphoma * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Ovarian adenoma * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Throat cancer * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Borderline ovarian tumour * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Ovarian cancer * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Nervous system disorders     
cervical myelopathy * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Headache * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Paraplegia * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Presyncope * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Syncope * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Transient ischaemic attack * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Psychiatric disorders     
Depression * 1  1/10015 (0.01%)  1 1/5005 (0.02%)  1
Bipolar disorder * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Major depression * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Renal and urinary disorders     
Acute prerenal failure * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Focal segmental glomerulosclerosis * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Renal cyst ruptured * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Ruptured ectopic pregnancy * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Reproductive system and breast disorders     
Ovarian cyst * 1  2/10015 (0.02%)  2 0/5005 (0.00%)  0
Benign prostatic hyperplasia * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Cervical polyp * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Endometriosis * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Haemorrhagic ovarian cyst * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Ovarian cyst ruptured * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Vaginal prolapse * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism * 1  1/10015 (0.01%)  1 1/5005 (0.02%)  1
Haemothorax * 1  0/10015 (0.00%)  0 1/5005 (0.02%)  1
Pleurisy * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Pneumonia aspiration * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Pneumothorax * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Tracheal inflammation * 1  1/10015 (0.01%)  1 0/5005 (0.00%)  0
Vascular disorders     
Deep vein thrombosis * 1  2/10015 (0.02%)  2 1/5005 (0.02%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
CSL's IVV Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3028/10015 (30.23%)      1549/5005 (30.95%)    
Infections and infestations     
Upper respiratory tract infection  1  387/10015 (3.86%)  402 201/5005 (4.02%)  205
Nasopharyngitis  1  110/10015 (1.10%)  113 55/5005 (1.10%)  56
Musculoskeletal and connective tissue disorders     
Back pain  1  135/10015 (1.35%)  155 70/5005 (1.40%)  78
Nervous system disorders     
Headache  1  1128/10015 (11.26%)  1567 558/5005 (11.15%)  712
Reproductive system and breast disorders     
Dysmenorrhea  1  144/10015 (1.44%)  148 73/5005 (1.46%)  77
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1  501/10015 (5.00%)  529 258/5005 (5.15%)  276
Nasal congestion  1  248/10015 (2.48%)  273 150/5005 (3.00%)  160
Cough  1  220/10015 (2.20%)  228 104/5005 (2.08%)  112
Rhinorrhea  1  155/10015 (1.55%)  163 80/5005 (1.60%)  82
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Study Disclosure Manager
Organization: Seqirus
EMail: Seqirus.ClinicalTrials@Seqirus.com
Layout table for additonal information
Responsible Party: Seqirus
ClinicalTrials.gov Identifier: NCT00562484    
Other Study ID Numbers: CSLCT-USF-06-28
First Submitted: November 20, 2007
First Posted: November 22, 2007
Results First Submitted: July 8, 2011
Results First Posted: September 12, 2011
Last Update Posted: November 21, 2017