A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults
Sponsor
Seqirus (Industry)
Overall Status
Completed
CT.gov ID
NCT00562484
Collaborator
(none)
7,500
24
2
22
312.5
14.2
Study Details
Study Description
Brief Summary
This study will assess the Efficacy, Safety and Tolerability profile of CSL's Influenza Vaccine administered intramuscularly against laboratory-confirmed influenza illness in a population defined as being not at risk of severe complications following influenza infection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
7500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Phase IV, Randomized, Observer-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Efficacy, Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in Adults Aged ≥ 18 to < 65 Years.
Study Start Date
:
Mar 1, 2008
Actual Primary Completion Date
:
Nov 1, 2009
Actual Study Completion Date
:
Jan 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Biological: CSL Limited Influenza Vaccine
A single 0.5 mL, intramuscular Injection in the deltoid region of the arm on day 0.
|
| Other: 2
|
Biological: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection [2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009]
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.
Secondary Outcome Measures
- 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 [2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009]
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.
- Incidence of Influenza-like Illness (ILI) [2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009]
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.
- Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008 [21 days after study vaccination]
- Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009 [21 days after study vaccination]
- Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008 [21 days after study vaccination]
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.
- Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009 [21 days after study vaccination]
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.
- Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008 [21 days after study vaccination]
Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.
- Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009 [21 days after study vaccination]
Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.
- Frequency and Intensity of Local and Systemic Solicited Symptoms [5 days after study vaccination]
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)
- Frequency and Intensity of Unsolicited Adverse Events (UAEs) [21 days after study vaccination]
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.
- Serious Adverse Events (SAEs) [180 days after study vaccination]
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
- New Onsets of Chronic Illness (NOCI) [180 days after study vaccination]
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).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Healthy males and females aged ≥ 18 to < 65 years at the time of vaccination
-
Non pregnant/ non lactating females
Exclusion Criteria:
-
Hypersensitivity to influenza vaccine or allergy to any components of the Study Vaccines
-
Vaccination against influenza in the previous 6 months
-
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
-
Known history of Guillain-Barré Syndrome;
-
Clinical signs of active infection and/or an oral temperature of ≥ 37.8 oC.
-
History of neurological disorders or seizures
-
Confirmed or suspected immunosuppressive condition or a previously diagnosed immunodeficiency disorder
-
Current or recent immunosuppressive or immunomodulative therapy, including systemic corticosteroids
-
Administration of immunoglobulins and/or any blood products;
-
Participation in a clinical trial or use of an investigational compound;
-
Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior;
-
Participants indicated to receive an influenza vaccine on an annual basis according to the local public health recommendations.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Clinical Trials Unit, Canberra Hospital | Canberra | Australian Capital Territory | Australia | |
| 2 | Australian Clinical Research Organisation | Brookvale | New South Wales | Australia | |
| 3 | Australian Clinical Research Organisation | Caringbah | New South Wales | Australia | |
| 4 | Eastern Area Health Service, Prince of Wales Hospital | Randwick | New South Wales | Australia | |
| 5 | National Centre for Immunisation Research & Surveillance (NCIRS) The Children's Hospital at Westmead | Westmead | New South Wales | Australia | |
| 6 | Australian Clinical Research Organisation | Auchenflower | Queensland | Australia | 4066 |
| 7 | Trialworks Clinical Research Services | Brisbane | Queensland | Australia | |
| 8 | Australian Clinical Research Organisation Caboolture Clinical Research Centre | Caboolture | Queensland | Australia | 4510 |
| 9 | School of Medicine, James Cook University, Cairns Base Hospital | Cairns | Queensland | Australia | |
| 10 | Gold Coast Hospital | Gold Coast | Queensland | Australia | |
| 11 | Australian Clinical Research Organisation | Kippa Ring | Queensland | Australia | |
| 12 | CMAX, a division of IDT Australia | Adelaide | South Australia | Australia | |
| 13 | Paediatric Trials Unit, Women's and Children's Hospital | Adelaide | South Australia | Australia | |
| 14 | Primary Old Port Road Medical and Dental Centre | Royal Park | South Australia | Australia | 5014 |
| 15 | Sexual Health Service | Hobart | Tasmania | Australia | |
| 16 | Barwon Health, Geelong Hospital | Geelong | Victoria | Australia | |
| 17 | Emeritus Research | Malvern East | Victoria | Australia | |
| 18 | Murdoch Childrens Research Institute | Melbourne | Victoria | Australia | |
| 19 | Lung Institute of Western Australia | Perth | Western Australia | Australia | |
| 20 | Princess Margaret Hospital for Children | Perth | Western Australia | Australia | |
| 21 | Auckland Clinical Studies | Auckland | New Zealand | ||
| 22 | 198 Youth Health Centre | Christchurch | New Zealand | ||
| 23 | Southern Clinical Trials | Christchurch | New Zealand | ||
| 24 | RMC Medical Centre | Dunedin | New Zealand |
Sponsors and Collaborators
- Seqirus
Investigators
- Study Director: Clinical Director Vaccines, Seqirus
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Seqirus
ClinicalTrials.gov Identifier:
NCT00562484
Other Study ID Numbers:
- CSLCT-USF-06-28
First Posted:
Nov 22, 2007
Last Update Posted:
Nov 21, 2017
Last Verified:
Oct 1, 2017
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | CSL's IVV | Placebo |
|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | CSL's IVV | Placebo | Total |
|---|---|---|---|
| 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 Participants | 10033 | 5011 | 15044 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
10033
100%
|
5011
100%
|
15044
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
35.5
(14.69)
|
35.4
(14.69)
|
35.5
(14.69)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
5523
55%
|
2667
53.2%
|
8190
54.4%
|
| Male |
4510
45%
|
2344
46.8%
|
6854
45.6%
|
| Region of Enrollment (participants) [Number] | |||
| Australia |
8201
81.7%
|
4090
81.6%
|
12291
81.7%
|
| New Zealand |
1832
18.3%
|
921
18.4%
|
2753
18.3%
|
Outcome Measures
| Title | CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 |
| Measure Participants | 9889 | 4960 |
| Number (95% Confidence Interval) [Ratio] |
2.24
|
3.87
|
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 | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Efficacy |
| Estimated Value | 42 | |
| Confidence Interval |
(2-Sided) 95% 30 to 52 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| 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 |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 |
| Measure Participants | 9889 | 4960 |
| Number (95% Confidence Interval) [Ratio] |
0.59
|
1.47
|
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 | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine efficacy |
| Estimated Value | 60 | |
| Confidence Interval |
(2-Sided) 95% 44 to 72 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Incidence of Influenza-like Illness (ILI) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 |
| Measure Participants | 9889 | 4960 |
| Reported ILI (protocol definition) |
11.9
0.1%
|
13.5
0.3%
|
| Culture-confirmed ILI |
1.5
0%
|
2.4
0%
|
| Reported ILI (CDC definition) |
2.6
0%
|
3.6
0.1%
|
| Laboratory-confirmed ILI (CDC definition) |
0.9
0%
|
1.7
0%
|
| Title | Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008 |
|---|---|
| Description | |
| Time Frame | 21 days after study vaccination |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 |
| Measure Participants | 303 | 147 |
| H1N1 (A/Solomon Islands/3/2006) |
99
1%
|
42
0.8%
|
| H3N2 (A/Brisbane/10/2007) |
97
1%
|
35
0.7%
|
| B (B/Brisbane/3/2007) |
77
0.8%
|
13
0.3%
|
| Title | Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009 |
|---|---|
| Description | |
| Time Frame | 21 days after study vaccination |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 |
| Measure Participants | 291 | 149 |
| H1N1 (A/Brisbane/59/2007) |
94
0.9%
|
36
0.7%
|
| H3N2 (A/Uruguay/2007) |
94
0.9%
|
43
0.9%
|
| B (B/Florida/4/2006) |
89
0.9%
|
30
0.6%
|
| Title | Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008 |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 |
| Measure Participants | 303 | 147 |
| H1N1 (A/Solomon Islands/3/2006) |
81
0.8%
|
1
0%
|
| H3N2 (A/Brisbane/10/2007) |
87
0.9%
|
1
0%
|
| B (B/Brisbane/3/2007) |
63
0.6%
|
1
0%
|
| Title | Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009 |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 |
| Measure Participants | 291 | 149 |
| H1N1 (A/Brisbane/59/2007) |
78
0.8%
|
1
0%
|
| H3N2 (A/Uruguay/2007) |
81
0.8%
|
1
0%
|
| B (B/Florida/4/2006) |
61
0.6%
|
0
0%
|
| Title | Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008 |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 |
| Measure Participants | 303 | 147 |
| H1N1 (A/Solomon Islands/3/2006) |
21
|
1
|
| H3N2 (A/Brisbane/10/2007) |
18
|
1
|
| B (B/Brisbane/3/2007) |
8
|
1
|
| Title | Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009 |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 |
| Measure Participants | 291 | 149 |
| H1N1 (A/Brisbane/59/2007) |
13
|
1
|
| H3N2 (A/Uruguay/2007) |
15
|
1
|
| B (B/Florida/4/2006) |
6
|
1
|
| Title | Frequency and Intensity of Local and Systemic Solicited Symptoms |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 |
| Measure Participants | 10015 | 5005 |
| Any local solicited symptom |
7474
74.5%
|
1021
20.4%
|
| Any pain |
4850
48.3%
|
539
10.8%
|
| Grade 3 pain |
19
0.2%
|
0
0%
|
| Any tenderness |
6956
69.3%
|
874
17.4%
|
| Grade 3 tenderness |
30
0.3%
|
2
0%
|
| Any redness |
362
3.6%
|
18
0.4%
|
| Grade 3 redness |
3
0%
|
0
0%
|
| Any swelling / induration |
433
4.3%
|
20
0.4%
|
| Grade 3 swelling / induration |
6
0.1%
|
0
0%
|
| Any bruising |
135
1.3%
|
29
0.6%
|
| Grade 3 bruising |
1
0%
|
0
0%
|
| Any systemic solicited symptom |
4670
46.5%
|
1955
39%
|
| Any fever |
258
2.6%
|
93
1.9%
|
| Grade 3 fever |
8
0.1%
|
2
0%
|
| Any headache |
2553
25.4%
|
1176
23.5%
|
| Grade 3 headache |
43
0.4%
|
19
0.4%
|
| Any malaise |
2916
29.1%
|
1277
25.5%
|
| Grade 3 malaise |
67
0.7%
|
24
0.5%
|
| Any myalgia |
2150
21.4%
|
609
12.2%
|
| Grade 3 myalgia |
33
0.3%
|
5
0.1%
|
| Any chills |
509
5.1%
|
187
3.7%
|
| Grade 3 chills |
17
0.2%
|
3
0.1%
|
| Any nausea |
678
6.8%
|
287
5.7%
|
| Grade 3 nausea |
22
0.2%
|
16
0.3%
|
| Any vomiting |
83
0.8%
|
38
0.8%
|
| Grade 3 vomiting |
10
0.1%
|
4
0.1%
|
| Title | Frequency and Intensity of Unsolicited Adverse Events (UAEs) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 |
| Measure Participants | 9889 | 4960 |
| Number of participants with at least one UAE |
3519
35.1%
|
1698
33.9%
|
| Number of participants reported Grade 1 UAE |
1604
16%
|
750
15%
|
| Number of participants reported Grade 2 UAE |
1536
15.3%
|
784
15.6%
|
| Number of participants reported Grade 3 UAE |
378
3.8%
|
162
3.2%
|
| Title | Serious Adverse Events (SAEs) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 |
| Measure Participants | 9889 | 4960 |
| Number of participants with at least one SAE |
100
1%
|
44
0.9%
|
| Number rof participants with related SAE |
0
0%
|
0
0%
|
| Title | New Onsets of Chronic Illness (NOCI) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 |
| Measure Participants | 9889 | 4960 |
| Number of participants with at least one NOCI |
80
0.8%
|
46
0.9%
|
| Number of participants with related NOCI |
3
0%
|
0
0%
|
Adverse Events
| 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 | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| CSL's IVV | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 100/10015 (1%) | 44/5005 (0.9%) | ||
| Cardiac disorders | ||||
| Acute myocardial infarction | 1/10015 (0%) | 1 | 1/5005 (0%) | 1 |
| Myocardial infarction | 2/10015 (0%) | 2 | 0/5005 (0%) | 0 |
| Angina unstable | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Aortic valve incompetence | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Atrial fibrillation | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Cardiac arrest | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Coronary artery disease | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Pericarditis | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Sick sinus syndrome | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Myocardial ischaemia | 0/10015 (0%) | 0 | 1/5005 (0%) | 2 |
| Congenital, familial and genetic disorders | ||||
| Bicuspid aortic valve | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Heart disease congenital | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Trisomy 21 | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Pancreatitis | 1/10015 (0%) | 1 | 2/5005 (0%) | 2 |
| Crohn's disease | 1/10015 (0%) | 1 | 1/5005 (0%) | 1 |
| Abdominal hernia obstructive | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Abdominal pain lower | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Diverticular perforation | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Gastritis | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Gastrooesophageal reflux disease | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Haemorrhoids | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Ileitis | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Inguinal hernia | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Intussusception | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Irritable bowel syndrome | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Pancreatitis relapsing | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Reflux oesophagitis | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Umbilical hernia obstructive | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Uvulitis | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Hepatobiliary disorders | ||||
| Cholecystitis acute | 2/10015 (0%) | 2 | 0/5005 (0%) | 0 |
| Cholecystitis | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Cholecystitis chronic | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Cholelithiasis | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Immune system disorders | ||||
| Amyloidosis | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Drug hypersensitivity | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Infections and infestations | ||||
| Appendicitis | 8/10015 (0.1%) | 8 | 2/5005 (0%) | 2 |
| Cellulitis | 4/10015 (0%) | 4 | 2/5005 (0%) | 2 |
| Pneumonia | 2/10015 (0%) | 2 | 2/5005 (0%) | 2 |
| Vestibular neuronitis | 2/10015 (0%) | 2 | 0/5005 (0%) | 0 |
| Viral infection | 1/10015 (0%) | 1 | 1/5005 (0%) | 1 |
| Bacterial pyelonephritis | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Bartholin's abscess | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Cellulitis of male external genital organ | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Gastroenteritis | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Gastroenteritis viral | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Haemophilus infection | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Herpes simplex hepatitis | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Liver abscess | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Measles | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Peritonsillar abscess | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Pyomyositis | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Tonsillitis | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Urosepsis | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Uterine leiomyoma | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Lower limb fracture | 1/10015 (0%) | 1 | 2/5005 (0%) | 2 |
| Ankle fracture | 1/10015 (0%) | 1 | 1/5005 (0%) | 1 |
| Humerus fracture | 2/10015 (0%) | 2 | 0/5005 (0%) | 0 |
| Ligament rupture | 1/10015 (0%) | 1 | 1/5005 (0%) | 1 |
| Anaesthetic complication pulmonary | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Cervical vertebral fracture | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Facial bones fracture | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Fibula fracture | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Foot fracture | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Hand fracture | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Head injury | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Incisional hernia | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Jaw fracture | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Multiple injuries | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Pubic rami fracture | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Rib fracture | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Road traffic accident | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Subdural haemorrhage | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Heart injury | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Dehydration | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Fracture nonunion | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Osteoarthritis | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Rotator cuff syndrome | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Spondylolisthesis | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Tendonitis | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Breast cancer | 4/10015 (0%) | 4 | 1/5005 (0%) | 1 |
| B precursor type acute leukaemia | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Breast cancer in situ | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Breast cancer metastatic | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Colon cancer stage II | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Leiomyosarcoma metastatic | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Malignant pleural effusion | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Non-Hodgkin's lymphoma | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Ovarian adenoma | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Throat cancer | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Borderline ovarian tumour | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Ovarian cancer | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Nervous system disorders | ||||
| cervical myelopathy | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Headache | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Paraplegia | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Presyncope | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Syncope | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Transient ischaemic attack | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Pregnancy, puerperium and perinatal conditions | ||||
| Abortion spontaneous | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Psychiatric disorders | ||||
| Depression | 1/10015 (0%) | 1 | 1/5005 (0%) | 1 |
| Bipolar disorder | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Major depression | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Renal and urinary disorders | ||||
| Acute prerenal failure | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Focal segmental glomerulosclerosis | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Renal cyst ruptured | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Ruptured ectopic pregnancy | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Ovarian cyst | 2/10015 (0%) | 2 | 0/5005 (0%) | 0 |
| Benign prostatic hyperplasia | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Cervical polyp | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Endometriosis | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Haemorrhagic ovarian cyst | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Ovarian cyst ruptured | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Vaginal prolapse | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Pulmonary embolism | 1/10015 (0%) | 1 | 1/5005 (0%) | 1 |
| Haemothorax | 0/10015 (0%) | 0 | 1/5005 (0%) | 1 |
| Pleurisy | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Pneumonia aspiration | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Pneumothorax | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Tracheal inflammation | 1/10015 (0%) | 1 | 0/5005 (0%) | 0 |
| Vascular disorders | ||||
| Deep vein thrombosis | 2/10015 (0%) | 2 | 1/5005 (0%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| CSL's IVV | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3028/10015 (30.2%) | 1549/5005 (30.9%) | ||
| Infections and infestations | ||||
| Upper respiratory tract infection | 387/10015 (3.9%) | 402 | 201/5005 (4%) | 205 |
| Nasopharyngitis | 110/10015 (1.1%) | 113 | 55/5005 (1.1%) | 56 |
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 135/10015 (1.3%) | 155 | 70/5005 (1.4%) | 78 |
| Nervous system disorders | ||||
| Headache | 1128/10015 (11.3%) | 1567 | 558/5005 (11.1%) | 712 |
| Reproductive system and breast disorders | ||||
| Dysmenorrhea | 144/10015 (1.4%) | 148 | 73/5005 (1.5%) | 77 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Oropharyngeal pain | 501/10015 (5%) | 529 | 258/5005 (5.2%) | 276 |
| Nasal congestion | 248/10015 (2.5%) | 273 | 150/5005 (3%) | 160 |
| Cough | 220/10015 (2.2%) | 228 | 104/5005 (2.1%) | 112 |
| Rhinorrhea | 155/10015 (1.5%) | 163 | 80/5005 (1.6%) | 82 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Clinical Study Disclosure Manager |
|---|---|
| Organization | Seqirus |
| Phone | |
| Seqirus.ClinicalTrials@Seqirus.com |
Responsible Party:
Seqirus
ClinicalTrials.gov Identifier:
NCT00562484
Other Study ID Numbers:
- CSLCT-USF-06-28
First Posted:
Nov 22, 2007
Last Update Posted:
Nov 21, 2017
Last Verified:
Oct 1, 2017