A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults in the USA
Sponsor
Seqirus (Industry)
Overall Status
Completed
CT.gov ID
NCT00958126
Collaborator
(none)
1,313
11
4
8
119.4
15
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1313 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Phase II, Multicenter, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults Aged 18 Years and Older
Study Start Date
:
Aug 1, 2009
Actual Primary Completion Date
:
Nov 1, 2009
Actual Study Completion Date
:
Apr 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CSL425 (7.5 mcg) 7.5 mcg of hemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21 |
Biological: CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free.
|
| Experimental: CSL425 (15 mcg) 15 mcg of hemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
Biological: CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume).
|
| Experimental: CSL425 (30 mcg) 30 mcg of hemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21 |
Biological: CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume).
|
| Placebo Comparator: Placebo Vaccine diluent. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
Biological: Placebo
Vaccine diluent, thimerosal 0.01% (weight/volume).
|
Outcome Measures
Primary Outcome Measures
- Seroconversion Rate 21 Days After the First Vaccination [21 days after the first vaccination]
Seroconversion rate: the proportion of participants achieving seroconversion in hemagglutination inhibition (HI) antibody titer. Seroconversion is defined as participants with a baseline titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a baseline HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
- Seroconversion Rate 21 Days After the Second Vaccination [21 days after the second vaccination]
Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
- Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination [21 days after the first vaccination]
- Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination [21 days after the second vaccination]
Secondary Outcome Measures
- Frequency and Intensity of Solicited Adverse Events After the First Vaccination [During the 7 days after the first vaccination]
Grade 3 solicited adverse event (AE) definitions: Prevented normal daily activities; Size > 100 mm for injection site redness or induration/swelling; Temperature 102.2°F (39.0°C) or more for fevers.
- Duration of Solicited Local Adverse Events After the First Vaccination [During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs]
- Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) [Up to 180 days after the last vaccination]
A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).
- Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination [Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI]
Unsolicited adverse event (UAE) grading: Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities. Grade 2 (moderate): Enough discomfort to cause some interference with daily activities. Grade 3 (severe): Symptoms that prevented normal, everyday activities.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Male or female aged 18 and older, inclusive, at the time of providing informed consent.
-
Females of child bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child bearing potential must return a negative urine pregnancy test result at enrolment and prior to each study vaccination.
Exclusion Criteria:
- Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thimerosal, neomycin, polymyxin, or any components of the Study Vaccine.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Study Site | Huntsville | Alabama | United States | 35802 |
| 2 | Study Site | San Diego | California | United States | 92108 |
| 3 | Study Site | Melbourne | Florida | United States | 32935 |
| 4 | Study Site | Peoria | Illinois | United States | 61602 |
| 5 | Study Site | South Bend | Indiana | United States | 46601 |
| 6 | Study Site | Metairie | Louisiana | United States | 70006 |
| 7 | Study Site | Baltimore | Maryland | United States | 21205 |
| 8 | Study Site | Rockville | Maryland | United States | 20850 |
| 9 | Study Site | Austin | Texas | United States | 78705 |
| 10 | Study Site | Fort Worth | Texas | United States | 76135 |
| 11 | Study Site | Salt Lake City | Utah | United States | 84124 |
Sponsors and Collaborators
- Seqirus
Investigators
- Study Director: Director, Vaccines Clinical Development, Seqirus
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Seqirus
ClinicalTrials.gov Identifier:
NCT00958126
Other Study ID Numbers:
- CSLCT-CAL-09-61
First Posted:
Aug 13, 2009
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 | Placebo, Adults | CSL425 (7.5 mcg), Adults | CSL425 (15 Mcg), Adults | CSL425 (30 Mcg), Adults | Placebo, Older Adults | CSL425 (7.5 Mcg), Older Adults | CSL425 (15 Mcg), Older Adults | CSL425 (30 Mcg), Older Adults |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Vaccine diluent; Adults aged 18 to 64 years | 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | Vaccine diluent; Older adults aged 65 years or older | 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older |
| Period Title: Overall Study | ||||||||
| STARTED | 49 | 205 | 201 | 203 | 50 | 203 | 200 | 202 |
| COMPLETED | 48 | 196 | 191 | 192 | 50 | 202 | 199 | 202 |
| NOT COMPLETED | 1 | 9 | 10 | 11 | 0 | 1 | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Placebo, Adults | CSL425 (7.5 mcg), Adults | CSL425 (15 Mcg), Adults | CSL425 (30 Mcg), Adults | Placebo, Older Adults | CSL425 (7.5 Mcg), Older Adults | CSL425 (15 Mcg), Older Adults | CSL425 (30 Mcg), Older Adults | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Vaccine diluent; Adults aged 18 to 64 years | 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | Vaccine diluent; Older adults aged 65 years or older | 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | Total of all reporting groups |
| Overall Participants | 49 | 205 | 201 | 203 | 50 | 203 | 200 | 202 | 1313 |
| Age, Customized (participants) [Number] | |||||||||
| >= 18 years to 64 years |
49
100%
|
205
100%
|
201
100%
|
203
100%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
658
50.1%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
50
100%
|
203
100%
|
200
100%
|
202
100%
|
655
49.9%
|
| Sex: Female, Male (Count of Participants) | |||||||||
| Female |
31
63.3%
|
123
60%
|
113
56.2%
|
113
55.7%
|
29
58%
|
120
59.1%
|
108
54%
|
112
55.4%
|
749
57%
|
| Male |
18
36.7%
|
82
40%
|
88
43.8%
|
90
44.3%
|
21
42%
|
83
40.9%
|
92
46%
|
90
44.6%
|
564
43%
|
Outcome Measures
| Title | Seroconversion Rate 21 Days After the First Vaccination |
|---|---|
| Description | Seroconversion rate: the proportion of participants achieving seroconversion in hemagglutination inhibition (HI) antibody titer. Seroconversion is defined as participants with a baseline titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a baseline HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer. |
| Time Frame | 21 days after the first vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). |
| Arm/Group Title | Placebo, Adults | CSL425 (7.5 mcg), Adults | CSL425 (15 Mcg), Adults | CSL425 (30 Mcg), Adults | Placebo, Older Adults | CSL425 (7.5 Mcg), Older Adults | CSL425 (15 Mcg), Older Adults | CSL425 (30 Mcg), Older Adults |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Vaccine diluent; Adults aged 18 to 64 years | 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | Vaccine diluent; Older adults aged 65 years or older | 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older |
| Measure Participants | 48 | 200 | 195 | 199 | 48 | 201 | 197 | 200 |
| Number (95% Confidence Interval) [percentage of participants] |
0
0%
|
82
40%
|
88.2
43.9%
|
94.5
46.6%
|
2.1
4.2%
|
51.2
25.2%
|
58.9
29.5%
|
73.0
36.1%
|
| Title | Frequency and Intensity of Solicited Adverse Events After the First Vaccination |
|---|---|
| Description | Grade 3 solicited adverse event (AE) definitions: Prevented normal daily activities; Size > 100 mm for injection site redness or induration/swelling; Temperature 102.2°F (39.0°C) or more for fevers. |
| Time Frame | During the 7 days after the first vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety Population (first vaccination) comprised all randomized participants who received the first vaccination and provided follow-up safety data. |
| Arm/Group Title | Placebo, Adults | CSL425 (7.5 mcg), Adults | CSL425 (15 Mcg), Adults | CSL425 (30 Mcg), Adults | Placebo, Older Adults | CSL425 (7.5 Mcg), Older Adults | CSL425 (15 Mcg), Older Adults | CSL425 (30 Mcg), Older Adults |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Vaccine diluent; Adults aged 18 to 64 years | 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | Vaccine diluent; Older adults aged 65 years or older | 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older |
| Measure Participants | 49 | 204 | 201 | 203 | 50 | 203 | 200 | 202 |
| Any local solicited adverse event |
22.4
45.7%
|
28.9
14.1%
|
35.8
17.8%
|
52.7
26%
|
4.0
8%
|
13.3
6.6%
|
23.5
11.8%
|
21.8
10.8%
|
| Any pain at injection site |
14.3
29.2%
|
14.7
7.2%
|
17.4
8.7%
|
31.0
15.3%
|
2.0
4%
|
2.0
1%
|
4.0
2%
|
6.9
3.4%
|
| Grade 3 pain at injection site |
0
0%
|
0
0%
|
0
0%
|
0.5
0.2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any redness at injection site |
0
0%
|
1.0
0.5%
|
0.5
0.2%
|
1.0
0.5%
|
0
0%
|
0.5
0.2%
|
1.0
0.5%
|
0
0%
|
| Grade 3 redness at injection site |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any swelling/induration at injection site |
0
0%
|
3.9
1.9%
|
2.5
1.2%
|
3.9
1.9%
|
0
0%
|
2.0
1%
|
3.0
1.5%
|
2.5
1.2%
|
| Grade 3 swelling/induration at injection site |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any tenderness at injection site |
18.4
37.6%
|
23.5
11.5%
|
32.8
16.3%
|
46.8
23.1%
|
4.0
8%
|
10.3
5.1%
|
20.0
10%
|
18.3
9.1%
|
| Grade 3 tenderness at injection site |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any bruising at injection site |
0
0%
|
4.4
2.1%
|
4.0
2%
|
1.0
0.5%
|
0
0%
|
1.5
0.7%
|
3.0
1.5%
|
1.5
0.7%
|
| Grade 3 bruising at injection site |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any solicited systemic adverse event |
28.6
58.4%
|
35.3
17.2%
|
34.8
17.3%
|
40.9
20.1%
|
18.0
36%
|
16.7
8.2%
|
24.0
12%
|
22.8
11.3%
|
| Any headache |
16.3
33.3%
|
19.6
9.6%
|
21.4
10.6%
|
27.1
13.3%
|
8.0
16%
|
9.4
4.6%
|
10.5
5.3%
|
10.4
5.1%
|
| Grade 3 headache |
0
0%
|
1.0
0.5%
|
1.0
0.5%
|
0
0%
|
0
0%
|
0.5
0.2%
|
0
0%
|
0.5
0.2%
|
| Any malaise |
8.2
16.7%
|
10.8
5.3%
|
16.4
8.2%
|
17.2
8.5%
|
10.0
20%
|
5.4
2.7%
|
9.5
4.8%
|
11.9
5.9%
|
| Grade 3 malaise |
0
0%
|
1.0
0.5%
|
1.0
0.5%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any myalgia |
4.1
8.4%
|
14.7
7.2%
|
15.9
7.9%
|
17.7
8.7%
|
8.0
16%
|
8.9
4.4%
|
13.0
6.5%
|
13.4
6.6%
|
| Grade 3 myalgia |
0
0%
|
0.5
0.2%
|
0.5
0.2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any nausea |
4.1
8.4%
|
6.4
3.1%
|
8.0
4%
|
7.9
3.9%
|
2.0
4%
|
1.0
0.5%
|
2.5
1.3%
|
3.5
1.7%
|
| Grade 3 nausea |
0
0%
|
0.5
0.2%
|
0
0%
|
0.5
0.2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any chills |
2.0
4.1%
|
3.9
1.9%
|
5.0
2.5%
|
5.4
2.7%
|
0
0%
|
0.5
0.2%
|
1.0
0.5%
|
3.0
1.5%
|
| Grade 3 chills |
0
0%
|
0.5
0.2%
|
0.5
0.2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any vomiting |
0
0%
|
2.9
1.4%
|
1.0
0.5%
|
1.0
0.5%
|
0
0%
|
0
0%
|
0.5
0.3%
|
0.5
0.2%
|
| Grade 3 vomiting |
0
0%
|
0.5
0.2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any fever |
2.0
4.1%
|
3.4
1.7%
|
3.0
1.5%
|
3.4
1.7%
|
0
0%
|
0
0%
|
0.5
0.3%
|
0.5
0.2%
|
| Grade 3 fever |
0
0%
|
0.5
0.2%
|
1.0
0.5%
|
0.5
0.2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Duration of Solicited Local Adverse Events After the First Vaccination |
|---|---|
| Description | |
| Time Frame | During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety Population (first vaccination) comprised all randomized participants who received the first vaccination and provided follow-up safety data. |
| Arm/Group Title | Placebo, Adults | CSL425 (7.5 mcg), Adults | CSL425 (15 Mcg), Adults | CSL425 (30 Mcg), Adults | Placebo, Older Adults | CSL425 (7.5 Mcg), Older Adults | CSL425 (15 Mcg), Older Adults | CSL425 (30 Mcg), Older Adults |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Vaccine diluent; Adults aged 18 to 64 years | 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | Vaccine diluent; Older adults aged 65 years or older | 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older |
| Measure Participants | 49 | 204 | 201 | 203 | 50 | 203 | 200 | 202 |
| Pain at injection site |
1.14
(0.378)
|
1.87
(2.705)
|
1.71
(0.926)
|
1.91
(1.237)
|
1.00
(NA)
|
1.75
(0.957)
|
1.75
(0.886)
|
1.27
(0.594)
|
| Redness at injection site |
NA
(NA)
|
1.00
(0.000)
|
1.00
(NA)
|
2.50
(0.707)
|
NA
(NA)
|
1.00
(NA)
|
1.00
(0.000)
|
NA
(NA)
|
| Swelling/induration at injection site |
NA
(NA)
|
1.56
(0.726)
|
1.2
(0.447)
|
3.38
(2.615)
|
NA
(NA)
|
6.00
(10.00)
|
1.5
(0.837)
|
3.2
(4.382)
|
| Tenderness at injection site |
2.1
(1.912)
|
2.04
(2.813)
|
1.85
(0.966)
|
1.90
(1.082)
|
1.5
(0.707)
|
1.27
(0.550)
|
1.71
(0.955)
|
1.65
(1.075)
|
| Bruising at injection site |
NA
(NA)
|
3.00
(2.539)
|
2.25
(1.669)
|
2.00
(0.000)
|
NA
(NA)
|
8.00
(11.269)
|
4.33
(2.503)
|
1.20
(0.447)
|
| Title | Seroconversion Rate 21 Days After the Second Vaccination |
|---|---|
| Description | Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer. |
| Time Frame | 21 days after the second vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). |
| Arm/Group Title | Placebo, Adults | CSL425 (7.5 mcg), Adults | CSL425 (15 Mcg), Adults | CSL425 (30 Mcg), Adults | Placebo, Older Adults | CSL425 (7.5 Mcg), Older Adults | CSL425 (15 Mcg), Older Adults | CSL425 (30 Mcg), Older Adults |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Vaccine diluent; Adults aged 18 to 64 years | 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | Vaccine diluent; Older adults aged 65 years or older | 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older |
| Measure Participants | 48 | 196 | 191 | 193 | 48 | 200 | 196 | 198 |
| Number (95% Confidence Interval) [percentage of participants] |
6.3
12.9%
|
83.2
40.6%
|
91.1
45.3%
|
95.9
47.2%
|
8.3
16.6%
|
59.5
29.3%
|
67.3
33.7%
|
75.3
37.3%
|
| Title | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination |
|---|---|
| Description | |
| Time Frame | 21 days after the first vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). |
| Arm/Group Title | Placebo, Adults | CSL425 (7.5 mcg), Adults | CSL425 (15 Mcg), Adults | CSL425 (30 Mcg), Adults | Placebo, Older Adults | CSL425 (7.5 Mcg), Older Adults | CSL425 (15 Mcg), Older Adults | CSL425 (30 Mcg), Older Adults |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Vaccine diluent; Adults aged 18 to 64 years | 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | Vaccine diluent; Older adults aged 65 years or older | 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older |
| Measure Participants | 48 | 200 | 195 | 199 | 48 | 201 | 197 | 200 |
| Number (95% Confidence Interval) [percentage of participants] |
22.9
46.7%
|
97.0
47.3%
|
96.4
48%
|
99.5
49%
|
39.6
79.2%
|
92.0
45.3%
|
90.9
45.5%
|
94.0
46.5%
|
| Title | Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination |
|---|---|
| Description | |
| Time Frame | 21 days after the second vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). |
| Arm/Group Title | Placebo, Adults | CSL425 (7.5 mcg), Adults | CSL425 (15 Mcg), Adults | CSL425 (30 Mcg), Adults | Placebo, Older Adults | CSL425 (7.5 Mcg), Older Adults | CSL425 (15 Mcg), Older Adults | CSL425 (30 Mcg), Older Adults |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Vaccine diluent; Adults aged 18 to 64 years | 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | Vaccine diluent; Older adults aged 65 years or older | 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older |
| Measure Participants | 48 | 196 | 191 | 193 | 48 | 200 | 196 | 198 |
| Number (95% Confidence Interval) [percentage of participants] |
29.2
59.6%
|
98.5
48%
|
99.5
49.5%
|
99.5
49%
|
35.4
70.8%
|
96.0
47.3%
|
93.4
46.7%
|
94.9
47%
|
| Title | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) |
|---|---|
| Description | A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma). |
| Time Frame | Up to 180 days after the last vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety Population comprised all randomized participants who received at least one dose of study vaccine and provided follow-up safety data. |
| Arm/Group Title | Placebo, Adults | CSL425 (7.5 mcg), Adults | CSL425 (15 Mcg), Adults | CSL425 (30 Mcg), Adults | Placebo, Older Adults | CSL425 (7.5 Mcg), Older Adults | CSL425 (15 Mcg), Older Adults | CSL425 (30 Mcg), Older Adults |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Vaccine diluent; Adults aged 18 to 64 years | 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | Vaccine diluent; Older adults aged 65 years or older | 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older |
| Measure Participants | 49 | 204 | 201 | 203 | 50 | 203 | 200 | 202 |
| Percentage of participants with at least one SAE |
0
0%
|
2.9
1.4%
|
2.0
1%
|
1.5
0.7%
|
6.0
12%
|
4.4
2.2%
|
3.0
1.5%
|
4.5
2.2%
|
| Percentage of participants with related SAE |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Percentage of participants with at least one AESI |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Percentage of participants with related AESI |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Percentage of participants with at least one NOCI |
4.1
8.4%
|
0.5
0.2%
|
0.5
0.2%
|
0.5
0.2%
|
2.0
4%
|
1.0
0.5%
|
2.5
1.3%
|
2.0
1%
|
| Percentage of participants with related NOCI |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination |
|---|---|
| Description | Unsolicited adverse event (UAE) grading: Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities. Grade 2 (moderate): Enough discomfort to cause some interference with daily activities. Grade 3 (severe): Symptoms that prevented normal, everyday activities. |
| Time Frame | Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety Population comprised all randomized participants who received at least one dose of study vaccine and provided follow-up safety data. |
| Arm/Group Title | Placebo, Age Cohorts Combined | CSL425 (7.5 mcg), Age Cohorts Combined | CSL425 (15 Mcg), Age Cohorts Combined | CSL425 (30 Mcg), Age Cohorts Combined |
|---|---|---|---|---|
| Arm/Group Description | Vaccine diluent | 7.5 mcg of hemagglutinin antigen per dose | 15 mcg of hemagglutinin antigen per dose | 30 mcg of hemagglutinin antigen per dose |
| Measure Participants | 99 | 407 | 401 | 405 |
| Percentage of participants with at least one UAE |
27.3
55.7%
|
27.5
13.4%
|
30.2
15%
|
27.9
13.7%
|
| Percentage of participants reporting Grade 1 UAE |
7.1
14.5%
|
12.8
6.2%
|
10.0
5%
|
12.8
6.3%
|
| Percentage of participants reporting Grade 2 UAE |
15.2
31%
|
8.8
4.3%
|
14.0
7%
|
10.4
5.1%
|
| Percentage of participants reporting Grade 3 UAE |
5.1
10.4%
|
5.9
2.9%
|
6.2
3.1%
|
4.7
2.3%
|
Adverse Events
| Time Frame | For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI). | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Serious Adverse Events were collected from Day 0 to 180 days after the last vaccination. The other adverse events presented are unsolicited adverse events from Day 0 to Day 20 days after the first study vaccination, AESI and NOCI from Day 0 to 180 days after the last vaccination. | |||||||||||||||
| Arm/Group Title | Placebo, Adults | CSL425 (7.5 mcg), Adults | CSL425 (15 Mcg), Adults | CSL425 (30 Mcg), Adults | Placebo, Older Adults | CSL425 (7.5 Mcg), Older Adults | CSL425 (15 Mcg), Older Adults | CSL425 (30 Mcg), Older Adults | ||||||||
| Arm/Group Description | Vaccine diluent; Adults aged 18 to 64 years | 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | Vaccine diluent; Older adults aged 65 years or older | 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | ||||||||
All Cause Mortality |
||||||||||||||||
| Placebo, Adults | CSL425 (7.5 mcg), Adults | CSL425 (15 Mcg), Adults | CSL425 (30 Mcg), Adults | Placebo, Older Adults | CSL425 (7.5 Mcg), Older Adults | CSL425 (15 Mcg), Older Adults | CSL425 (30 Mcg), Older Adults | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||
Serious Adverse Events |
||||||||||||||||
| Placebo, Adults | CSL425 (7.5 mcg), Adults | CSL425 (15 Mcg), Adults | CSL425 (30 Mcg), Adults | Placebo, Older Adults | CSL425 (7.5 Mcg), Older Adults | CSL425 (15 Mcg), Older Adults | CSL425 (30 Mcg), Older Adults | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/49 (0%) | 6/204 (2.9%) | 4/201 (2%) | 3/203 (1.5%) | 3/50 (6%) | 9/203 (4.4%) | 6/200 (3%) | 9/202 (4.5%) | ||||||||
| Blood and lymphatic system disorders | ||||||||||||||||
| Anaemia | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 1/201 (0.5%) | 1 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Disseminated intravascular coagulation | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 1/202 (0.5%) | 1 |
| Cardiac disorders | ||||||||||||||||
| Myocardial infarction | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 1/201 (0.5%) | 1 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Atrial fibrillation | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 2/200 (1%) | 2 | 0/202 (0%) | 0 |
| Acute myocardial infarction | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 1/200 (0.5%) | 1 | 0/202 (0%) | 0 |
| Cardiac failure | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 1/203 (0.5%) | 1 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Pericarditis | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 1/50 (2%) | 1 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Ventricular fibrillation | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 1/200 (0.5%) | 1 | 0/202 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||||||||||||||
| Atrial septal defect | 0/49 (0%) | 0 | 1/204 (0.5%) | 1 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Fibrous dysplasia of bone | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 1/201 (0.5%) | 1 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||||
| Umbilical hernia, obstructive | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 1/203 (0.5%) | 1 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Infections and infestations | ||||||||||||||||
| Pneumonia | 0/49 (0%) | 0 | 1/204 (0.5%) | 1 | 1/201 (0.5%) | 1 | 0/203 (0%) | 0 | 1/50 (2%) | 1 | 1/203 (0.5%) | 1 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Appendicitis | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 1/203 (0.5%) | 1 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Cellulitis | 0/49 (0%) | 0 | 1/204 (0.5%) | 1 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 2/202 (1%) | 2 |
| Subcutaneous abscess | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 1/203 (0.5%) | 1 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Viral infection | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 1/201 (0.5%) | 1 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Acute sinusitis | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 1/203 (0.5%) | 1 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Arthritis bacterial | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 1/202 (0.5%) | 1 |
| Viral myocarditis | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 1/202 (0.5%) | 1 |
| Injury, poisoning and procedural complications | ||||||||||||||||
| Accidental overdose | 0/49 (0%) | 0 | 1/204 (0.5%) | 1 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Acetabulum fracture | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 1/203 (0.5%) | 1 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Arterial injury | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 1/202 (0.5%) | 1 |
| Humerus fracture | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 1/200 (0.5%) | 1 | 0/202 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| Athralgia | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 1/203 (0.5%) | 1 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Arthritis | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 1/203 (0.5%) | 1 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Osteoarthritis | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 1/50 (2%) | 1 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Torticollis | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 1/202 (0.5%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||
| Lip and/or oral cavity cancer | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 1/202 (0.5%) | 1 |
| Lung metastatic cancer | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 1/202 (0.5%) | 1 |
| Lung neoplasm malignant | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 1/203 (0.5%) | 1 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Prostate cancer | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 1/202 (0.5%) | 1 |
| Renal cell carcinoma | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 1/202 (0.5%) | 1 |
| Tonsil cancer | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 1/202 (0.5%) | 1 |
| Nervous system disorders | ||||||||||||||||
| Presyncope | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 1/203 (0.5%) | 1 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||||||
| Urinary retention | 0/49 (0%) | 0 | 1/204 (0.5%) | 1 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Urinary bladder haemorrhage | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 1/200 (0.5%) | 1 | 0/202 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||||||||
| Prostatic obstruction | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 1/202 (0.5%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Chronic obstructive pulmonary disease | 0/49 (0%) | 0 | 1/204 (0.5%) | 1 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 1/200 (0.5%) | 1 | 0/202 (0%) | 0 |
| Sleep apnoea syndrome | 0/49 (0%) | 0 | 1/204 (0.5%) | 1 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Asthma | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 1/203 (0.5%) | 1 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Pulmonary embolism | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 1/203 (0.5%) | 1 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Respiratory distress | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 1/202 (0.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| Placebo, Adults | CSL425 (7.5 mcg), Adults | CSL425 (15 Mcg), Adults | CSL425 (30 Mcg), Adults | Placebo, Older Adults | CSL425 (7.5 Mcg), Older Adults | CSL425 (15 Mcg), Older Adults | CSL425 (30 Mcg), Older Adults | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/49 (24.5%) | 27/204 (13.2%) | 25/201 (12.4%) | 27/203 (13.3%) | 5/50 (10%) | 20/203 (9.9%) | 23/200 (11.5%) | 18/202 (8.9%) | ||||||||
| Ear and labyrinth disorders | ||||||||||||||||
| Ear pain | 0/49 (0%) | 0 | 1/204 (0.5%) | 1 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 1/50 (2%) | 1 | 1/203 (0.5%) | 1 | 1/200 (0.5%) | 1 | 0/202 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||||
| Diarrhoea | 1/49 (2%) | 1 | 4/204 (2%) | 4 | 1/201 (0.5%) | 2 | 2/203 (1%) | 2 | 0/50 (0%) | 0 | 2/203 (1%) | 2 | 5/200 (2.5%) | 5 | 0/202 (0%) | 0 |
| Nausea | 1/49 (2%) | 1 | 1/204 (0.5%) | 1 | 1/201 (0.5%) | 2 | 0/203 (0%) | 0 | 1/50 (2%) | 1 | 2/203 (1%) | 2 | 0/200 (0%) | 0 | 2/202 (1%) | 2 |
| Toothache | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 1/203 (0.5%) | 1 | 1/50 (2%) | 1 | 1/203 (0.5%) | 1 | 1/200 (0.5%) | 1 | 0/202 (0%) | 0 |
| General disorders | ||||||||||||||||
| Pyrexia | 0/49 (0%) | 0 | 2/204 (1%) | 2 | 5/201 (2.5%) | 5 | 2/203 (1%) | 3 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 2/200 (1%) | 2 | 2/202 (1%) | 2 |
| Malaise | 1/49 (2%) | 1 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 1/203 (0.5%) | 1 | 0/50 (0%) | 0 | 1/203 (0.5%) | 1 | 1/200 (0.5%) | 1 | 4/202 (2%) | 4 |
| Infections and infestations | ||||||||||||||||
| Nasopharyngitis | 2/49 (4.1%) | 2 | 4/204 (2%) | 4 | 4/201 (2%) | 5 | 3/203 (1.5%) | 3 | 0/50 (0%) | 0 | 1/203 (0.5%) | 1 | 1/200 (0.5%) | 1 | 2/202 (1%) | 2 |
| Oral herpes | 1/49 (2%) | 1 | 2/204 (1%) | 2 | 1/201 (0.5%) | 1 | 1/203 (0.5%) | 1 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 1/200 (0.5%) | 1 | 0/202 (0%) | 0 |
| Rhinitis | 1/49 (2%) | 1 | 1/204 (0.5%) | 1 | 0/201 (0%) | 0 | 2/203 (1%) | 2 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 1/200 (0.5%) | 1 | 1/202 (0.5%) | 1 |
| Pneumonia | 1/49 (2%) | 1 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 1/200 (0.5%) | 1 | 0/202 (0%) | 0 |
| Urinary tract infection | 1/49 (2%) | 1 | 1/204 (0.5%) | 1 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 2/203 (1%) | 2 | 1/200 (0.5%) | 1 | 0/202 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||||||
| Hyperlipidaemia | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 1/203 (0.5%) | 1 | 1/50 (2%) | 1 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| Myalgia | 1/49 (2%) | 1 | 1/204 (0.5%) | 1 | 1/201 (0.5%) | 2 | 3/203 (1.5%) | 3 | 0/50 (0%) | 0 | 1/203 (0.5%) | 1 | 2/200 (1%) | 3 | 4/202 (2%) | 4 |
| Back pain | 1/49 (2%) | 1 | 0/204 (0%) | 0 | 2/201 (1%) | 2 | 1/203 (0.5%) | 1 | 0/50 (0%) | 0 | 1/203 (0.5%) | 1 | 3/200 (1.5%) | 3 | 2/202 (1%) | 4 |
| Pain in extremity | 1/49 (2%) | 1 | 1/204 (0.5%) | 1 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 1/203 (0.5%) | 2 | 1/200 (0.5%) | 1 | 1/202 (0.5%) | 1 |
| Muscle spasms | 1/49 (2%) | 1 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 1/203 (0.5%) | 1 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||
| Headache | 2/49 (4.1%) | 4 | 8/204 (3.9%) | 8 | 5/201 (2.5%) | 7 | 4/203 (2%) | 4 | 0/50 (0%) | 0 | 7/203 (3.4%) | 8 | 3/200 (1.5%) | 3 | 2/202 (1%) | 2 |
| Psychiatric disorders | ||||||||||||||||
| Anxiety | 1/49 (2%) | 1 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 1/203 (0.5%) | 1 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 1/202 (0.5%) | 1 |
| Insomnia | 1/49 (2%) | 1 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 1/203 (0.5%) | 1 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 1/200 (0.5%) | 1 | 0/202 (0%) | 0 |
| Depression | 1/49 (2%) | 1 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||||||||
| Pelvic prolapse | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 0/201 (0%) | 0 | 0/203 (0%) | 0 | 1/50 (2%) | 1 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Oropharyngeal pain | 1/49 (2%) | 1 | 6/204 (2.9%) | 6 | 8/201 (4%) | 8 | 8/203 (3.9%) | 8 | 0/50 (0%) | 0 | 1/203 (0.5%) | 1 | 2/200 (1%) | 2 | 1/202 (0.5%) | 1 |
| Cough | 1/49 (2%) | 1 | 5/204 (2.5%) | 5 | 7/201 (3.5%) | 7 | 9/203 (4.4%) | 9 | 0/50 (0%) | 0 | 3/203 (1.5%) | 4 | 1/200 (0.5%) | 1 | 4/202 (2%) | 4 |
| Nasal congestion | 0/49 (0%) | 0 | 2/204 (1%) | 2 | 2/201 (1%) | 2 | 7/203 (3.4%) | 7 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 1/200 (0.5%) | 1 | 0/202 (0%) | 0 |
| Asthma | 1/49 (2%) | 1 | 0/204 (0%) | 0 | 1/201 (0.5%) | 1 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 0/203 (0%) | 0 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Rhinorrhoea | 0/49 (0%) | 0 | 2/204 (1%) | 2 | 0/201 (0%) | 0 | 3/203 (1.5%) | 3 | 1/50 (2%) | 2 | 2/203 (1%) | 3 | 1/200 (0.5%) | 1 | 2/202 (1%) | 2 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| Dermatitis contact | 0/49 (0%) | 0 | 0/204 (0%) | 0 | 1/201 (0.5%) | 1 | 0/203 (0%) | 0 | 1/50 (2%) | 1 | 0/0 (NaN) | 0 | 0/200 (0%) | 0 | 0/202 (0%) | 0 |
| Vascular disorders | ||||||||||||||||
| Hypertension | 2/49 (4.1%) | 2 | 0/204 (0%) | 0 | 1/201 (0.5%) | 1 | 0/203 (0%) | 0 | 0/50 (0%) | 0 | 1/203 (0.5%) | 1 | 1/200 (0.5%) | 1 | 0/202 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | Clinical Trials Disclosure Manager |
|---|---|
| Organization | Seqirus |
| Phone | |
| Seqirus.ClinicalTrials@Seqirus.com |
Responsible Party:
Seqirus
ClinicalTrials.gov Identifier:
NCT00958126
Other Study ID Numbers:
- CSLCT-CAL-09-61
First Posted:
Aug 13, 2009
Last Update Posted:
Nov 21, 2017
Last Verified:
Oct 1, 2017