A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population in the USA
Sponsor
Seqirus (Industry)
Overall Status
Completed
CT.gov ID
NCT00958243
Collaborator
(none)
473
13
3
8
36.4
4.6
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
473 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 a Healthy Pediatric Population
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 |
|---|---|
| Placebo Comparator: Placebo Placebo |
Biological: Placebo
Placebo
|
| Experimental: CSL425 (7.5 mcg) 7.5 mcg of hemagglutinin antigen per dose |
Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)
0.25 mL intramuscular injection on Day 0 and Day 21
|
| Experimental: CSL425 (15 mcg) 15 mcg of hemagglutinin antigen per dose |
Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)
0.5 mL intramuscular injection on Day 0 and Day 21
|
Outcome Measures
Primary Outcome Measures
- Seroconversion Rate 21 Days After First Study Vaccination [21 days after the first study 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.
- Seroconversion Rate 21 Days After Second Study Vaccination [21 days after the second study 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 First Study Vaccination [21 days after the first study vaccination]
- Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination [21 days after the second study vaccination]
Secondary Outcome Measures
- Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A [During the 7 days after each study vaccination]
Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Cried when limb was moved/spontaneously painful (aged < 3 years) for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers.
- Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A [During the 7 days after each study vaccination]
- Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B [During the 7 days after each study vaccination]
Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Prevented normal daily activities (aged >= 3 years)for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers.
- Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B [During the 7 days after each study vaccination]
- Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination [During the 21 days after each vaccination]
UAE grading: Grade 1: Symptoms were easily tolerated and did not interfere with daily activities. Grade 2: Enough discomfort to cause some interference with daily activities. Grade 3: Symptoms that prevented normal, everyday activities.
- Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) [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 (e.g., diabetes, asthma).
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Months
to 9 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Male or female aged >= 6 months to < 9 years at the time of the first study vaccination.
-
For children < 3 years of age at the time of first vaccination, born at or after 36 weeks gestation.
Exclusion Criteria:
- Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chandler | Arizona | United States | 85224 | |
| 2 | Melbourne | Florida | United States | 32935 | |
| 3 | Bardstown | Kentucky | United States | 40004 | |
| 4 | Metairie | Louisiana | United States | 70006 | |
| 5 | Omaha | Nebraska | United States | 68134 | |
| 6 | Austintown | Ohio | United States | 44515 | |
| 7 | Cincinnati | Ohio | United States | 45246 | |
| 8 | Latrobe | Pennsylvania | United States | 15650 | |
| 9 | Pittsburgh | Pennsylvania | United States | 15227 | |
| 10 | Austin | Texas | United States | 78705 | |
| 11 | Fort Worth | Texas | United States | 76135 | |
| 12 | Houston | Texas | United States | 77030 | |
| 13 | Murray | Utah | United States | 84107 |
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:
NCT00958243
Other Study ID Numbers:
- CSLCT-CAL-09-62
First Posted:
Aug 13, 2009
Last Update Posted:
May 23, 2018
Last Verified:
Apr 1, 2018
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Placebo Cohort A | CSL425 (7.5 mcg) Cohort A | CSL425 (15 mcg) Cohort A | Placebo Cohort B | CSL425 (7.5 mcg) Cohort B | CSL425 (15 mcg) Cohort B |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo, Aged 6 months to less than 3 years | 7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | 15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | Placebo, Aged 3 years to less than 9 years | 7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years | 15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years |
| Period Title: Overall Study | ||||||
| STARTED | 26 | 105 | 96 | 28 | 109 | 109 |
| COMPLETED | 24 | 99 | 82 | 25 | 100 | 99 |
| NOT COMPLETED | 2 | 6 | 14 | 3 | 9 | 10 |
Baseline Characteristics
| Arm/Group Title | Placebo Cohort A | CSL425 (7.5 mcg) Cohort A | CSL425 (15 mcg) Cohort A | Placebo Cohort B | CSL425 (7.5 mcg) Cohort B | CSL425 (15 mcg) Cohort B | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo, Aged 6 months to less than 3 years | 7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | 15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | Placebo, Aged 3 years to less than 9 years | 7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years | 15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years | Total of all reporting groups |
| Overall Participants | 26 | 105 | 96 | 28 | 109 | 109 | 473 |
| Age (Count of Participants) | |||||||
| <=18 years |
26
100%
|
105
100%
|
96
100%
|
28
100%
|
109
100%
|
109
100%
|
473
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
1.87
(0.77)
|
1.73
(0.72)
|
1.85
(0.66)
|
5.90
(1.71)
|
5.94
(1.71)
|
5.91
(1.70)
|
3.93
(2.45)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
11
42.3%
|
57
54.3%
|
44
45.8%
|
13
46.4%
|
53
48.6%
|
50
45.9%
|
228
48.2%
|
| Male |
15
57.7%
|
48
45.7%
|
52
54.2%
|
15
53.6%
|
56
51.4%
|
59
54.1%
|
245
51.8%
|
| Region of Enrollment (participants) [Number] | |||||||
| United States |
26
100%
|
105
100%
|
96
100%
|
28
100%
|
109
100%
|
109
100%
|
473
100%
|
Outcome Measures
| Title | Seroconversion Rate 21 Days After First Study 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 first study vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3). |
| Arm/Group Title | Placebo Cohort A | CSL425 (7.5 mcg) Cohort A | CSL425 (15 mcg) Cohort A | Placebo Cohort B | CSL425 (7.5 mcg) Cohort B | CSL425 (15 mcg) Cohort B |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo, Aged 6 months to less than 3 years | 7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | 15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | Placebo, Aged 3 years to less than 9 years | 7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years | 15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years |
| Measure Participants | 25 | 102 | 89 | 27 | 104 | 102 |
| Number (95% Confidence Interval) [Percentage of participants] |
4.0
15.4%
|
88.2
84%
|
83.1
86.6%
|
3.7
13.2%
|
84.6
77.6%
|
88.2
80.9%
|
| Title | Seroconversion Rate 21 Days After Second Study 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 study 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 (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3). |
| Arm/Group Title | Placebo Cohort A | CSL425 (7.5 mcg) Cohort A | CSL425 (15 mcg) Cohort A | Placebo Cohort B | CSL425 (7.5 mcg) Cohort B | CSL425 (15 mcg) Cohort B |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo, Aged 6 months to less than 3 years | 7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | 15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | Placebo, Aged 3 years to less than 9 years | 7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years | 15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years |
| Measure Participants | 21 | 90 | 80 | 26 | 98 | 98 |
| Number (95% Confidence Interval) [Percentage of participants] |
28.6
110%
|
98.9
94.2%
|
100.0
104.2%
|
15.4
55%
|
98.0
89.9%
|
99.0
90.8%
|
| Title | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A |
|---|---|
| Description | Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Cried when limb was moved/spontaneously painful (aged < 3 years) for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers. |
| Time Frame | During the 7 days after each study vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data. |
| Arm/Group Title | Placebo Cohort A | CSL425 (7.5 mcg) Cohort A | CSL425 (15 mcg) Cohort A |
|---|---|---|---|
| Arm/Group Description | Placebo | 7.5 mcg of hemagglutinin antigen per dose | 15 mcg of hemagglutinin antigen per dose |
| Measure Participants | 26 | 105 | 96 |
| Any local solicited adverse event |
42
161.5%
|
44
41.9%
|
37
38.5%
|
| Any pain |
35
134.6%
|
33
31.4%
|
27
28.1%
|
| Grade 3 pain |
0
0%
|
0
0%
|
0
0%
|
| Any redness |
23
88.5%
|
27
25.7%
|
19
19.8%
|
| Grade 3 redness |
0
0%
|
0
0%
|
0
0%
|
| Any swelling / induration |
8
30.8%
|
16
15.2%
|
6
6.3%
|
| Grade 3 swelling / induration |
0
0%
|
0
0%
|
0
0%
|
| Any systemic solicited adverse event |
58
223.1%
|
70
66.7%
|
65
67.7%
|
| Any fever |
23
88.5%
|
25
23.8%
|
43
44.8%
|
| Grade 3 fever |
0
0%
|
3
2.9%
|
4
4.2%
|
| Any nausea / vomiting |
8
30.8%
|
11
10.5%
|
15
15.6%
|
| Grade 3 nausea / vomiting |
0
0%
|
0
0%
|
0
0%
|
| Any diarrhea |
39
150%
|
37
35.2%
|
38
39.6%
|
| Grade 3 diarrhea |
0
0%
|
1
1%
|
2
2.1%
|
| Any loss of appetite |
12
46.2%
|
24
22.9%
|
22
22.9%
|
| Grade 3 loss of appetite |
0
0%
|
0
0%
|
1
1%
|
| Any irritability |
23
88.5%
|
48
45.7%
|
34
35.4%
|
| Grade 3 irritability |
0
0%
|
1
1%
|
2
2.1%
|
| Title | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A |
|---|---|
| Description | |
| Time Frame | During the 7 days after each study vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.In Cohort A, Safety Population after the first vaccination are placebo group 26, 7.5 mcg group 105 and 15 mcg group 96; and 25, 101 and 91 respectively after the second vaccination. |
| Arm/Group Title | Placebo Cohort A | CSL425 (7.5 mcg) Cohort A | CSL425 (15 mcg) Cohort A |
|---|---|---|---|
| Arm/Group Description | Placebo | 7.5 mcg of hemagglutinin antigen per dose | 15 mcg of hemagglutinin antigen per dose |
| Measure Participants | 26 | 105 | 96 |
| Any pain after first vaccination |
1.00
(0.000)
|
1.52
(0.677)
|
1.91
(1.743)
|
| Any redness after first vaccination |
1.50
(0.577)
|
2.20
(1.323)
|
2.56
(1.459)
|
| Any swelling / induration after first vaccination |
1.50
(0.707)
|
1.63
(0.957)
|
2.00
(1.549)
|
| Any fever after first vaccination |
3.33
(3.215)
|
1.32
(0.557)
|
1.29
(0.893)
|
| Any nausea / vomiting after first vaccination |
1.00
(0.000)
|
1.43
(0.535)
|
1.11
(0.333)
|
| Any diarrhea after first vaccination |
1.67
(0.707)
|
2.38
(1.996)
|
3.95
(4.248)
|
| Any loss of appetite after first vaccination |
2.00
(NA)
|
3.13
(2.500)
|
2.07
(1.486)
|
| Any irritability after first vaccination |
6.00
(7.810)
|
2.08
(1.412)
|
1.97
(1.224)
|
| Any pain after second vaccination |
1.43
(0.787)
|
1.57
(0.676)
|
1.23
(0.599)
|
| Any redness after second vaccination |
2.40
(2.608)
|
2.00
(1.240)
|
1.63
(0.916)
|
| Any swelling / induration after second vaccination |
3.00
(NA)
|
3.00
(2.098)
|
2.50
(0.707)
|
| Any fever after second vaccination |
1.40
(0.894)
|
1.40
(0.894)
|
2.19
(2.344)
|
| Any nausea / vomiting after second vaccination |
NA
(NA)
|
1.27
(0.647)
|
1.50
(0.837)
|
| Any diarrhea after second vaccination |
8.00
(9.899)
|
1.92
(1.248)
|
4.33
(6.754)
|
| Any loss of appetite after second vaccination |
1.50
(0.707)
|
1.75
(1.183)
|
3.60
(5.168)
|
| Any irritability after second vaccination |
1.50
(0.577)
|
1.81
(1.001)
|
2.86
(4.597)
|
| Title | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B |
|---|---|
| Description | Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Prevented normal daily activities (aged >= 3 years)for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers. |
| Time Frame | During the 7 days after each study vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data. |
| Arm/Group Title | Placebo Cohort B | CSL425 (7.5 mcg) Cohort B | CSL425 (15 mcg) Cohort B |
|---|---|---|---|
| Arm/Group Description | Placebo | 7.5 mcg of hemagglutinin antigen per dose | 15 mcg of hemagglutinin antigen per dose |
| Measure Participants | 28 | 107 | 109 |
| Any local solicited adverse event |
43
165.4%
|
38
36.2%
|
49
51%
|
| Any pain |
29
111.5%
|
34
32.4%
|
40
41.7%
|
| Grade 3 pain |
0
0%
|
0
0%
|
0
0%
|
| Any redness |
29
111.5%
|
18
17.1%
|
26
27.1%
|
| Grade 3 redness |
0
0%
|
0
0%
|
0
0%
|
| Any swelling / induration |
11
42.3%
|
13
12.4%
|
17
17.7%
|
| Grade 3 swelling / induration |
0
0%
|
0
0%
|
0
0%
|
| Any systemic solicited adverse event |
46
176.9%
|
44
41.9%
|
46
47.9%
|
| Any fever |
14
53.8%
|
19
18.1%
|
20
20.8%
|
| Grade 3 fever |
0
0%
|
0
0%
|
0
0%
|
| Any nausea / vomiting |
14
53.8%
|
8
7.6%
|
13
13.5%
|
| Grade 3 nausea / vomiting |
0
0%
|
2
1.9%
|
1
1%
|
| Any diarrhea |
21
80.8%
|
8
7.6%
|
9
9.4%
|
| Grade 3 diarrhea |
0
0%
|
1
1%
|
0
0%
|
| Any headache |
21
80.8%
|
17
16.2%
|
25
26%
|
| Grade 3 headache |
0
0%
|
1
1%
|
0
0%
|
| Any malaise |
21
80.8%
|
27
25.7%
|
20
20.8%
|
| Grade 3 malaise |
4
15.4%
|
0
0%
|
0
0%
|
| Any myalgia |
21
80.8%
|
14
13.3%
|
22
22.9%
|
| Grade 3 myalgia |
0
0%
|
0
0%
|
0
0%
|
| Title | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination |
|---|---|
| Description | |
| Time Frame | 21 days after the first study vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3). |
| Arm/Group Title | Placebo Cohort A | CSL425 (7.5 mcg) Cohort A | CSL425 (15 mcg) Cohort A | Placebo Cohort B | CSL425 (7.5 mcg) Cohort B | CSL425 (15 mcg) Cohort B |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo, Aged 6 months to less than 3 years | 7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | 15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | Placebo, Aged 3 years to less than 9 years | 7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years | 15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years |
| Measure Participants | 25 | 102 | 89 | 27 | 104 | 102 |
| Number (95% Confidence Interval) [Percentage of participants] |
8.0
30.8%
|
90.2
85.9%
|
84.3
87.8%
|
25.9
92.5%
|
84.6
77.6%
|
89.2
81.8%
|
| Title | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination |
|---|---|
| Description | |
| Time Frame | 21 days after the second study 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 (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3). |
| Arm/Group Title | Placebo Cohort A | CSL425 (7.5 mcg) Cohort A | CSL425 (15 mcg) Cohort A | Placebo Cohort B | CSL425 (7.5 mcg) Cohort B | CSL425 (15 mcg) Cohort B |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo, Aged 6 months to less than 3 years | 7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | 15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | Placebo, Aged 3 years to less than 9 years | 7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years | 15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years |
| Measure Participants | 21 | 90 | 80 | 26 | 98 | 98 |
| Number (95% Confidence Interval) [Percentage of participants] |
28.6
110%
|
98.9
94.2%
|
100.0
104.2%
|
34.6
123.6%
|
98.0
89.9%
|
100.0
91.7%
|
| Title | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B |
|---|---|
| Description | |
| Time Frame | During the 7 days after each study vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data. In Cohort B, Safety Population after the first vaccination are placebo group 28, 7.5 mcg group 107 and 15 mcg group 109; and 27, 105 and 103 respectively after the second vaccination. |
| Arm/Group Title | Placebo Cohort B | CSL425 (7.5 mcg) Cohort B | CSL425 (15 mcg) Cohort B |
|---|---|---|---|
| Arm/Group Description | Placebo | 7.5 mcg of hemagglutinin antigen per dose | 15 mcg of hemagglutinin antigen per dose |
| Measure Participants | 28 | 107 | 109 |
| Any pain after first vaccination |
1.33
(0.516)
|
1.63
(1.066)
|
1.46
(0.691)
|
| Any redness after first vaccination |
2.29
(1.254)
|
2.17
(1.339)
|
2.24
(1.809)
|
| Any swelling / induration after first vaccination |
2.00
(1.732)
|
1.80
(0.632)
|
1.79
(0.975)
|
| Any fever after first vaccination |
1.20
(0.447)
|
1.12
(0.332)
|
1.56
(0.856)
|
| Any nausea / vomiting after first vaccination |
1.00
(0.000)
|
1.25
(0.500)
|
1.00
(0.000)
|
| Any diarrhea after first vaccination |
1.13
(0.354)
|
1.00
(0.000)
|
1.22
(0.441)
|
| Any malaise after first vaccination |
1.38
(0.744)
|
1.47
(0.964)
|
1.60
(0.995)
|
| Any myalgia after first vaccination |
1.60
(0.548)
|
1.42
(0.669)
|
1.56
(0.984)
|
| Any headache after first vaccination |
1.40
(0.894)
|
1.15
(0.376)
|
1.25
(0.645)
|
| Any pain after second vaccination |
1.25
(0.500)
|
1.56
(0.856)
|
1.33
(0.555)
|
| Any redness after second vaccination |
2.00
(0.000)
|
1.67
(0.516)
|
1.60
(0.699)
|
| Any swelling / induration after second vaccination |
2.00
(NA)
|
1.17
(0.408)
|
1.63
(0.744)
|
| Any fever after second vaccination |
1.00
(NA)
|
1.40
(0.548)
|
1.57
(1.134)
|
| Any nausea / vomiting after second vaccination |
1.00
(NA)
|
1.25
(0.500)
|
1.17
(0.408)
|
| Any diarrhea after second vaccination |
1
(NA)
|
1.00
(0.000)
|
1.00
(0.000)
|
| Any malaise after second vaccination |
1.50
(0.707)
|
1.75
(0.754)
|
1.83
(1.467)
|
| Any myalgia after second vaccination |
1.00
(NA)
|
1.38
(0.518)
|
1.42
(0.669)
|
| Any headache after second vaccination |
1.50
(0.707)
|
1.38
(0.518)
|
1.29
(0.488)
|
| Title | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination |
|---|---|
| Description | UAE grading: Grade 1: Symptoms were easily tolerated and did not interfere with daily activities. Grade 2: Enough discomfort to cause some interference with daily activities. Grade 3: Symptoms that prevented normal, everyday activities. |
| Time Frame | During the 21 days after each vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data. |
| Arm/Group Title | Placebo Cohort A | CSL425 (7.5 mcg) Cohort A | CSL425 (15 mcg) Cohort A | Placebo Cohort B | CSL425 (7.5 mcg) Cohort B | CSL425 (15 mcg) Cohort B |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo, Aged 6 months to less than 3 years | 7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | 15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | Placebo, Aged 3 years to less than 9 years | 7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years | 15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years |
| Measure Participants | 26 | 105 | 96 | 28 | 107 | 109 |
| Proportion of participants with at least one UAE |
69
265.4%
|
52
49.5%
|
55
57.3%
|
50
178.6%
|
49
45%
|
41
37.6%
|
| Proportion of participants reported Grade 1 UAE |
31
119.2%
|
26
24.8%
|
22
22.9%
|
14
50%
|
23
21.1%
|
19
17.4%
|
| Proportion of participants reported Grade 2 UAE |
39
150%
|
22
21%
|
27
28.1%
|
25
89.3%
|
21
19.3%
|
17
15.6%
|
| Proportion of participants reported Grade 3 UAE |
0
0%
|
5
4.8%
|
6
6.3%
|
11
39.3%
|
5
4.6%
|
6
5.5%
|
| Title | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) |
|---|---|
| Description | A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma). |
| Time Frame | Up to 180 days after the last vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data. |
| Arm/Group Title | Placebo Cohort A | CSL425 (7.5 mcg) Cohort A | CSL425 (15 mcg) Cohort A | Placebo Cohort B | CSL425 (7.5 mcg) Cohort B | CSL425 (15 mcg) Cohort B |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo, Aged 6 months to less than 3 years | 7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | 15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | Placebo, Aged 3 years to less than 9 years | 7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years | 15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years |
| Measure Participants | 26 | 105 | 96 | 28 | 107 | 109 |
| Proportion of participants with at least one SAE |
0
0%
|
2
1.9%
|
3
3.1%
|
0
0%
|
0
0%
|
0
0%
|
| Proportion of participants with related SAE |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Proportion of participants with at least one AESI |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Proportion of participants with related AESI |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Proportion of participants with at least one NOCI |
0
0%
|
0
0%
|
1
1%
|
0
0%
|
1
0.9%
|
0
0%
|
| Proportion of participants with related NOCI |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events. | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Other adverse events presented are unsolicited adverse events 21 days after either study vaccination. | |||||||||||
| Arm/Group Title | Placebo Cohort A | CSL425 (7.5 mcg) Cohort A | CSL425 (15 mcg) Cohort A | Placebo Cohort B | CSL425 (7.5 mcg) Cohort B | CSL425 (15 mcg) Cohort B | ||||||
| Arm/Group Description | Placebo, Aged 6 months to less than 3 years | 7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | 15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | Placebo, Aged 3 years to less than 9 years | 7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years | 15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years | ||||||
All Cause Mortality |
||||||||||||
| Placebo Cohort A | CSL425 (7.5 mcg) Cohort A | CSL425 (15 mcg) Cohort A | Placebo Cohort B | CSL425 (7.5 mcg) Cohort B | CSL425 (15 mcg) Cohort B | |||||||
| 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) | ||||||
Serious Adverse Events |
||||||||||||
| Placebo Cohort A | CSL425 (7.5 mcg) Cohort A | CSL425 (15 mcg) Cohort A | Placebo Cohort B | CSL425 (7.5 mcg) Cohort B | CSL425 (15 mcg) Cohort B | |||||||
| 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 | 0/26 (0%) | 2/105 (1.9%) | 3/96 (3.1%) | 0/28 (0%) | 0/107 (0%) | 0/109 (0%) | ||||||
| Infections and infestations | ||||||||||||
| Bronchiolitis | 0/26 (0%) | 0 | 0/105 (0%) | 0 | 1/96 (1%) | 1 | 0/28 (0%) | 0 | 0/107 (0%) | 0 | 0/109 (0%) | 0 |
| Influenza | 0/26 (0%) | 0 | 0/105 (0%) | 0 | 1/96 (1%) | 1 | 0/28 (0%) | 0 | 0/107 (0%) | 0 | 0/109 (0%) | 0 |
| Pneumonia viral | 0/26 (0%) | 0 | 0/105 (0%) | 0 | 1/96 (1%) | 1 | 0/28 (0%) | 0 | 0/107 (0%) | 0 | 0/109 (0%) | 0 |
| Respiratory syncytial virus infection | 0/26 (0%) | 0 | 0/105 (0%) | 0 | 1/96 (1%) | 1 | 0/28 (0%) | 0 | 0/107 (0%) | 0 | 0/109 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||
| Dehydration | 0/26 (0%) | 0 | 1/105 (1%) | 1 | 0/96 (0%) | 0 | 0/28 (0%) | 0 | 0/107 (0%) | 0 | 0/109 (0%) | 0 |
| Nervous system disorders | ||||||||||||
| Ataxia | 0/26 (0%) | 0 | 1/105 (1%) | 1 | 0/96 (0%) | 0 | 0/28 (0%) | 0 | 0/107 (0%) | 0 | 0/109 (0%) | 0 |
| Psychiatric disorders | ||||||||||||
| Mental status changes | 0/26 (0%) | 0 | 0/105 (0%) | 0 | 1/96 (1%) | 1 | 0/28 (0%) | 0 | 0/107 (0%) | 0 | 0/109 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||
| Placebo Cohort A | CSL425 (7.5 mcg) Cohort A | CSL425 (15 mcg) Cohort A | Placebo Cohort B | CSL425 (7.5 mcg) Cohort B | CSL425 (15 mcg) Cohort B | |||||||
| 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 | 25/26 (96.2%) | 58/105 (55.2%) | 82/96 (85.4%) | 22/28 (78.6%) | 70/107 (65.4%) | 49/109 (45%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Diarrhea | 1/26 (3.8%) | 1 | 5/105 (4.8%) | 5 | 5/96 (5.2%) | 7 | 0/28 (0%) | 0 | 7/107 (6.5%) | 7 | 2/109 (1.8%) | 2 |
| Teething | 1/26 (3.8%) | 1 | 5/105 (4.8%) | 7 | 7/96 (7.3%) | 10 | 0/28 (0%) | 0 | 0/107 (0%) | 0 | 0/109 (0%) | 0 |
| Vomiting | 0/26 (0%) | 0 | 4/105 (3.8%) | 4 | 4/96 (4.2%) | 5 | 2/28 (7.1%) | 2 | 7/107 (6.5%) | 7 | 2/109 (1.8%) | 2 |
| General disorders | ||||||||||||
| Pyrexia | 5/26 (19.2%) | 6 | 8/105 (7.6%) | 8 | 14/96 (14.6%) | 15 | 6/28 (21.4%) | 9 | 15/107 (14%) | 17 | 10/109 (9.2%) | 11 |
| Irritability | 0/26 (0%) | 0 | 2/105 (1.9%) | 2 | 7/96 (7.3%) | 7 | 0/28 (0%) | 0 | 0/107 (0%) | 0 | 3/109 (2.8%) | 5 |
| Malaise | 1/26 (3.8%) | 1 | 2/105 (1.9%) | 3 | 1/96 (1%) | 1 | 2/28 (7.1%) | 2 | 3/107 (2.8%) | 3 | 1/109 (0.9%) | 1 |
| Infections and infestations | ||||||||||||
| Ear infection | 2/26 (7.7%) | 2 | 2/105 (1.9%) | 2 | 1/96 (1%) | 1 | 1/28 (3.6%) | 1 | 0/107 (0%) | 0 | 0/109 (0%) | 0 |
| Nervous system disorders | ||||||||||||
| Headache | 0/26 (0%) | 0 | 0/105 (0%) | 0 | 1/96 (1%) | 1 | 4/28 (14.3%) | 5 | 8/107 (7.5%) | 8 | 4/109 (3.7%) | 4 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Rhinorrhea | 10/26 (38.5%) | 13 | 17/105 (16.2%) | 19 | 14/96 (14.6%) | 17 | 3/28 (10.7%) | 3 | 6/107 (5.6%) | 8 | 7/109 (6.4%) | 7 |
| Cough | 4/26 (15.4%) | 6 | 9/105 (8.6%) | 11 | 17/96 (17.7%) | 21 | 3/28 (10.7%) | 3 | 21/107 (19.6%) | 22 | 15/109 (13.8%) | 17 |
| Nasal congestion | 1/26 (3.8%) | 1 | 4/105 (3.8%) | 5 | 11/96 (11.5%) | 12 | 1/28 (3.6%) | 1 | 3/107 (2.8%) | 3 | 5/109 (4.6%) | 5 |
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 | 1-855-358-8966 |
| Seqirus.ClinicalTrials@Seqirus.com |
Responsible Party:
Seqirus
ClinicalTrials.gov Identifier:
NCT00958243
Other Study ID Numbers:
- CSLCT-CAL-09-62
First Posted:
Aug 13, 2009
Last Update Posted:
May 23, 2018
Last Verified:
Apr 1, 2018