A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine in a Pediatric Population
Sponsor
Seqirus (Industry)
Overall Status
Completed
CT.gov ID
NCT00959049
Collaborator
(none)
1,474
23
6
8
64.1
8.1
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18 years.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1474 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Phase III, Randomized, Observer-blind, Multi-center, Noninferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Trivalent Inactivated Split-Virion Influenza Vaccine in a Pediatric Population Aged Greater Than or Equal to 6 Months to Less Than 18 Years.
Study Start Date
:
Sep 1, 2009
Actual Primary Completion Date
:
Dec 1, 2009
Actual Study Completion Date
:
May 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Afluria Cohort A Age 6 months to < 3 years |
Biological: CSL's Influenza Virus Vaccine (Afluria)
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
|
| Experimental: Afluria Cohort B Age 3 to < 9 years |
Biological: CSL's Influenza Virus Vaccine (Afluria)
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
|
| Experimental: Afluria Cohort C Age 9 to < 18 years |
Biological: CSL's Influenza Virus Vaccine (Afluria)
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
|
| Active Comparator: Fluzone Cohort A Age 6 months to < 3 years |
Biological: Influenza Virus Vaccine (Fluzone)
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
|
| Active Comparator: Fluzone Cohort B Age 3 to < 9 years |
Biological: Influenza Virus Vaccine (Fluzone)
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
|
| Active Comparator: Fluzone Cohort C Age 9 to < 18 years |
Biological: Influenza Virus Vaccine (Fluzone)
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
|
Outcome Measures
Primary Outcome Measures
- Geometric Mean Titer 30 Days After the Last Study Vaccination [30 days after the last study vaccination]
- Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination [30 days after the last study vaccination]
Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.
Secondary Outcome Measures
- Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) [7 days after each vaccination]
- Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B [7 days after each vaccination]
- Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C [7 days after vaccination]
- Frequency and Intensity of Unsolicited Adverse Events (UAEs) [30 days after each vaccination]
UAE stands for Unsolicited Adverse Events
- New Onset of Chronic Illnesses (NOCIs) [6 months after last study vaccination]
New onset of chronic illness after any vaccine dose. A new onset of chronic illness was defined as the diagnosis of a new medical condition which was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).
- Serious Adverse Events (SAEs) [6 months after last study vaccination]
- Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) [7 days after each vaccination]
- Duration of Local and Systemic Solicited Symptoms, Cohort B [7 days after each vaccination]
- Duration of Local and Systemic Solicited Symptoms, Cohort C [7 days after vaccination]
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Months
to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Healthy male or non-pregnant female participants aged ≥ 6 calendar months to < 18 years at the time of the first study vaccination.
-
For participants aged ≥ 6 months to < 9 years, born after a normal gestation period (between 36 and 42 weeks).
-
Females of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for at least 2 months after vaccination. Females aged ≥ 9 years must also return a negative urine pregnancy test at enrollment.
Exclusion Criteria:
- Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chandler | Arizona | United States | 85224 | |
| 2 | Harrisburg | Arkansas | United States | 72432 | |
| 3 | Jonesboro | Arkansas | United States | 72401 | |
| 4 | Little Rock | Arkansas | United States | 72205 | |
| 5 | Mountain Home | Arkansas | United States | 72653 | |
| 6 | Melbourne | Florida | United States | 32935 | |
| 7 | Bardstown | Kentucky | United States | 40004 | |
| 8 | Omaha | Nebraska | United States | 68134 | |
| 9 | Binghamton | New York | United States | 13901 | |
| 10 | Elmira | New York | United States | 14901 | |
| 11 | Cincinnati Children's Hospital Medical Center- Division of Infectious Disease | Cincinnati | Ohio | United States | 45229 |
| 12 | Warr Acres | Oklahoma | United States | 73132 | |
| 13 | UPMC / Community Medicine Inc | Greenville | Pennsylvania | United States | 16125 |
| 14 | Pediatric Associates of Latrobe | Latrobe | Pennsylvania | United States | 15650 |
| 15 | Pediatric Alliance Greentree Division | Pittsburgh | Pennsylvania | United States | 15220 |
| 16 | South Hills Pediatrics | Pittsburgh | Pennsylvania | United States | 15227 |
| 17 | Pittsburgh | Pennsylvania | United States | 15241 | |
| 18 | Salt Lake City | Utah | United States | 84109 | |
| 19 | Salt Lake City | Utah | United States | 84121 | |
| 20 | Salt Lake City | Utah | United States | 84124 | |
| 21 | South Jordan | Utah | United States | 84095 | |
| 22 | Burke | Virginia | United States | 22015 | |
| 23 | Vienna | Virginia | United States | 22180 |
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:
NCT00959049
Other Study ID Numbers:
- CSLCT-USF-07-36
First Posted:
Aug 14, 2009
Last Update Posted:
May 16, 2017
Last Verified:
Apr 1, 2017
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled into this study during the autumn of 2009 at 23 sites in the US. |
|---|---|
| Pre-assignment Detail | A total of 1474 participants were enrolled, vaccinated and analyzed. |
| Arm/Group Title | Afluria Cohort A | Afluria Cohort B | Afluria Cohort C | Fluzone Cohort A | Fluzone Cohort B | Fluzone Cohort C |
|---|---|---|---|---|---|---|
| Arm/Group Description | Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria. | Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria. | Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria. | Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. | Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. | Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. |
| Period Title: Overall Study | ||||||
| STARTED | 231 | 254 | 254 | 228 | 257 | 250 |
| COMPLETED | 213 | 247 | 253 | 217 | 248 | 249 |
| NOT COMPLETED | 18 | 7 | 1 | 11 | 9 | 1 |
Baseline Characteristics
| Arm/Group Title | Afluria Cohort A | Afluria Cohort B | Afluria Cohort C | Fluzone Cohort A | Fluzone Cohort B | Fluzone Cohort C | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria. | Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria. | Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria. | Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. | Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. | Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. | Total of all reporting groups |
| Overall Participants | 231 | 254 | 254 | 228 | 257 | 250 | 1474 |
| Age (Count of Participants) | |||||||
| <=18 years |
231
100%
|
254
100%
|
254
100%
|
228
100%
|
257
100%
|
250
100%
|
1474
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] |
1.94
(0.667)
|
5.93
(1.725)
|
12.98
(2.388)
|
1.96
(0.673)
|
5.82
(1.748)
|
12.86
(2.474)
|
7.06
(4.855)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
119
51.5%
|
140
55.1%
|
121
47.6%
|
101
44.3%
|
127
49.4%
|
120
48%
|
728
49.4%
|
| Male |
112
48.5%
|
114
44.9%
|
133
52.4%
|
127
55.7%
|
130
50.6%
|
130
52%
|
746
50.6%
|
| Region of Enrollment (participants) [Number] | |||||||
| United States |
231
100%
|
254
100%
|
254
100%
|
228
100%
|
257
100%
|
250
100%
|
1474
100%
|
Outcome Measures
| Title | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) |
|---|---|
| Description | |
| Time Frame | 7 days after each vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population; Afluria Cohort A receiving 2 doses N=96, Fluzone Cohort A receiving 2 doses N=110 |
| Arm/Group Title | Afluria Cohort A | Fluzone Cohort A |
|---|---|---|
| Arm/Group Description | Age 6 months to < 3 years | Age 6 months to < 3 years |
| Measure Participants | 229 | 228 |
| Any local solicited symptom post-dose 1 |
116
50.2%
|
100
39.4%
|
| Any pain (post dose 1) |
98
42.4%
|
78
30.7%
|
| Grade 3 pain (post dose 1) |
1
0.4%
|
0
0%
|
| Any redness (> 0 mm) (post dose 1) |
53
22.9%
|
53
20.9%
|
| Grade 3 redness (> 30 mm) (post dose 1) |
0
0%
|
1
0.4%
|
| Any swelling (> 0 mm) (post dose 1) |
30
13%
|
26
10.2%
|
| Grade 3 swelling (> 30 mm) (post dose 1) |
1
0.4%
|
0
0%
|
| Any local solicited symptom post-dose 2 |
30
13%
|
32
12.6%
|
| Any pain (post dose 2) |
28
12.1%
|
22
8.7%
|
| Grade 3 pain (post dose 2) |
0
0%
|
0
0%
|
| Any redness (> 0 mm) (post dose 2) |
15
6.5%
|
22
8.7%
|
| Grade 3 redness (> 30 mm) (post dose 2) |
1
0.4%
|
0
0%
|
| Any swelling (> 0 mm) (post dose 2) |
9
3.9%
|
7
2.8%
|
| Grade 3 swelling (> 30 mm) (post dose 2) |
0
0%
|
0
0%
|
| Any systemic solicited symptom, post dose 1 |
171
74%
|
121
47.6%
|
| Any fever ≥ 99.5°F ax or≥ 100.4°F oral, dose1 |
85
36.8%
|
31
12.2%
|
| Grade 3 fever > 103.1°F ax or> 104.0°F oral, dose1 |
6
2.6%
|
0
0%
|
| Any nausea/vomiting, dose 1 |
27
11.7%
|
17
6.7%
|
| Grade 3 nausea/vomiting prevented activities,dose1 |
22
9.5%
|
6
2.4%
|
| Any diarrhea, dose 1 |
61
26.4%
|
54
21.3%
|
| Grade 3 diarrhea prevented activities, dose 1 |
4
1.7%
|
3
1.2%
|
| Any loss of appetite, dose 1 |
73
31.6%
|
45
17.7%
|
| Grade3 loss of appetite prevented activities dose1 |
3
1.3%
|
1
0.4%
|
| Any irritability, dose 1 |
134
58%
|
85
33.5%
|
| Grade 3 irritability prevented activities dose 1 |
10
4.3%
|
5
2%
|
| Any systemic solicited symptom post-dose 2 |
48
20.8%
|
44
17.3%
|
| Any fever ≥ 99.5°F ax or≥ 100.4°F oral, dose 2 |
14
6.1%
|
15
5.9%
|
| Grade 3 fever > 103.1°F ax or> 104.0°F oral, dose2 |
1
0.4%
|
0
0%
|
| Any nausea/vomiting, dose 2 |
4
1.7%
|
8
3.1%
|
| Grade3 nausea/vomiting prevented activities, dose2 |
2
0.9%
|
0
0%
|
| Any diarrhea, dose 2 |
17
7.4%
|
16
6.3%
|
| Grade3 diarrhea (prevented activities), dose 2 |
1
0.4%
|
0
0%
|
| Any loss of appetite, dose 2 |
15
6.5%
|
14
5.5%
|
| Grade3 loss of appetite prevented activities dose2 |
1
0.4%
|
0
0%
|
| Any irritability, dose 2 |
38
16.5%
|
31
12.2%
|
| Grade 3 irritability prevented activities, dose 2 |
1
0.4%
|
0
0%
|
| Title | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B |
|---|---|
| Description | |
| Time Frame | 7 days after each vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population; Afluria cohort B receiving 2 doses N=68, Fluzone cohort B receiving 2 doses N=78 |
| Arm/Group Title | Afluria Cohort B | Fluzone Cohort B |
|---|---|---|
| Arm/Group Description | Age 3 to < 9 years | Age 3 to < 9 years |
| Measure Participants | 252 | 255 |
| Any local solicited symptom post-dose 1 |
164
71%
|
152
59.8%
|
| Any pain, post dose 1 |
149
64.5%
|
131
51.6%
|
| Grade 3 pain, post dose 1 |
1
0.4%
|
4
1.6%
|
| Any redness (> 0 mm), post dose 1 |
59
25.5%
|
60
23.6%
|
| Grade 3 redness (> 30 mm), post dose 1 |
7
3%
|
4
1.6%
|
| Any swelling (> 0 mm), post dose 1 |
36
15.6%
|
43
16.9%
|
| Grade 3 swelling (> 30 mm), post dose 1 |
6
2.6%
|
2
0.8%
|
| Any local solicited symptom post-dose 2 |
24
10.4%
|
26
10.2%
|
| Any pain, post dose 2 |
23
10%
|
23
9.1%
|
| Grade 3 pain, post dose 2 |
0
0%
|
0
0%
|
| Any redness (> 0 mm), post dose 2 |
5
2.2%
|
13
5.1%
|
| Grade 3 redness (> 30 mm), post dose 2 |
0
0%
|
0
0%
|
| Any swelling (> 0 mm), post dose 2 |
4
1.7%
|
11
4.3%
|
| Grade 3 swelling (> 30 mm), post dose 2 |
0
0%
|
0
0%
|
| Any systemic solicited symptom post-dose 1 |
140
60.6%
|
113
44.5%
|
| Any fever ≥ 99.5°F ax or ≥ 100.4°F oral, dose 1 |
55
23.8%
|
24
9.4%
|
| Grade 3 fever > 103.1°F ax or > 104.0°F oral dose1 |
3
1.3%
|
1
0.4%
|
| Any nausea/vomiting, dose 1 |
33
14.3%
|
20
7.9%
|
| Grade3 nausea/vomiting prevented activities, dose1 |
2
0.9%
|
1
0.4%
|
| Any diarrhea, dose 1 |
17
7.4%
|
24
9.4%
|
| Grade 3 diarrhea (prevented activities), dose 1 |
0
0%
|
0
0%
|
| Any malaise, dose 1 |
72
31.2%
|
34
13.4%
|
| Grade 3 malaise (prevented activities), dose 1 |
9
3.9%
|
1
0.4%
|
| Any headache, dose 1 |
54
23.4%
|
41
16.1%
|
| Grade 3 headache (prevented activities), dose 1 |
5
2.2%
|
0
0%
|
| Any myalgia, dose 1 |
82
35.5%
|
63
24.8%
|
| Grade 3 myalgia (prevented activities), dose 1 |
1
0.4%
|
1
0.4%
|
| Any systemic solicited symptom post-dose 2 |
17
7.4%
|
18
7.1%
|
| Any fever ≥ 99.5°F ax or ≥ 100.4°F oral dose 2 |
4
1.7%
|
5
2%
|
| Grade3 fever > 103.1°F ax or> 104.0°F oral, dose 2 |
1
0.4%
|
0
0%
|
| Any nausea/vomiting, dose 2 |
2
0.9%
|
4
1.6%
|
| Grade3 nausea/vomiting prevented activities ,dose2 |
1
0.4%
|
0
0%
|
| Any diarrhea, dose 2 |
6
2.6%
|
5
2%
|
| Grade 3 diarrhea (prevented activities), dose 2 |
0
0%
|
0
0%
|
| Any malaise, dose 2 |
6
2.6%
|
6
2.4%
|
| Grade 3 malaise (prevented activities), dose 2 |
0
0%
|
0
0%
|
| Any headache, dose 2 |
6
2.6%
|
8
3.1%
|
| Grade 3 headache (prevented activities), dose 2 |
0
0%
|
0
0%
|
| Any myalgia, dose 2 |
7
3%
|
12
4.7%
|
| Grade 3 myalgia (prevented activities), dose 2 |
0
0%
|
0
0%
|
| Title | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C |
|---|---|
| Description | |
| Time Frame | 7 days after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | Afluria Cohort C | Fluzone Cohort C |
|---|---|---|
| Arm/Group Description | Age 9 to < 18 years | Age 9 to < 18 years |
| Measure Participants | 254 | 250 |
| Any local solicited symptom post-dose 1 |
174
75.3%
|
169
66.5%
|
| Any pain |
167
72.3%
|
151
59.4%
|
| Grade 3 pain (prevented activities) |
1
0.4%
|
4
1.6%
|
| Any redness (> 0 mm) |
43
18.6%
|
43
16.9%
|
| Grade 3 redness (> 30 mm) |
1
0.4%
|
3
1.2%
|
| Any swelling (> 0 mm) |
39
16.9%
|
41
16.1%
|
| Grade 3 swelling (> 30 mm) |
4
1.7%
|
7
2.8%
|
| Any systemic solicited symptom post-dose 1 |
144
62.3%
|
126
49.6%
|
| Any fever (≥ 99.5°F ax or ≥ 100.4°F oral) |
16
6.9%
|
10
3.9%
|
| Grade 3 fever (> 103.1°F ax or > 104.0°F oral) |
2
0.9%
|
0
0%
|
| Any nausea/vomiting |
23
10%
|
24
9.4%
|
| Grade 3 nausea/vomiting (prevented activities) |
3
1.3%
|
3
1.2%
|
| Any diarrhea |
20
8.7%
|
25
9.8%
|
| Grade 3 diarrhea (prevented activities) |
1
0.4%
|
0
0%
|
| Any malaise |
55
23.8%
|
51
20.1%
|
| Grade 3 malaise (prevented activities) |
10
4.3%
|
3
1.2%
|
| Any headache |
69
29.9%
|
66
26%
|
| Grade 3 headache (prevented activities) |
7
3%
|
3
1.2%
|
| Any myalgia |
101
43.7%
|
93
36.6%
|
| Grade 3 myalgia (prevented activities) |
5
2.2%
|
4
1.6%
|
| Title | Geometric Mean Titer 30 Days After the Last Study Vaccination |
|---|---|
| Description | |
| Time Frame | 30 days after the last study vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-protocol population |
| Arm/Group Title | Afluria Cohort A | Afluria Cohort B | Afluria Cohort C | Fluzone Cohort A | Fluzone Cohort B | Fluzone Cohort C |
|---|---|---|---|---|---|---|
| Arm/Group Description | Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria. | Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria. | Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria. | Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. | Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. | Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. |
| Measure Participants | 195 | 229 | 230 | 201 | 236 | 233 |
| H1N1 (A/Brisbane/59/2007) |
235.44
|
345.50
|
652.99
|
227.19
|
351.88
|
652.17
|
| H3N2 ( A/Uruguay/716/2007) |
309.19
|
909.22
|
948.86
|
340.49
|
870.34
|
1069.7
|
| B (B/Brisbane/60/2008) |
73.46
|
122.71
|
107.92
|
57.92
|
104.91
|
126.99
|
| Title | Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination |
|---|---|
| Description | Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination. |
| Time Frame | 30 days after the last study vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-Protocol Population |
| Arm/Group Title | Afluria Cohort A | Afluria Cohort B | Afluria Cohort C | Fluzone Cohort A | Fluzone Cohort B | Fluzone Cohort C |
|---|---|---|---|---|---|---|
| Arm/Group Description | Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria. | Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria. | Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria. | Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. | Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. | Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. |
| Measure Participants | 195 | 229 | 230 | 201 | 236 | 233 |
| H1N1 (A/Brisbane/59/2007) |
84
36.4%
|
66
26%
|
64
25.2%
|
74
32.5%
|
64
24.9%
|
61
24.4%
|
| H3N2 ( A/Uruguay/716/2007) |
83
35.9%
|
71
28%
|
72
28.3%
|
85
37.3%
|
74
28.8%
|
73
29.2%
|
| B (B/Brisbane/60/2008) |
67
29%
|
73
28.7%
|
67
26.4%
|
61
26.8%
|
76
29.6%
|
73
29.2%
|
| Title | Frequency and Intensity of Unsolicited Adverse Events (UAEs) |
|---|---|
| Description | UAE stands for Unsolicited Adverse Events |
| Time Frame | 30 days after each vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | Afluria Cohort A | Afluria Cohort B | Afluria Cohort C | Fluzone Cohort A | Fluzone Cohort B | Fluzone Cohort C |
|---|---|---|---|---|---|---|
| Arm/Group Description | Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria. | Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria. | Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria. | Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. | Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. | Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. |
| Measure Participants | 229 | 252 | 254 | 228 | 255 | 250 |
| Any |
123
53.2%
|
100
39.4%
|
88
34.6%
|
112
49.1%
|
84
32.7%
|
70
28%
|
| Grade 3 |
28
12.1%
|
25
9.8%
|
17
6.7%
|
24
10.5%
|
22
8.6%
|
16
6.4%
|
| Any related |
37
16%
|
24
9.4%
|
20
7.9%
|
16
7%
|
18
7%
|
14
5.6%
|
| Title | New Onset of Chronic Illnesses (NOCIs) |
|---|---|
| Description | New onset of chronic illness after any vaccine dose. A new onset of chronic illness was defined as the diagnosis of a new medical condition which was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma). |
| Time Frame | 6 months after last study vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | Afluria Cohort A | Afluria Cohort B | Afluria Cohort C | Fluzone Cohort A | Fluzone Cohort B | Fluzone Cohort C |
|---|---|---|---|---|---|---|
| Arm/Group Description | Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria. | Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria. | Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria. | Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. | Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. | Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. |
| Measure Participants | 229 | 252 | 254 | 228 | 255 | 250 |
| Total number of participants with NOCI |
2
0.9%
|
0
0%
|
2
0.8%
|
2
0.9%
|
1
0.4%
|
0
0%
|
| Number of participants with related NOCI |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asthma |
1
0.4%
|
0
0%
|
2
0.8%
|
1
0.4%
|
0
0%
|
0
0%
|
| Von Willebrand's Disease |
1
0.4%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Eczema |
0
0%
|
0
0%
|
0
0%
|
1
0.4%
|
0
0%
|
0
0%
|
| Attention deficit disorder |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.4%
|
0
0%
|
| Title | Serious Adverse Events (SAEs) |
|---|---|
| Description | |
| Time Frame | 6 months after last study vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | Afluria Cohort A | Afluria Cohort B | Afluria Cohort C | Fluzone Cohort A | Fluzone Cohort B | Fluzone Cohort C |
|---|---|---|---|---|---|---|
| Arm/Group Description | Age 6 months to < 3 years | Age 3 to < 9 years | Age 9 to < 18 years | Age 6 months to < 3 years | Age 3 to < 9 years | Age 3 to < 9 years |
| Measure Participants | 229 | 252 | 254 | 228 | 255 | 250 |
| Number of participants with SAEs |
4
1.7%
|
2
0.8%
|
2
0.8%
|
4
1.8%
|
0
0%
|
0
0%
|
| Number of participants with related SAEs |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) |
|---|---|
| Description | |
| Time Frame | 7 days after each vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | Afluria Cohort A | Fluzone Cohort A |
|---|---|---|
| Arm/Group Description | Age 6 months to < 3 years | Age 6 months to < 3 years |
| Measure Participants | 229 | 228 |
| Any pain post-dose 1 |
1.57
(0.952)
|
1.43
(0.728)
|
| Any redness (> 0 mm), post dose 1 |
2.09
(1.405)
|
2.22
(1.939)
|
| Any swelling (> 0 mm), post dose 1 |
3.13
(2.930)
|
2.00
(1.569)
|
| Any pain post-dose 2 |
1.54
(0.793)
|
1.45
(0.739)
|
| Any redness (> 0 mm), post dose 2 |
1.80
(1.014)
|
1.73
(0.935)
|
| Any swelling (> 0 mm), post dose 2 |
1.67
(0.707)
|
1.57
(0.787)
|
| Any fever dose 1 (≥ 99.5°F ax or ≥ 100.4°F oral) |
1.38
(0.869)
|
1.49
(0.989)
|
| Any nausea/vomiting, post dose 1 |
1.42
(1.119)
|
1.29
(1.042)
|
| Any diarrhea, post dose 1 |
2.23
(2.157)
|
2.16
(2.189)
|
| Any loss of appetite, post dose 1 |
2.61
(3.695)
|
2.85
(4.458)
|
| Any irritability, post dose 1 |
2.26
(2.858)
|
2.64
(3.825)
|
| Any fever dose 2 (≥ 99.5°F ax or ≥ 100.4°F oral) |
1.80
(1.146)
|
1.81
(1.559)
|
| Any nausea/vomiting, post dose 2 |
2.50
(1.291)
|
1.78
(1.093)
|
| Any diarrhea, post dose 2 |
2.83
(2.431)
|
2.44
(2.332)
|
| Any loss of appetite, post dose 2 |
2.47
(1.586)
|
2.33
(1.447)
|
| Any irritability, post dose 2 |
2.31
(1.732)
|
2.17
(1.543)
|
| Title | Duration of Local and Systemic Solicited Symptoms, Cohort B |
|---|---|
| Description | |
| Time Frame | 7 days after each vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | Afluria Cohort B | Fluzone Cohort B |
|---|---|---|
| Arm/Group Description | Age 3 to < 9 years | Age 3 to < 9 years |
| Measure Participants | 252 | 255 |
| Any pain post-dose 1 |
1.89
(1.138)
|
1.89
(1.337)
|
| Any redness (> 0 mm), post dose 1 |
2.32
(1.621)
|
2.10
(2.014)
|
| Any swelling (> 0 mm), post dose 1 |
2.39
(2.021)
|
2.09
(1.273)
|
| Any pain post-dose 2 |
1.96
(1.637)
|
1.65
(0.775)
|
| Any redness (> 0 mm), post dose 2 |
2.40
(2.191)
|
1.77
(1.235)
|
| Any swelling (> 0 mm), post dose 2 |
3.00
(2.160)
|
1.69
(1.251)
|
| Any fever dose 1 (≥ 99.5°F ax or ≥ 100.4°F oral) |
1.45
(1.032)
|
1.40
(0.707)
|
| Any nausea/vomiting, post dose 1 |
1.27
(0.719)
|
1.43
(1.165)
|
| Any diarrhea, post dose 1 |
2.89
(4.988)
|
1.44
(1.044)
|
| Any malaise, post dose 1 |
1.86
(1.324)
|
1.74
(1.094)
|
| Any headache, post dose 1 |
1.50
(0.770)
|
1.66
(1.328)
|
| Any myalgia, post dose 1 |
1.72
(1.007)
|
1.63
(1.009)
|
| Any fever dose 2 (≥ 99.5°F ax or ≥ 100.4°F oral) |
1.50
(0.577)
|
1.00
(0.000)
|
| Any nausea/vomiting, post dose 2 |
1.00
(0.000)
|
1.20
(0.447)
|
| Any diarrhea, post dose 2 |
1.33
(0.816)
|
2.20
(0.447)
|
| Any malaise, post dose 2 |
1.83
(1.602)
|
1.71
(0.756)
|
| Any headache, post dose 2 |
1.00
(0.000)
|
1.30
(0.483)
|
| Any myalgia, post dose 2 |
2.00
(1.528)
|
1.54
(0.660)
|
| Title | Duration of Local and Systemic Solicited Symptoms, Cohort C |
|---|---|
| Description | |
| Time Frame | 7 days after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | Afluria Cohort C | Fluzone Cohort C |
|---|---|---|
| Arm/Group Description | Age 9 to < 18 years | Age 9 to < 18 years |
| Measure Participants | 254 | 250 |
| Any pain |
1.96
(1.087)
|
1.99
(1.136)
|
| Any redness (> 0 mm) |
2.02
(1.669)
|
2.38
(1.992)
|
| Any swelling (> 0 mm) |
1.75
(1.171)
|
2.38
(1.724)
|
| Any fever (≥ 99.5°F ax or ≥ 100.4°F oral) |
1.82
(1.590)
|
3.10
(2.644)
|
| Any nausea/vomiting |
1.36
(0.569)
|
2.88
(3.791)
|
| Any diarrhea |
1.18
(0.395)
|
1.36
(0.911)
|
| Any malaise |
2.09
(1.487)
|
2.82
(3.449)
|
| Any headache |
1.77
(1.443)
|
2.05
(1.945)
|
| Any myalgia |
1.76
(1.100)
|
2.11
(1.491)
|
Adverse Events
| Time Frame | Adverse event data were collected for 180 days after the last study vaccination. | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||
| Arm/Group Title | Afluria Cohort A | Afluria Cohort B | Afluria Cohort C | Fluzone Cohort A | Fluzone Cohort B | Fluzone Cohort C | ||||||
| Arm/Group Description | Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria. | Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria. | Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria. | Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. | Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. | Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. | ||||||
All Cause Mortality |
||||||||||||
| Afluria Cohort A | Afluria Cohort B | Afluria Cohort C | Fluzone Cohort A | Fluzone Cohort B | Fluzone Cohort C | |||||||
| 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 |
||||||||||||
| Afluria Cohort A | Afluria Cohort B | Afluria Cohort C | Fluzone Cohort A | Fluzone Cohort B | Fluzone Cohort C | |||||||
| 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 | 4/229 (1.7%) | 3/252 (1.2%) | 2/254 (0.8%) | 4/228 (1.8%) | 0/255 (0%) | 0/250 (0%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Lymphadenitis | 0/229 (0%) | 0 | 0/252 (0%) | 0 | 1/254 (0.4%) | 1 | 0/228 (0%) | 0 | 0/255 (0%) | 0 | 0/250 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||
| Colonic polyp | 0/229 (0%) | 0 | 1/252 (0.4%) | 1 | 0/254 (0%) | 0 | 0/228 (0%) | 0 | 0/255 (0%) | 0 | 0/250 (0%) | 0 |
| Infections and infestations | ||||||||||||
| Gastroenteritis | 1/229 (0.4%) | 1 | 0/252 (0%) | 0 | 0/254 (0%) | 0 | 0/228 (0%) | 0 | 0/255 (0%) | 0 | 0/250 (0%) | 0 |
| Pneumonia | 1/229 (0.4%) | 1 | 1/252 (0.4%) | 1 | 0/254 (0%) | 0 | 0/228 (0%) | 0 | 0/255 (0%) | 0 | 0/250 (0%) | 0 |
| Bronchiolitis | 1/229 (0.4%) | 1 | 0/252 (0%) | 0 | 0/254 (0%) | 0 | 1/228 (0.4%) | 1 | 0/255 (0%) | 0 | 0/250 (0%) | 0 |
| Appendicitis | 0/229 (0%) | 0 | 0/252 (0%) | 0 | 1/254 (0.4%) | 1 | 0/228 (0%) | 0 | 0/255 (0%) | 0 | 0/250 (0%) | 0 |
| Abscess limb | 0/229 (0%) | 0 | 0/252 (0%) | 0 | 0/254 (0%) | 0 | 1/228 (0.4%) | 1 | 0/255 (0%) | 0 | 0/250 (0%) | 0 |
| Furuncle | 0/229 (0%) | 0 | 0/252 (0%) | 0 | 0/254 (0%) | 0 | 1/228 (0.4%) | 1 | 0/255 (0%) | 0 | 0/250 (0%) | 0 |
| Respiratory syncitial virus bronchiolitis | 0/229 (0%) | 0 | 0/252 (0%) | 0 | 0/254 (0%) | 0 | 1/228 (0.4%) | 1 | 0/255 (0%) | 0 | 0/250 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||
| Dehydration | 1/229 (0.4%) | 1 | 0/252 (0%) | 0 | 0/254 (0%) | 0 | 0/228 (0%) | 0 | 0/255 (0%) | 0 | 0/250 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Asthma | 0/229 (0%) | 0 | 1/252 (0.4%) | 1 | 0/254 (0%) | 0 | 0/228 (0%) | 0 | 0/255 (0%) | 0 | 0/250 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||
| Afluria Cohort A | Afluria Cohort B | Afluria Cohort C | Fluzone Cohort A | Fluzone Cohort B | Fluzone Cohort C | |||||||
| 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 | 210/231 (90.9%) | 216/254 (85%) | 214/254 (84.3%) | 187/228 (82%) | 202/257 (78.6%) | 202/250 (80.8%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Nausea/vomiting | 31/229 (13.5%) | 35/252 (13.9%) | 23/254 (9.1%) | 23/228 (10.1%) | 24/255 (9.4%) | 24/250 (9.6%) | ||||||
| Diarrhea | 69/229 (30.1%) | 22/252 (8.7%) | 20/254 (7.9%) | 63/228 (27.6%) | 27/255 (10.6%) | 25/250 (10%) | ||||||
| Diarrhea | 10/229 (4.4%) | 3/252 (1.2%) | 4/254 (1.6%) | 13/228 (5.7%) | 3/255 (1.2%) | 1/250 (0.4%) | ||||||
| General disorders | ||||||||||||
| Pain at the injection site | 107/229 (46.7%) | 157/252 (62.3%) | 167/254 (65.7%) | 89/228 (39%) | 134/255 (52.5%) | 151/250 (60.4%) | ||||||
| Redness at the injection site | 60/229 (26.2%) | 62/252 (24.6%) | 43/254 (16.9%) | 60/228 (26.3%) | 67/255 (26.3%) | 43/250 (17.2%) | ||||||
| Swelling at the injection site | 34/229 (14.8%) | 38/252 (15.1%) | 39/254 (15.4%) | 29/228 (12.7%) | 50/255 (19.6%) | 41/250 (16.4%) | ||||||
| Fever | 91/229 (39.7%) | 58/252 (23%) | 16/254 (6.3%) | 42/228 (18.4%) | 29/255 (11.4%) | 10/250 (4%) | ||||||
| Loss of appetite | 79/229 (34.5%) | 0/252 (0%) | 0/254 (0%) | 54/228 (23.7%) | 0/255 (0%) | 0/250 (0%) | ||||||
| Irritability | 142/229 (62%) | 0/252 (0%) | 0/254 (0%) | 99/228 (43.4%) | 0/255 (0%) | 0/250 (0%) | ||||||
| Malaise | 0/229 (0%) | 74/252 (29.4%) | 55/254 (21.7%) | 0/228 (0%) | 37/255 (14.5%) | 51/250 (20.4%) | ||||||
| Headache | 0/229 (0%) | 58/252 (23%) | 69/254 (27.2%) | 0/228 (0%) | 45/255 (17.6%) | 66/250 (26.4%) | ||||||
| Myalgia | 0/229 (0%) | 87/252 (34.5%) | 101/254 (39.8%) | 0/228 (0%) | 66/255 (25.9%) | 93/250 (37.2%) | ||||||
| Pyrexia | 32/229 (14%) | 24/252 (9.5%) | 12/254 (4.7%) | 22/228 (9.6%) | 17/255 (6.7%) | 7/250 (2.8%) | ||||||
| Infections and infestations | ||||||||||||
| Upper respiratory tract infection | 9/229 (3.9%) | 6/252 (2.4%) | 4/254 (1.6%) | 14/228 (6.1%) | 5/255 (2%) | 4/250 (1.6%) | ||||||
| Nervous system disorders | ||||||||||||
| Headache | 6/229 (2.6%) | 6/252 (2.4%) | 17/254 (6.7%) | 3/228 (1.3%) | 8/255 (3.1%) | 12/250 (4.8%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Cough | 39/229 (17%) | 40/252 (15.9%) | 19/254 (7.5%) | 31/228 (13.6%) | 33/255 (12.9%) | 17/250 (6.8%) | ||||||
| Rhinorrhea | 25/229 (10.9%) | 14/252 (5.6%) | 5/254 (2%) | 24/228 (10.5%) | 10/255 (3.9%) | 5/250 (2%) | ||||||
| Nasal congestion | 14/229 (6.1%) | 8/252 (3.2%) | 16/254 (6.3%) | 11/228 (4.8%) | 4/255 (1.6%) | 6/250 (2.4%) | ||||||
| Oropharyngeal pain | 4/229 (1.7%) | 7/252 (2.8%) | 19/254 (7.5%) | 2/228 (0.9%) | 6/255 (2.4%) | 13/250 (5.2%) | ||||||
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 Program Director |
|---|---|
| Organization | Seqirus |
| Phone | |
| Seqirus.ClinicalTrials@Seqirus.com |
Responsible Party:
Seqirus
ClinicalTrials.gov Identifier:
NCT00959049
Other Study ID Numbers:
- CSLCT-USF-07-36
First Posted:
Aug 14, 2009
Last Update Posted:
May 16, 2017
Last Verified:
Apr 1, 2017