A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children
Sponsor
Seqirus (Industry)
Overall Status
Completed
CT.gov ID
NCT00940108
Collaborator
(none)
370
5
2
8
74
9.3
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 children.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
370 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Phase II, Multicentre, Randomised, Observer-blind Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children Aged >= 6 Months to < 9 Years.
Study Start Date
:
Aug 1, 2009
Actual Primary Completion Date
:
Oct 1, 2009
Actual Study Completion Date
:
Apr 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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-free
|
| 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-free
|
Outcome Measures
Primary Outcome Measures
- Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination [Before and 21 days after the first vaccination]
HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
- HI Antibody Titre Seroconversion Rate After the Second Vaccination [Before and 21 days after the second vaccination]
HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
- Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination [Before and 21 days after the first vaccination]
GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
- GMFI in the HI Antibody Titre After the Second Vaccination [Before and 21 days after the second vaccination]
GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
- Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination [21 days after the first vaccination]
- Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination [21 days after the second vaccination]
Secondary Outcome Measures
- Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination [During the 7 days after each vaccination]
Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Cried when limb was moved/spontaneously painful (Cohort A) or prevented normal daily activities (Cohort B) for injection site pain; Size > 100 mm for injection site redness and induration/swelling; Temperature > 103.1°F (39.5°C) for fevers; Prevented normal daily activities or required medical intervention for all other systemic AEs.
- Duration of Solicited AEs After the First Vaccination [During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7.]
Solicited AEs included AEs that were specifically sought for.
- Duration of Solicited AEs After the Second Vaccination [During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7.]
Solicited AEs included AEs that were specifically sought for.
- Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) [Up to 180 days after the last vaccination]
An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. 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 After the First or Second Vaccination [During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs]
Unsolicited AEs included AEs other than those specifically sought for. Grade 1 unsolicited AE definition: Easily tolerated and did not interfere with normal daily activities. Grade 2 unsolicited AE definition: Some interference with normal daily activities. Grade 3 unsolicited AE definition: Prevented normal daily activities.
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Months
to 8 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 of gestation.
Exclusion Criteria:
- Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thiomersal, neomycin, polymyxin, or any components of the Study Vaccine.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Study Site | Westmead | New South Wales | Australia | 2145 |
| 2 | Study Site | Brisbane | Queensland | Australia | 4006 |
| 3 | Study Site | North Adelaide | South Australia | Australia | 5006 |
| 4 | Study Site | Carlton | Victoria | Australia | 3010 |
| 5 | Study Site | Subiaco | Western Australia | Australia | 6027 |
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:
NCT00940108
Other Study ID Numbers:
- CSLCT-CAL-09-60
First Posted:
Jul 15, 2009
Last Update Posted:
Jun 28, 2018
Last Verified:
Apr 1, 2018
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | One randomized participant withdrew consent prior to vaccine administration and was not included in the participant flow data or in any analysis population. |
| Arm/Group Title | CSL425 (15 mcg) Cohort A | CSL425 (30 mcg) Cohort A | CSL425 (15 mcg) Cohort B | CSL425 (30 mcg) Cohort B |
|---|---|---|---|---|
| Arm/Group Description | Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| Period Title: Overall Study | ||||
| STARTED | 82 | 80 | 103 | 104 |
| COMPLETED | 77 | 71 | 100 | 99 |
| NOT COMPLETED | 5 | 9 | 3 | 5 |
Baseline Characteristics
| Arm/Group Title | CSL425 (15 mcg) Cohort A | CSL425 (30 mcg) Cohort A | CSL425 (15 mcg) Cohort B | CSL425 (30 mcg) Cohort B | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Total of all reporting groups |
| Overall Participants | 82 | 80 | 103 | 104 | 369 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
1.68
(0.67)
|
1.73
(0.74)
|
5.78
(1.69)
|
5.66
(1.74)
|
3.96
(2.42)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
41
50%
|
41
51.3%
|
53
51.5%
|
49
47.1%
|
184
49.9%
|
| Male |
41
50%
|
39
48.8%
|
50
48.5%
|
55
52.9%
|
185
50.1%
|
Outcome Measures
| Title | Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination |
|---|---|
| Description | HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre. |
| Time Frame | Before and 21 days after the first vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Evaluable Population (for the first vaccination) comprised all randomised 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 | CSL425 (15 mcg) Cohort A | CSL425 (30 mcg) Cohort A | CSL425 (15 mcg) Cohort B | CSL425 (30 mcg) Cohort B |
|---|---|---|---|---|
| Arm/Group Description | Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| Measure Participants | 76 | 73 | 98 | 99 |
| Number (95% Confidence Interval) [percentage of participants] |
88.2
107.6%
|
97.3
121.6%
|
85.7
83.2%
|
91.9
88.4%
|
| Title | HI Antibody Titre Seroconversion Rate After the Second Vaccination |
|---|---|
| Description | HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre. |
| Time Frame | Before and 21 days after the second vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Evaluable Population (for the second vaccination) comprised all randomised 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 | CSL425 (15 mcg) Cohort A | CSL425 (30 mcg) Cohort A | CSL425 (15 mcg) Cohort B | CSL425 (30 mcg) Cohort B |
|---|---|---|---|---|
| Arm/Group Description | Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| Measure Participants | 64 | 69 | 95 | 96 |
| Number (95% Confidence Interval) [percentage of participants] |
96.9
118.2%
|
98.6
123.3%
|
97.9
95%
|
96.9
93.2%
|
| Title | Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination |
|---|---|
| Description | GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre. |
| Time Frame | Before and 21 days after the first vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Evaluable Population (for the first vaccination) comprised all randomised 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 | CSL425 (15 mcg) Cohort A | CSL425 (30 mcg) Cohort A | CSL425 (15 mcg) Cohort B | CSL425 (30 mcg) Cohort B |
|---|---|---|---|---|
| Arm/Group Description | Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| Measure Participants | 76 | 73 | 98 | 99 |
| Geometric Mean (95% Confidence Interval) [geometric mean fold increase] |
13.95
|
22.17
|
13.25
|
15.93
|
| Title | GMFI in the HI Antibody Titre After the Second Vaccination |
|---|---|
| Description | GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre. |
| Time Frame | Before and 21 days after the second vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Evaluable Population (for the second vaccination) comprised all randomised 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 | CSL425 (15 mcg) Cohort A | CSL425 (30 mcg) Cohort A | CSL425 (15 mcg) Cohort B | CSL425 (30 mcg) Cohort B |
|---|---|---|---|---|
| Arm/Group Description | Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| Measure Participants | 64 | 69 | 95 | 96 |
| Geometric Mean (95% Confidence Interval) [geometric mean fold increase] |
57.64
|
72.93
|
37.48
|
37.06
|
| Title | Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More 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 randomised 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 | CSL425 (15 mcg) Cohort A | CSL425 (30 mcg) Cohort A | CSL425 (15 mcg) Cohort B | CSL425 (30 mcg) Cohort B |
|---|---|---|---|---|
| Arm/Group Description | Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| Measure Participants | 76 | 73 | 98 | 99 |
| Number (95% Confidence Interval) [percentage of participants] |
92.1
112.3%
|
100.0
125%
|
92.9
90.2%
|
96.0
92.3%
|
| Title | Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More 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 randomised 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 | CSL425 (15 mcg) Cohort A | CSL425 (30 mcg) Cohort A | CSL425 (15 mcg) Cohort B | CSL425 (30 mcg) Cohort B |
|---|---|---|---|---|
| Arm/Group Description | Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| Measure Participants | 64 | 69 | 95 | 96 |
| Number (95% Confidence Interval) [percentage of participants] |
100.0
122%
|
100.0
125%
|
100.0
97.1%
|
100.0
96.2%
|
| Title | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination |
|---|---|
| Description | Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Cried when limb was moved/spontaneously painful (Cohort A) or prevented normal daily activities (Cohort B) for injection site pain; Size > 100 mm for injection site redness and induration/swelling; Temperature > 103.1°F (39.5°C) for fevers; Prevented normal daily activities or required medical intervention for all other systemic AEs. |
| Time Frame | During the 7 days after each vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. |
| Arm/Group Title | CSL425 (15 mcg) Cohort A | CSL425 (30 mcg) Cohort A | CSL425 (15 mcg) Cohort B | CSL425 (30 mcg) Cohort B |
|---|---|---|---|---|
| Arm/Group Description | Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| Measure Participants | 82 | 80 | 103 | 104 |
| Any solicited local AE |
69.5
84.8%
|
63.8
79.8%
|
68.0
66%
|
71.2
68.5%
|
| Any pain at injection site |
48.8
59.5%
|
43.8
54.8%
|
59.2
57.5%
|
64.4
61.9%
|
| Grade 3 pain at injection site |
1.2
1.5%
|
1.3
1.6%
|
0
0%
|
1.0
1%
|
| Any redness at injection site |
53.7
65.5%
|
38.8
48.5%
|
37.9
36.8%
|
37.5
36.1%
|
| Grade 3 redness at injection site |
0
0%
|
1.3
1.6%
|
2.9
2.8%
|
2.9
2.8%
|
| Any swelling/induration at injection site |
30.5
37.2%
|
32.5
40.6%
|
25.2
24.5%
|
26.9
25.9%
|
| Grade 3 swelling/induration at injection site |
0
0%
|
2.5
3.1%
|
0
0%
|
4.8
4.6%
|
| Any solicited systemic AE |
79.3
96.7%
|
93.8
117.3%
|
54.4
52.8%
|
61.5
59.1%
|
| Any nausea/vomiting |
13.4
16.3%
|
30.0
37.5%
|
15.5
15%
|
20.2
19.4%
|
| Grade 3 nausea/vomiting |
1.2
1.5%
|
1.3
1.6%
|
0
0%
|
1.0
1%
|
| Any diarrhoea |
26.8
32.7%
|
32.5
40.6%
|
12.6
12.2%
|
12.5
12%
|
| Grade 3 diarrhoea |
1.2
1.5%
|
0
0%
|
0
0%
|
0
0%
|
| Any loss of appetite |
40.2
49%
|
50.0
62.5%
|
NA
NaN
|
NA
NaN
|
| Grade 3 loss of appetite |
1.2
1.5%
|
0
0%
|
NA
NaN
|
NA
NaN
|
| Any irritability |
63.4
77.3%
|
72.5
90.6%
|
NA
NaN
|
NA
NaN
|
| Grade 3 irritability |
2.4
2.9%
|
1.3
1.6%
|
NA
NaN
|
NA
NaN
|
| Any fever |
50.0
61%
|
71.3
89.1%
|
20.4
19.8%
|
29.8
28.7%
|
| Grade 3 fever |
1.2
1.5%
|
8.8
11%
|
0
0%
|
2.9
2.8%
|
| Any headache |
NA
NaN
|
NA
NaN
|
27.2
26.4%
|
23.1
22.2%
|
| Grade 3 headache |
NA
NaN
|
NA
NaN
|
0
0%
|
1.0
1%
|
| Any muscle ache |
NA
NaN
|
NA
NaN
|
15.5
15%
|
22.1
21.3%
|
| Grade 3 muscle ache |
NA
NaN
|
NA
NaN
|
0
0%
|
1.0
1%
|
| Any malaise |
NA
NaN
|
NA
NaN
|
19.4
18.8%
|
26.9
25.9%
|
| Grade 3 malaise |
NA
NaN
|
NA
NaN
|
0
0%
|
1.9
1.8%
|
| Title | Duration of Solicited AEs After the First Vaccination |
|---|---|
| Description | Solicited AEs included AEs that were specifically sought for. |
| Time Frame | During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. |
| Arm/Group Title | CSL425 (15 mcg) Cohort A | CSL425 (30 mcg) Cohort A | CSL425 (15 mcg) Cohort B | CSL425 (30 mcg) Cohort B |
|---|---|---|---|---|
| Arm/Group Description | Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| Measure Participants | 82 | 80 | 103 | 104 |
| Pain at injection site |
1.48
(0.677)
|
1.52
(0.823)
|
1.91
(1.221)
|
1.80
(1.016)
|
| Redness at injection site |
2.08
(1.382)
|
2.23
(1.602)
|
2.26
(1.347)
|
2.00
(1.134)
|
| Swelling/induration at injection site |
1.88
(0.957)
|
1.64
(0.745)
|
1.60
(0.737)
|
2.04
(1.136)
|
| Nausea/vomiting |
1.33
(0.500)
|
1.05
(0.213)
|
1.18
(0.405)
|
1.53
(1.837)
|
| Diarrhoea |
1.67
(1.328)
|
1.55
(0.945)
|
1.11
(0.333)
|
1.17
(0.577)
|
| Loss of appetite |
2.32
(1.906)
|
1.97
(1.447)
|
NA
(NA)
|
NA
(NA)
|
| Irritability |
1.78
(1.560)
|
1.73
(1.574)
|
NA
(NA)
|
NA
(NA)
|
| Fever |
1.77
(1.547)
|
1.52
(1.079)
|
1.40
(0.737)
|
1.54
(1.319)
|
| Headache |
NA
(NA)
|
NA
(NA)
|
2.04
(2.911)
|
1.63
(1.149)
|
| Muscle ache |
NA
(NA)
|
NA
(NA)
|
1.45
(0.688)
|
1.86
(2.175)
|
| Malaise |
NA
(NA)
|
NA
(NA)
|
1.60
(0.910)
|
1.69
(1.966)
|
| Title | Duration of Solicited AEs After the Second Vaccination |
|---|---|
| Description | Solicited AEs included AEs that were specifically sought for. |
| Time Frame | During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. |
| Arm/Group Title | CSL425 (15 mcg) Cohort A | CSL425 (30 mcg) Cohort A | CSL425 (15 mcg) Cohort B | CSL425 (30 mcg) Cohort B |
|---|---|---|---|---|
| Arm/Group Description | Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| Measure Participants | 77 | 71 | 100 | 99 |
| Pain at injection site |
1.67
(0.966)
|
1.64
(1.002)
|
1.90
(1.179)
|
1.80
(1.040)
|
| Redness at injection site |
1.69
(1.004)
|
2.14
(1.037)
|
1.92
(1.055)
|
1.70
(0.822)
|
| Swelling/induration at injection site |
1.74
(0.872)
|
2.32
(1.108)
|
2.24
(1.348)
|
2.27
(1.751)
|
| Nausea/vomiting |
5.00
(8.832)
|
1.00
(0.000)
|
1.43
(0.787)
|
1.11
(0.333)
|
| Diarrhoea |
3.40
(3.777)
|
1.25
(0.452)
|
1.40
(0.894)
|
2.00
(1.000)
|
| Loss of appetite |
3.15
(4.475)
|
1.73
(0.883)
|
NA
(NA)
|
NA
(NA)
|
| Irritability |
2.57
(2.410)
|
2.10
(1.533)
|
NA
(NA)
|
NA
(NA)
|
| Fever |
2.14
(3.005)
|
1.63
(1.165)
|
1.54
(0.877)
|
1.67
(1.414)
|
| Headache |
NA
(NA)
|
NA
(NA)
|
1.33
(0.686)
|
1.73
(2.412)
|
| Muscle ache |
NA
(NA)
|
NA
(NA)
|
1.60
(0.516)
|
1.29
(0.756)
|
| Malaise |
NA
(NA)
|
NA
(NA)
|
1.20
(0.422)
|
2.00
(1.826)
|
| Title | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) |
|---|---|
| Description | An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. 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 participants who received at least one dose of the vaccine and provided follow-up safety data. |
| Arm/Group Title | CSL425 (15 mcg) Cohort A | CSL425 (30 mcg) Cohort A | CSL425 (15 mcg) Cohort B | CSL425 (30 mcg) Cohort B |
|---|---|---|---|---|
| Arm/Group Description | Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| Measure Participants | 82 | 80 | 103 | 104 |
| At least one SAE |
4.9
6%
|
1.3
1.6%
|
1.0
1%
|
1.0
1%
|
| Related SAE |
0
0%
|
0
0%
|
0
0%
|
1.0
1%
|
| At least one AESI |
2.4
2.9%
|
1.3
1.6%
|
0
0%
|
0
0%
|
| Related AESI |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| At least one NOCI |
1.2
1.5%
|
3.8
4.8%
|
1.9
1.8%
|
0
0%
|
| Related NOCI |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination |
|---|---|
| Description | Unsolicited AEs included AEs other than those specifically sought for. Grade 1 unsolicited AE definition: Easily tolerated and did not interfere with normal daily activities. Grade 2 unsolicited AE definition: Some interference with normal daily activities. Grade 3 unsolicited AE definition: Prevented normal daily activities. |
| Time Frame | During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. |
| Arm/Group Title | CSL425 (15 mcg) Cohort A | CSL425 (30 mcg) Cohort A | CSL425 (15 mcg) Cohort B | CSL425 (30 mcg) Cohort B |
|---|---|---|---|---|
| Arm/Group Description | Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| Measure Participants | 82 | 80 | 103 | 104 |
| At least one unsolicited AE |
78.0
95.1%
|
82.5
103.1%
|
67.0
65%
|
76.0
73.1%
|
| Grade 1 unsolicited AE |
26.8
32.7%
|
33.8
42.3%
|
27.2
26.4%
|
37.5
36.1%
|
| Grade 2 unsolicited AE |
41.5
50.6%
|
41.3
51.6%
|
37.9
36.8%
|
26.9
25.9%
|
| Grade 3 unsolicited AE |
9.8
12%
|
7.5
9.4%
|
1.9
1.8%
|
11.5
11.1%
|
Adverse Events
| Time Frame | For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA V13.0", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC. | |||||||
| Arm/Group Title | CSL425 (15 mcg) Cohort A | CSL425 (30 mcg) Cohort A | CSL425 (15 mcg) Cohort B | CSL425 (30 mcg) Cohort B | ||||
| Arm/Group Description | Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | ||||
All Cause Mortality |
||||||||
| CSL425 (15 mcg) Cohort A | CSL425 (30 mcg) Cohort A | CSL425 (15 mcg) Cohort B | CSL425 (30 mcg) Cohort B | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| CSL425 (15 mcg) Cohort A | CSL425 (30 mcg) Cohort A | CSL425 (15 mcg) Cohort B | CSL425 (30 mcg) Cohort B | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/82 (4.9%) | 1/80 (1.3%) | 1/103 (1%) | 1/104 (1%) | ||||
| General disorders | ||||||||
| Pyrexia | 0/82 (0%) | 0 | 0/80 (0%) | 0 | 0/103 (0%) | 0 | 1/104 (1%) | 1 |
| Infections and infestations | ||||||||
| Gastroenteritis viral | 1/82 (1.2%) | 1 | 0/80 (0%) | 0 | 0/103 (0%) | 0 | 0/104 (0%) | 0 |
| Lobar pneumonia | 0/82 (0%) | 0 | 0/80 (0%) | 0 | 1/103 (1%) | 1 | 0/104 (0%) | 0 |
| Nervous system disorders | ||||||||
| Convulsion | 2/82 (2.4%) | 2 | 0/80 (0%) | 0 | 0/103 (0%) | 0 | 0/104 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Asthma | 1/82 (1.2%) | 2 | 0/80 (0%) | 0 | 0/103 (0%) | 0 | 0/104 (0%) | 0 |
| Vascular disorders | ||||||||
| Kawasaki's disease | 0/82 (0%) | 0 | 1/80 (1.3%) | 1 | 0/103 (0%) | 0 | 0/104 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| CSL425 (15 mcg) Cohort A | CSL425 (30 mcg) Cohort A | CSL425 (15 mcg) Cohort B | CSL425 (30 mcg) Cohort B | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 81/82 (98.8%) | 78/80 (97.5%) | 91/103 (88.3%) | 96/104 (92.3%) | ||||
| Ear and labyrinth disorders | ||||||||
| Ear pain | 0/82 (0%) | 0 | 2/80 (2.5%) | 2 | 8/103 (7.8%) | 8 | 4/104 (3.8%) | 5 |
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 1/82 (1.2%) | 1 | 0/80 (0%) | 0 | 4/103 (3.9%) | 4 | 1/104 (1%) | 1 |
| Diarrhoea | 3/82 (3.7%) | 3 | 3/80 (3.8%) | 3 | 3/103 (2.9%) | 3 | 2/104 (1.9%) | 2 |
| Abdominal pain upper | 0/82 (0%) | 0 | 1/80 (1.3%) | 1 | 1/103 (1%) | 1 | 3/104 (2.9%) | 3 |
| Teething | 14/82 (17.1%) | 18 | 12/80 (15%) | 19 | 0/103 (0%) | 0 | 0/104 (0%) | 0 |
| Vomiting | 0/82 (0%) | 0 | 4/80 (5%) | 4 | 2/103 (1.9%) | 2 | 2/104 (1.9%) | 2 |
| General disorders | ||||||||
| Influenza-like illness | 12/82 (14.6%) | 14 | 10/80 (12.5%) | 10 | 7/103 (6.8%) | 8 | 9/104 (8.7%) | 9 |
| Pyrexia | 10/82 (12.2%) | 10 | 4/80 (5%) | 4 | 3/103 (2.9%) | 4 | 2/104 (1.9%) | 2 |
| Malaise | 0/82 (0%) | 0 | 2/80 (2.5%) | 2 | 3/103 (2.9%) | 3 | 0/104 (0%) | 0 |
| Fatigue | 0/82 (0%) | 0 | 2/80 (2.5%) | 2 | 0/103 (0%) | 0 | 0/104 (0%) | 0 |
| Pain at Injection Site | 40/82 (48.8%) | 52 | 35/80 (43.8%) | 47 | 61/103 (59.2%) | 96 | 67/104 (64.4%) | 105 |
| Redness at Injection Site | 44/82 (53.7%) | 66 | 31/80 (38.8%) | 44 | 39/103 (37.9%) | 53 | 39/104 (37.5%) | 52 |
| Swelling/Induration at Injection Site | 25/82 (30.5%) | 35 | 26/80 (32.5%) | 33 | 26/103 (25.2%) | 32 | 28/104 (26.9%) | 40 |
| Nausea/Vomiting | 11/82 (13.4%) | 15 | 24/80 (30%) | 26 | 16/103 (15.5%) | 18 | 21/104 (20.2%) | 28 |
| Diarrhoea | 22/82 (26.8%) | 28 | 26/80 (32.5%) | 32 | 13/103 (12.6%) | 14 | 13/104 (12.5%) | 15 |
| Loss of Appetite | 33/82 (40.2%) | 48 | 40/80 (50%) | 55 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Irritability | 52/82 (63.4%) | 92 | 58/80 (72.5%) | 99 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Fever | 41/82 (50%) | 51 | 57/80 (71.3%) | 75 | 21/103 (20.4%) | 28 | 31/104 (29.8%) | 37 |
| Headache | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 28/103 (27.2%) | 42 | 24/104 (23.1%) | 38 |
| Muscle Ache (Myalgia) | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 16/103 (15.5%) | 21 | 23/104 (22.1%) | 28 |
| Malaise | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 20/103 (19.4%) | 25 | 28/104 (26.9%) | 39 |
| Immune system disorders | ||||||||
| Seasonal allergy | 1/82 (1.2%) | 1 | 0/80 (0%) | 0 | 3/103 (2.9%) | 3 | 3/104 (2.9%) | 3 |
| Infections and infestations | ||||||||
| Upper respiratory tract infection | 22/82 (26.8%) | 28 | 28/80 (35%) | 31 | 22/103 (21.4%) | 26 | 24/104 (23.1%) | 26 |
| Viral infection | 4/82 (4.9%) | 4 | 0/80 (0%) | 0 | 3/103 (2.9%) | 4 | 9/104 (8.7%) | 9 |
| Croup infectious | 3/82 (3.7%) | 3 | 1/80 (1.3%) | 1 | 4/103 (3.9%) | 4 | 0/104 (0%) | 0 |
| Tonsillitis | 1/82 (1.2%) | 1 | 1/80 (1.3%) | 1 | 1/103 (1%) | 1 | 3/104 (2.9%) | 3 |
| Nasopharyngitis | 1/82 (1.2%) | 1 | 1/80 (1.3%) | 1 | 3/103 (2.9%) | 3 | 0/104 (0%) | 0 |
| Otitis media | 4/82 (4.9%) | 5 | 1/80 (1.3%) | 1 | 3/103 (2.9%) | 3 | 0/104 (0%) | 0 |
| Hand-foot-and-mouth disease | 4/82 (4.9%) | 4 | 3/80 (3.8%) | 3 | 1/103 (1%) | 1 | 0/104 (0%) | 0 |
| Gastroenteritis | 2/82 (2.4%) | 2 | 3/80 (3.8%) | 3 | 1/103 (1%) | 1 | 2/104 (1.9%) | 2 |
| Viral upper respiratory tract infection | 1/82 (1.2%) | 1 | 2/80 (2.5%) | 2 | 0/103 (0%) | 0 | 2/104 (1.9%) | 2 |
| Ear infection | 2/82 (2.4%) | 2 | 0/80 (0%) | 0 | 1/103 (1%) | 1 | 0/104 (0%) | 0 |
| Lower respiratory tract infection | 0/82 (0%) | 0 | 2/80 (2.5%) | 2 | 0/103 (0%) | 0 | 0/104 (0%) | 0 |
| Rhinitis | 2/82 (2.4%) | 2 | 0/80 (0%) | 0 | 0/103 (0%) | 0 | 1/104 (1%) | 1 |
| Injury, poisoning and procedural complications | ||||||||
| Fall | 3/82 (3.7%) | 3 | 6/80 (7.5%) | 6 | 4/103 (3.9%) | 5 | 7/104 (6.7%) | 7 |
| Excoriation | 2/82 (2.4%) | 2 | 1/80 (1.3%) | 1 | 3/103 (2.9%) | 3 | 6/104 (5.8%) | 8 |
| Contusion | 1/82 (1.2%) | 1 | 1/80 (1.3%) | 1 | 0/103 (0%) | 0 | 6/104 (5.8%) | 6 |
| Injury | 1/82 (1.2%) | 1 | 0/80 (0%) | 0 | 1/103 (1%) | 1 | 4/104 (3.8%) | 5 |
| Accident | 1/82 (1.2%) | 1 | 0/80 (0%) | 0 | 1/103 (1%) | 1 | 3/104 (2.9%) | 4 |
| Head injury | 0/82 (0%) | 0 | 3/80 (3.8%) | 5 | 0/103 (0%) | 0 | 4/104 (3.8%) | 5 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 0/82 (0%) | 0 | 0/80 (0%) | 0 | 3/103 (2.9%) | 3 | 1/104 (1%) | 1 |
| Nervous system disorders | ||||||||
| Headache | 1/82 (1.2%) | 1 | 2/80 (2.5%) | 2 | 4/103 (3.9%) | 4 | 4/104 (3.8%) | 4 |
| Lethargy | 1/82 (1.2%) | 1 | 3/80 (3.8%) | 3 | 1/103 (1%) | 1 | 0/104 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 6/82 (7.3%) | 6 | 11/80 (13.8%) | 12 | 13/103 (12.6%) | 13 | 11/104 (10.6%) | 12 |
| Rhinorrhea | 8/82 (9.8%) | 8 | 17/80 (21.3%) | 17 | 4/103 (3.9%) | 4 | 8/104 (7.7%) | 10 |
| Oropharyngeal pain | 2/82 (2.4%) | 2 | 0/80 (0%) | 0 | 4/103 (3.9%) | 6 | 4/104 (3.8%) | 4 |
| Asthma | 2/82 (2.4%) | 2 | 4/80 (5%) | 4 | 3/103 (2.9%) | 4 | 3/104 (2.9%) | 4 |
| Nasal congestion | 0/82 (0%) | 0 | 3/80 (3.8%) | 4 | 2/103 (1.9%) | 4 | 2/104 (1.9%) | 2 |
| Skin and subcutaneous tissue disorders | ||||||||
| Rash | 7/82 (8.5%) | 7 | 3/80 (3.8%) | 3 | 0/103 (0%) | 0 | 2/104 (1.9%) | 2 |
| Dermatitis diaper | 7/82 (8.5%) | 7 | 1/80 (1.3%) | 1 | 0/103 (0%) | 0 | 0/104 (0%) | 0 |
| Dermatitis | 1/82 (1.2%) | 1 | 2/80 (2.5%) | 2 | 0/103 (0%) | 0 | 2/104 (1.9%) | 3 |
| Eczema | 1/82 (1.2%) | 1 | 2/80 (2.5%) | 3 | 0/103 (0%) | 0 | 0/104 (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 Study Disclosure Manager |
|---|---|
| Organization | Seqirus |
| Phone | 1-855-358-8966 |
| Seqirus.ClinicalTrials@Seqirus.com |
Responsible Party:
Seqirus
ClinicalTrials.gov Identifier:
NCT00940108
Other Study ID Numbers:
- CSLCT-CAL-09-60
First Posted:
Jul 15, 2009
Last Update Posted:
Jun 28, 2018
Last Verified:
Apr 1, 2018