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Trial record 3 of 12 for:    CSL+H1N1+Influenza+Vaccine

A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children

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ClinicalTrials.gov Identifier: NCT00940108
Recruitment Status : Completed
First Posted : July 15, 2009
Results First Posted : November 20, 2013
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Seqirus

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza Caused by the Novel Influenza A (H1N1) Virus
Intervention Biological: CSL425
Enrollment 370
Recruitment Details  
Pre-assignment Details 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
Hide 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
Reason Not Completed
Adverse Event             2             4             0             2
Withdrew Consent             2             1             0             1
Dose 2 contraindicated             1             1             0             1
Declined further vaccination             0             1             3             0
Refused - pyrexia after Dose 1             0             1             0             0
Viral illness after Dose 1             0             1             0             0
Diagnosed with H1N1             0             0             0             1
Arm/Group Title CSL425 (15 mcg) Cohort A CSL425 (30 mcg) Cohort A CSL425 (15 mcg) Cohort B CSL425 (30 mcg) Cohort B Total
Hide 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 Number of Baseline Participants 82 80 103 104 369
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 82 participants 80 participants 103 participants 104 participants 369 participants
1.68  (0.67) 1.73  (0.74) 5.78  (1.69) 5.66  (1.74) 3.96  (2.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 80 participants 103 participants 104 participants 369 participants
Female
41
  50.0%
41
  51.2%
53
  51.5%
49
  47.1%
184
  49.9%
Male
41
  50.0%
39
  48.8%
50
  48.5%
55
  52.9%
185
  50.1%
1.Primary Outcome
Title Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 76 73 98 99
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
88.2
(78.7 to 94.4)
97.3
(90.5 to 99.7)
85.7
(77.2 to 92.0)
91.9
(84.7 to 96.4)
2.Primary Outcome
Title HI Antibody Titre Seroconversion Rate After the Second Vaccination
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 64 69 95 96
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.9
(89.2 to 99.6)
98.6
(92.2 to 100.0)
97.9
(92.6 to 99.7)
96.9
(91.1 to 99.4)
3.Primary Outcome
Title Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 76 73 98 99
Geometric Mean (95% Confidence Interval)
Unit of Measure: geometric mean fold increase
13.95
(11.39 to 17.09)
22.17
(17.87 to 27.49)
13.25
(10.84 to 16.19)
15.93
(12.87 to 19.71)
4.Primary Outcome
Title GMFI in the HI Antibody Titre After the Second Vaccination
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 64 69 95 96
Geometric Mean (95% Confidence Interval)
Unit of Measure: geometric mean fold increase
57.64
(42.87 to 77.50)
72.93
(56.10 to 94.80)
37.48
(28.33 to 49.58)
37.06
(28.77 to 47.75)
5.Primary Outcome
Title Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination
Hide Description [Not Specified]
Time Frame 21 days after the first vaccination
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 76 73 98 99
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
92.1
(83.6 to 97.0)
100.0
(95.1 to 100.0)
92.9
(85.8 to 97.1)
96.0
(90.0 to 98.9)
6.Primary Outcome
Title Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination
Hide Description [Not Specified]
Time Frame 21 days after the second vaccination
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 64 69 95 96
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(94.4 to 100.0)
100.0
(94.8 to 100.0)
100.0
(96.2 to 100.0)
100.0
(96.2 to 100.0)
7.Secondary Outcome
Title Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 82 80 103 104
Measure Type: Number
Unit of Measure: percentage of participants
Any solicited local AE 69.5 63.8 68.0 71.2
Any pain at injection site 48.8 43.8 59.2 64.4
Grade 3 pain at injection site 1.2 1.3 0 1.0
Any redness at injection site 53.7 38.8 37.9 37.5
Grade 3 redness at injection site 0 1.3 2.9 2.9
Any swelling/induration at injection site 30.5 32.5 25.2 26.9
Grade 3 swelling/induration at injection site 0 2.5 0 4.8
Any solicited systemic AE 79.3 93.8 54.4 61.5
Any nausea/vomiting 13.4 30.0 15.5 20.2
Grade 3 nausea/vomiting 1.2 1.3 0 1.0
Any diarrhoea 26.8 32.5 12.6 12.5
Grade 3 diarrhoea 1.2 0 0 0
Any loss of appetite 40.2 50.0 NA [1]  NA [1] 
Grade 3 loss of appetite 1.2 0 NA [1]  NA [1] 
Any irritability 63.4 72.5 NA [1]  NA [1] 
Grade 3 irritability 2.4 1.3 NA [1]  NA [1] 
Any fever 50.0 71.3 20.4 29.8
Grade 3 fever 1.2 8.8 0 2.9
Any headache NA [2]  NA [2]  27.2 23.1
Grade 3 headache NA [2]  NA [2]  0 1
Any muscle ache NA [2]  NA [2]  15.5 22.1
Grade 3 muscle ache NA [2]  NA [2]  0 1
Any malaise NA [2]  NA [2]  19.4 26.9
Grade 3 malaise NA [2]  NA [2]  0 1.9
[1]
Not solicited for in Cohort B
[2]
Not solicited for in Cohort A
8.Secondary Outcome
Title Duration of Solicited AEs After the First Vaccination
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 82 80 103 104
Mean (Standard Deviation)
Unit of Measure: days
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 [1]   (NA) NA [1]   (NA)
Irritability 1.78  (1.560) 1.73  (1.574) NA [1]   (NA) NA [1]   (NA)
Fever 1.77  (1.547) 1.52  (1.079) 1.40  (0.737) 1.54  (1.319)
Headache NA [2]   (NA) NA [2]   (NA) 2.04  (2.911) 1.63  (1.149)
Muscle ache NA [2]   (NA) NA [2]   (NA) 1.45  (0.688) 1.86  (2.175)
Malaise NA [2]   (NA) NA [2]   (NA) 1.60  (0.910) 1.69  (1.966)
[1]
Not solicited for in Cohort B
[2]
Not solicited for in Cohort A
9.Secondary Outcome
Title Duration of Solicited AEs After the Second Vaccination
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 77 71 100 99
Mean (Standard Deviation)
Unit of Measure: days
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 [1]   (NA) NA [1]   (NA)
Irritability 2.57  (2.410) 2.10  (1.533) NA [1]   (NA) NA [1]   (NA)
Fever 2.14  (3.005) 1.63  (1.165) 1.54  (0.877) 1.67  (1.414)
Headache NA [2]   (NA) NA [2]   (NA) 1.33  (0.686) 1.73  (2.412)
Muscle ache NA [2]   (NA) NA [2]   (NA) 1.60  (0.516) 1.29  (0.756)
Malaise NA [2]   (NA) NA [2]   (NA) 1.20  (0.422) 2.00  (1.826)
[1]
Not solicited for in Cohort B
[2]
Not solicited for in Cohort A
10.Secondary Outcome
Title Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 82 80 103 104
Measure Type: Number
Unit of Measure: percentage of participants
At least one SAE 4.9 1.3 1.0 1.0
Related SAE 0 0 0 1
At least one AESI 2.4 1.3 0 0
Related AESI 0 0 0 0
At least one NOCI 1.2 3.8 1.9 0
Related NOCI 0 0 0 0
11.Secondary Outcome
Title Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 82 80 103 104
Measure Type: Number
Unit of Measure: percentage of participants
At least one unsolicited AE 78.0 82.5 67.0 76.0
Grade 1 unsolicited AE 26.8 33.8 27.2 37.5
Grade 2 unsolicited AE 41.5 41.3 37.9 26.9
Grade 3 unsolicited AE 9.8 7.5 1.9 11.5
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide 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 (4.88%)      1/80 (1.25%)      1/103 (0.97%)      1/104 (0.96%)    
General disorders         
Pyrexia  1  0/82 (0.00%)  0 0/80 (0.00%)  0 0/103 (0.00%)  0 1/104 (0.96%)  1
Infections and infestations         
Gastroenteritis viral  1  1/82 (1.22%)  1 0/80 (0.00%)  0 0/103 (0.00%)  0 0/104 (0.00%)  0
Lobar pneumonia  1  0/82 (0.00%)  0 0/80 (0.00%)  0 1/103 (0.97%)  1 0/104 (0.00%)  0
Nervous system disorders         
Convulsion  1  2/82 (2.44%)  2 0/80 (0.00%)  0 0/103 (0.00%)  0 0/104 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Asthma  1  1/82 (1.22%)  2 0/80 (0.00%)  0 0/103 (0.00%)  0 0/104 (0.00%)  0
Vascular disorders         
Kawasaki's disease  1  0/82 (0.00%)  0 1/80 (1.25%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA V13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
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 (98.78%)      78/80 (97.50%)      91/103 (88.35%)      96/104 (92.31%)    
Ear and labyrinth disorders         
Ear pain  1  0/82 (0.00%)  0 2/80 (2.50%)  2 8/103 (7.77%)  8 4/104 (3.85%)  5
Gastrointestinal disorders         
Abdominal pain  1  1/82 (1.22%)  1 0/80 (0.00%)  0 4/103 (3.88%)  4 1/104 (0.96%)  1
Diarrhoea  1  3/82 (3.66%)  3 3/80 (3.75%)  3 3/103 (2.91%)  3 2/104 (1.92%)  2
Abdominal pain upper  1  0/82 (0.00%)  0 1/80 (1.25%)  1 1/103 (0.97%)  1 3/104 (2.88%)  3
Teething  1  14/82 (17.07%)  18 12/80 (15.00%)  19 0/103 (0.00%)  0 0/104 (0.00%)  0
Vomiting  1  0/82 (0.00%)  0 4/80 (5.00%)  4 2/103 (1.94%)  2 2/104 (1.92%)  2
General disorders         
Influenza-like illness  1  12/82 (14.63%)  14 10/80 (12.50%)  10 7/103 (6.80%)  8 9/104 (8.65%)  9
Pyrexia  1  10/82 (12.20%)  10 4/80 (5.00%)  4 3/103 (2.91%)  4 2/104 (1.92%)  2
Malaise  1  0/82 (0.00%)  0 2/80 (2.50%)  2 3/103 (2.91%)  3 0/104 (0.00%)  0
Fatigue  1  0/82 (0.00%)  0 2/80 (2.50%)  2 0/103 (0.00%)  0 0/104 (0.00%)  0
Pain at Injection Site   40/82 (48.78%)  52 35/80 (43.75%)  47 61/103 (59.22%)  96 67/104 (64.42%)  105
Redness at Injection Site   44/82 (53.66%)  66 31/80 (38.75%)  44 39/103 (37.86%)  53 39/104 (37.50%)  52
Swelling/Induration at Injection Site   25/82 (30.49%)  35 26/80 (32.50%)  33 26/103 (25.24%)  32 28/104 (26.92%)  40
Nausea/Vomiting   11/82 (13.41%)  15 24/80 (30.00%)  26 16/103 (15.53%)  18 21/104 (20.19%)  28
Diarrhoea   22/82 (26.83%)  28 26/80 (32.50%)  32 13/103 (12.62%)  14 13/104 (12.50%)  15
Loss of Appetite  [1]  33/82 (40.24%)  48 40/80 (50.00%)  55 0/0  0 0/0  0
Irritability  [1]  52/82 (63.41%)  92 58/80 (72.50%)  99 0/0  0 0/0  0
Fever   41/82 (50.00%)  51 57/80 (71.25%)  75 21/103 (20.39%)  28 31/104 (29.81%)  37
Headache  [2]  0/0  0 0/0  0 28/103 (27.18%)  42 24/104 (23.08%)  38
Muscle Ache (Myalgia)  [2]  0/0  0 0/0  0 16/103 (15.53%)  21 23/104 (22.12%)  28
Malaise  [2]  0/0  0 0/0  0 20/103 (19.42%)  25 28/104 (26.92%)  39
Immune system disorders         
Seasonal allergy  1  1/82 (1.22%)  1 0/80 (0.00%)  0 3/103 (2.91%)  3 3/104 (2.88%)  3
Infections and infestations         
Upper respiratory tract infection  1  22/82 (26.83%)  28 28/80 (35.00%)  31 22/103 (21.36%)  26 24/104 (23.08%)  26
Viral infection  1  4/82 (4.88%)  4 0/80 (0.00%)  0 3/103 (2.91%)  4 9/104 (8.65%)  9
Croup infectious  1  3/82 (3.66%)  3 1/80 (1.25%)  1 4/103 (3.88%)  4 0/104 (0.00%)  0
Tonsillitis  1  1/82 (1.22%)  1 1/80 (1.25%)  1 1/103 (0.97%)  1 3/104 (2.88%)  3
Nasopharyngitis  1  1/82 (1.22%)  1 1/80 (1.25%)  1 3/103 (2.91%)  3 0/104 (0.00%)  0
Otitis media  1  4/82 (4.88%)  5 1/80 (1.25%)  1 3/103 (2.91%)  3 0/104 (0.00%)  0
Hand-foot-and-mouth disease  1  4/82 (4.88%)  4 3/80 (3.75%)  3 1/103 (0.97%)  1 0/104 (0.00%)  0
Gastroenteritis  1  2/82 (2.44%)  2 3/80 (3.75%)  3 1/103 (0.97%)  1 2/104 (1.92%)  2
Viral upper respiratory tract infection  1  1/82 (1.22%)  1 2/80 (2.50%)  2 0/103 (0.00%)  0 2/104 (1.92%)  2
Ear infection  1  2/82 (2.44%)  2 0/80 (0.00%)  0 1/103 (0.97%)  1 0/104 (0.00%)  0
Lower respiratory tract infection  1  0/82 (0.00%)  0 2/80 (2.50%)  2 0/103 (0.00%)  0 0/104 (0.00%)  0
Rhinitis  1  2/82 (2.44%)  2 0/80 (0.00%)  0 0/103 (0.00%)  0 1/104 (0.96%)  1
Injury, poisoning and procedural complications         
Fall  1  3/82 (3.66%)  3 6/80 (7.50%)  6 4/103 (3.88%)  5 7/104 (6.73%)  7
Excoriation  1  2/82 (2.44%)  2 1/80 (1.25%)  1 3/103 (2.91%)  3 6/104 (5.77%)  8
Contusion  1  1/82 (1.22%)  1 1/80 (1.25%)  1 0/103 (0.00%)  0 6/104 (5.77%)  6
Injury  1  1/82 (1.22%)  1 0/80 (0.00%)  0 1/103 (0.97%)  1 4/104 (3.85%)  5
Accident  1  1/82 (1.22%)  1 0/80 (0.00%)  0 1/103 (0.97%)  1 3/104 (2.88%)  4
Head injury  1  0/82 (0.00%)  0 3/80 (3.75%)  5 0/103 (0.00%)  0 4/104 (3.85%)  5
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/82 (0.00%)  0 0/80 (0.00%)  0 3/103 (2.91%)  3 1/104 (0.96%)  1
Nervous system disorders         
Headache  1  1/82 (1.22%)  1 2/80 (2.50%)  2 4/103 (3.88%)  4 4/104 (3.85%)  4
Lethargy  1  1/82 (1.22%)  1 3/80 (3.75%)  3 1/103 (0.97%)  1 0/104 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1  6/82 (7.32%)  6 11/80 (13.75%)  12 13/103 (12.62%)  13 11/104 (10.58%)  12
Rhinorrhea  1  8/82 (9.76%)  8 17/80 (21.25%)  17 4/103 (3.88%)  4 8/104 (7.69%)  10
Oropharyngeal pain  1  2/82 (2.44%)  2 0/80 (0.00%)  0 4/103 (3.88%)  6 4/104 (3.85%)  4
Asthma  1  2/82 (2.44%)  2 4/80 (5.00%)  4 3/103 (2.91%)  4 3/104 (2.88%)  4
Nasal congestion  1  0/82 (0.00%)  0 3/80 (3.75%)  4 2/103 (1.94%)  4 2/104 (1.92%)  2
Skin and subcutaneous tissue disorders         
Rash  1  7/82 (8.54%)  7 3/80 (3.75%)  3 0/103 (0.00%)  0 2/104 (1.92%)  2
Dermatitis diaper  1  7/82 (8.54%)  7 1/80 (1.25%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0
Dermatitis  1  1/82 (1.22%)  1 2/80 (2.50%)  2 0/103 (0.00%)  0 2/104 (1.92%)  3
Eczema  1  1/82 (1.22%)  1 2/80 (2.50%)  3 0/103 (0.00%)  0 0/104 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA V13.0
[1]
Not solicited for in Cohort B.
[2]
Not solicited for in Cohort A.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Responsible Party: Seqirus
ClinicalTrials.gov Identifier: NCT00940108     History of Changes
Other Study ID Numbers: CSLCT-CAL-09-60
First Submitted: July 13, 2009
First Posted: July 15, 2009
Results First Submitted: July 9, 2013
Results First Posted: November 20, 2013
Last Update Posted: June 28, 2018