Trial Outcomes & Findings for Safety Study of CSL Limited's Influenza Virus Vaccine in the Paediatric Population Aged >= 6 Months to < 18 Years (NCT NCT00825162)

Last Updated: 2018-05-23

Results Overview

Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1992 participants

Primary outcome timeframe

7 days post-vaccination

Results posted on

2018-05-23

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort A Participants aged 6 months to less than 3 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.	Cohort B Participants aged 3 to less than 9 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.	Cohort C Participants aged 9 to less than 18 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
Overall Study STARTED	710	880	402
Overall Study COMPLETED	682	859	396
Overall Study NOT COMPLETED	28	21	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A Participants aged 6 months to less than 3 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.	Cohort B Participants aged 3 to less than 9 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.	Cohort C Participants aged 9 to less than 18 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
Overall Study Withdrawal by Subject	11	13	3
Overall Study Lost to Follow-up	9	6	3
Overall Study Physician Decision	2	0	0
Overall Study Move away from the study area	1	0	0
Overall Study Unable to attend the study visit	5	2	0

Baseline Characteristics

Safety Study of CSL Limited's Influenza Virus Vaccine in the Paediatric Population Aged >= 6 Months to < 18 Years

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A n=710 Participants Participants aged 6 months to less than 3 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.	Cohort B n=880 Participants Participants aged 3 to less than 9 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.	Cohort C n=402 Participants Participants aged 9 to less than 18 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.	Total n=1992 Participants Total of all reporting groups
Age, Categorical <=18 years	710 Participants n=93 Participants	880 Participants n=4 Participants	402 Participants n=27 Participants	1992 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Continuous	1.84 years STANDARD_DEVIATION 0.74 • n=93 Participants	5.54 years STANDARD_DEVIATION 1.66 • n=4 Participants	12.64 years STANDARD_DEVIATION 2.48 • n=27 Participants	5.66 years STANDARD_DEVIATION 4.21 • n=483 Participants
Sex: Female, Male Female	325 Participants n=93 Participants	439 Participants n=4 Participants	202 Participants n=27 Participants	966 Participants n=483 Participants
Sex: Female, Male Male	385 Participants n=93 Participants	441 Participants n=4 Participants	200 Participants n=27 Participants	1026 Participants n=483 Participants
Region of Enrollment Australia	710 participants n=93 Participants	880 participants n=4 Participants	402 participants n=27 Participants	1992 participants n=483 Participants

PRIMARY outcome

Timeframe: 7 days post-vaccination

Population: The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.

Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.

Outcome measures

Outcome measures
Measure	After First Vaccination, Cohort A n=703 Participants Participants aged 6 months to less than 3 years	After Second Vaccination, Cohort A n=615 Participants Participants aged 6 months to less than 3 years	Cohort C
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Any local solicited adverse event	254 Participants	167 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Any pain	160 Participants	111 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Grade 3 pain	1 Participants	2 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Any redness (> 0 mm)	148 Participants	109 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Grade 3 redness (> 30 mm)	2 Participants	1 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Any swelling / induration (> 0 mm)	66 Participants	64 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Grade 3 swelling / induration (> 30 mm)	2 Participants	0 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Any systemic solicited adverse event	424 Participants	261 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Any fever (≥99.5°F axillary or ≥100.4 °F oral)	201 Participants	110 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Grade 3 fever (≥103.1 F°axillary or ≥104 °F oral)	13 Participants	6 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Any headache	25 Participants	12 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Grade 3 headache (prevent activities)	1 Participants	0 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Any myalgia	26 Participants	16 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Grade 3 myalgia (prevent activities)	3 Participants	1 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Any nausea / vomiting	79 Participants	31 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Grade 3 nausea / vomiting (prevent activities)	12 Participants	4 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Any diarrhea	100 Participants	52 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Grade 3 diarrhea (prevent activities)	4 Participants	3 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Any loss of appetite	141 Participants	82 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Grade 3 loss of appetite (prevent activities)	8 Participants	4 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Any irritability	295 Participants	175 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Grade 3 irritability (prevent activities)	24 Participants	7 Participants	—

PRIMARY outcome

Timeframe: 7 days post-vaccination

Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.

Outcome measures

Outcome measures
Measure	After First Vaccination, Cohort A n=703 Participants Participants aged 6 months to less than 3 years	After Second Vaccination, Cohort A n=615 Participants Participants aged 6 months to less than 3 years	Cohort C
Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Any pain	1.83 Days Standard Deviation 1.264	1.76 Days Standard Deviation 1.315	—
Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Any redness (> 0 mm)	2.55 Days Standard Deviation 1.930	2.74 Days Standard Deviation 2.478	—
Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Any swelling / induration (> 0 mm)	3.06 Days Standard Deviation 4.011	3.20 Days Standard Deviation 3.301	—
Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Any fever (≥99.5°F axillary or ≥100.4 °F oral)	1.54 Days Standard Deviation 1.164	1.67 Days Standard Deviation 1.148	—
Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Any headache	2.50 Days Standard Deviation 4.492	1.23 Days Standard Deviation 0.439	—
Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Any myalgia	1.54 Days Standard Deviation 1.071	1.70 Days Standard Deviation 1.129	—
Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Any nausea / vomiting	1.87 Days Standard Deviation 2.587	2.84 Days Standard Deviation 4.919	—
Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Any diarrhea	2.43 Days Standard Deviation 3.473	2.50 Days Standard Deviation 2.573	—
Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Any loss of appetite	2.53 Days Standard Deviation 3.204	3.02 Days Standard Deviation 4.325	—
Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) Any irritability	2.28 Days Standard Deviation 2.503	2.42 Days Standard Deviation 2.726	—

PRIMARY outcome

Timeframe: 7 days post-vaccination

Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.

Outcome measures

Outcome measures
Measure	After First Vaccination, Cohort A n=875 Participants Participants aged 6 months to less than 3 years	After Second Vaccination, Cohort A n=634 Participants Participants aged 6 months to less than 3 years	Cohort C
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Any local solicited adverse event	512 Participants	312 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Any pain	463 Participants	282 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Grade 3 pain	2 Participants	2 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Any redness (> 0 mm)	189 Participants	109 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Grade 3 redness (> 30 mm)	18 Participants	7 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Any swelling / induration (> 0 mm)	137 Participants	77 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Grade 3 swelling / induration (> 30 mm)	19 Participants	8 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Any systemic solicited adverse event	346 Participants	157 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Any fever (≥99.5°F axillary or ≥100.4 °F oral)	171 Participants	63 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Grade 3 fever (≥103.1 F°axillary or ≥104 °F oral)	7 Participants	2 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Any headache	136 Participants	38 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Grade 3 headache (prevent activities)	4 Participants	4 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Any myalgia	87 Participants	34 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Grade 3 myalgia (prevent activities)	3 Participants	3 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Any nausea / vomiting	75 Participants	35 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Grade 3 nausea / vomiting (prevent activities)	6 Participants	5 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Any diarrhea	40 Participants	20 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Grade 3 diarrhea (prevent activities)	2 Participants	0 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Any malaise	179 Participants	72 Participants	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Grade 3 malaise (prevent activities)	14 Participants	10 Participants	—

PRIMARY outcome

Timeframe: 7 days post-vaccination

Population: The Safety Population comprised all participants who received CSL's IVV at Visit 1 and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.

Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.

Outcome measures

Outcome measures
Measure	After First Vaccination, Cohort A n=875 Participants Participants aged 6 months to less than 3 years	After Second Vaccination, Cohort A n=634 Participants Participants aged 6 months to less than 3 years	Cohort C
Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Any pain	1.89 Days Standard Deviation 1.178	1.68 Days Standard Deviation 1.030	—
Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Any redness (> 0 mm)	2.45 Days Standard Deviation 1.713	2.21 Days Standard Deviation 1.316	—
Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Any swelling / induration (> 0 mm)	2.48 Days Standard Deviation 1.688	2.09 Days Standard Deviation 1.696	—
Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Any fever (≥99.5°F axillary or ≥100.4 °F oral)	1.40 Days Standard Deviation 1.114	1.58 Days Standard Deviation 1.117	—
Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Any headache	1.79 Days Standard Deviation 1.373	1.66 Days Standard Deviation 1.311	—
Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Any myalgia	1.74 Days Standard Deviation 1.264	1.38 Days Standard Deviation 0.590	—
Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Any nausea / vomiting	1.52 Days Standard Deviation 1.305	1.36 Days Standard Deviation 0.757	—
Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Any diarrhea	2.00 Days Standard Deviation 1.593	2.00 Days Standard Deviation 1.612	—
Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) Any malaise	1.89 Days Standard Deviation 1.763	2.13 Days Standard Deviation 1.584	—

PRIMARY outcome

Timeframe: 7 days post-vaccination

Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.

Outcome measures

Outcome measures
Measure	After First Vaccination, Cohort A n=398 Participants Participants aged 6 months to less than 3 years	After Second Vaccination, Cohort A Participants aged 6 months to less than 3 years	Cohort C
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Any local solicited adverse event	281 Participants	—	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Any pain	271 Participants	—	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Grade 3 pain	1 Participants	—	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Any redness (> 0 mm)	66 Participants	—	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Grade 3 redness (> 30 mm)	8 Participants	—	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Any swelling / induration (> 0 mm)	52 Participants	—	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Grade 3 swelling / induration (> 30 mm)	12 Participants	—	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Any systemic solicited adverse event	170 Participants	—	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Any fever (≥99.5°F axillary or ≥100.4 °F oral)	20 Participants	—	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Grade 3 fever (≥103.1 F°axillary or ≥104 °F oral)	0 Participants	—	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Any headache	107 Participants	—	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Grade 3 headache (prevent activities)	2 Participants	—	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Any myalgia	80 Participants	—	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Grade 3 myalgia (prevent activities)	0 Participants	—	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Any nausea / vomiting	21 Participants	—	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Grade 3 nausea / vomiting (prevent activities)	1 Participants	—	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Any diarrhea	21 Participants	—	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Grade 3 diarrhea (prevent activities)	1 Participants	—	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Any malaise	66 Participants	—	—
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Grade 3 malaise (prevent activities)	1 Participants	—	—

PRIMARY outcome

Timeframe: 7 days post-vaccination

Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.

Outcome measures

Outcome measures
Measure	After First Vaccination, Cohort A n=398 Participants Participants aged 6 months to less than 3 years	After Second Vaccination, Cohort A Participants aged 6 months to less than 3 years	Cohort C
Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Any pain	2.02 Days Standard Deviation 1.317	—	—
Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Any redness (> 0 mm)	2.52 Days Standard Deviation 1.867	—	—
Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Any swelling / induration (> 0 mm)	2.81 Days Standard Deviation 1.854	—	—
Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Any fever (≥99.5°F axillary or ≥100.4 °F oral)	1.21 Days Standard Deviation 0.415	—	—
Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Any headache	1.97 Days Standard Deviation 1.851	—	—
Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Any myalgia	2.20 Days Standard Deviation 3.123	—	—
Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Any nausea / vomiting	1.65 Days Standard Deviation 1.164	—	—
Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Any diarrhea	2.23 Days Standard Deviation 1.771	—	—
Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) Any malaise	2.56 Days Standard Deviation 1.853	—	—

SECONDARY outcome

Timeframe: 30 days after each study vaccination

Population: The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination.

UAE stands for Unsolicited Adverse Event.

Outcome measures

Outcome measures
Measure	After First Vaccination, Cohort A n=703 Participants Participants aged 6 months to less than 3 years	After Second Vaccination, Cohort A n=875 Participants Participants aged 6 months to less than 3 years	Cohort C n=398 Participants
Frequency and Intensity of Unsolicited Adverse Events (UAEs) Number of participants with at least one UAE	531 Participants	521 Participants	167 Participants
Frequency and Intensity of Unsolicited Adverse Events (UAEs) Number of participants reported Grade 1 UAE	115 Participants	183 Participants	63 Participants
Frequency and Intensity of Unsolicited Adverse Events (UAEs) Number of participants reported Grade 2 UAE	300 Participants	251 Participants	82 Participants
Frequency and Intensity of Unsolicited Adverse Events (UAEs) Number of participants reported Grade 3 UAE	116 Participants	87 Participants	22 Participants

SECONDARY outcome

Timeframe: 180 days after the last study vaccination

Population: The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination.

Outcome measures

Outcome measures
Measure	After First Vaccination, Cohort A n=703 Participants Participants aged 6 months to less than 3 years	After Second Vaccination, Cohort A n=875 Participants Participants aged 6 months to less than 3 years	Cohort C n=398 Participants
Frequency of Serious Adverse Events Number of participants with at least one SAE	19 Participants	5 Participants	2 Participants
Frequency of Serious Adverse Events Number of participants with related SAE	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 180 days after the last study vaccination

Population: The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination.

Outcome measures

Outcome measures
Measure	After First Vaccination, Cohort A n=703 Participants Participants aged 6 months to less than 3 years	After Second Vaccination, Cohort A n=875 Participants Participants aged 6 months to less than 3 years	Cohort C n=398 Participants
Frequency of New Onsets of Chronic Illness Number of participants with at least one NOCI	10 Participants	5 Participants	2 Participants
Frequency of New Onsets of Chronic Illness Number of participants with related NOCI	2 Participants	0 Participants	0 Participants

Adverse Events

Cohort A

Serious events: 19 serious events

Other events: 531 other events

Deaths: 0 deaths

Cohort B

Serious events: 5 serious events

Other events: 467 other events

Deaths: 0 deaths

Cohort C

Serious events: 2 serious events

Other events: 97 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Cohort A n=703 participants at risk Participants aged 6 months to less than 3 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.	Cohort B n=875 participants at risk Participants aged 3 to less than 9 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.	Cohort C n=398 participants at risk Participants aged 9 to less than 18 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
Infections and infestations Upper respiratory tract infection	29.6% 208/703 • Number of events 262 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.	16.2% 142/875 • Number of events 171 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.	8.3% 33/398 • Number of events 37 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.
Infections and infestations Nasopharyngitis	7.1% 50/703 • Number of events 59 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.	4.5% 39/875 • Number of events 46 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.	1.0% 4/398 • Number of events 4 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.
Infections and infestations Respiratory tract infection	5.3% 37/703 • Number of events 41 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.	1.3% 11/875 • Number of events 11 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.	0.75% 3/398 • Number of events 3 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.
Nervous system disorders Headache	0.28% 2/703 • Number of events 3 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.	3.5% 31/875 • Number of events 38 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.	8.3% 33/398 • Number of events 37 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.
Respiratory, thoracic and mediastinal disorders Cough	11.4% 80/703 • Number of events 97 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.	9.8% 86/875 • Number of events 101 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.	1.5% 6/398 • Number of events 6 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	12.8% 90/703 • Number of events 111 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.	7.4% 65/875 • Number of events 73 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.	3.0% 12/398 • Number of events 13 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.
Gastrointestinal disorders Teething	16.1% 113/703 • Number of events 165 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.	0.23% 2/875 • Number of events 2 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.	0.00% 0/398 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.
Gastrointestinal disorders Vomiting	6.5% 46/703 • Number of events 53 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.	3.0% 26/875 • Number of events 27 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.	0.25% 1/398 • Number of events 1 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.
Skin and subcutaneous tissue disorders Rash	5.1% 36/703 • Number of events 40 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.	1.1% 10/875 • Number of events 10 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.	0.25% 1/398 • Number of events 1 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.
General disorders Pyrexia	10.8% 76/703 • Number of events 95 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.	6.3% 55/875 • Number of events 58 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.	1.0% 4/398 • Number of events 4 • SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.

Additional Information

Clinical Study Disclosure Manager

Seqirus

Phone: 1-855-358-8966

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60