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Clinical Trial Results:
A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged greater than or equal to 6 months to less than 18 years

Summary
EudraCT number	2014-004131-40
Trial protocol	Outside EU/EEA
Global end of trial date	22 Feb 2010

Results information
Results version number	v1(current)
This version publication date	30 Jun 2016
First version publication date	30 Jul 2015
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

CSLCT-USF-06-29

ISRCTN number

US NCT number

NCT00825162

WHO universal trial number (UTN)

Sponsor organisation name

CSL Limited

Sponsor organisation address

45 Poplar Road, Parkville, Australia, 3052

Public contact

Clinical Program Director, bioCSL, bioCSL PTY LTD, biocsl.clinicaltrials@biocsl.com.au

Scientific contact

Clinical Program Director, bioCSL, bioCSL PTY LTD, biocsl.clinicaltrials@biocsl.com.au

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

15 Apr 2010

Is this the analysis of the primary completion data?

Yes

Primary completion date

22 Feb 2010

Global end of trial reached?

Yes

Global end of trial date

22 Feb 2010

Was the trial ended prematurely?

Main objective of the trial

Safety and tolerability of CSL Limited’s Influenza Virus Vaccine (CSL’s IVV) in a pediatric population aged 6 months to less than 18 years.

Protection of trial subjects

The study protocol, the Participant Information Sheet (PIS), the Informed Consent Form (ICF) and any other written information provided to the participant were reviewed and approved by an Independent Ethics Committee (IEC) at each study site. This study was conducted in accordance with the standards of Good Clinical Practice, as defined by the International Conference on Harmonisation, the principles outlined in the Declaration of Helsinki, and all applicable federal and local regulations.

Background therapy

None

Evidence for comparator

Not applicable

Actual start date of recruitment

06 Mar 2009

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 1992

Worldwide total number of subjects

1992

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

390

Children (2-11 years)

1384

Adolescents (12-17 years)

218

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Active Study Initiation Date: 06 March 2009 (First participant, First Visit) Study Completion Date: 22 February 2010 (Last participant followed up, 180 days after last vaccination) The study was conducted at seven sites in Australia.

Screening details

2024 participants provided informed consent, 1992 participants were enrolled into the study.

Period 1 title

Overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Cohort A

Arm description

participants aged 6 months to < 3 years

Arm type

Experimental

Investigational medicinal product name

CSL Limited’s Influenza Virus Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

The 2009 Southern Hemisphere formulation of CSL’s IVV was supplied as a thimerosal-free aqueous suspension in pre-filled syringes. Each 0.25 mL dose contained 7.5 mcg HA antigen for each of the three strains recommended by the World Health Organization for the 2009 Southern Hemisphere influenza season (nominal 22.5 mcg HA antigen per 0.25 mL dose). The dosing regimen (a single vaccination or two vaccinations) was determined by the participant’s influenza vaccination history. Participants were administered a single vaccination of CSL’s IVV if they had received two doses of influenza vaccine during the 2008 Southern Hemisphere influenza season, or one or more doses of influenza vaccine during an influenza season before 2008. Each vaccination was administered by intramuscular injection into either the anterolateral aspect of the thigh (recommended for participants aged 12 months or younger) or deltoid region of the arm (recommended for participants aged older than 12 months).

Cohort B

Arm description

participants aged 3 years to < 9 years

Arm type

Experimental

Investigational medicinal product name

CSL Limited’s Influenza Virus Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

The 2009 Southern Hemisphere formulation of CSL’s IVV was supplied as a thimerosal-free aqueous suspension in pre-filled syringes. Each 0.5 mL dose contained 15 mcg HA antigen for each of the three strains recommended by the World Health Organization for the 2009 Southern Hemisphere influenza season (nominal 45 mcg HA antigen per 0.5 mL dose). The dosing regimen (a single vaccination or two vaccinations) was determined by the participant’s influenza vaccination history. Participants were administered a single vaccination of CSL’s IVV if they had received two doses of influenza vaccine during the 2008 Southern Hemisphere influenza season, or one or more doses of influenza vaccine during an influenza season before 2008. Each vaccination was administered by intramuscular injection into the deltoid region of the arm.

Cohort C

Arm description

participants aged 9 years to < 18 years

Arm type

Experimental

Investigational medicinal product name

CSL Limited’s Influenza Virus Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Number of subjects in period 1	Cohort A	Cohort B	Cohort C
Started	710	880	402
Completed	682	859	396
Not completed	28	21	6
Physician decision	2	-	-
Unable to attend study visit	5	2	-
Moved away from study area	1	-	-
Lost to follow-up	9	6	3
Withdrawal by subject	11	13	3

Baseline characteristics

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Reporting group title

Cohort A

Reporting group description

participants aged 6 months to < 3 years

Reporting group title

Cohort B

Reporting group description

participants aged 3 years to < 9 years

Reporting group title

Cohort C

Reporting group description

participants aged 9 years to < 18 years

Reporting group values	Cohort A	Cohort B	Cohort C	Total
Number of subjects	710	880	402	1992
Age categorical
Units: Subjects
Cohort A - 6 months to less than 3 years	710	0	0	710
Cohort B - 3 to less than 9 years	0	880	0	880
Cohort C - 9 to less than 18 years	0	0	402	402
Age continuous
Units: years
arithmetic mean (standard deviation)	1.84 ( 0.74 )	5.54 ( 1.66 )	12.64 ( 2.48 )	-
Gender categorical
Units: Subjects
Female	325	439	202	966
Male	385	441	200	1026

Subject analysis set title

Safety Set

Subject analysis set type

Safety analysis

Subject analysis set description

A total of 1992 participants received at least one vaccination with CSL’s IVV. Of these, 16 participants did not provide follow-up safety data; therefore, 1976 participants comprised the Safety Set.

Subject analysis sets values	Safety Set
Number of subjects	1976
Age categorical
Units: Subjects
Cohort A - 6 months to less than 3 years	710
Cohort B - 3 to less than 9 years	880
Cohort C - 9 to less than 18 years	402
Age continuous
Units: years
arithmetic mean (standard deviation)	5.66 ( 4.21 )
Gender categorical
Units: Subjects
Female	966
Male	1026

End points

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Reporting group title

Cohort A

Reporting group description

participants aged 6 months to < 3 years

Reporting group title

Cohort B

Reporting group description

participants aged 3 years to < 9 years

Reporting group title

Cohort C

Reporting group description

participants aged 9 years to < 18 years

Subject analysis set title

Safety Set

Subject analysis set type

Safety analysis

Subject analysis set description

Primary: Frequency and Intensity of Solicited Adverse Events after First Vaccination

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End point title

Frequency and Intensity of Solicited Adverse Events after First Vaccination ^[1]

End point description

Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, and diarrhea. Loss of appetite and irritability were also collected in cohort A only. Malaise was also collected in cohorts B and C only.

End point type

Primary

End point timeframe

Collected for 6 days (total 7 days) following vaccination

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Summary descriptive statistics of continuous data were presented as number of observations, mean, standard deviation, median, minimum and maximum. For categorical variables, statistical summaries included counts and percentages relative to the appropriate population. A 95% confidence interval was provided for descriptive statistics, as warranted.

End point values	Cohort A	Cohort B	Cohort C
Number of subjects analysed	703	875	398
Units: Number of subjects
Any local solicited adverse event	254	512	281
Any pain	160	463	271
Grade 3 pain	1	2	1
Any redness (> 0 mm)	148	189	66
Grade 3 redness (> 30 mm)	2	18	8
Any swelling/induration (> 0 mm)	66	137	52
Grade 3 swelling/induration (> 30 mm)	2	19	12
Any systemic solicited adverse event	424	346	170
Any fever (≥99.5°F axillary or ≥100.4 °F oral)	201	171	20
Grade 3 fever (≥103.1 F°axillary or ≥104 °F oral)	13	7	0
Any headache	25	136	107
Grade 3 headache (prevents activities)	1	4	2
Any myalgia	26	87	80
Grade 3 myalgia (prevents activities)	3	3	0
Any nausea/vomiting	79	75	21
Grade 3 nausea/vomiting (prevents activities)	12	6	1
Any diarrhea	100	40	21
Grade 3 diarrhea (prevents activities)	4	2	1
Any loss of appetite	141	0	0
Grade 3 loss of appetite (prevents activities)	8	0	0
Any irritability	295	0	0
Grade 3 irritability (prevents activities)	24	0	0
Any malaise	0	179	66
Grade 3 malaise (prevents activities)	0	14	1

No statistical analyses for this end point

Primary: Duration of Solicited Adverse Events after First Vaccination

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End point title

Duration of Solicited Adverse Events after First Vaccination ^[2]

End point description

End point type

Primary

End point timeframe

7 days post-vaccination

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Summary descriptive statistics of continuous data were presented as number of observations, mean, standard deviation, median, minimum and maximum. For categorical variables, statistical summaries included counts and percentages relative to the appropriate population. A 95% confidence interval was provided for descriptive statistics, as warranted.

End point values	Cohort A	Cohort B	Cohort C
Number of subjects analysed	703	875	398
Units: Days
arithmetic mean (standard deviation)
Any pain	1.83 ( 1.264 )	1.89 ( 1.178 )	2.02 ( 1.317 )
Any redness (> 0 mm)	2.55 ( 1.93 )	2.45 ( 1.713 )	2.52 ( 1.867 )
Any swelling / induration (> 0 mm)	3.06 ( 4.011 )	2.48 ( 1.688 )	2.81 ( 1.854 )
Any fever (≥99.5°F axillary or ≥100.4 °F oral)	1.54 ( 1.164 )	1.4 ( 1.114 )	1.21 ( 0.415 )
Any headache	2.5 ( 4.492 )	1.79 ( 1.373 )	1.97 ( 1.851 )
Any myalgia	1.54 ( 1.071 )	1.74 ( 1.264 )	2.2 ( 3.123 )
Any nausea / vomiting	1.87 ( 2.587 )	1.52 ( 1.305 )	1.65 ( 1.164 )
Any diarrhea	2.43 ( 3.473 )	2 ( 1.593 )	2.23 ( 1.771 )
Any loss of appetite	2.53 ( 3.204 )	0 ( 0 )	0 ( 0 )
Any irritability	2.28 ( 2.503 )	0 ( 0 )	0 ( 0 )
Any malaise	0 ( 0 )	1.89 ( 1.763 )	2.56 ( 1.853 )

No statistical analyses for this end point

Primary: Frequency and Intensity of Solicited Adverse Events after Second Vaccination

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End point title

Frequency and Intensity of Solicited Adverse Events after Second Vaccination ^[3] ^[4]

End point description

End point type

Primary

End point timeframe

7 days post-vaccination

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Summary descriptive statistics of continuous data were presented as number of observations, mean, standard deviation, median, minimum and maximum. For categorical variables, statistical summaries included counts and percentages relative to the appropriate population. A 95% confidence interval was provided for descriptive statistics, as warranted.
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Participants in Cohort C did not receive a second vaccination.

End point values	Cohort A	Cohort B
Number of subjects analysed	615	634
Units: Number of Participants
Any local solicited adverse event	167	312
Any pain	111	282
Grade 3 pain	2	2
Any redness (> 0 mm)	109	109
Grade 3 redness (> 30 mm)	1	7
Any swelling / induration (> 0 mm)	64	77
Grade 3 swelling / induration (> 30 mm)	0	8
Any systemic solicited adverse event	261	157
Any fever (≥99.5°F axillary or ≥100.4 °F oral)	110	63
Grade 3 fever (≥103.1 F°axillary or ≥104 °F oral)	6	2
Any headache	12	38
Grade 3 headache (prevent activities)	0	4
Any myalgia	16	34
Grade 3 myalgia (prevent activities)	1	3
Any nausea / vomiting	31	35
Grade 3 nausea / vomiting (prevent activities)	4	5
Any diarrhea	52	20
Grade 3 diarrhea (prevent activities)	3	0
Any loss of appetite	82	0
Grade 3 loss of appetite (prevent activities)	4	0
Any irritability	175	0
Grade 3 irritability (prevent activities)	7	0
Any malaise	0	72
Grade 3 malaise (prevent activities)	0	10

No statistical analyses for this end point

Primary: Duration of Solicited Adverse Events after Second Vaccination

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End point title

Duration of Solicited Adverse Events after Second Vaccination ^[5] ^[6]

End point description

End point type

Primary

End point timeframe

7 days post-vaccination

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Summary descriptive statistics of continuous data were presented as number of observations, mean, standard deviation, median, minimum and maximum. For categorical variables, statistical summaries included counts and percentages relative to the appropriate population. A 95% confidence interval was provided for descriptive statistics, as warranted.
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Participants in Cohort C did not receive a second vaccination.

End point values	Cohort A	Cohort B
Number of subjects analysed	615	634
Units: Days
arithmetic mean (standard deviation)
Any pain	1.76 ( 1.315 )	1.68 ( 1.03 )
Any redness (> 0 mm)	2.74 ( 2.478 )	2.21 ( 1.316 )
Any swelling / induration (> 0 mm)	3.2 ( 3.301 )	2.09 ( 1.696 )
Any fever (≥99.5°F axillary or ≥100.4 °F oral)	1.67 ( 1.148 )	1.58 ( 1.117 )
Any headache	1.23 ( 0.439 )	1.66 ( 1.311 )
Any myalgia	1.7 ( 1.129 )	1.38 ( 0.59 )
Any nausea / vomiting	2.84 ( 4.919 )	1.36 ( 0.757 )
Any diarrhea	2.5 ( 2.573 )	2 ( 1.612 )
Any loss of appetite	3.02 ( 4.325 )	0 ( 0 )
Any irritability	2.42 ( 2.726 )	0 ( 0 )
Any malaise	0 ( 0 )	2.13 ( 1.584 )

No statistical analyses for this end point

Secondary: Frequency and Intensity of Unsolicited Adverse Events (UAEs)

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End point title

Frequency and Intensity of Unsolicited Adverse Events (UAEs)

End point description

UAE stands for Unsolicited Adverse Event. No statistical analysis provided for frequency and intensity of UAEs

End point type

Secondary

End point timeframe

30 days after each study vaccination

End point values	Cohort A	Cohort B	Cohort C
Number of subjects analysed	703	875	398
Units: Number of subjects
Number of participants with at least one UA	531	521	167
Number of participants reported Grade 1 UAE	115	183	63
Number of participants reported Grade 2 UAE	300	251	82
Number of participants reported Grade 3 UAE	116	87	22

No statistical analyses for this end point

Secondary: Frequency of Serious Adverse Events (SAEs)

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End point title

Frequency of Serious Adverse Events (SAEs)

End point description

No statistical analysis provided

End point type

Secondary

End point timeframe

180 days after the last vaccination

End point values	Cohort A	Cohort B	Cohort C
Number of subjects analysed	703	875	398
Units: Number of participants
Number of participants with at least one SAE	19	5	2
Number of participants with related SAE	0	0	0

No statistical analyses for this end point

Secondary: Frequency of New Onsets of Chronic Illness (NOCIs)

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End point title

Frequency of New Onsets of Chronic Illness (NOCIs)

End point description

No statistical analysis provided

End point type

Secondary

End point timeframe

180 days after the last study vaccination

End point values	Cohort A	Cohort B	Cohort C
Number of subjects analysed	703	875	398
Units: Numbers of participants
Number of participants with at least one NOCI	10	5	2
Number of participants with related NOCI	2	0	0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Local and systemic solicited AEs were collected for 7 days after each study vaccination. Unsolicited AEs were collected for 30 days after each study vaccination. SAEs and NOCIs were collected up to 180 days after the last study vaccination.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

12.1

Reporting group title

Cohort A

Reporting group description

participants aged 6 months to < 3 years

Reporting group title

Cohort B

Reporting group description

participants aged 3 years to < 9 years

Reporting group title

Cohort C

Reporting group description

participants aged 9 years to less than 18 years

Serious adverse events	Cohort A	Cohort B	Cohort C
Total subjects affected by serious adverse events
subjects affected / exposed	19 / 703 (2.70%)	5 / 875 (0.57%)	2 / 398 (0.50%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events
Injury, poisoning and procedural complications
Forearm fracture
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 703 (0.14%)	0 / 875 (0.00%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hand fracture
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 703 (0.00%)	1 / 875 (0.11%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
Convulsion
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 703 (0.14%)	0 / 875 (0.00%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Febrile convulsion
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 703 (0.14%)	0 / 875 (0.00%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Asthma
alternative assessment type: Non-systematic
subjects affected / exposed	5 / 703 (0.71%)	0 / 875 (0.00%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonitis
subjects affected / exposed	1 / 703 (0.14%)	0 / 875 (0.00%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Conversion disorder
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 703 (0.00%)	1 / 875 (0.11%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Pelvi-ureteric obstruction
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 703 (0.00%)	1 / 875 (0.11%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Pneumonia
alternative assessment type: Non-systematic
subjects affected / exposed	2 / 703 (0.28%)	0 / 875 (0.00%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchiolitis
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 703 (0.14%)	0 / 875 (0.00%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Croup infectious
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 703 (0.14%)	0 / 875 (0.00%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Eczema infected
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 703 (0.00%)	1 / 875 (0.11%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis viral
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 703 (0.14%)	0 / 875 (0.00%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lower respiratory tract infection
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 703 (0.14%)	0 / 875 (0.00%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	1 / 703 (0.14%)	0 / 875 (0.00%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pharyngitis
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 703 (0.00%)	0 / 875 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory tract infection
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 703 (0.14%)	0 / 875 (0.00%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory tract infection viral
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 703 (0.00%)	1 / 875 (0.11%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Soft tissue infection
subjects affected / exposed	0 / 703 (0.00%)	0 / 875 (0.00%)	1 / 398 (0.25%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Upper respiratory tract infection
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 703 (0.14%)	0 / 875 (0.00%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Viral infection
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 703 (0.14%)	0 / 875 (0.00%)	0 / 398 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Cohort A	Cohort B	Cohort C
Total subjects affected by non serious adverse events
subjects affected / exposed	531 / 703 (75.53%)	467 / 875 (53.37%)	97 / 398 (24.37%)
Nervous system disorders
Headache
alternative assessment type: Non-systematic
subjects affected / exposed	2 / 703 (0.28%)	31 / 875 (3.54%)	33 / 398 (8.29%)
occurrences all number	3	38	37
General disorders and administration site conditions
Pyrexia
alternative assessment type: Non-systematic
subjects affected / exposed	76 / 703 (10.81%)	55 / 875 (6.29%)	4 / 398 (1.01%)
occurrences all number	95	58	4
Gastrointestinal disorders
Teething
alternative assessment type: Non-systematic
subjects affected / exposed	113 / 703 (16.07%)	2 / 875 (0.23%)	0 / 398 (0.00%)
occurrences all number	165	2	0
Vomiting
alternative assessment type: Non-systematic
subjects affected / exposed	46 / 703 (6.54%)	26 / 875 (2.97%)	1 / 398 (0.25%)
occurrences all number	53	27	1
Respiratory, thoracic and mediastinal disorders
Cough
alternative assessment type: Non-systematic
subjects affected / exposed	80 / 703 (11.38%)	86 / 875 (9.83%)	6 / 398 (1.51%)
occurrences all number	97	101	6
Rhinorrhoea
alternative assessment type: Non-systematic
subjects affected / exposed	90 / 703 (12.80%)	65 / 875 (7.43%)	12 / 398 (3.02%)
occurrences all number	111	73	13
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	36 / 703 (5.12%)	10 / 875 (1.14%)	1 / 398 (0.25%)
occurrences all number	40	10	1
Infections and infestations
Upper respiratory tract infection
subjects affected / exposed	208 / 703 (29.59%)	142 / 875 (16.23%)	33 / 398 (8.29%)
occurrences all number	262	171	37
Nasopharyngitis
alternative assessment type: Non-systematic
subjects affected / exposed	50 / 703 (7.11%)	39 / 875 (4.46%)	4 / 398 (1.01%)
occurrences all number	59	46	4
Respiratory tract infection
alternative assessment type: Non-systematic
subjects affected / exposed	37 / 703 (5.26%)	11 / 875 (1.26%)	3 / 398 (0.75%)
occurrences all number	41	11	3

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged greater than or equal to 6 months to less than 18 years

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Frequency and Intensity of Solicited Adverse Events after First Vaccination

Primary: Frequency and Intensity of Solicited Adverse Events after First Vaccination

Primary: Duration of Solicited Adverse Events after First Vaccination

Primary: Duration of Solicited Adverse Events after First Vaccination

Primary: Frequency and Intensity of Solicited Adverse Events after Second Vaccination

Primary: Frequency and Intensity of Solicited Adverse Events after Second Vaccination

Primary: Duration of Solicited Adverse Events after Second Vaccination

Primary: Duration of Solicited Adverse Events after Second Vaccination

Secondary: Frequency and Intensity of Unsolicited Adverse Events (UAEs)

Secondary: Frequency and Intensity of Unsolicited Adverse Events (UAEs)

Secondary: Frequency of Serious Adverse Events (SAEs)

Secondary: Frequency of Serious Adverse Events (SAEs)

Secondary: Frequency of New Onsets of Chronic Illness (NOCIs)

Secondary: Frequency of New Onsets of Chronic Illness (NOCIs)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged greater than or equal to 6 months to less than 18 years

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Frequency and Intensity of Solicited Adverse Events after First Vaccination

Primary: Frequency and Intensity of Solicited Adverse Events after First Vaccination

Primary: Duration of Solicited Adverse Events after First Vaccination

Primary: Duration of Solicited Adverse Events after First Vaccination

Primary: Frequency and Intensity of Solicited Adverse Events after Second Vaccination

Primary: Frequency and Intensity of Solicited Adverse Events after Second Vaccination

Primary: Duration of Solicited Adverse Events after Second Vaccination

Primary: Duration of Solicited Adverse Events after Second Vaccination

Secondary: Frequency and Intensity of Unsolicited Adverse Events (UAEs)

Secondary: Frequency and Intensity of Unsolicited Adverse Events (UAEs)

Secondary: Frequency of Serious Adverse Events (SAEs)

Secondary: Frequency of Serious Adverse Events (SAEs)

Secondary: Frequency of New Onsets of Chronic Illness (NOCIs)

Secondary: Frequency of New Onsets of Chronic Illness (NOCIs)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged greater than or equal to 6 months to less than 18 years