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Clinical Trial Results:
A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization With Vaccine Serotypes of Streptococcus Pneumoniae in Healthy Infants in Israel.

Summary
EudraCT number	2008-003708-77
Trial protocol	Outside EU/EEA
Global end of trial date	08 Aug 2011

Results information
Results version number	v1(current)
This version publication date	29 Jun 2016
First version publication date	01 Aug 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

6096A1-3006

ISRCTN number

US NCT number

NCT00508742

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

235 E 42nd Street, New York, United States, NY 10017

Public contact

Clinical Trials.gov Call Center, Pfizer Inc, 001 8007181021, ClinicalTrials.govCallCenter@pfizer.com

Scientific contact

Clinical Trials.gov Call Center, Pfizer Inc, 001 800-718-1021, ClinicalTrials.govCallCenter@pfizer.com

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

Yes

EMA paediatric investigation plan number(s)

EMEA-000036-PIP01-07

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

28 Feb 2012

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

08 Aug 2011

Was the trial ended prematurely?

Main objective of the trial

To demonstrate that 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) reduces newly identified nasopharyngeal acquisitions of Streptococcus pneumoniae (S pneumoniae) serotypes 6A and 19A combined compared with 7-valent pneumococcal conjugate vaccine (7vPnC) from 1 month after the infant series to 24 months of age.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

11 Feb 2008

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Israel: 1866

Worldwide total number of subjects

1866

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)

1866

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

This study was conducted at 11 sites in Israel between 11 Feb 2008 to 8 Aug 2011. Total 1866 subjects were enrolled and received 13vPnC or 7vPnC at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).

Period 1 title

Infant Series

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

13vPnC Infant series

Arm description

13vPnC administered at 2, 4, and 6 months of age.

Arm type

Experimental

Investigational medicinal product name

13vPnC

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 milliliter (mL) dose of 13vPnC at 2, 4, and 6 months of age.

7vPnC Infant series

Arm description

7vPnC administered at 2, 4, and 6 months of age.

Arm type

Active comparator

Investigational medicinal product name

7vPnC

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL dose of 7vPnC at 2, 4, and 6 months of age.

Number of subjects in period 1	13vPnC Infant series	7vPnC Infant series
Started	932	934
Vaccinated Dose 1 (at 2 Months of Age)	930	933
Vaccinated Dose 2 (at 4 Months of Age)	904	902
Vaccinated Dose 3 (at 6 Months of Age)	898	892
Completed	890	889
Not completed	42	45
Physician decision	1	-
Adverse Event	5	4
Protocol Violation	1	-
Unspecified	4	1
Parent/Legal Guardian Request	31	40

Period 2 title

After Infant Series

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

13vPnC After Infant series

Arm description

Subjects who received 13vPnC at 2, 4, and 6 months of age.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

7vPnC After Infant series

Arm description

Subjects who received 7vPnC at 2, 4, and 6 months of age.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Number of subjects in period 2	13vPnC After Infant series	7vPnC After Infant series
Started	890	889
Completed	883	878
Not completed	7	11
Adverse Event	2	6
Unspecified	2	1
Protocol Violation	1	-
Failed to Return	1	-
Lost to follow-up	1	1
Parent/Legal Guardian Request	-	3

Period 3 title

Toddler Dose

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

13vPnC Toddler dose

Arm description

13vPnC administered at 12 months of age.

Arm type

Experimental

Investigational medicinal product name

13vPnC

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL dose of 13vPnC at 12 months of age.

7vPnC Toddler dose

Arm description

7vPnC administered at 12 months of age.

Arm type

Active comparator

Investigational medicinal product name

7vPnC

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL dose of 7vPnC at 12 months of age.

Number of subjects in period 3	13vPnC Toddler dose	7vPnC Toddler dose
Started	883	878
Completed	858	863
Not completed	25	15
Adverse Event	1	-
Unspecified	5	4
Lost to follow-up	2	3
Parent/Legal Guardian Request	17	8

Baseline characteristics

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Reporting group title

13vPnC Infant series

Reporting group description

13vPnC administered at 2, 4, and 6 months of age.

Reporting group title

7vPnC Infant series

Reporting group description

7vPnC administered at 2, 4, and 6 months of age.

Reporting group values	13vPnC Infant series	7vPnC Infant series	Total
Number of subjects	932	934	1866
Age categorical
Units: Subjects
Age continuous
Units: months
arithmetic mean (standard deviation)	2.2 ( 0.3 )	2.2 ( 0.3 )	-
Gender categorical
Units: Subjects
Female	474	471	945
Male	458	463	921

Subject analysis set title

13vPnC

Subject analysis set type

Per protocol

Subject analysis set description

13vPnC 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).

Subject analysis set title

7vPnC

Subject analysis set type

Per protocol

Subject analysis set description

7vPnC 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).

Subject analysis sets values	13vPnC	7vPnC
Number of subjects	881	873
Age categorical
Units: Subjects
Age continuous
Units: months
arithmetic mean (standard deviation)	2.2 ( 0.3 )	2.2 ( 0.3 )
Gender categorical
Units: Subjects
Female
Male

End points

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Reporting group title

13vPnC Infant series

Reporting group description

13vPnC administered at 2, 4, and 6 months of age.

Reporting group title

7vPnC Infant series

Reporting group description

7vPnC administered at 2, 4, and 6 months of age.

Reporting group title

13vPnC After Infant series

Reporting group description

Subjects who received 13vPnC at 2, 4, and 6 months of age.

Reporting group title

7vPnC After Infant series

Reporting group description

Subjects who received 7vPnC at 2, 4, and 6 months of age.

Reporting group title

13vPnC Toddler dose

Reporting group description

13vPnC administered at 12 months of age.

Reporting group title

7vPnC Toddler dose

Reporting group description

7vPnC administered at 12 months of age.

Subject analysis set title

13vPnC

Subject analysis set type

Per protocol

Subject analysis set description

13vPnC 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).

Subject analysis set title

7vPnC

Subject analysis set type

Per protocol

Subject analysis set description

7vPnC 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).

Primary: Percentage of Subjects With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age

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End point title

Percentage of Subjects With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age

End point description

A new acquisition was defined as the detection of a serotype (here 6A’ [6A + 6C] or 19A), once a subject was fully vaccinated (one month after dose 3), that had not been detected previously in the baseline samples at 2, 4, 6 months of age. Evaluable culture population included all subjects who adhered to protocol requirements; received the treatment to which they were randomized; had at least 1 nasopharyngeal swab for the proposed analysis and no major protocol violations.

End point type

Primary

End point timeframe

Month 7 through Month 24

End point values	13vPnC	7vPnC
Number of subjects analysed	881	873
Units: percentage of subjects
number (confidence interval 95%)	20 (17.4 to 22.8)	36 (32.8 to 39.3)

Serotype 6A' (6A + 6C) or 19A

Comparison groups

7vPnC v 13vPnC

Number of subjects included in analysis

1754

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Rate Ratio

Point estimate

0.56

Confidence interval

level

95%

sides

2-sided

lower limit

0.47

upper limit

0.65

Secondary: Percentage of Subjects With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus pneumoniae (S. pneumoniae) at 7, 12, 13, 18 and 24 Months of Age

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End point title

Percentage of Subjects With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus pneumoniae (S. pneumoniae) at 7, 12, 13, 18 and 24 Months of Age

End point description

Percentage of Subjects With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of S. pneumoniae at 7, 12, 13, 18 and 24 Months of Age. Evaluable culture population; 'n' is number of subjects with at least 1 determinate nasopharyngeal culture result for given serotype combination at specified time points for each arm group respectively.

End point type

Secondary

End point timeframe

Month 7, 12, 13, 18, 24

End point values	13vPnC	7vPnC
Number of subjects analysed	881	873
Units: percentage of subjects
number (confidence interval 95%)
Month 7 (n= 881, 871)	7.3 (5.6 to 9.2)	10.9 (8.9 to 13.2)
Month 12 (n= 881, 873)	8.1 (6.3 to 10.1)	13.7 (11.5 to 16.2)
Month 13 (n= 871, 870)	5.4 (4 to 7.1)	13.6 (11.4 to 16)
Month 18 (n= 864, 864)	7.1 (5.4 to 9)	13.5 (11.3 to 16)
Month 24 (n= 855, 856)	6.2 (4.7 to 8)	10.7 (8.8 to 13)

Month 7

Statistical analysis description

13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.

Comparison groups

7vPnC v 13vPnC

Number of subjects included in analysis

1754

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Odds ratio (OR)

Point estimate

0.6

Confidence interval

level

95%

sides

2-sided

lower limit

0.5

upper limit

0.9

Month 12

Statistical analysis description

13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.

Comparison groups

13vPnC v 7vPnC

Number of subjects included in analysis

1754

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Odds ratio (OR)

Point estimate

0.6

Confidence interval

level

95%

sides

2-sided

lower limit

0.4

upper limit

0.7

Month 13

Statistical analysis description

13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.

Comparison groups

13vPnC v 7vPnC

Number of subjects included in analysis

1754

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Odds ratio (OR)

Point estimate

0.4

Confidence interval

level

95%

sides

2-sided

lower limit

0.3

upper limit

0.5

Month 18

Statistical analysis description

13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.

Comparison groups

13vPnC v 7vPnC

Number of subjects included in analysis

1754

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Odds ratio (OR)

Point estimate

0.5

Confidence interval

level

95%

sides

2-sided

lower limit

0.4

upper limit

0.7

Month 24

Statistical analysis description

13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.

Comparison groups

13vPnC v 7vPnC

Number of subjects included in analysis

1754

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Odds ratio (OR)

Point estimate

0.5

Confidence interval

level

95%

sides

2-sided

lower limit

0.4

upper limit

0.8

Adverse events

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Timeframe for reporting adverse events

Adverse Events (AEs)/Serious Adverse Events (SAEs): recorded from signing of informed consent form to completion of study.

Adverse event reporting additional description

Safety population: all randomized subjects with at least 1 dose of study treatment. Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as non serious in another, or one subject may have experienced both a serious and non serious event during study.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

14.0

Reporting group title

Infant Series 13vPnC

Reporting group description

Subjects who received 13vPnC 0.5 mL intramuscularly at 2, 4 and 6 months of age (infant series), assessed from dose 1 of the infant series through the blood draw 1 month after the infant series.

Reporting group title

Infant Series 7vPnC

Reporting group description

Subjects who received 7vPnC 0.5 mL intramuscularly at 2, 4 and 6 months of age (infant series), assessed from dose 1 of the infant series through the blood draw 1 month after the infant series.

Reporting group title

After Infant Series 13vPnC

Reporting group description

Subjects who received 13vPnC 0.5 mL intramuscularly at 2, 4, and 6 months of age in infant series, assessed after the infant series blood draw to the toddler dose.

Reporting group title

After Infant Series 7vPnC

Reporting group description

Subjects who received 7vPnC 0.5 mL intramuscularly at 2, 4, and 6 months of age in infant series, assessed after the infant series blood draw to the toddler dose.

Reporting group title

Toddler Dose 13vPnC

Reporting group description

Subjects who received 13vPnC 0.5 mL intramuscularly at 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after the toddler dose.

Reporting group title

Toddler Dose 7vPnC

Reporting group description

Subjects who received 7vPnC 0.5 mL dose intramuscularly at 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after the toddler dose.

Reporting group title

After Toddler Dose 13vPnC

Reporting group description

Subjects who received 13vPnC 0.5 mL intramuscularly at 12 months of age in toddler dose, assessed after the toddler dose blood draw through the Month 24 visit.

Reporting group title

After Toddler Dose 7vPnC

Reporting group description

Subjects who received 7vPnC 0.5 mL intramuscularly at 12 months of age in toddler dose, assessed after the toddler dose blood draw through the Month 24 visit.

Serious adverse events	Infant Series 13vPnC	Infant Series 7vPnC	After Infant Series 13vPnC	After Infant Series 7vPnC	Toddler Dose 13vPnC	Toddler Dose 7vPnC	After Toddler Dose 13vPnC	After Toddler Dose 7vPnC
Total subjects affected by serious adverse events
subjects affected / exposed	64 / 930 (6.88%)	57 / 933 (6.11%)	48 / 929 (5.17%)	64 / 931 (6.87%)	15 / 882 (1.70%)	23 / 875 (2.63%)	91 / 882 (10.32%)	73 / 875 (8.34%)
number of deaths (all causes)	1	0	0	0	0	0	0	0
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Medulloblastoma
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Hypertension
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Cephalhaematoma
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Irritability
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	8 / 930 (0.86%)	4 / 933 (0.43%)	6 / 929 (0.65%)	4 / 931 (0.43%)	0 / 882 (0.00%)	4 / 875 (0.46%)	11 / 882 (1.25%)	10 / 875 (1.14%)
occurrences causally related to treatment / all	0 / 8	0 / 4	0 / 6	0 / 4	0 / 0	0 / 4	0 / 11	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sudden death
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gait disturbance
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)	3 / 882 (0.34%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
Milk allergy
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Social circumstances
Overfeeding of infant
subjects affected / exposed	0 / 930 (0.00%)	2 / 933 (0.21%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Testicular torsion
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Apparent life threatening event
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Asthma
subjects affected / exposed	2 / 930 (0.22%)	0 / 933 (0.00%)	3 / 929 (0.32%)	1 / 931 (0.11%)	1 / 882 (0.11%)	2 / 875 (0.23%)	7 / 882 (0.79%)	5 / 875 (0.57%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 3	0 / 1	0 / 1	0 / 2	0 / 7	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bronchial hyperreactivity
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Choking
subjects affected / exposed	3 / 930 (0.32%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cough
subjects affected / exposed	0 / 930 (0.00%)	2 / 933 (0.21%)	0 / 929 (0.00%)	1 / 931 (0.11%)	2 / 882 (0.23%)	0 / 875 (0.00%)	0 / 882 (0.00%)	2 / 875 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 1	0 / 2	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Grunting
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lung infiltration
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	3 / 875 (0.34%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory distress
subjects affected / exposed	2 / 930 (0.22%)	1 / 933 (0.11%)	1 / 929 (0.11%)	2 / 931 (0.21%)	1 / 882 (0.11%)	2 / 875 (0.23%)	2 / 882 (0.23%)	2 / 875 (0.23%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 1	0 / 2	0 / 1	0 / 2	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sleep apnoea syndrome
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	1 / 875 (0.11%)	2 / 882 (0.23%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Stridor
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	1 / 929 (0.11%)	0 / 931 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)	0 / 882 (0.00%)	2 / 875 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Wheezing
subjects affected / exposed	2 / 930 (0.22%)	0 / 933 (0.00%)	2 / 929 (0.22%)	2 / 931 (0.21%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	2 / 875 (0.23%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 3	0 / 3	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Haemoptysis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Breath holding
subjects affected / exposed	1 / 930 (0.11%)	1 / 933 (0.11%)	1 / 929 (0.11%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Restlessness
subjects affected / exposed	1 / 930 (0.11%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Apathy
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Urine analysis abnormal
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Influenza virus test positive
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Head injury
subjects affected / exposed	3 / 930 (0.32%)	2 / 933 (0.21%)	1 / 929 (0.11%)	4 / 931 (0.43%)	0 / 882 (0.00%)	2 / 875 (0.23%)	4 / 882 (0.45%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 2	0 / 1	0 / 4	0 / 0	0 / 2	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skull fracture
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	1 / 929 (0.11%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Burns second degree
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Exposure to toxic agent
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	3 / 882 (0.34%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Foreign body
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	1 / 929 (0.11%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Near drowning
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Thermal burn
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	2 / 931 (0.21%)	1 / 882 (0.11%)	1 / 875 (0.11%)	1 / 882 (0.11%)	2 / 875 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 1	0 / 1	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skull fractured base
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Laceration
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Accidental poisoning
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Contusion
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hand fracture
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mouth injury
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Postoperative fever
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Radius fracture
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Congenital, familial and genetic disorders
Ventricular septal defect
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Cardiac failure congestive
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cyanosis
subjects affected / exposed	1 / 930 (0.11%)	2 / 933 (0.21%)	0 / 929 (0.00%)	0 / 931 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Cerebral infarction
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Convulsion
subjects affected / exposed	2 / 930 (0.22%)	2 / 933 (0.21%)	1 / 929 (0.11%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Febrile convulsion
subjects affected / exposed	1 / 930 (0.11%)	2 / 933 (0.21%)	3 / 929 (0.32%)	5 / 931 (0.54%)	1 / 882 (0.11%)	1 / 875 (0.11%)	7 / 882 (0.79%)	8 / 875 (0.91%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 4	0 / 5	0 / 1	0 / 1	0 / 7	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Fontanelle bulging
subjects affected / exposed	2 / 930 (0.22%)	3 / 933 (0.32%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 3	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypotonia
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Partial seizures
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Status epilepticus
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infantile spasms
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	1 / 929 (0.11%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Myoclonic epilepsy
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Leukocytosis
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	1 / 929 (0.11%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lymphadenitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	2 / 882 (0.23%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	1 / 929 (0.11%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Anaemia
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
Eye movement disorder
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Conjunctivitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Corneal perforation
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	3 / 930 (0.32%)	1 / 933 (0.11%)	2 / 929 (0.22%)	2 / 931 (0.21%)	0 / 882 (0.00%)	1 / 875 (0.11%)	2 / 882 (0.23%)	3 / 875 (0.34%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 2	0 / 2	0 / 0	0 / 1	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intussusception
subjects affected / exposed	1 / 930 (0.11%)	1 / 933 (0.11%)	0 / 929 (0.00%)	3 / 931 (0.32%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	2 / 875 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 4	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Oral disorder
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	2 / 930 (0.22%)	5 / 933 (0.54%)	2 / 929 (0.22%)	0 / 931 (0.00%)	0 / 882 (0.00%)	4 / 875 (0.46%)	14 / 882 (1.59%)	7 / 875 (0.80%)
occurrences causally related to treatment / all	0 / 3	0 / 5	0 / 2	0 / 0	0 / 0	0 / 4	0 / 14	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Aphthous stomatitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	4 / 882 (0.45%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Haematemesis
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Stomatitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	1 / 929 (0.11%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Hepatomegaly
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rash maculo-papular
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Henoch-Schonlein purpura
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	1 / 929 (0.11%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rash macular
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Petechiae
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	2 / 882 (0.23%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pruritus
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Leukocyturia
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Kidney enlargement
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dysuria
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Trigger finger
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Monarthritis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pain in extremity
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Anal abscess
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bronchiolitis
subjects affected / exposed	10 / 930 (1.08%)	8 / 933 (0.86%)	3 / 929 (0.32%)	4 / 931 (0.43%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 10	0 / 8	0 / 3	0 / 4	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bronchitis viral
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Croup infectious
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dysentery
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	1 / 929 (0.11%)	0 / 931 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)	4 / 882 (0.45%)	3 / 875 (0.34%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	11 / 930 (1.18%)	8 / 933 (0.86%)	12 / 929 (1.29%)	13 / 931 (1.40%)	3 / 882 (0.34%)	4 / 875 (0.46%)	13 / 882 (1.47%)	14 / 875 (1.60%)
occurrences causally related to treatment / all	0 / 13	0 / 8	0 / 12	0 / 13	0 / 3	0 / 4	0 / 14	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lower respiratory tract infection
subjects affected / exposed	1 / 930 (0.11%)	4 / 933 (0.43%)	5 / 929 (0.54%)	4 / 931 (0.43%)	0 / 882 (0.00%)	1 / 875 (0.11%)	3 / 882 (0.34%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 4	0 / 5	0 / 4	0 / 0	0 / 1	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Meningitis aseptic
subjects affected / exposed	1 / 930 (0.11%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Meningitis viral
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Meningococcal infection
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Otitis media
subjects affected / exposed	3 / 930 (0.32%)	5 / 933 (0.54%)	9 / 929 (0.97%)	10 / 931 (1.07%)	1 / 882 (0.11%)	3 / 875 (0.34%)	13 / 882 (1.47%)	11 / 875 (1.26%)
occurrences causally related to treatment / all	0 / 3	0 / 5	0 / 9	0 / 10	0 / 1	0 / 3	0 / 13	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Otitis media acute
subjects affected / exposed	2 / 930 (0.22%)	2 / 933 (0.21%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	3 / 875 (0.34%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pertussis
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pharyngitis
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	2 / 930 (0.22%)	1 / 933 (0.11%)	5 / 929 (0.54%)	7 / 931 (0.75%)	0 / 882 (0.00%)	1 / 875 (0.11%)	9 / 882 (1.02%)	5 / 875 (0.57%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 5	0 / 7	0 / 0	0 / 1	0 / 9	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory syncytial virus bronchiolitis
subjects affected / exposed	3 / 930 (0.32%)	0 / 933 (0.00%)	0 / 929 (0.00%)	3 / 931 (0.32%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	2 / 875 (0.23%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 3	0 / 0	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	1 / 929 (0.11%)	0 / 931 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rotavirus infection
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Streptococcal bacteraemia
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	4 / 930 (0.43%)	4 / 933 (0.43%)	1 / 929 (0.11%)	2 / 931 (0.21%)	0 / 882 (0.00%)	2 / 875 (0.23%)	2 / 882 (0.23%)	3 / 875 (0.34%)
occurrences causally related to treatment / all	0 / 4	0 / 4	0 / 1	0 / 2	0 / 0	0 / 2	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 930 (0.00%)	3 / 933 (0.32%)	1 / 929 (0.11%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	2 / 882 (0.23%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 2	0 / 0	0 / 0	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Viral infection
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Exanthema subitum
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	1 / 929 (0.11%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	1 / 929 (0.11%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis rotavirus
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	1 / 929 (0.11%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	2 / 882 (0.23%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Parainfluenzae virus infection
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Periorbital cellulitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	2 / 931 (0.21%)	1 / 882 (0.11%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumococcal bacteraemia
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia influenzal
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia viral
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Herpangina
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tonsillitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Corynebacterium infection
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Endophthalmitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
H1N1 influenza
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Influenza
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intervertebral discitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Localised infection
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia respiratory syncytial viral
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary tuberculosis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sinusitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Subcutaneous abscess
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tooth abscess
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Wound infection
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Acute tonsillitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	1 / 930 (0.11%)	1 / 933 (0.11%)	1 / 929 (0.11%)	0 / 931 (0.00%)	0 / 882 (0.00%)	2 / 875 (0.23%)	8 / 882 (0.91%)	6 / 875 (0.69%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1	0 / 0	0 / 0	0 / 2	0 / 8	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diet refusal
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lactose intolerance
subjects affected / exposed	2 / 930 (0.22%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolic acidosis
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Weight gain poor
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Feeding disorder
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	1 / 929 (0.11%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Infant Series 13vPnC	Infant Series 7vPnC	After Infant Series 13vPnC	After Infant Series 7vPnC	Toddler Dose 13vPnC	Toddler Dose 7vPnC	After Toddler Dose 13vPnC	After Toddler Dose 7vPnC
Total subjects affected by non serious adverse events
subjects affected / exposed	454 / 930 (48.82%)	433 / 933 (46.41%)	290 / 929 (31.22%)	324 / 931 (34.80%)	238 / 882 (26.98%)	240 / 875 (27.43%)	462 / 882 (52.38%)	455 / 875 (52.00%)
Surgical and medical procedures
Antibiotic prophylaxis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences all number	0	0	0	0	0	0	0	1
General disorders and administration site conditions
Inflammation
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Injection site erythema
subjects affected / exposed	4 / 930 (0.43%)	2 / 933 (0.21%)	0 / 929 (0.00%)	0 / 931 (0.00%)	3 / 882 (0.34%)	1 / 875 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	4	2	0	0	3	1	0	0
Injection site swelling
subjects affected / exposed	14 / 930 (1.51%)	10 / 933 (1.07%)	0 / 929 (0.00%)	0 / 931 (0.00%)	6 / 882 (0.68%)	3 / 875 (0.34%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	14	11	0	0	6	3	0	0
Pyrexia
subjects affected / exposed	216 / 930 (23.23%)	194 / 933 (20.79%)	32 / 929 (3.44%)	37 / 931 (3.97%)	90 / 882 (10.20%)	89 / 875 (10.17%)	64 / 882 (7.26%)	68 / 875 (7.77%)
occurrences all number	279	263	33	39	91	90	71	71
Developmental delay
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	1 / 929 (0.11%)	2 / 931 (0.21%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	0	1	2	0	0	0	0
Gait disturbance
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)	2 / 882 (0.23%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	1	0	2	0
Oedema peripheral
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	1 / 882 (0.11%)	1 / 875 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0
Chills
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Immune system disorders
Food allergy
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Choking
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Cough
subjects affected / exposed	11 / 930 (1.18%)	4 / 933 (0.43%)	8 / 929 (0.86%)	10 / 931 (1.07%)	4 / 882 (0.45%)	1 / 875 (0.11%)	31 / 882 (3.51%)	20 / 875 (2.29%)
occurrences all number	11	4	8	11	4	1	33	23
Lung infiltration
subjects affected / exposed	1 / 930 (0.11%)	1 / 933 (0.11%)	1 / 929 (0.11%)	3 / 931 (0.32%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	2 / 875 (0.23%)
occurrences all number	1	1	1	3	0	0	0	2
Respiratory distress
subjects affected / exposed	1 / 930 (0.11%)	2 / 933 (0.21%)	1 / 929 (0.11%)	1 / 931 (0.11%)	1 / 882 (0.11%)	0 / 875 (0.00%)	0 / 882 (0.00%)	3 / 875 (0.34%)
occurrences all number	1	2	1	1	1	0	0	3
Sleep apnoea syndrome
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	0	2	0	0	0	0	1	0
Stridor
subjects affected / exposed	1 / 930 (0.11%)	2 / 933 (0.21%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences all number	1	2	0	0	0	0	0	1
Wheezing
subjects affected / exposed	1 / 930 (0.11%)	2 / 933 (0.21%)	1 / 929 (0.11%)	4 / 931 (0.43%)	1 / 882 (0.11%)	0 / 875 (0.00%)	3 / 882 (0.34%)	3 / 875 (0.34%)
occurrences all number	1	2	2	5	1	0	3	3
Rhinorrhoea
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Asthma
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences all number	0	0	0	0	1	0	0	1
Pharyngeal erythema
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Pneumonitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Dyspnoea
subjects affected / exposed	3 / 930 (0.32%)	0 / 933 (0.00%)	2 / 929 (0.22%)	2 / 931 (0.21%)	0 / 882 (0.00%)	1 / 875 (0.11%)	3 / 882 (0.34%)	2 / 875 (0.23%)
occurrences all number	3	0	2	3	0	1	3	2
Psychiatric disorders
Restlessness
subjects affected / exposed	98 / 930 (10.54%)	89 / 933 (9.54%)	0 / 929 (0.00%)	0 / 931 (0.00%)	11 / 882 (1.25%)	11 / 875 (1.26%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	125	102	0	0	11	11	1	0
Apathy
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences all number	0	0	0	0	0	0	0	1
Investigations
Laboratory test
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Urine analysis abnormal
subjects affected / exposed	3 / 930 (0.32%)	1 / 933 (0.11%)	1 / 929 (0.11%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences all number	3	1	1	0	0	0	0	1
White blood cells urine positive
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Injury, poisoning and procedural complications
Limb injury
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences all number	0	1	0	0	0	0	0	1
Animal bite
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	1 / 929 (0.11%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences all number	0	0	1	0	0	0	0	1
Hand fracture
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	0	0	0	1	0	0	1	0
Head injury
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Contusion
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Fracture
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Laceration
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	2 / 882 (0.23%)	1 / 875 (0.11%)
occurrences all number	0	0	0	0	0	0	2	1
Post procedural haemorrhage
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences all number	0	0	0	0	0	0	0	1
Postoperative fever
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Tooth fracture
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Tooth injury
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Nervous system disorders
Somnolence
subjects affected / exposed	5 / 930 (0.54%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	5	1	0	0	0	0	0	0
Nervous system disorder
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Febrile convulsion
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	1 / 875 (0.11%)
occurrences all number	0	0	0	0	0	0	1	1
Blood and lymphatic system disorders
Leukocytosis
subjects affected / exposed	6 / 930 (0.65%)	9 / 933 (0.96%)	13 / 929 (1.40%)	17 / 931 (1.83%)	4 / 882 (0.45%)	4 / 875 (0.46%)	15 / 882 (1.70%)	15 / 875 (1.71%)
occurrences all number	6	9	13	19	4	4	15	16
Lymphadenitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	1 / 929 (0.11%)	1 / 931 (0.11%)	0 / 882 (0.00%)	1 / 875 (0.11%)	3 / 882 (0.34%)	2 / 875 (0.23%)
occurrences all number	0	0	2	1	0	1	3	2
Lymphadenopathy
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Leukopenia
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences all number	0	0	0	0	0	0	0	1
Neutropenia
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences all number	0	0	0	0	0	0	0	2
Ear and labyrinth disorders
Tympanic membrane hyperaemia
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	1 / 929 (0.11%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0
Otorrhoea
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Eye disorders
Conjunctivitis
subjects affected / exposed	2 / 930 (0.22%)	1 / 933 (0.11%)	0 / 929 (0.00%)	2 / 931 (0.21%)	0 / 882 (0.00%)	1 / 875 (0.11%)	1 / 882 (0.11%)	4 / 875 (0.46%)
occurrences all number	2	1	0	2	0	1	1	4
Eye swelling
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences all number	0	0	0	0	0	0	0	1
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Diarrhoea
subjects affected / exposed	16 / 930 (1.72%)	9 / 933 (0.96%)	13 / 929 (1.40%)	8 / 931 (0.86%)	4 / 882 (0.45%)	7 / 875 (0.80%)	25 / 882 (2.83%)	34 / 875 (3.89%)
occurrences all number	16	9	14	8	4	7	25	37
Vomiting
subjects affected / exposed	2 / 930 (0.22%)	4 / 933 (0.43%)	3 / 929 (0.32%)	2 / 931 (0.21%)	1 / 882 (0.11%)	3 / 875 (0.34%)	13 / 882 (1.47%)	8 / 875 (0.91%)
occurrences all number	2	4	3	2	1	3	13	8
Aphthous stomatitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	1 / 929 (0.11%)	2 / 931 (0.21%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	2 / 875 (0.23%)
occurrences all number	0	0	1	2	0	0	1	2
Constipation
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Gingivitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Rectal haemorrhage
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Cheilitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences all number	0	0	0	0	0	0	0	1
Haematochezia
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences all number	0	0	0	0	0	0	0	2
Lip swelling
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences all number	0	0	0	0	0	0	0	1
Stomatitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	2 / 882 (0.23%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0
Swollen tongue
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences all number	0	0	0	0	0	0	0	1
Skin and subcutaneous tissue disorders
Dermatitis
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	1	0	1	0	0	0	0
Dermatitis atopic
subjects affected / exposed	1 / 930 (0.11%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0
Ingrowing nail
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Rash
subjects affected / exposed	1 / 930 (0.11%)	1 / 933 (0.11%)	0 / 929 (0.00%)	1 / 931 (0.11%)	2 / 882 (0.23%)	2 / 875 (0.23%)	2 / 882 (0.23%)	1 / 875 (0.11%)
occurrences all number	1	2	0	1	2	2	2	1
Seborrhoeic dermatitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Renal and urinary disorders
Dysuria
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Vesicoureteric reflux
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Musculoskeletal and connective tissue disorders
Monarthritis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences all number	0	0	0	0	0	0	0	1
Infections and infestations
Bacteraemia
subjects affected / exposed	5 / 930 (0.54%)	3 / 933 (0.32%)	2 / 929 (0.22%)	3 / 931 (0.32%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	5 / 875 (0.57%)
occurrences all number	5	3	2	3	0	0	1	5
Bronchiolitis
subjects affected / exposed	1 / 930 (0.11%)	3 / 933 (0.32%)	1 / 929 (0.11%)	1 / 931 (0.11%)	0 / 882 (0.00%)	3 / 875 (0.34%)	5 / 882 (0.57%)	13 / 875 (1.49%)
occurrences all number	1	3	1	2	0	4	5	14
Bronchitis
subjects affected / exposed	2 / 930 (0.22%)	5 / 933 (0.54%)	1 / 929 (0.11%)	2 / 931 (0.21%)	1 / 882 (0.11%)	1 / 875 (0.11%)	9 / 882 (1.02%)	10 / 875 (1.14%)
occurrences all number	2	5	1	2	1	1	10	10
Cellulitis
subjects affected / exposed	1 / 930 (0.11%)	5 / 933 (0.54%)	1 / 929 (0.11%)	1 / 931 (0.11%)	1 / 882 (0.11%)	2 / 875 (0.23%)	6 / 882 (0.68%)	5 / 875 (0.57%)
occurrences all number	1	5	1	1	1	2	6	6
Dysentery
subjects affected / exposed	6 / 930 (0.65%)	4 / 933 (0.43%)	4 / 929 (0.43%)	6 / 931 (0.64%)	1 / 882 (0.11%)	1 / 875 (0.11%)	10 / 882 (1.13%)	13 / 875 (1.49%)
occurrences all number	6	4	4	7	1	1	10	14
Ear infection
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Gastroenteritis
subjects affected / exposed	1 / 930 (0.11%)	1 / 933 (0.11%)	3 / 929 (0.32%)	3 / 931 (0.32%)	2 / 882 (0.23%)	0 / 875 (0.00%)	7 / 882 (0.79%)	3 / 875 (0.34%)
occurrences all number	1	1	5	3	2	0	7	3
Infection
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	1 / 929 (0.11%)	0 / 931 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)	3 / 882 (0.34%)	2 / 875 (0.23%)
occurrences all number	0	1	1	0	0	1	3	5
Influenza
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	1	0	0	0	0	0	1	0
Lower respiratory tract infection
subjects affected / exposed	2 / 930 (0.22%)	0 / 933 (0.00%)	2 / 929 (0.22%)	0 / 931 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)	2 / 882 (0.23%)	4 / 875 (0.46%)
occurrences all number	2	0	2	0	0	1	2	4
Meningitis
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Otitis media
subjects affected / exposed	165 / 930 (17.74%)	137 / 933 (14.68%)	176 / 929 (18.95%)	195 / 931 (20.95%)	93 / 882 (10.54%)	92 / 875 (10.51%)	267 / 882 (30.27%)	246 / 875 (28.11%)
occurrences all number	202	174	228	235	102	102	419	391
Otitis media acute
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	1 / 929 (0.11%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	2 / 882 (0.23%)	2 / 875 (0.23%)
occurrences all number	0	1	1	1	0	0	2	3
Paronychia
subjects affected / exposed	1 / 930 (0.11%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Pneumonia
subjects affected / exposed	16 / 930 (1.72%)	14 / 933 (1.50%)	21 / 929 (2.26%)	25 / 931 (2.69%)	7 / 882 (0.79%)	13 / 875 (1.49%)	57 / 882 (6.46%)	58 / 875 (6.63%)
occurrences all number	16	14	24	25	7	13	61	65
Rhinitis
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	1 / 929 (0.11%)	4 / 931 (0.43%)	1 / 882 (0.11%)	0 / 875 (0.00%)	7 / 882 (0.79%)	2 / 875 (0.23%)
occurrences all number	0	1	1	4	1	0	7	2
Tonsillitis
subjects affected / exposed	1 / 930 (0.11%)	1 / 933 (0.11%)	1 / 929 (0.11%)	1 / 931 (0.11%)	0 / 882 (0.00%)	2 / 875 (0.23%)	9 / 882 (1.02%)	13 / 875 (1.49%)
occurrences all number	1	1	1	1	0	2	9	14
Upper respiratory tract infection
subjects affected / exposed	13 / 930 (1.40%)	5 / 933 (0.54%)	12 / 929 (1.29%)	15 / 931 (1.61%)	2 / 882 (0.23%)	11 / 875 (1.26%)	37 / 882 (4.20%)	43 / 875 (4.91%)
occurrences all number	14	5	12	17	2	12	44	55
Urinary tract infection
subjects affected / exposed	11 / 930 (1.18%)	16 / 933 (1.71%)	10 / 929 (1.08%)	5 / 931 (0.54%)	2 / 882 (0.23%)	3 / 875 (0.34%)	10 / 882 (1.13%)	6 / 875 (0.69%)
occurrences all number	11	19	10	6	2	4	14	6
Adenoiditis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	3 / 882 (0.34%)	0 / 875 (0.00%)
occurrences all number	0	0	0	1	0	0	3	0
Anal abscess
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	1 / 875 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	0	0	2	0	1	0	0
Cellulitis orbital
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	1 / 929 (0.11%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	1 / 875 (0.11%)
occurrences all number	0	0	1	0	0	0	1	1
Hordeolum
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	1 / 929 (0.11%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0
Impetigo
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	1 / 929 (0.11%)	0 / 931 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)	2 / 882 (0.23%)	6 / 875 (0.69%)
occurrences all number	0	0	1	0	1	0	2	6
Infectious mononucleosis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	1 / 929 (0.11%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	0	0	1	0	0	0	1	0
Localised infection
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	2 / 931 (0.21%)	0 / 882 (0.00%)	1 / 875 (0.11%)	3 / 882 (0.34%)	0 / 875 (0.00%)
occurrences all number	0	0	0	2	0	1	3	0
Nasopharyngitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	1 / 929 (0.11%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	0	0	2	0	0	0	1	0
Pertussis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Respiratory tract infection
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	2 / 931 (0.21%)	0 / 882 (0.00%)	1 / 875 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	0	0	2	0	1	0	0
Sinusitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	3 / 929 (0.32%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	2 / 882 (0.23%)	2 / 875 (0.23%)
occurrences all number	0	0	3	1	0	0	2	2
Varicella
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	1 / 931 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Viral infection
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	1 / 929 (0.11%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	3 / 875 (0.34%)
occurrences all number	0	0	1	0	0	0	1	3
Wound infection
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	2 / 931 (0.21%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	1 / 875 (0.11%)
occurrences all number	0	0	0	2	0	0	1	1
Bullous impetigo
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Hand-foot-and-mouth disease
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Oral candidiasis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Periorbital cellulitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	2 / 882 (0.23%)	0 / 875 (0.00%)	5 / 882 (0.57%)	3 / 875 (0.34%)
occurrences all number	0	0	0	0	2	0	5	3
Subcutaneous abscess
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences all number	0	0	0	0	0	1	0	1
Abscess
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences all number	0	0	0	0	0	0	0	1
Acute tonsillitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	4 / 882 (0.45%)	3 / 875 (0.34%)
occurrences all number	0	0	0	0	0	0	4	4
Brucellosis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences all number	0	0	0	0	0	0	0	1
Erysipelas
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
External ear cellulitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Infected bites
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences all number	0	0	0	0	0	0	0	1
Oral infection
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences all number	0	0	0	0	0	0	0	1
Parotitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Scarlet fever
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	2 / 875 (0.23%)
occurrences all number	0	0	0	0	0	0	1	2
Skin infection
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	2 / 875 (0.23%)
occurrences all number	0	0	0	0	0	0	0	2
Tooth abscess
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Tracheitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	1 / 875 (0.11%)
occurrences all number	0	0	0	0	0	0	0	1
Vulvovaginal candidiasis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Osteomyelitis
subjects affected / exposed	0 / 930 (0.00%)	0 / 933 (0.00%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	1 / 882 (0.11%)	0 / 875 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Pharyngitis
subjects affected / exposed	12 / 930 (1.29%)	24 / 933 (2.57%)	35 / 929 (3.77%)	32 / 931 (3.44%)	34 / 882 (3.85%)	27 / 875 (3.09%)	112 / 882 (12.70%)	114 / 875 (13.03%)
occurrences all number	13	26	37	34	34	27	134	134
Metabolism and nutrition disorders
Weight gain poor
subjects affected / exposed	0 / 930 (0.00%)	1 / 933 (0.11%)	0 / 929 (0.00%)	0 / 931 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)	0 / 882 (0.00%)	0 / 875 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0

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Were there any global substantial amendments to the protocol? Yes

11 Jan 2008

1- AEs associated with antibiotic use were to be summarized. 2- Enterally administered vaccines given at any time were added as a permitted treatment.

16 Apr 2008

1- Topical antibiotics were excluded as a type of antibiotic use to be considered when AEs associated antibiotic use were to be summarized and for the criterion for temporarily delaying vaccine administration due to antibiotic use. 2- Live vaccines administered by the parenteral route were allowed to be given on the same day as the study vaccine.

24 Jul 2008

The randomization procedure was modified to use new treatment codes after the shipping error. Subjects enrolled with the first set of treatment codes were designated cohort 1 and the subjects enrolled with the second set of treatment codes were designated cohort 2.

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.

Study designated analysis of effect of 13vPnC on serotypes 6A+19A, changed prior to unblinding, to effect on 6A’+19A. Serotype 6A found to include serotype 6A isolates and isolates of newly identified serotype 6C. Serotype 6A assessed as 6A+6C (6A’).

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Clinical trials

Clinical Trial Results:
A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization With Vaccine Serotypes of Streptococcus Pneumoniae in Healthy Infants in Israel.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age

Primary: Percentage of Subjects With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age

Secondary: Percentage of Subjects With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus pneumoniae (S. pneumoniae) at 7, 12, 13, 18 and 24 Months of Age

Secondary: Percentage of Subjects With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus pneumoniae (S. pneumoniae) at 7, 12, 13, 18 and 24 Months of Age

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Cyprus
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Denmark
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Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
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Malta
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Outside EU/EEA

Clinical trials

Clinical Trial Results: A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization With Vaccine Serotypes of Streptococcus Pneumoniae in Healthy Infants in Israel.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age

Primary: Percentage of Subjects With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age

Secondary: Percentage of Subjects With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus pneumoniae (S. pneumoniae) at 7, 12, 13, 18 and 24 Months of Age

Secondary: Percentage of Subjects With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus pneumoniae (S. pneumoniae) at 7, 12, 13, 18 and 24 Months of Age

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization With Vaccine Serotypes of Streptococcus Pneumoniae in Healthy Infants in Israel.