Clinical Trial Results:
A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Canada

Due to a system error, the data reported in v1 is not correct and has been removed from public view.

Summary
EudraCT number	2008-004765-26
Trial protocol	Outside EU/EEA
Global end of trial date	04 May 2009

Results information
Results version number	v2(current)
This version publication date	29 Jul 2016
First version publication date	01 Aug 2015
Other versions	v1 (removed from public view)
Version creation reason	Correction of full data set reporting periods and duplicate AEs in their data

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

6096A1-3008

ISRCTN number

US NCT number

NCT00475033

WHO universal trial number (UTN)

Other trial identifiers

Alias: B1851008

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., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

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

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

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

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

Yes

Analysis stage

Final

Date of interim/final analysis

19 Feb 2010

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

04 May 2009

Was the trial ended prematurely?

Main objective of the trial

To demonstrate that immune response induced by meningococcal group C conjugate vaccine (NeisVac-C) given with 13vPnC is noninferior to the immune response induced by NeisVac-C given with 7 valent pneumococcal conjugate vaccine (7vPnC) when measured 1 month after the 2-dose NeisVac-C infant series. To demonstrate that immune responses induced by Pentacel given with 13vPnC are noninferior to immune responses induced by Pentacel given with 7vPnC when measured 1 month after 3-dose infant series. The immune responses to the following antigens in Pentacel will be assessed: pertussis antigens (pertussis toxoid [PT], filamentous haemagglutinin [FHA], pertactin [PRN], and fimbrial agglutinogens [FIM]) and Haemophilus influenzae type b (Hib).

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

21 Jun 2007

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

6 Months

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 603

Worldwide total number of subjects

603

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)

603

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

Subjects were recruited in Canada from June 2007 through November 2007.

Screening details

A total of 608 subjects were screened out of which 603 subjects were randomly assigned in a 1:1 ratio to either 13vPnC group (n=300) or the 7vPnC group (n=303).

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

Subjects received 13vPnC at 2, 4, and 6 months of age (infant series) co-administered with Pentacel (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio, aluminium and Hib conjugate vaccine) at 2, 4, and 6 months of age; NeisVac-C (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series).

Arm type

Experimental

Investigational medicinal product name

13vPnC

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 1 single 0.5 milliliter (mL) dose of 13vPnC at 2, 4, and 6 months of age (infant series).

Investigational medicinal product name

Pentacel

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 1 single 0.5 mL dose of Pentacel at 2, 4 and 6 months of age (infant series).

Investigational medicinal product name

NeisVac-C

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 1 single 0.5 mL dose of NeisVac-C at 2 and 6 months of age (infant series).

7vPnC Infant Series

Arm description

Subjects received 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) co-administered with Pentacel (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio, aluminium and Hib conjugate vaccine) at 2, 4, and 6 months of age; NeisVac-C (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series).

Arm type

Experimental

Investigational medicinal product name

7vPnC

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 1 single 0.5 mL dose of 7vPnC at 2, 4, and 6 months of age (infant series).

Investigational medicinal product name

Pentacel

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 1 single 0.5 mL dose of Pentacel at 2, 4, and 6 months of age (infant series).

Investigational medicinal product name

NeisVac-C

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 1 single 0.5 mL dose of NeisVac-C at 2 and 6 months of age (infant series).

Number of subjects in period 1	13vPnC Infant Series	7vPnC Infant Series
Started	300	303
Vaccinated Dose 1	300	303
Vaccinated Dose 2	297	296
Vaccinated Dose 3	293	294
Completed	293	291
Not completed	7	12
Parent or legal guardian request	1	5
Failed to return	3	4
Adverse Event	-	1
Protocol Violation	1	2
Lost to follow-up	2	-

Period 2 title

After the 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 the Infant Series

Arm description

Included subjects who received 13vPnC co-administered with Pentacel at 2, 4, and 6 months of age (infant series); NeisVac-C at 2 and 6 months of age (infant series).

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

7vPnC After the Infant Series

Arm description

Included subjects who received 7vPnC co-administered with Pentacel at 2, 4, and 6 months of age (infant series); NeisVac-C at 2 and 6 months of age (infant series).

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Number of subjects in period 2	13vPnC After the Infant Series	7vPnC After the Infant Series
Started	293	291
Completed	287	282
Not completed	6	9
Parent or legal guardian request	2	2
Failed to return	2	1
Adverse Event	-	4
Protocol Violation	1	-
Unspecified	-	2
Lost to follow-up	1	-

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

Subjects received 13vPnC co-administered with NeisVac-C at 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.

Arm type

Experimental

Investigational medicinal product name

13vPnC

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 1 single 0.5 mL dose of 13vPnC at 12 months of age (toddler dose).

Investigational medicinal product name

NeisVac-C

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 1 single 0.5 mL dose of NeisVac-C at 12 months of age (toddler dose).

Investigational medicinal product name

MMR II

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received 1 single 0.5 mL dose of MMR at 12 months of age (toddler dose).

Investigational medicinal product name

Varivax III

Investigational medicinal product code

Other name

Varicella vaccine

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received 1 single 0.5 mL dose of varicella vaccine at 12 months of age (toddler dose).

7vPnC Toddler Dose

Arm description

Subjects received 7vPnC co-administered with NeisVac-C at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.

Arm type

Experimental

Investigational medicinal product name

7vPnC

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 1 single 0.5 mL dose of 7vPnC at 12 months of age (toddler dose).

Investigational medicinal product name

NeisVac-C

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 1 single 0.5 mL dose of NeisVac-C at 12 months of age (toddler dose).

Investigational medicinal product name

MMR II

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received 1 single 0.5 mL dose of MMR at 12 months of age (toddler dose).

Investigational medicinal product name

Varivax III

Investigational medicinal product code

Other name

Varicella vaccine

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received 1 single 0.5 mL dose of varicella vaccine at 12 months of age (toddler dose).

Number of subjects in period 3	13vPnC Toddler Dose	7vPnC Toddler Dose
Started	287	282
Completed	283	282
Not completed	4	0
Parent or legal guardian request	2	-
Failed to return	1	-
Lost to follow-up	1	-

Baseline characteristics

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Reporting group title

13vPnC Infant Series

Reporting group description

Reporting group title

7vPnC Infant Series

Reporting group description

Reporting group values	13vPnC Infant Series	7vPnC Infant Series	Total
Number of subjects	300	303	603
Age categorical
Units: Subjects
Age continuous
Units: months
arithmetic mean (standard deviation)	2.1 ± 0.3	2.1 ± 0.3	-
Gender categorical
Units: Subjects
Female	143	152	295
Male	157	151	308

End points

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Reporting group title

13vPnC Infant Series

Reporting group description

Reporting group title

7vPnC Infant Series

Reporting group description

Reporting group title

13vPnC After the Infant Series

Reporting group description

Included subjects who received 13vPnC co-administered with Pentacel at 2, 4, and 6 months of age (infant series); NeisVac-C at 2 and 6 months of age (infant series).

Reporting group title

7vPnC After the Infant Series

Reporting group description

Included subjects who received 7vPnC co-administered with Pentacel at 2, 4, and 6 months of age (infant series); NeisVac-C at 2 and 6 months of age (infant series).

Reporting group title

13vPnC Toddler Dose

Reporting group description

Reporting group title

7vPnC Toddler Dose

Reporting group description

Primary: Percentage of Subjects Achieving Predefined Antibody Level Greater than or Equal to (≥) 1:8 for Meningococcal C Serum Bactericidal Assay (SBA) in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C in the Infant Series

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End point title

Percentage of Subjects Achieving Predefined Antibody Level Greater than or Equal to (≥) 1:8 for Meningococcal C Serum Bactericidal Assay (SBA) in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C in the Infant Series

End point description

Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups >-10%. Evaluable immunogenicity population: had treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.

End point type

Primary

End point timeframe

1 month after 2 doses of NeisVac-C in the infant series (7 months of age)

End point values	13vPnC Infant Series	7vPnC Infant Series
Number of subjects analysed	284 ^[1]	278 ^[2]
Units: Percentage of subjects
number (confidence interval 95%)	96.8 (94.1 to 98.5)	99.3 (97.4 to 99.9)

Notes
[1] - Subjects analyzed with a determinate post-infant series antibody concentration to the given antigen.
[2] - Subjects analyzed with a determinate post-infant series antibody concentration to the given antigen.

Analysis of Subjects With Meningococcal C antibody

Statistical analysis description

Meningococcal C: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.

Comparison groups

13vPnC Infant Series v 7vPnC Infant Series

Number of subjects included in analysis

562

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[3]

Method

Parameter type

Difference

Point estimate

-2.4

Confidence interval

level

95%

sides

2-sided

lower limit

-5.3

upper limit

-0.1

Notes
[3] - Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%. Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.

Primary: Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C in the Infant Series

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End point title

Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C in the Infant Series

End point description

Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the geometric means for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale. The evaluable immunogenicity population was the primary analysis population. Geometric means (GMs) were calculated using all subjects with available data for the specified blood draw.

End point type

Primary

End point timeframe

1 month after 2 doses of NeisVac-C in the infant series (7 months of age)

End point values	13vPnC Infant Series	7vPnC Infant Series
Number of subjects analysed	284 ^[4]	278 ^[5]
Units: GMT
geometric mean (confidence interval 95%)	361.16 (305.46 to 427)	302.55 (263.89 to 346.86)

Notes
[4] - Subjects analyzed with a determinate antibody titer to the given antigen.
[5] - Subjects analyzed with a determinate antibody titer to the given antigen.

Analysis of GMT for Meningococcal C

Statistical analysis description

Ratio of GMs (13vPnC, 7vPnC). CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).

Comparison groups

13vPnC Infant Series v 7vPnC Infant Series

Number of subjects included in analysis

562

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[6]

Method

Parameter type

Ratio of geometric means

Point estimate

1.19

Confidence interval

level

95%

sides

2-sided

lower limit

0.96

upper limit

1.48

Notes
[6] - Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the GMT ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).

Primary: Percentage of Subjects Achieving Predefined Antibody Level to Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

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End point title

Percentage of Subjects Achieving Predefined Antibody Level to Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

End point description

Percentage of subjects achieving predefined antibody threshold >=5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95 % CI for concomitant antigens pertussis (PT, FHA, and PRN and ≥ 2.2 EU/mL FIM) are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%. The evaluable immunogenicity population was the primary analysis population; (n)=number of subjects with an antibody concentration (titer) ≥ to prespecified level for the given antigen for 13vPnC and 7vPnC, respectively.

End point type

Primary

End point timeframe

1 month after the 3-dose infant series (7 months of age)

End point values	13vPnC Infant Series	7vPnC Infant Series
Number of subjects analysed	285	278
Units: percentage of subjects
number (confidence interval 95%)
PT ≥5 EU/mL (n=282, 277)	99.6 (98 to 100)	99.6 (98 to 100)
FHA ≥5 EU/mL (n=283, 278)	100 (98.7 to 100)	100 (98.7 to 100)
PRN ≥5 EU/mL (n=283, 277)	97.9 (95.4 to 99.2)	96.8 (93.9 to 98.5)
FIM ≥2.2 EU/mL (n=282, 275)	95.4 (92.2 to 97.5)	97.5 (94.8 to 99)

Analysis for PT

Statistical analysis description

PT: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.

Comparison groups

13vPnC Infant Series v 7vPnC Infant Series

Number of subjects included in analysis

563

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[7]

Method

Parameter type

Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1.6

upper limit

1.7

Notes
[7] - Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%. Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.

Analysis for FHA

Statistical analysis description

FHA: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.

Comparison groups

13vPnC Infant Series v 7vPnC Infant Series

Number of subjects included in analysis

563

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[8]

Method

Parameter type

Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1.3

upper limit

1.3

Notes
[8] - Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%. Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.

Analysis for PRN

Statistical analysis description

PRN: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.

Comparison groups

13vPnC Infant Series v 7vPnC Infant Series

Number of subjects included in analysis

563

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[9]

Method

Parameter type

Difference

Point estimate

1.1

Confidence interval

level

95%

sides

2-sided

lower limit

-1.7

upper limit

4.2

Notes
[9] - Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%. Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.

Analysis for FIM

Statistical analysis description

FIM: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.

Comparison groups

13vPnC Infant Series v 7vPnC Infant Series

Number of subjects included in analysis

563

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[10]

Method

Parameter type

Difference

Point estimate

-2.1

Confidence interval

level

95%

sides

2-sided

lower limit

-5.5

upper limit

1.2

Notes
[10] - Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%. Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.

Primary: Geometric Mean Concentration (GMC) of Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

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End point title

Geometric Mean Concentration (GMC) of Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

End point description

Antibody GMC of pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence intervals on the ratio of the GMCs for 13vPnC relative to 7vPnC were constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale. The evaluable immunogenicity population was the primary analysis population; (n)=number of subjects with a determinate antibody concentration (titer) to the given antigen. Geometric means (GMs) were calculated using all subjects with available data for the specified blood draw.

End point type

Primary

End point timeframe

1 month after the 3-dose infant Series (7 months of age)

End point values	13vPnC Infant Series	7vPnC Infant Series
Number of subjects analysed	285	278
Units: GMC EU/mL
geometric mean (confidence interval 95%)
PT (n=282, 277)	46.06 (42.83 to 49.53)	40.37 (37.24 to 43.75)
FHA (n=283, 278)	78.08 (72.47 to 84.13)	69.52 (64.39 to 75.05)
PRN (n=283, 277)	42.9 (38.17 to 48.22)	40.69 (36.16 to 45.79)
FIM (n=282, 275)	11.54 (10.48 to 12.71)	12.98 (11.81 to 14.27)

Analysis of GMC for PT

Statistical analysis description

PT: Ratio of geometric means (13vPnC, 7vPnC).

Comparison groups

13vPnC Infant Series v 7vPnC Infant Series

Number of subjects included in analysis

563

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[11]

Method

Parameter type

Ratio of geometric means

Point estimate

1.14

Confidence interval

level

95%

sides

2-sided

lower limit

1.02

upper limit

1.27

Notes
[11] - Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).

Analysis of GMC for FHA

Statistical analysis description

FHA: Ratio of geometric means (13vPnC, 7vPnC). CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).

Comparison groups

7vPnC Infant Series v 13vPnC Infant Series

Number of subjects included in analysis

563

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[12]

Method

Parameter type

Ratio of geometric means

Point estimate

1.12

Confidence interval

level

95%

sides

2-sided

lower limit

1.01

upper limit

1.25

Notes
[12] - Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).

Analysis of GMC for PRN

Statistical analysis description

PRN: Ratio of geometric means (13vPnC, 7vPnC). CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).

Comparison groups

13vPnC Infant Series v 7vPnC Infant Series

Number of subjects included in analysis

563

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[13]

Method

Parameter type

Ratio of geometric means

Point estimate

1.05

Confidence interval

level

95%

sides

2-sided

lower limit

0.89

upper limit

1.24

Notes
[13] - Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).

Analysis of GMC for FIM

Statistical analysis description

FIM: Ratio of geometric means (13vPnC, 7vPnC). CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).

Comparison groups

13vPnC Infant Series v 7vPnC Infant Series

Number of subjects included in analysis

563

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[14]

Method

Parameter type

Ratio of geometric means

Point estimate

0.89

Confidence interval

level

95%

sides

2-sided

lower limit

0.78

upper limit

1.02

Notes
[14] - Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).

Primary: Percentage of Subjects Achieving Predefined Antibody Level ≥0.15 Micrograms Per mL (μg/mL) for Polyribosylribitol Phosphate (PRP) in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

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End point title

Percentage of Subjects Achieving Predefined Antibody Level ≥0.15 Micrograms Per mL (μg/mL) for Polyribosylribitol Phosphate (PRP) in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

End point description

Percentage of subjects achieving predefined antibody threshold ≥0.15 μg/mL along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%. The evaluable immunogenicity population was the primary analysis population.

End point type

Primary

End point timeframe

1 month after the 3-dose Infant Series (7 months of age)

End point values	13vPnC Infant Series	7vPnC Infant Series
Number of subjects analysed	272 ^[15]	266 ^[16]
Units: percentage of subjects
number (confidence interval 95%)	97.8 (95.3 to 99.2)	99.6 (97.9 to 100)

Notes
[15] - Subjects analyzed with a determinate post-infant series antibody concentration to the given antigen.
[16] - Subjects analyzed with a determinate post-infant series antibody concentration to the given antigen.

Analysis for PRP in Hib

Statistical analysis description

Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.

Comparison groups

13vPnC Infant Series v 7vPnC Infant Series

Number of subjects included in analysis

538

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[17]

Method

Parameter type

Difference

Point estimate

-1.8

Confidence interval

level

95%

sides

2-sided

lower limit

-4.4

upper limit

0.1

Notes
[17] - Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%. Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.

Primary: Geometric Mean Concentration (GMC) of PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

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End point title

Geometric Mean Concentration (GMC) of PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

End point description

Antibody GMC of PRP in Hib as measured by μg/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMCs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale. The evaluable immunogenicity population was the primary analysis population. Geometric means (GMs) were calculated using all subjects with available data for the specified blood draw.

End point type

Primary

End point timeframe

1 month after the 3-dose Infant Series (7 months of age)

End point values	13vPnC Infant Series	7vPnC Infant Series
Number of subjects analysed	272 ^[18]	266 ^[19]
Units: GMC μg/mL
geometric mean (confidence interval 95%)	2.87 (2.48 to 3.32)	3.14 (2.74 to 3.6)

Notes
[18] - Subjects analyzed with a determinate antibody concentration (titer) to the given antigen.
[19] - Subjects analyzed with a determinate antibody concentration (titer) to the given antigen.

Analysis of GMC for PRP in Hib

Statistical analysis description

PRP in Hib: Ratio of geometric means (13vPnC, 7vPnC). CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).

Comparison groups

13vPnC Infant Series v 7vPnC Infant Series

Number of subjects included in analysis

538

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[20]

Method

Parameter type

Ratio of geometric means

Point estimate

0.91

Confidence interval

level

95%

sides

2-sided

lower limit

0.75

upper limit

1.12

Notes
[20] - Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).

Secondary: Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C SBA in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose of NeisVac-C

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End point title

Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C SBA in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose of NeisVac-C

End point description

Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%. The evaluable immunogenicity population was the primary analysis population.

End point type

Secondary

End point timeframe

1 month after the toddler dose of NeisVac-C (13 months of age)

End point values	13vPnC Toddler Dose	7vPnC Toddler Dose
Number of subjects analysed	265 ^[21]	268 ^[22]
Units: percentage of subjects
number (confidence interval 95%)	100 (98.6 to 100)	100 (98.6 to 100)

Notes
[21] - Subjects with a determinate post-toddler dose antibody concentration (titer) to the given antigen.
[22] - Subjects with a determinate post-toddler dose antibody concentration (titer) to the given antigen.

Antibody Level ≥1:8 for Meningococcal C SBA

Statistical analysis description

Meningococcal C: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.

Comparison groups

13vPnC Toddler Dose v 7vPnC Toddler Dose

Number of subjects included in analysis

533

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[23]

Method

Parameter type

Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1.4

upper limit

1.4

Notes
[23] - Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%. Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.

Secondary: Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose

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End point title

Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose

End point description

Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale. The evaluable immunogenicity population was the primary analysis population; Geometric means (GMs) were calculated using all subjects with available data for the specified blood draw.

End point type

Secondary

End point timeframe

1 month after the toddler dose (13 months of age)

End point values	13vPnC Toddler Dose	7vPnC Toddler Dose
Number of subjects analysed	265 ^[24]	268 ^[25]
Units: GMT
geometric mean (confidence interval 95%)	1379.75 (1235.06 to 1541.39)	1083.96 (962.54 to 1220.69)

Notes
[24] - Subjects analyzed with a determinate antibody titer to the given antigen.
[25] - Subjects analyzed with a determinate antibody titer to the given antigen.

Analysis of GMT for Meningococcal Antigen

Statistical analysis description

Meningococcal C: Ratio of geometric means (13vPnC, 7vPnC). CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).

Comparison groups

13vPnC Toddler Dose v 7vPnC Toddler Dose

Number of subjects included in analysis

533

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[26]

Method

Parameter type

Ratio of geometric means

Point estimate

1.27

Confidence interval

level

95%

sides

2-sided

lower limit

1.08

upper limit

1.5

Notes
[26] - Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the GMT ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).

Secondary: Percentage of Subjects Achieving Predefined Antibody Level ≥1.0 μg/mL for PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

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End point title

Percentage of Subjects Achieving Predefined Antibody Level ≥1.0 μg/mL for PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

End point description

Percentage of subjects achieving predefined antibody threshold ≥1.0 μg/mL along with the corresponding 95% CI for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%. The evaluable immunogenicity population was the primary analysis population.

End point type

Secondary

End point timeframe

1 month after the 3-dose infant series (7 months of age)

End point values	13vPnC Infant Series	7vPnC Infant Series
Number of subjects analysed	272 ^[27]	266 ^[28]
Units: percentage of subjects
number (confidence interval 95%)	81.6 (76.5 to 86)	84.6 (79.7 to 88.7)

Notes
[27] - Subjects with a determinate post-infant series antibody concentration (titer) to the given antigen.
[28] - Subjects with a determinate post-infant series antibody concentration (titer) to the given antigen.

Antibody Level >=1.0 μg/mL for PRP in Hib

Statistical analysis description

PRP: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.

Comparison groups

13vPnC Infant Series v 7vPnC Infant Series

Number of subjects included in analysis

538

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[29]

Method

Parameter type

Difference

Point estimate

-3

Confidence interval

level

95%

sides

2-sided

lower limit

-9.4

upper limit

3.4

Notes
[29] - Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%. Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.

Other pre-specified: Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the 3-dose Infant Series

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End point title

Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the 3-dose Infant Series ^[30]

End point description

Percentage of subjects achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. The evaluable immunogenicity population was the primary analysis population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for 13vPnC.

End point type

Other pre-specified

End point timeframe

1 month after the 3-dose infant series (7 months of age)

Notes
[30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per the end point title, data for only the 13vPnC group was meant to be reported.

End point values	13vPnC Infant Series
Number of subjects analysed	277
Units: percentage of subjects
number (confidence interval 95%)
Common serotypes - serotype 4 (n=277)	97.1 (94.4 to 98.7)
Common serotypes - serotype 6B (n=276)	93.1 (89.5 to 95.8)
Common serotypes - serotype 9V (n=277)	95.3 (92.1 to 97.5)
Common serotypes - serotype 14 (n=275)	98.2 (95.8 to 99.4)
Common serotypes - serotype 18C n=277)	96.4 (93.5 to 98.3)
Common serotypes - serotype 19F (n=273)	98.5 (96.3 to 99.6)
Common serotypes - serotype 23F (n=275)	90.2 (86 to 93.4)
Additional serotypes - serotype 1 (n=277)	95.7 (92.6 to 97.7)
Additional serotypes - serotype 3 (n=275)	79.6 (74.4 to 84.2)
Additional serotypes - serotype 5 (n=276)	87 (82.4 to 90.7)
Additional serotypes - serotype 6A (n=276)	96.4 (93.4 to 98.2)
Additional serotypes - serotype 7F (n=276)	98.6 (96.3 to 99.6)
Additional serotypes - serotype 19A (n=272)	97.8 (95.3 to 99.2)

No statistical analyses for this end point

Other pre-specified: Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the 3-dose Infant Series

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End point title

Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the 3-dose Infant Series ^[31]

End point description

Antibody GMC as measured by μg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. The evaluable immunogenicity population was the primary analysis population; (n)=number of subjects with a determinate antibody concentration for the given serotype for 13vPnC.

End point type

Other pre-specified

End point timeframe

1 month after the 3-dose infant series (7 months of age)

Notes
[31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As per the end point title, data for only the 13vPnC group was meant to be reported.

End point values	13vPnC Infant Series
Number of subjects analysed	277
Units: GMC μg/mL
geometric mean (confidence interval 95%)
Common serotypes - serotype 4 (n=277)	1.46 (1.33 to 1.6)
Common serotypes - serotype 6B (n=276)	2.16 (1.87 to 2.49)
Common serotypes - serotype 9V (n=277)	1.12 (1.03 to 1.22)
Common serotypes - serotype 14 (n=275)	5.43 (4.86 to 6.06)
Common serotypes - serotype 18C n=277)	1.37 (1.23 to 1.52)
Common serotypes - serotype 19F (n=273)	2.18 (1.99 to 2.39)
Common serotypes - serotype 23F (n=275)	1.15 (1.03 to 1.3)
Additional serotypes - serotype 1 (n=277)	1.82 (1.63 to 2.04)
Additional serotypes - serotype 3 (n=275)	0.63 (0.58 to 0.7)
Additional serotypes - serotype 5 (n=276)	0.9 (0.81 to 0.99)
Additional serotypes - serotype 6A (n=276)	1.92 (1.73 to 2.12)
Additional serotypes - serotype 7F (n=276)	2.26 (2.09 to 2.45)
Additional serotypes - serotype 19A (n=272)	2 (1.82 to 2.19)

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the Toddler Dose

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End point title

Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the Toddler Dose

End point description

Percentage of subjects achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. The evaluable immunogenicity population was the primary analysis population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for 13vPnC.

End point type

Other pre-specified

End point timeframe

1 month after the toddler dose (13 months of age)

End point values	13vPnC Toddler Dose
Number of subjects analysed	264
Units: percentage of subjects
number (confidence interval 95%)
Common serotypes - serotype 4 (n=264)	100 (98.6 to 100)
Common serotypes - serotype 6B (n=263)	100 (98.6 to 100)
Common serotypes - serotype 9V (n=264)	99.2 (97.3 to 99.9)
Common serotypes - serotype 14 (n=264)	100 (98.6 to 100)
Common serotypes - serotype 18C (n=262)	98.9 (96.7 to 99.8)
Common serotypes - serotype 19F (n=263)	98.1 (95.6 to 99.4)
Common serotypes - serotype 23F (n=263)	99.6 (97.9 to 100)
Additional serotypes - serotype 1 (n=264)	100 (98.6 to 100)
Additional serotypes - serotype 3 (n=264)	84.8 (79.9 to 88.9)
Additional serotypes - serotype 5 (n=264)	98.5 (96.2 to 99.6)
Additional serotypes - serotype 6A (n=264)	100 (98.6 to 100)
Additional serotypes - serotype 7F (n=264)	100 (98.6 to 100)
Additional serotypes - serotype 19A (n=263)	100 (98.6 to 100)

No statistical analyses for this end point

Other pre-specified: Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the Toddler Dose

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End point title

Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the Toddler Dose

End point description

End point type

Other pre-specified

End point timeframe

1 month after the toddler dose (13 months of age)

End point values	13vPnC Toddler Dose
Number of subjects analysed	264
Units: GMC μg/mL
geometric mean (confidence interval 95%)
Common serotypes - serotype 4 (n=264)	2.67 (2.43 to 2.92)
Common serotypes - serotype 6B (n=263)	9.83 (8.83 to 10.94)
Common serotypes - serotype 9V (n=264)	2.04 (1.87 to 2.23)
Common serotypes - serotype 14 (n=264)	7.58 (6.86 to 8.37)
Common serotypes - serotype 18C (n=262)	2 (1.8 to 2.21)
Common serotypes - serotype 19F (n=263)	5.7 (5.06 to 6.42)
Common serotypes - serotype 23F (n=263)	3.59 (3.21 to 4.01)
Additional serotypes - serotype 1 (n=264)	3.45 (3.11 to 3.82)
Additional serotypes - serotype 3 (n=264)	0.74 (0.67 to 0.81)
Additional serotypes - serotype 5 (n=264)	2.38 (2.15 to 2.62)
Additional serotypes - serotype 6A (n=264)	6.47 (5.87 to 7.12)
Additional serotypes - serotype 7F (n=264)	3.88 (3.59 to 4.21)
Additional serotypes - serotype 19A (n=263)	8.36 (7.61 to 9.19)

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 1 (2 Months of Age)

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End point title

Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 1 (2 Months of Age)

End point description

Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Safety population: all subjects who received at least 1 dose of study vaccine. (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.

End point type

Other pre-specified

End point timeframe

Within 4 days after dose (2 months of age)

End point values	13vPnC Infant Series	7vPnC Infant Series
Number of subjects analysed	284 ^[32]	284 ^[33]
Units: percentage of subjects
number (not applicable)
Tenderness: Any (n=281, 283)	44.5	43.8
Tenderness: Significant (n=270, 274)	4.4	4
Induration: Any (n=271, 276)	5.9	7.2
Induration: Mild (n=270, 275)	5.6	5.5
Induration: Moderate (n=267, 274)	0.7	2.6
Induration: Severe (n=266, 273)	0	0
Erythema: Any (n=270, 275)	11.1	14.5
Erythema: Mild (n=270, 275)	10.7	14.2
Erythema: Moderate (n=266, 273)	0.4	0.7
Erythema: Severe (n=266, 273)	0	0

Notes
[32] - N=number of subjects reporting any local reactions.
[33] - N=number of subjects reporting any local reactions

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 2 (4 Months of Age)

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End point title

Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 2 (4 Months of Age)

End point description

Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Safety population. (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.

End point type

Other pre-specified

End point timeframe

Within 4 days after dose (4 months of age)

End point values	13vPnC Infant Series	7vPnC Infant Series
Number of subjects analysed	271 ^[34]	268 ^[35]
Units: percentage of subjects
number (not applicable)
Tenderness: Any (n=264, 266)	37.5	32.7
Tenderness: Significant (n=248, 252)	3.6	3.6
Induration: Any (n=251, 253)	10.8	11.5
Induration: Mild (n=251, 253)	10.4	11.5
Induration: Moderate (n=245, 252)	0.8	0.4
Induration: Severe (n=245, 252)	0	0
Erythema: Any (n=258, 257)	18.2	18.3
Erythema: Mild (n=256, 257)	16.8	17.9
Erythema: Moderate (n=247, 252)	2	0.8
Erythema: Severe (n=245, 252)	0	0

Notes
[34] - N=number of subjects reporting any local reactions.
[35] - N=number of subjects reporting any local reactions.

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 3 (6 Months of Age)

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End point title

Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 3 (6 Months of Age)

End point description

Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Safety population; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.

End point type

Other pre-specified

End point timeframe

Within 4 days after dose (6 months of age)

End point values	13vPnC Infant Series	7vPnC Infant Series
Number of subjects analysed	251 ^[36]	264 ^[37]
Units: percentage of subjects
number (not applicable)
Tenderness: Any (n=245, 257)	27.3	28
Tenderness: Significant (n=238, 244)	3.8	0.8
Induration: Any (n=243, 250)	11.5	10
Induration: Mild (n=243, 250)	11.1	9.6
Induration: Moderate (n=238, 244)	0.8	1.2
Induration: Severe (n=237, 244)	0	0
Erythema: Any (n=244, 253)	16.4	17.8
Erythema: Mild (n=244, 253)	16.4	17
Erythema: Moderate (n=237, 244)	0.4	0.8
Erythema: Severe (n=237, 244)	0	0

Notes
[36] - N=number of subjects reporting any local reactions.
[37] - N=number of subjects reporting any local reactions.

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Toddler Dose (12 Months of Age)

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End point title

Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Toddler Dose (12 Months of Age)

End point description

Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Safety population; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.

End point type

Other pre-specified

End point timeframe

Within 4 days after dose (12 months of age)

End point values	13vPnC Toddler Dose	7vPnC Toddler Dose
Number of subjects analysed	223 ^[38]	227 ^[39]
Units: percentage of subjects
number (not applicable)
Tenderness: Any (n=216, 223)	25	28.7
Tenderness: Significant (n=198, 210)	2.5	1
Induration: Any (n=198, 213)	11.1	9.4
Induration: Mild (n=198, 213)	10.6	8.9
Induration: Moderate (n=196, 210)	1	2.4
Induration: Severe (n=195, 210)	0	0
Erythema: Any (n=204, 216)	19.6	16.7
Erythema: Mild (n=202, 216)	18.8	14.8
Erythema: Moderate (n=197, 210)	2.5	2.4
Erythema: Severe (n=195, 210)	0	0

Notes
[38] - N=number of subjects reporting any local reactions.
[39] - N=number of subjects reporting any local reactions.

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)

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End point title

Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)

End point description

Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.

End point type

Other pre-specified

End point timeframe

Within 4 days after dose (2 months of age)

End point values	13vPnC Infant Series	7vPnC Infant Series
Number of subjects analysed	296 ^[40]	298 ^[41]
Units: percentage of subjects
number (not applicable)
Fever ≥38 but ≤39 degrees C (n=269, 273)	8.9	9.2
Fever >39 but ≤40 degrees C (n=267, 273)	0.7	0
Fever >40 degrees C (n=266, 273)	0	0
Decreased appetite (n=279, 283)	42.7	36
Irritability (n=291, 288)	80.8	83
Increased sleep (n=286, 292)	62.9	64.7
Decreased sleep (n=276, 276)	29.7	28.3

Notes
[40] - Subjects reporting any systemic events.
[41] - Subjects reporting any systemic events.

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)

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End point title

Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)

End point description

Systemic events (any fever ≥38 degrees C, decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.

End point type

Other pre-specified

End point timeframe

Within 4 days after dose (4 months of age)

End point values	13vPnC Infant Series	7vPnC Infant Series
Number of subjects analysed	288 ^[42]	290 ^[43]
Units: percentage of subjects
number (not applicable)
Fever ≥38 but ≤39 degrees C (n=249, 255)	8	7.5
Fever >39 but ≤40 degrees C (n=245, 253)	0.4	0.4
Fever >40 degrees C (n=245, 252)	0	0
Decreased appetite (n=254, 262)	28.7	31.3
Irritability (n=283, 281)	71	70.1
Increased sleep (n=263, 275)	54.4	52.4
Decreased sleep (n=256, 261)	25.8	31

Notes
[42] - Subjects reporting any systemic events.
[43] - Subjects reporting any systemic events.

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)

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End point title

Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)

End point description

End point type

Other pre-specified

End point timeframe

Within 4 days after dose (6 months of age)

End point values	13vPnC Infant Series	7vPnC Infant Series
Number of subjects analysed	275 ^[44]	277 ^[45]
Units: percentage of subjects
number (not applicable)
Fever ≥38 but ≤39 degrees C (n=237, 244)	8.9	5.7
Fever >39 but ≤40 degrees C (n=237, 244)	0.4	0.8
Fever >40 degrees C (n=237, 244)	0	0
Decreased appetite (n=249, 253)	33.3	31.2
Irritability (n=266, 270)	68	65.9
Increased sleep (n=255, 258)	35.7	39.9
Decreased sleep (n=251, 254)	29.9	28.3

Notes
[44] - Subjects reporting any systemic events.
[45] - Subjects reporting any systemic events.

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Toddler Dose (12 Months of Age)

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End point title

Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Toddler Dose (12 Months of Age)

End point description

Systemic events (any fever ≥38 degrees Celsius C, decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively

End point type

Other pre-specified

End point timeframe

Within 4 days after dose (12 months of age)

End point values	13vPnC Toddler Dose	7vPnC Toddler Dose
Number of subjects analysed	247 ^[46]	252 ^[47]
Units: percentage of subjects
number (not applicable)
Fever ≥38 but ≤39 degrees C (n=203, 213)	13.3	12.2
Fever >39 but ≤40 degrees C (n=196, 210)	2	1.4
Fever >40 degrees C (n=195, 210)	0	0.5
Decreased appetite (n=211, 225)	37	34.2
Irritability (n=240, 241)	68.8	58.5
Increased sleep (n=212, 226)	33.5	33.2
Decreased sleep (n=212, 227)	34	33.9

Notes
[46] - Subjects reporting any systemic events.
[47] - Subjects reporting any systemic events.

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

AEs: from signing of ICF to 1 month after infant series,and from toddler dose to 1 month after toddler dose. SAEs: from signing of ICF to 6 months after the last study vaccination. Local reactions,systemic events assessed within 4 days of each vaccination

Adverse event reporting additional description

Safety population was analysed. Adverse Event(AE) term may be reported as both serious,non-serious AE, but are distinct events.AE may = serious for 1 subject and = non-serious for another or subject may have experienced both serious,non-serious episode of the same event. MedDRA version was not captured,here 0.0 is mentioned for dictionary version.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

0.0

Reporting group title

13vPnC Infant Series

Reporting group description

Subjects received 1 single 0.5 mL dose of 13vPnC at 2, 4, and 6 months of age (infant series), co-administered with Pentacel at 2, 4, and 6 months of age; NeisVac-C at 2 and 6 months of age (infant series). Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=229; systematic (solicited) Any Local Reactions N=144; systematic (solicited) Any Systemic Events N=273.

Reporting group title

7vPnC Infant Series

Reporting group description

Subjects received 1 single 0.5 mL dose of 7vPnC at 2, 4, and 6 months of age (infant series), co-administered with Pentacel at 2, 4, and 6 months of age; NeisVac-C at 2 and 6 months of age (infant series). Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=230; systematic (solicited) Any Local Reactions N=148; systematic (solicited) Any Systemic Events N=279.

Reporting group title

13vPnC After the Infant Series

Reporting group description

Reporting group title

7vPnC After the Infant Series

Reporting group description

Reporting group title

13vPnC Toddler Dose

Reporting group description

Subjects received 1 single 0.5 mL dose of 13vPnC at 12 months of age (toddler dose), co-administered NeisVac-C at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age. Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=110; systematic (solicited) Any Local Reactions N=84; systematic (solicited) Any Systemic Events N=199.

Reporting group title

7vPnC Toddler Dose

Reporting group description

Subjects received 1 single 0.5 mL dose of 7vPnC at 12 months of age (toddler dose), co-administered with NeisVac-C at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age. Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=108; systematic (solicited) Any Local Reactions N=86; systematic (solicited) Any Systemic Events N=193.

Reporting group title

13vPnC Toddler Dose 6-Month Follow-up

Reporting group description

Reporting group title

7vPnC Toddler Dose 6-Month Follow-up

Reporting group description

Serious adverse events	13vPnC Infant Series	7vPnC Infant Series	13vPnC After the Infant Series	7vPnC After the Infant Series	13vPnC Toddler Dose	7vPnC Toddler Dose	13vPnC Toddler Dose 6-Month Follow-up	7vPnC Toddler Dose 6-Month Follow-up
Total subjects affected by serious adverse events
subjects affected / exposed	5 / 300 (1.67%)	5 / 303 (1.65%)	11 / 299 (3.68%)	7 / 301 (2.33%)	2 / 286 (0.70%)	2 / 280 (0.71%)	7 / 299 (2.34%)	3 / 301 (1.00%)
number of deaths (all causes)	0	0	0	0	0	0	0	0
number of deaths resulting from adverse events
Investigations
Physical testicle examination abnormal
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	1 / 299 (0.33%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (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
Injury, poisoning and procedural complications
Post procedural haemorrhage
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (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
Congenital, familial and genetic disorders
Hydrocele
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	1 / 299 (0.33%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (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
Nervous system disorders
Febrile convulsion
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	1 / 299 (0.33%)	1 / 301 (0.33%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (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
Complex partial seizures
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	1 / 299 (0.33%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (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
Convulsion
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	1 / 301 (0.33%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (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
Blood and lymphatic system disorders
Febrile neutropenia
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	1 / 301 (0.33%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (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
Lymphadenitis
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	1 / 301 (0.33%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (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
General disorders and administration site conditions
Developmental delay
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (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
Pyrexia
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	1 / 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
Eye disorders
Cataract
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (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
Eye swelling
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	1 / 299 (0.33%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (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
Gastrointestinal disorders
Vomiting
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (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, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	1 / 301 (0.33%)
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
Bronchospasm
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (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
Infections and infestations
Bronchiolitis
subjects affected / exposed	4 / 300 (1.33%)	3 / 303 (0.99%)	2 / 299 (0.67%)	2 / 301 (0.66%)	0 / 286 (0.00%)	0 / 280 (0.00%)	3 / 299 (1.00%)	0 / 301 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 3	0 / 3	0 / 2	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
Croup infectious
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	1 / 299 (0.33%)	0 / 301 (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
Gastroenteritis
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	1 / 299 (0.33%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	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
Mastoiditis
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	1 / 299 (0.33%)	0 / 301 (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
Meningitis meningococcal
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (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
Pneumonia
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	2 / 299 (0.67%)	3 / 301 (1.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	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
Respiratory syncytial virus infection
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	1 / 299 (0.33%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	1 / 299 (0.33%)	0 / 301 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	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
Viral infection
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (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
Otitis media acute
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	1 / 299 (0.33%)	1 / 301 (0.33%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (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
Urinary tract infection
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	2 / 299 (0.67%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	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
Gastroenteritis rotavirus
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	1 / 299 (0.33%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (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
Influenza
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	1 / 299 (0.33%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (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
Periorbital cellulitis
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	1 / 299 (0.33%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (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
Pneumonia respiratory syncytial viral
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	1 / 299 (0.33%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (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	13vPnC Infant Series	7vPnC Infant Series	13vPnC After the Infant Series	7vPnC After the Infant Series	13vPnC Toddler Dose	7vPnC Toddler Dose	13vPnC Toddler Dose 6-Month Follow-up	7vPnC Toddler Dose 6-Month Follow-up
Total subjects affected by non serious adverse events
subjects affected / exposed	273 / 300 (91.00%)	279 / 303 (92.08%)	20 / 299 (6.69%)	16 / 301 (5.32%)	199 / 286 (69.58%)	193 / 280 (68.93%)	6 / 299 (2.01%)	4 / 301 (1.33%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Pregnancy, puerperium and perinatal conditions
Perineal laceration
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
General disorders and administration site conditions
Fatigue
subjects affected / exposed	2 / 300 (0.67%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	2	0	0	0	1	0	0	0
Feeling abnormal
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Feeling hot
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Influenza like illness
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Injection site bruising
subjects affected / exposed	4 / 300 (1.33%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	4	1	0	0	0	0	0	0
Injection site erythema
subjects affected / exposed	15 / 300 (5.00%)	14 / 303 (4.62%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	19	21	0	0	1	1	0	0
Injection site haemorrhage
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0
Injection site induration
subjects affected / exposed	2 / 300 (0.67%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	3	0	0	0	0	1	0	0
Injection site mass
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Injection site pain
subjects affected / exposed	2 / 300 (0.67%)	2 / 303 (0.66%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	2	3	0	0	0	0	0	0
Injection site reaction
subjects affected / exposed	1 / 300 (0.33%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0
Injection site swelling
subjects affected / exposed	4 / 300 (1.33%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	5	1	0	0	1	0	0	0
Irritability
subjects affected / exposed	18 / 300 (6.00%)	12 / 303 (3.96%)	0 / 299 (0.00%)	0 / 301 (0.00%)	2 / 286 (0.70%)	4 / 280 (1.43%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	23	14	0	0	3	4	0	0
Malaise
subjects affected / exposed	0 / 300 (0.00%)	3 / 303 (0.99%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	3	0	0	0	0	0	0
Oedema peripheral
subjects affected / exposed	2 / 300 (0.67%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0
Peripheral coldness
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Pyrexia
subjects affected / exposed	33 / 300 (11.00%)	43 / 303 (14.19%)	0 / 299 (0.00%)	0 / 301 (0.00%)	20 / 286 (6.99%)	23 / 280 (8.21%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	37	55	0	0	21	27	0	0
Tenderness
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Fever ≥38 degrees Celsius (C) but ≤39 degrees C: Infant Series Dose 1 and Toddler Dose
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish 1 occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[1]	24 / 269 (8.92%)	25 / 273 (9.16%)	0 / 299 (0.00%)	0 / 301 (0.00%)	27 / 203 (13.30%)	26 / 213 (12.21%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	24	25	0	0	27	26	0	0
Fever ≥38 degrees Celsius C but ≤39 degrees C: Infant Series Dose 2
Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[2]	20 / 249 (8.03%)	19 / 255 (7.45%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	20	19	0	0	0	0	0	0
Fever ≥38 degrees Celsius C but ≤39 degrees C: Infant Series Dose 3
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[3]	21 / 237 (8.86%)	14 / 244 (5.74%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	21	14	0	0	0	0	0	0
Fever >39 degrees C but ≤40 degrees C: Infant Series Dose 1 and Toddler Dose
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[4]	2 / 267 (0.75%)	0 / 273 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	4 / 196 (2.04%)	3 / 210 (1.43%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	2	0	0	0	4	3	0	0
Fever >39 degrees C but ≤40 degrees C: Infant Series Dose 2
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[5]	1 / 245 (0.41%)	1 / 253 (0.40%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0
Fever >39 degrees C but ≤40 degrees C: Infant Series Dose 3
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[6]	1 / 237 (0.42%)	2 / 244 (0.82%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	2	0	0	0	0	0	0
Fever >40 degrees C: Infant Series Dose 1 and Toddler dose
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[7]	0 / 266 (0.00%)	0 / 273 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 195 (0.00%)	1 / 210 (0.48%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Decreased appetite: Infant Series Dose 1 and Toddler dose
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[8]	119 / 279 (42.65%)	102 / 283 (36.04%)	0 / 299 (0.00%)	0 / 301 (0.00%)	78 / 211 (36.97%)	77 / 225 (34.22%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	119	102	0	0	78	77	0	0
Decreased appetite: Infant Series Dose 2
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[9]	73 / 254 (28.74%)	82 / 262 (31.30%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	73	82	0	0	0	0	0	0
Decreased appetite: Infant Series Dose 3
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[10]	83 / 249 (33.33%)	79 / 253 (31.23%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	83	79	0	0	0	0	0	0
Irritability: Infant Series Dose 1 and Toddler Dose
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[11]	235 / 291 (80.76%)	239 / 288 (82.99%)	0 / 299 (0.00%)	0 / 301 (0.00%)	165 / 240 (68.75%)	141 / 241 (58.51%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	235	239	0	0	165	141	0	0
Irritability: Infant Series Dose 2
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[12]	201 / 283 (71.02%)	197 / 281 (70.11%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	201	197	0	0	0	0	0	0
Irritability: Infant Series Dose 3
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[13]	181 / 266 (68.05%)	178 / 270 (65.93%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	181	178	0	0	0	0	0	0
Increased sleep: Infant Series Dose 1 and Toddler dose
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[14]	180 / 286 (62.94%)	189 / 292 (64.73%)	0 / 299 (0.00%)	0 / 301 (0.00%)	71 / 212 (33.49%)	75 / 226 (33.19%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	180	189	0	0	71	75	0	0
Increased sleep: Infant Series Dose 2
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[15]	143 / 263 (54.37%)	144 / 275 (52.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	143	144	0	0	0	0	0	0
Increased sleep: Infant Series Dose 3
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[16]	91 / 255 (35.69%)	103 / 258 (39.92%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	91	103	0	0	0	0	0	0
Decreased sleep: Infant Series Dose 1 and Toddler Dose
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[17]	82 / 276 (29.71%)	78 / 276 (28.26%)	0 / 299 (0.00%)	0 / 301 (0.00%)	72 / 212 (33.96%)	77 / 227 (33.92%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	82	78	0	0	72	77	0	0
Decreased sleep: Infant Series Dose 2
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[18]	66 / 256 (25.78%)	81 / 261 (31.03%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	66	81	0	0	0	0	0	0
Decreased sleep: Infant Series Dose 3
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[19]	75 / 251 (29.88%)	72 / 254 (28.35%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	75	72	0	0	0	0	0	0
Immune system disorders
Allergy to metals
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Food allergy
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	3 / 299 (1.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	1 / 299 (0.33%)	0 / 301 (0.00%)
occurrences all number	1	0	3	0	0	0	1	0
Milk allergy
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	1 / 299 (0.33%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	1	0	0	0	0	0
Reproductive system and breast disorders
Genital labial adhesions
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Genital rash
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	2 / 280 (0.71%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0
Vulval disorder
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	2 / 299 (0.67%)	1 / 301 (0.33%)
occurrences all number	0	0	0	0	0	0	2	1
Bronchial hyperreactivity
subjects affected / exposed	0 / 300 (0.00%)	2 / 303 (0.66%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0
Cough
subjects affected / exposed	29 / 300 (9.67%)	22 / 303 (7.26%)	1 / 299 (0.33%)	0 / 301 (0.00%)	4 / 286 (1.40%)	6 / 280 (2.14%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	36	28	1	0	5	6	0	0
Dysphonia
subjects affected / exposed	2 / 300 (0.67%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	2	1	0	0	0	0	0	0
Dyspnoea
subjects affected / exposed	1 / 300 (0.33%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0
Nasal congestion
subjects affected / exposed	31 / 300 (10.33%)	21 / 303 (6.93%)	1 / 299 (0.33%)	0 / 301 (0.00%)	8 / 286 (2.80%)	3 / 280 (1.07%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	40	24	1	0	9	3	0	0
Oropharyngeal pain
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Pharyngeal erythema
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Pharyngolaryngeal pain
subjects affected / exposed	1 / 300 (0.33%)	3 / 303 (0.99%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	3	0	0	0	0	0	0
Pharyngeal ulceration
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Respiratory disorder
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Rhinorrhoea
subjects affected / exposed	23 / 300 (7.67%)	20 / 303 (6.60%)	0 / 299 (0.00%)	1 / 301 (0.33%)	9 / 286 (3.15%)	4 / 280 (1.43%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	28	20	0	1	9	4	0	0
Sneezing
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	2	0	0	0	1	0	0	0
Upper respiratory tract congestion
subjects affected / exposed	0 / 300 (0.00%)	2 / 303 (0.66%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	2	0	0	0	1	0	0
Wheezing
subjects affected / exposed	3 / 300 (1.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	3	0	0	0	0	0	0	0
Psychiatric disorders
Anxiety
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Crying
subjects affected / exposed	2 / 300 (0.67%)	5 / 303 (1.65%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	3	7	0	0	0	0	0	0
Insomnia
subjects affected / exposed	1 / 300 (0.33%)	2 / 303 (0.66%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	2	0	0	1	1	0	0
Listless
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Tearfulness
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Investigations
Cardiac murmur
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Physical examination abnormal
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Injury, poisoning and procedural complications
Accidental needle stick
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Head injury
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	1	0	0
Joint dislocation
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Joint injury
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Skin laceration
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Congenital, familial and genetic disorders
Cryptorchism
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Dacryostenosis congenital
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Hydrocele
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Plagiocephaly
subjects affected / exposed	1 / 300 (0.33%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	1	0	0	0	1	0	0
Ventricular septal defect
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	1 / 301 (0.33%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0
Ankyloglossia congenital
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	1 / 301 (0.33%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Cardiac disorders
Cyanosis
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Nervous system disorders
Febrile convulsion
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	1 / 299 (0.33%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Headache
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Head titubation
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Hyperaesthesia
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Hypersomnia
subjects affected / exposed	1 / 300 (0.33%)	2 / 303 (0.66%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	2	0	0	0	0	0	0
Lethargy
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Poor quality sleep
subjects affected / exposed	2 / 300 (0.67%)	2 / 303 (0.66%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	2	2	0	0	0	1	0	0
Psychomotor hyperactivity
subjects affected / exposed	1 / 300 (0.33%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0
Somnolence
subjects affected / exposed	1 / 300 (0.33%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0
Tremor
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Dyskinesia
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	1 / 299 (0.33%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0
Movement disorder
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	1 / 301 (0.33%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	1 / 301 (0.33%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0
Ear and labyrinth disorders
Ear pain
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Eye disorders
Conjunctivitis
subjects affected / exposed	5 / 300 (1.67%)	9 / 303 (2.97%)	0 / 299 (0.00%)	0 / 301 (0.00%)	3 / 286 (1.05%)	3 / 280 (1.07%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	5	10	0	0	3	3	0	0
Dacryostenosis acquired
subjects affected / exposed	0 / 300 (0.00%)	3 / 303 (0.99%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	3	0	0	0	0	0	0
Eye discharge
subjects affected / exposed	7 / 300 (2.33%)	4 / 303 (1.32%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	8	5	0	0	0	1	0	0
Eye oedema
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Lacrimation increased
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Ocular hyperaemia
subjects affected / exposed	1 / 300 (0.33%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	1	0	0	1	0	0	0
Hypermetropia
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	1 / 299 (0.33%)	1 / 301 (0.33%)
occurrences all number	0	0	0	0	0	0	1	1
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	3 / 300 (1.00%)	6 / 303 (1.98%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	4	6	0	0	0	0	0	0
Constipation
subjects affected / exposed	13 / 300 (4.33%)	3 / 303 (0.99%)	3 / 299 (1.00%)	1 / 301 (0.33%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	1 / 301 (0.33%)
occurrences all number	15	3	3	1	0	0	0	1
Dental discomfort
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Diarrhoea
subjects affected / exposed	30 / 300 (10.00%)	29 / 303 (9.57%)	1 / 299 (0.33%)	0 / 301 (0.00%)	6 / 286 (2.10%)	5 / 280 (1.79%)	1 / 299 (0.33%)	0 / 301 (0.00%)
occurrences all number	35	32	1	0	6	5	1	0
Faecal volume increased
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Faeces discoloured
subjects affected / exposed	0 / 300 (0.00%)	2 / 303 (0.66%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0
Flatulence
subjects affected / exposed	4 / 300 (1.33%)	2 / 303 (0.66%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	4	2	0	0	0	0	0	0
Frequent bowel movements
subjects affected / exposed	2 / 300 (0.67%)	2 / 303 (0.66%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	2	2	0	0	0	0	0	0
Gastrooesophageal reflux disease
subjects affected / exposed	6 / 300 (2.00%)	7 / 303 (2.31%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	7	8	0	0	0	0	0	0
Gingival cyst
subjects affected / exposed	0 / 300 (0.00%)	2 / 303 (0.66%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0
Gingival pain
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	3	0	0	0	0	0	0
Infantile spitting up
subjects affected / exposed	1 / 300 (0.33%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0
Melaena
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Nausea
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Regurgitation
subjects affected / exposed	2 / 300 (0.67%)	7 / 303 (2.31%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	3	13	0	0	0	0	0	0
Teething
subjects affected / exposed	16 / 300 (5.33%)	14 / 303 (4.62%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	21	17	0	0	2	2	0	0
Umbilical hernia
subjects affected / exposed	1 / 300 (0.33%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0
Vomiting
subjects affected / exposed	22 / 300 (7.33%)	19 / 303 (6.27%)	0 / 299 (0.00%)	0 / 301 (0.00%)	8 / 286 (2.80%)	5 / 280 (1.79%)	1 / 299 (0.33%)	0 / 301 (0.00%)
occurrences all number	24	23	0	0	8	5	1	0
Vomiting neonatal
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Vomiting projectile
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Abdominal pain upper
subjects affected / exposed	2 / 300 (0.67%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	3	0	0	1	0	0	0
Blister
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Cold sweat
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Dandruff
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Dermatitis
subjects affected / exposed	2 / 300 (0.67%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	2	1	0	0	0	0	0	0
Dermatitis atopic
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Dermatitis contact
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0
Dermatitis diaper
subjects affected / exposed	12 / 300 (4.00%)	7 / 303 (2.31%)	1 / 299 (0.33%)	0 / 301 (0.00%)	3 / 286 (1.05%)	2 / 280 (0.71%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	16	8	1	0	3	2	0	0
Drug eruption
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Dry skin
subjects affected / exposed	3 / 300 (1.00%)	2 / 303 (0.66%)	1 / 299 (0.33%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	3	2	1	0	0	0	0	0
Eczema
subjects affected / exposed	19 / 300 (6.33%)	24 / 303 (7.92%)	1 / 299 (0.33%)	0 / 301 (0.00%)	3 / 286 (1.05%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	21	26	1	0	3	0	0	0
Erythema
subjects affected / exposed	1 / 300 (0.33%)	5 / 303 (1.65%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	5	0	0	0	0	0	0
Erythema multiforme
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Heat rash
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Night sweats
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	1	0	0
Pustular psoriasis
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Rash
subjects affected / exposed	14 / 300 (4.67%)	19 / 303 (6.27%)	0 / 299 (0.00%)	1 / 301 (0.33%)	17 / 286 (5.94%)	19 / 280 (6.79%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	14	21	0	1	17	23	0	0
Rash erythematous
subjects affected / exposed	1 / 300 (0.33%)	2 / 303 (0.66%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	2 / 280 (0.71%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	2	0	0	1	2	0	0
Rash generalised
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Rash macular
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0
Rash papular
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	1	0	0	0
Seborrhoea
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Seborrhoeic dermatitis
subjects affected / exposed	2 / 300 (0.67%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0
Skin discoloration
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Skin irritation
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Skin nodule
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Skin plaque
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Skin ulcer
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Skin warm
subjects affected / exposed	1 / 300 (0.33%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0
Swelling face
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Urticaria
subjects affected / exposed	4 / 300 (1.33%)	3 / 303 (0.99%)	1 / 299 (0.33%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	4	3	1	0	1	0	0	0
Xeroderma
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Livedo reticularis
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	1 / 301 (0.33%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Psoriasis
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	1 / 299 (0.33%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0
Skin lesion
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	1 / 299 (0.33%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0
Tenderness (any): Infant Series Dose 1 and Toddler Dose
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[20]	125 / 281 (44.48%)	124 / 283 (43.82%)	0 / 299 (0.00%)	0 / 301 (0.00%)	54 / 216 (25.00%)	64 / 223 (28.70%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	125	124	0	0	54	64	0	0
Tenderness (any): Infant Series Dose 2
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[21]	99 / 264 (37.50%)	87 / 266 (32.71%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	99	87	0	0	0	0	0	0
Tenderness (any): Infant Series Dose 3
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[22]	67 / 245 (27.35%)	72 / 257 (28.02%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	67	72	0	0	0	0	0	0
Tenderness(significant): Infant Series Dose 1 and Toddler Dose
Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Tenderness (significant)=present and interfered with limb movement.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[23]	12 / 270 (4.44%)	11 / 274 (4.01%)	0 / 299 (0.00%)	0 / 301 (0.00%)	5 / 198 (2.53%)	2 / 210 (0.95%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	12	11	0	0	5	2	0	0
Tenderness(significant): Infant Series Dose 2
Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[24]	9 / 248 (3.63%)	9 / 252 (3.57%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	9	9	0	0	0	0	0	0
Tenderness(significant): Infant Series Dose 3
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[25]	9 / 238 (3.78%)	2 / 244 (0.82%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	9	2	0	0	0	0	0	0
Induration (any): Infant Series Dose 1 and Toddler Dose
Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Induration (any)=present at site of vaccination.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[26]	16 / 271 (5.90%)	20 / 276 (7.25%)	0 / 299 (0.00%)	0 / 301 (0.00%)	22 / 198 (11.11%)	20 / 213 (9.39%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	16	20	0	0	22	20	0	0
Induration (any): Infant Series Dose 2
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[27]	27 / 251 (10.76%)	29 / 253 (11.46%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	27	29	0	0	0	0	0	0
Induration (any): Infant Series Dose 3
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[28]	28 / 243 (11.52%)	25 / 250 (10.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	28	25	0	0	0	0	0	0
Induration (mild): Infant Series Dose 1 and Toddler Dose
Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Induration (mild)=0.5 centimeters (cm) to 2.0 cm.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[29]	15 / 270 (5.56%)	15 / 275 (5.45%)	0 / 299 (0.00%)	0 / 301 (0.00%)	21 / 198 (10.61%)	19 / 213 (8.92%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	15	15	0	0	21	19	0	0
Induration (mild): Infant Series Dose 2
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[30]	26 / 251 (10.36%)	29 / 253 (11.46%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	26	29	0	0	0	0	0	0
Induration (mild): Infant Series Dose 3
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[31]	27 / 243 (11.11%)	24 / 250 (9.60%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	27	24	0	0	0	0	0	0
Induration (moderate): Infant Series Dose 1 and Toddler Dose
Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Induration (moderate)=2.5 cm to 7.0 cm.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[32]	2 / 267 (0.75%)	7 / 274 (2.55%)	0 / 299 (0.00%)	0 / 301 (0.00%)	2 / 196 (1.02%)	5 / 210 (2.38%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	2	7	0	0	2	5	0	0
Induration (moderate): Infant Series Dose 2
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[33]	2 / 245 (0.82%)	1 / 252 (0.40%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	2	1	0	0	0	0	0	0
Induration (moderate): Infant Series Dose 3
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[34]	2 / 238 (0.84%)	3 / 244 (1.23%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	2	3	0	0	0	0	0	0
Erythema (any): Infant Series Dose 1 and Toddler Dose
Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Erythema (any)=present at site of vaccination.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[35]	30 / 270 (11.11%)	40 / 275 (14.55%)	0 / 299 (0.00%)	0 / 301 (0.00%)	40 / 204 (19.61%)	36 / 216 (16.67%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	30	40	0	0	40	36	0	0
Erythema (any): Infant Series Dose 2
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[36]	47 / 258 (18.22%)	47 / 257 (18.29%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	47	47	0	0	0	0	0	0
Erythema (mild): Infant Series Dose 1 and Toddler Dose
Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Erythema (mild)=0.5 cm to 2.0 cm.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[37]	29 / 270 (10.74%)	39 / 275 (14.18%)	0 / 299 (0.00%)	0 / 301 (0.00%)	38 / 202 (18.81%)	32 / 216 (14.81%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	29	39	0	0	38	32	0	0
Erythema (mild): Infant Series Dose 2
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[38]	43 / 256 (16.80%)	46 / 257 (17.90%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	43	46	0	0	0	0	0	0
Erythema (mild): Infant Series Dose 3
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[39]	40 / 244 (16.39%)	43 / 253 (17.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	40	43	0	0	0	0	0	0
Erythema (moderate): Infant Series Dose 1 and Toddler Dose
Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Erythema (moderate)=2.5 cm to 7.0 cm.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[40]	1 / 266 (0.38%)	2 / 273 (0.73%)	0 / 299 (0.00%)	0 / 301 (0.00%)	5 / 197 (2.54%)	5 / 210 (2.38%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	2	0	0	5	5	0	0
Erythema (moderate): Infant Series Dose 2
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[41]	5 / 247 (2.02%)	2 / 252 (0.79%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	5	2	0	0	0	0	0	0
Erythema (moderate): Infant Series Dose 3
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[42]	1 / 237 (0.42%)	2 / 244 (0.82%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	2	0	0	0	0	0	0
Erythema (any): Infant Series Dose 3
Additional description: Subjects affected and occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. LRs, SEs were assessed only for infant series and toddler dose groups.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[43]	40 / 244 (16.39%)	45 / 253 (17.79%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	40	45	0	0	0	0	0	0
Renal and urinary disorders
Chromaturia
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Hydronephrosis
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	1 / 301 (0.33%)
occurrences all number	1	0	0	0	0	0	0	1
Renal cyst
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Musculoskeletal and connective tissue disorders
Muscle spasms
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Pain in extremity
subjects affected / exposed	1 / 300 (0.33%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	1	0	0	1	0	0	0
Torticollis
subjects affected / exposed	0 / 300 (0.00%)	2 / 303 (0.66%)	0 / 299 (0.00%)	2 / 301 (0.66%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	2	0	2	0	0	0	0
Positional plagiocephaly
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	1 / 301 (0.33%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Infections and infestations
Acarodermatitis
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Bronchiolitis
subjects affected / exposed	12 / 300 (4.00%)	11 / 303 (3.63%)	0 / 299 (0.00%)	0 / 301 (0.00%)	3 / 286 (1.05%)	3 / 280 (1.07%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	12	12	0	0	3	3	0	0
Bronchitis
subjects affected / exposed	2 / 300 (0.67%)	2 / 303 (0.66%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	2	2	0	0	0	0	0	0
Candida nappy rash
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	2 / 286 (0.70%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	2	1	0	0
Candidiasis
subjects affected / exposed	3 / 300 (1.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	3	1	0	0	0	0	0	0
Cellulitis
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Conjunctivitis infective
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	1	0	0
Croup infectious
subjects affected / exposed	5 / 300 (1.67%)	4 / 303 (1.32%)	0 / 299 (0.00%)	1 / 301 (0.33%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	5	4	0	1	1	0	0	0
Cystitis
subjects affected / exposed	2 / 300 (0.67%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0
Ear infection
subjects affected / exposed	8 / 300 (2.67%)	10 / 303 (3.30%)	0 / 299 (0.00%)	0 / 301 (0.00%)	8 / 286 (2.80%)	3 / 280 (1.07%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	10	10	0	0	8	3	0	0
Eye infection
subjects affected / exposed	4 / 300 (1.33%)	5 / 303 (1.65%)	0 / 299 (0.00%)	0 / 301 (0.00%)	3 / 286 (1.05%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	4	5	0	0	3	0	0	0
Gastroenteritis
subjects affected / exposed	13 / 300 (4.33%)	12 / 303 (3.96%)	0 / 299 (0.00%)	0 / 301 (0.00%)	2 / 286 (0.70%)	3 / 280 (1.07%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	14	12	0	0	2	3	0	0
Gastroenteritis viral
subjects affected / exposed	5 / 300 (1.67%)	2 / 303 (0.66%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	6	2	0	0	0	0	0	0
Fungal infection
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Impetigo
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	1	1	0	0
Influenza
subjects affected / exposed	1 / 300 (0.33%)	3 / 303 (0.99%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	3	0	0	1	0	0	0
Incision site infection
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Laryngitis
subjects affected / exposed	2 / 300 (0.67%)	2 / 303 (0.66%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	2	2	0	0	0	0	0	0
Localised infection
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Lower respiratory tract infection
subjects affected / exposed	3 / 300 (1.00%)	3 / 303 (0.99%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	3	3	0	0	0	0	0	0
Nasopharyngitis
subjects affected / exposed	68 / 300 (22.67%)	60 / 303 (19.80%)	0 / 299 (0.00%)	1 / 301 (0.33%)	10 / 286 (3.50%)	13 / 280 (4.64%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	90	78	0	1	11	14	0	0
Oral candidiasis
subjects affected / exposed	7 / 300 (2.33%)	2 / 303 (0.66%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	8	3	0	0	1	0	0	0
Otitis media
subjects affected / exposed	5 / 300 (1.67%)	9 / 303 (2.97%)	0 / 299 (0.00%)	1 / 301 (0.33%)	9 / 286 (3.15%)	6 / 280 (2.14%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	5	11	0	1	9	6	0	0
Otitis media acute
subjects affected / exposed	1 / 300 (0.33%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0
Paronychia
subjects affected / exposed	1 / 300 (0.33%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0
Pharyngitis
subjects affected / exposed	1 / 300 (0.33%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	2 / 286 (0.70%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	1	0	0	2	1	0	0
Pharyngitis streptococcal
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	1	0	0	0
Pneumonia
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Respiratory syncytial virus infection
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Respiratory tract infection
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Respiratory tract infection viral
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Rhinitis
subjects affected / exposed	1 / 300 (0.33%)	2 / 303 (0.66%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	2	0	0	0	1	0	0
Roseola
subjects affected / exposed	3 / 300 (1.00%)	5 / 303 (1.65%)	0 / 299 (0.00%)	0 / 301 (0.00%)	2 / 286 (0.70%)	3 / 280 (1.07%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	3	5	0	0	2	3	0	0
Sinusitis
subjects affected / exposed	1 / 300 (0.33%)	2 / 303 (0.66%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	2	0	0	1	0	0	0
Skin candida
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Staphylococcal skin infection
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Upper respiratory tract infection
subjects affected / exposed	60 / 300 (20.00%)	53 / 303 (17.49%)	4 / 299 (1.34%)	1 / 301 (0.33%)	18 / 286 (6.29%)	19 / 280 (6.79%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	82	77	4	1	19	19	0	0
Varicella
subjects affected / exposed	1 / 300 (0.33%)	2 / 303 (0.66%)	0 / 299 (0.00%)	1 / 301 (0.33%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	2	0	1	0	0	0	0
Viral infection
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	2 / 286 (0.70%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	2	1	0	0
Viral skin infection
subjects affected / exposed	2 / 300 (0.67%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0
Viral upper respiratory tract infection
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Coxsackie viral infection
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Fungal skin infection
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	4 / 280 (1.43%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	0	4	0	0
Gastroenteritis norovirus
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Hand-foot-and-mouth disease
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Injection site infection
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Measles
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Measles post vaccine
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	1 / 280 (0.36%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Tonsillitis
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	2 / 286 (0.70%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0
Viraemia
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Molluscum contagiosum
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	1 / 299 (0.33%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0
Otitis media chronic
subjects affected / exposed	0 / 300 (0.00%)	0 / 303 (0.00%)	0 / 299 (0.00%)	1 / 301 (0.33%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	1 / 300 (0.33%)	5 / 303 (1.65%)	0 / 299 (0.00%)	0 / 301 (0.00%)	1 / 286 (0.35%)	2 / 280 (0.71%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	5	0	0	1	2	0	0
Anorexia
subjects affected / exposed	1 / 300 (0.33%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0
Dehydration
subjects affected / exposed	1 / 300 (0.33%)	0 / 303 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Increased appetite
subjects affected / exposed	0 / 300 (0.00%)	1 / 303 (0.33%)	0 / 299 (0.00%)	0 / 301 (0.00%)	0 / 286 (0.00%)	0 / 280 (0.00%)	0 / 299 (0.00%)	0 / 301 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[31] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[32] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[33] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[34] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[35] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[36] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[37] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[38] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[39] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[40] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[41] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[42] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[43] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

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

None reported

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Clinical trials

Clinical Trial Results: A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Canada

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects Achieving Predefined Antibody Level Greater than or Equal to (≥) 1:8 for Meningococcal C Serum Bactericidal Assay (SBA) in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C in the Infant Series

Primary: Percentage of Subjects Achieving Predefined Antibody Level Greater than or Equal to (≥) 1:8 for Meningococcal C Serum Bactericidal Assay (SBA) in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C in the Infant Series

Primary: Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C in the Infant Series

Primary: Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C in the Infant Series

Primary: Percentage of Subjects Achieving Predefined Antibody Level to Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

Primary: Percentage of Subjects Achieving Predefined Antibody Level to Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

Primary: Geometric Mean Concentration (GMC) of Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

Primary: Geometric Mean Concentration (GMC) of Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

Primary: Percentage of Subjects Achieving Predefined Antibody Level ≥0.15 Micrograms Per mL (μg/mL) for Polyribosylribitol Phosphate (PRP) in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

Primary: Percentage of Subjects Achieving Predefined Antibody Level ≥0.15 Micrograms Per mL (μg/mL) for Polyribosylribitol Phosphate (PRP) in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

Primary: Geometric Mean Concentration (GMC) of PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

Primary: Geometric Mean Concentration (GMC) of PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

Secondary: Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C SBA in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose of NeisVac-C

Secondary: Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C SBA in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose of NeisVac-C

Secondary: Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose

Secondary: Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose

Secondary: Percentage of Subjects Achieving Predefined Antibody Level ≥1.0 μg/mL for PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

Secondary: Percentage of Subjects Achieving Predefined Antibody Level ≥1.0 μg/mL for PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

Other pre-specified: Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the 3-dose Infant Series

Other pre-specified: Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the 3-dose Infant Series

Other pre-specified: Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the 3-dose Infant Series

Other pre-specified: Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the 3-dose Infant Series

Other pre-specified: Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the Toddler Dose

Other pre-specified: Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the Toddler Dose

Other pre-specified: Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the Toddler Dose

Other pre-specified: Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the Toddler Dose

Other pre-specified: Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 1 (2 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 1 (2 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 2 (4 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 2 (4 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 3 (6 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 3 (6 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Toddler Dose (12 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Toddler Dose (12 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Toddler Dose (12 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Toddler Dose (12 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 Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Canada