Clinical Trial Results:
A Phase 4, Randomized, Open-label Trial Evaluating the Safety, Tolerability, and Immunogenicity of DTaP Vaccine in Healthy Infants Given with a 7-valent Pneumococcal Conjugate Vaccine in Japan.

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

Summary
EudraCT number	2014-004177-16
Trial protocol	Outside EU/EEA
Global end of trial date	24 Mar 2012

Results information
Results version number	v2(current)
This version publication date	29 Jul 2016
First version publication date	02 Aug 2015
Other versions	v1 (removed from public view)
Version creation reason	Correction of full data set Not completed reason having type "Other" with same other reason text

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

B1841007

ISRCTN number

US NCT number

NCT01250756

WHO universal trial number (UTN)

Other trial identifiers

Alias: 6107A1-4000

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

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

Public contact

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

Scientific contact

Pfizer ClinicalTrials.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

24 May 2013

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

24 Mar 2012

Was the trial ended prematurely?

Main objective of the trial

1. To demonstrate that the immune responses as measured by serum antibody responses to diphtheria toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by diphtheria, tetanus, and acellular pertussis vaccine (DTaP) given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP given alone when measured 1 month after the 3-dose infant series. 2. To measure the immune response to 7vPnC 1 month after a 3-dose infant series as measured by serum immunoglobulin G (IgG) levels. 3. To evaluate the safety profile of 7vPnC given with DTaP as measured by the incidence rates of local reactions, systemic events, and adverse events (AEs).

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 Council for Harmonisation (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

25 Nov 2010

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Japan: 321

Worldwide total number of subjects

321

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)

321

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

The study was conducted in Japan from 25 November 2010 to 24 March 2012.

Period 1 title

Infant Series

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

7vPnC + DTaP - Infant Series

Arm description

Subjects at 3 to 6 months of age received a single dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series). A single dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.

Arm type

Experimental

Investigational medicinal product name

7vPnC

Investigational medicinal product code

Other name

Prevenar

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects at 3 to 6 months of age received a single 0.5 mL dose of 7vPnC subcutaneously followed by 2 single 0.5 milliliter (mL) doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series).

Investigational medicinal product name

DTaP

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received a single 0.5 mL dose of DTaP subcutaneously followed by 2 single 0.5 mL doses of DTaP subcutaneously, 4 to 8 weeks after each previous dose (infant series)

DTaP (Catch-up 7vPnC) - Infant Series

Arm description

Subjects at 3 to 6 months of age received a single DTaP dose subcutaneously followed by 2 single DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously at 4 to 6 weeks apart.

Arm type

Experimental

Investigational medicinal product name

DTaP

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects at 3 to 6 months of age received a single 0.5 mL dose of DTaP subcutaneously followed by 2 single 0.5 mL doses of DTaP subcutaneously, 4 to 8 weeks after each previous dose (infant series).

Number of subjects in period 1	7vPnC + DTaP - Infant Series	DTaP (Catch-up 7vPnC) - Infant Series
Started	161	160
Vaccinated Dose 1	159	158
Vaccinated Dose 2	147	157
Vaccinated Dose 3	133	155
Completed	133	153
Not completed	28	7
Consent withdrawn by subject	4	5
Unspecified	22	-
Randomized, Not Vaccinated	2	2

Period 2 title

After Infant Series

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

7vPnC + DTaP - After the Infant Series

Arm description

Subjects at 3 to 6 months of age received a single dose of 7vPnC subcutaneously followed by 2 single doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series). A single dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

DTaP (Catch-up 7vPnC) - After the Infant Series

Arm description

Arm type

Experimental

Investigational medicinal product name

7vPnC

Investigational medicinal product code

Other name

Prevenar

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received 2 single catch-up doses of 7vPnC (Prevenar) administered subcutaneously, 4 to 6 weeks apart.

Number of subjects in period 2	7vPnC + DTaP - After the Infant Series	DTaP (Catch-up 7vPnC) - After the Infant Series
Started	133	153
Completed	122	149
Not completed	11	4
Consent withdrawn by subject	4	1
Adverse event, non-fatal	5	2
Unspecified	2	1

Period 3 title

Toddler Dose

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

7vPnC + DTaP - Toddler Dose

Arm description

Subjects received a single dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.

Arm type

Experimental

Investigational medicinal product name

7vPnC

Investigational medicinal product code

Other name

Prevenar

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose).

Investigational medicinal product name

DTaP

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received a single 0.5 mL dose of DTaP subcutaneously at 12 to 15 months of age (toddler dose).

DTaP (Catch-up 7vPnC) - Toddler Dose

Arm description

Subjects received a single DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.

Arm type

Experimental

Investigational medicinal product name

DTaP

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received a single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose).

Number of subjects in period 3	7vPnC + DTaP - Toddler Dose	DTaP (Catch-up 7vPnC) - Toddler Dose
Started	122	149
Completed	122	148
Not completed	0	1
Adverse Event	-	1

Period 4 title

After Toddler Dose

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

DTaP (Catch-up 7vPnC) - After the Toddler Dose

Arm description

Subjects received a single DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.

Arm type

Experimental

Investigational medicinal product name

7vPnC

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subject received a single 0.5 mL CU dose of 7vPnC (Prevenar) 4 to 6 weeks post-toddler dose.

Number of subjects in period 4 ^[1]	DTaP (Catch-up 7vPnC) - After the Toddler Dose
Started	148
Completed	147
Not completed	1
Adverse event, non-fatal	1

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Since no subject continued in 7vPnC + DTaP arm after the toddler dose, so data for DTaP (Catch-up 7vPnC) arm has been reported.

Baseline characteristics

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Reporting group title

7vPnC + DTaP - Infant Series

Reporting group description

Reporting group title

DTaP (Catch-up 7vPnC) - Infant Series

Reporting group description

Reporting group values	7vPnC + DTaP - Infant Series	DTaP (Catch-up 7vPnC) - Infant Series	Total
Number of subjects	161	160	321
Age categorical
Units: Subjects
Age Continuous
Units: months
arithmetic mean (standard deviation)	3.8 ( 0.91 )	3.9 ( 0.94 )	-
Gender, Male/Female
Units: participants
Female	80	82	162
Male	81	78	159

End points

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Reporting group title

7vPnC + DTaP - Infant Series

Reporting group description

Reporting group title

DTaP (Catch-up 7vPnC) - Infant Series

Reporting group description

Reporting group title

7vPnC + DTaP - After the Infant Series

Reporting group description

Reporting group title

DTaP (Catch-up 7vPnC) - After the Infant Series

Reporting group description

Reporting group title

7vPnC + DTaP - Toddler Dose

Reporting group description

Subjects received a single dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.

Reporting group title

DTaP (Catch-up 7vPnC) - Toddler Dose

Reporting group description

Subjects received a single DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.

Reporting group title

DTaP (Catch-up 7vPnC) - After the Toddler Dose

Reporting group description

Subjects received a single DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.

Primary: Percentage of Subjects Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series

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End point title

Percentage of Subjects Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series ^[1]

End point description

Percentage of subjects achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented. Exact 2-sided CI based on the observed proportion of subjects . Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA). Evaluable infant immunogenicity population: eligible subjects who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.

End point type

Primary

End point timeframe

1 month after the infant series

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be reported for this endpoint.

End point values	7vPnC + DTaP - Infant Series	DTaP (Catch-up 7vPnC) - Infant Series
Number of subjects analysed	132	149
Units: Percentage of subjects
number (confidence interval 95%)
Diphtheria	100 (97.2 to 100)	100 (97.6 to 100)
Tetanus	100 (97.2 to 100)	100 (97.6 to 100)
Pertussis toxoid (PT)	100 (97.2 to 100)	100 (97.6 to 100)
Filamentous hemagglutinin (FHA)	100 (97.2 to 100)	100 (97.6 to 100)

No statistical analyses for this end point

Primary: Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series

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End point title

Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series ^[2]

End point description

Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (CI) were evaluated for diphtheria and tetanus antibodies. Evaluable infant immunogenicity population: eligible subjects who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.

End point type

Primary

End point timeframe

1 month after the infant series

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be reported for this endpoint.

End point values	7vPnC + DTaP - Infant Series	DTaP (Catch-up 7vPnC) - Infant Series
Number of subjects analysed	132	149
Units: IU/mL
geometric mean (confidence interval 95%)
Diphtheria	1.38 (1.27 to 1.49)	0.99 (0.91 to 1.09)
Tetanus	1.91 (1.69 to 2.16)	2.05 (1.83 to 2.29)

No statistical analyses for this end point

Primary: Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series

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End point title

Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series ^[3]

End point description

GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies. Evaluable infant immunogenicity population: eligible subjects who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.

End point type

Primary

End point timeframe

1 month after the infant series

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be reported for this endpoint.

End point values	7vPnC + DTaP - Infant Series	DTaP (Catch-up 7vPnC) - Infant Series
Number of subjects analysed	132	149
Units: EU/mL
geometric mean (confidence interval 95%)
Pertussis toxoid (PT)	76.79 (70.81 to 83.28)	83.56 (77.54 to 90.05)
Filamentous hemagglutinin (FHA)	72.89 (65.8 to 80.74)	77.85 (71.01 to 85.35)

No statistical analyses for this end point

Primary: Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 microgram per milliliter (mcg/mL) 1 Month After the Infant Series

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End point title

Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 microgram per milliliter (mcg/mL) 1 Month After the Infant Series ^[4] ^[5]

End point description

Percentage of subjects achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of subjects. Evaluable infant immunogenicity population: eligible subjects who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.

End point type

Primary

End point timeframe

1 month after the infant series

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be reported for this endpoint.
[5] - 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: The endpoint was planned to be assessed for 7vPnC + DTaP - Infant Series reporting group only.

End point values	7vPnC + DTaP - Infant Series
Number of subjects analysed	132
Units: Percentage of subjects
number (confidence interval 95%)
Serotype 4	100 (97.2 to 100)
Serotype 6B	99.2 (95.9 to 100)
Serotype 9V	100 (97.2 to 100)
Serotype 14	99.2 (95.9 to 100)
Serotype 18C	99.2 (95.8 to 100)
Serotype 19F	97.7 (93.5 to 99.5)
Serotype 23F	98.5 (94.6 to 99.8)

No statistical analyses for this end point

Primary: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series

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End point title

Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series ^[6] ^[7]

End point description

Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all subjects with available data for the specified blood draw. Evaluable infant immunogenicity population: eligible subjects who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.

End point type

Primary

End point timeframe

1 month after the infant series

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be reported for this endpoint.
[7] - 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: The endpoint was planned to be assessed for 7vPnC + DTaP - Infant Series reporting group only.

End point values	7vPnC + DTaP - Infant Series
Number of subjects analysed	132
Units: mcg/mL
geometric mean (confidence interval 95%)
Serotype 4	11.82 (10.5 to 13.31)
Serotype 6B	4.23 (3.61 to 4.97)
Serotype 9V	5.96 (5.37 to 6.62)
Serotype 14	16.61 (14.66 to 18.81)
Serotype 18C	5.48 (4.76 to 6.31)
Serotype 19F	8.85 (7.54 to 10.4)
Serotype 23F	4.17 (3.54 to 4.91)

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose

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End point title

Percentage of Subjects Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose

End point description

Percentage of subjects achieving predefined antibody level along with the corresponding 95% CI were presented. Exact 2-sided CI based on the observed proportion of subjects. Predefined antibody levels were 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA. Evaluable toddler immunogenicity set: eligible subjects who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.

End point type

Secondary

End point timeframe

1 month after the toddler dose

End point values	7vPnC + DTaP - Toddler Dose	DTaP (Catch-up 7vPnC) - Toddler Dose
Number of subjects analysed	121	146
Units: Percentage of subjects
number (confidence interval 95%)
Diphtheria	100 (97 to 100)	100 (97.5 to 100)
Tetanus	100 (97 to 100)	100 (97.5 to 100)
Pertussis toxoid (PT)	100 (97 to 100)	100 (97.5 to 100)
Filamentous hemagglutinin (FHA)	100 (97 to 100)	100 (97.5 to 100)

No statistical analyses for this end point

Secondary: Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose

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End point title

Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose

End point description

GMCs were measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies. Evaluable toddler immunogenicity set: eligible subjects who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.

End point type

Secondary

End point timeframe

1 month after the toddler dose

End point values	7vPnC + DTaP - Toddler Dose	DTaP (Catch-up 7vPnC) - Toddler Dose
Number of subjects analysed	121	146
Units: IU/mL
geometric mean (confidence interval 95%)
Diphtheria	2.56 (2.35 to 2.78)	2.14 (1.94 to 2.35)
Tetanus	2.53 (2.26 to 2.82)	3.04 (2.74 to 3.38)

No statistical analyses for this end point

Secondary: Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose

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End point title

Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose

End point description

GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies. Evaluable toddler immunogenicity set: eligible subjects who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.

End point type

Secondary

End point timeframe

1 month after the toddler dose

End point values	7vPnC + DTaP - Toddler Dose	DTaP (Catch-up 7vPnC) - Toddler Dose
Number of subjects analysed	121	146
Units: EU/mL
geometric mean (confidence interval 95%)
PT	106.54 (96.1 to 118.12)	130.62 (119.6 to 142.65)
FHA	120.99 (109.75 to 133.39)	145.38 (132.41 to 159.63)

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose

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End point title

Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose

End point description

Percentage of subjects achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of subjects. Evaluable toddler immunogenicity set: eligible subjects who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.

End point type

Secondary

End point timeframe

1 month after the toddler dose

End point values	7vPnC + DTaP - Toddler Dose
Number of subjects analysed	121
Units: Percentage of subjects
number (confidence interval 95%)
Serotype 4	100 (97 to 100)
Serotype 6B	100 (97 to 100)
Serotype 9V	100 (97 to 100)
Serotype 14	100 (97 to 100)
Serotype 18C	99.2 (95.5 to 100)
Serotype 19F	99.2 (95.5 to 100)
Serotype 23F	100 (97 to 100)

No statistical analyses for this end point

Secondary: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose

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End point title

Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose

End point description

Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all subjects with available data for the specified blood draw. Evaluable toddler immunogenicity set: eligible subjects who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.

End point type

Secondary

End point timeframe

1 month after the toddler dose

End point values	7vPnC + DTaP - Toddler Dose
Number of subjects analysed	121
Units: mcg/mL
geometric mean (confidence interval 95%)
Serotype 4	12.15 (10.35 to 14.26)
Serotype 6B	10.66 (8.96 to 12.68)
Serotype 9V	6.43 (5.57 to 7.42)
Serotype 14	15.83 (13.81 to 18.14)
Serotype 18C	6.53 (5.49 to 7.76)
Serotype 19F	9.7 (8.15 to 11.56)
Serotype 23F	10.17 (8.58 to 12.07)

No statistical analyses for this end point

Secondary: Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose

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End point title

Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose

End point description

Geometric mean fold rises (GMFRs) for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results. Evaluable toddler immunogenicity set: eligible subjects who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.

End point type

Secondary

End point timeframe

Pre-toddler dose, 1 month after the toddler dose

End point values	7vPnC + DTaP - Toddler Dose
Number of subjects analysed	121
Units: Fold Rise
geometric mean (confidence interval 95%)
Serotype 4	6.74 (5.75 to 7.9)
Serotype 6B	5.89 (5.09 to 6.81)
Serotype 9V	4.34 (3.81 to 4.93)
Serotype 14	3.63 (3.22 to 4.09)
Serotype 18C	6.9 (6.06 to 7.85)
Serotype 19F	6.37 (5.35 to 7.59)
Serotype 23F	8.1 (7.01 to 9.35)

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Catch-up Dose 3

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End point title

Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Catch-up Dose 3

End point description

Percentage of subjects achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of subjects. Catch-up immunogenicity population: eligible subjects who received the vaccine to which they were randomized at all 3 catch-up doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.

End point type

Secondary

End point timeframe

1 month after the catch-up dose 3

End point values	DTaP (Catch-up 7vPnC) - After the Toddler Dose
Number of subjects analysed	148
Units: Percentage of subjects
number (confidence interval 95%)
Serotype 4	100 (97.5 to 100)
Serotype 6B	99.3 (96.3 to 100)
Serotype 9V	100 (97.5 to 100)
Serotype 14	100 (97.5 to 100)
Serotype 18C	99.3 (96.3 to 100)
Serotype 19F	100 (97.5 to 100)
Serotype 23F	99.3 (96.3 to 100)

No statistical analyses for this end point

Secondary: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3

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End point title

Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3

End point description

Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all subjects with available data for the specified blood draw. Catch-up immunogenicity population: eligible subjects who received the vaccine to which they were randomized at all 3 catch-up doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.

End point type

Secondary

End point timeframe

1 month after the catch-up dose 3

End point values	DTaP (Catch-up 7vPnC) - After the Toddler Dose
Number of subjects analysed	148
Units: mcg/mL
geometric mean (confidence interval 95%)
Serotype 4	6.63 (5.91 to 7.44)
Serotype 6B	4.3 (3.75 to 4.93)
Serotype 9V	3.48 (3.12 to 3.89)
Serotype 14	11.55 (10.3 to 12.95)
Serotype 18C	3.1 (2.69 to 3.57)
Serotype 19F	5.16 (4.45 to 5.99)
Serotype 23F	4.41 (3.78 to 5.14)

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)

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End point title

Percentage of Subjects Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group. Safety population included all subjects who received at least 1 dose of study vaccine. 'n'=subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.

End point type

Other pre-specified

End point timeframe

Within 7 days after Dose 1 of the infant series

End point values	7vPnC + DTaP - Infant Series	DTaP (Catch-up 7vPnC) - Infant Series
Number of subjects analysed	152 ^[8]	154 ^[9]
Units: Percentage of subjects
number (not applicable)
Erythema-Any (n= 152, 152)	57.2	14.5
Erythema-Mild (n= 152, 151)	52.6	12.6
Erythema-Moderate (n= 148, 152)	14.9	2
Erythema-Severe (n= 148, 151)	0	0
Induration-Any (n= 149, 153)	40.3	7.8
Induration-Mild (n= 149, 153)	38.3	7.8
Induration-Moderate (n= 148, 151)	10.1	0
Induration-Severe (n= 148, 151)	0	0
Tenderness-Any (n= 148, 151)	12.2	0.7
Tenderness-Significant (n= 148, 151)	0	0
Any local reaction (n= 152, 154)	66.4	15.6

Notes
[8] - N= subjects reporting yes for at least 1 day or no for all days for any local reaction.
[9] - N= subjects reporting yes for at least 1 day or no for all days for any local reaction.

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)

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End point title

Percentage of Subjects Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group. Safety population included all subjects who received at least 1 dose of study vaccine. 'n'= subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.

End point type

Other pre-specified

End point timeframe

Within 7 days after Dose 2 of the infant series

End point values	7vPnC + DTaP - Infant Series	DTaP (Catch-up 7vPnC) - Infant Series
Number of subjects analysed	143 ^[10]	151 ^[11]
Units: Percentage of subjects
number (not applicable)
Erythema-Any (n= 142, 150)	64.1	39.3
Erythema-Mild (n= 142, 150)	58.5	33.3
Erythema-Moderate (n= 134, 147)	32.1	6.8
Erythema-Severe (n= 133, 147)	0	0
Induration-Any (n= 137, 150)	51.8	30
Induration-Mild (n= 137, 150)	49.6	28.7
Induration-Moderate (n= 134, 148)	23.9	6.8
Induration-Severe (n= 133, 147)	0	0
Tenderness-Any (n= 133, 147)	7.5	4.1
Tenderness-Significant (n= 133, 147)	0	0
Any local reaction (n= 143, 151)	69.2	45

Notes
[10] - N= subjects reporting yes for at least 1 day or no for all days for any local reaction.
[11] - N= subjects reporting yes for at least 1 day or no for all days for any local reaction.

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)

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End point title

Percentage of Subjects Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group. Safety population included all subjects who received at least 1 dose of study vaccine. 'n'= subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.

End point type

Other pre-specified

End point timeframe

Within 7 days after Dose 3 of the infant series

End point values	7vPnC + DTaP - Infant Series	DTaP (Catch-up 7vPnC) - Infant Series
Number of subjects analysed	126 ^[12]	145 ^[13]
Units: Percentage of subjects
number (not applicable)
Erythema-Any (n= 123, 144)	52.8	30.6
Erythema-Mild (n= 123, 143)	46.3	28
Erythema-Moderate (n= 120, 139)	20	5.8
Erythema-Severe (n= 118, 138)	0	0
Induration-Any (n= 124, 144)	44.4	19.4
Induration-Mild (n= 124, 144)	42.7	19.4
Induration-Moderate (n= 119, 139)	11.8	2.2
Induration-Severe (n= 118, 138)	0	0
Tenderness-Any (n= 119, 138)	5	3.6
Tenderness-Significant (n= 118, 138)	0	0
Any local reaction (n= 126, 145)	61.1	33.1

Notes
[12] - N= subjects reporting yes for at least 1 day or no for all days for any local reaction.
[13] - N= subjects reporting yes for at least 1 day or no for all days for any local reaction.

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)

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End point title

Percentage of Subjects Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group. Safety population included all subjects who received at least 1 dose of study vaccine. 'n'= subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.

End point type

Other pre-specified

End point timeframe

Within 7 days after the toddler dose

End point values	7vPnC + DTaP - Toddler Dose	DTaP (Catch-up 7vPnC) - Toddler Dose
Number of subjects analysed	110 ^[14]	138 ^[15]
Units: Percentage of subject
number (not applicable)
Erythema-Any (n= 108, 137)	51.9	32.1
Erythema-Mild (n= 106, 137)	48.1	28.5
Erythema-Moderate (n= 102, 134)	23.5	7.5
Erythema-Severe (n= 98, 133)	0	0
Induration-Any (n= 108, 137)	42.6	23.4
Induration-Mild (n= 108, 137)	40.7	19.7
Induration-Moderate (n= 99, 133)	16.2	6.8
Induration-Severe (n= 98, 133)	0	0
Tenderness-Any (n= 99, 136)	11.1	4.4
Tenderness-Significant (n= 98, 133)	0	0
Any local reaction (n= 110, 138)	56.4	39.1

Notes
[14] - N= subjects reporting yes for at least 1 day or no for all days for any local reaction.
[15] - N= subjects reporting yes for at least 1 day or no for all days for any local reaction.

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)

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End point title

Percentage of Subjects Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group. Safety population included all subjects who received at least 1 dose of study vaccine. 'n'= subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.

End point type

Other pre-specified

End point timeframe

Within 7 days after Catch-up Dose 1

End point values	DTaP (Catch-up 7vPnC) - After the Infant Series
Number of subjects analysed	141 ^[16]
Units: Percentage of subjects
number (not applicable)
Erythema-Any (n= 139)	51.8
Erythema-Mild (n= 139)	45.3
Erythema-Moderate (n= 136)	10.3
Erythema-Severe (n= 135)	0
Induration-Any (n= 138)	34.8
Induration-Mild (n= 138)	32.6
Induration-Moderate (n= 135)	8.1
Induration-Severe (n= 135)	0
Tenderness-Any (n= 136)	8.1
Tenderness-Significant (n= 135)	0
Any local reaction (n= 141)	54.6

Notes
[16] - N= subjects reporting yes for at least 1 day or no for all days for any local reaction.

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)

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End point title

Percentage of Subjects Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group. Safety population included all subjects who received at least 1 dose of study vaccine. 'n'= subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.

End point type

Other pre-specified

End point timeframe

Within 7 days after Catch-up Dose 2

End point values	DTaP (Catch-up 7vPnC) - After the Infant Series
Number of subjects analysed	145 ^[17]
Units: Percentage of subjects
number (not applicable)
Erythema-Any (n= 144)	50.7
Erythema-Mild (n= 144)	45.1
Erythema-Moderate (n= 140)	13.6
Erythema-Severe (n= 138)	0
Induration-Any (n= 144)	32.6
Induration-Mild (n= 143)	30.1
Induration-Moderate (n= 140)	15
Induration-Severe (n= 138)	0
Tenderness-Any (n= 139)	5
Tenderness-Significant (n= 138)	0
Any local reaction (n= 145)	55.2

Notes
[17] - N= subjects reporting yes for at least 1 day or no for all days for any local reaction.

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)

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End point title

Percentage of Subjects Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to 16.5 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group. Safety population included all subjects who received at least 1 dose of study vaccine. 'n'= subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.

End point type

Other pre-specified

End point timeframe

Within 7 days after Catch-up Dose 3

End point values	DTaP (Catch-up 7vPnC) - After the Toddler Dose
Number of subjects analysed	137 ^[18]
Units: Percentage of subjects
number (not applicable)
Erythema-Any (n= 134)	32.1
Erythema-Mild (n= 133)	27.1
Erythema-Moderate (n= 131)	9.9
Erythema-Severe (n= 130)	0
Induration-Any (n= 134)	27.6
Induration-Mild (n= 133)	24.8
Induration-Moderate (n= 131)	9.9
Induration-Severe (n= 130)	0
Tenderness-Any (n= 132)	6.8
Tenderness-Significant (n= 130)	0
Any local reaction (n= 137)	40.9

Notes
[18] - N= subjects reporting yes for at least 1 day or no for all days for any local reaction.

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)

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End point title

Percentage of Subjects Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)

End point description

Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population included all subjects who received at least 1 dose of study vaccine. 'n'= subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.

End point type

Other pre-specified

End point timeframe

Within 7 days after Dose 1 of the infant series

End point values	7vPnC + DTaP - Infant Series	DTaP (Catch-up 7vPnC) - Infant Series
Number of subjects analysed	154 ^[19]	153 ^[20]
Units: Percentage of subjects
number (not applicable)
Fever >=37.5 but =<39 degrees C(n=149,152)	18.8	15.8
Fever >39 but =<40.0 degrees C(n=148,151)	2	2
Fever >40 degrees C(n=148,151)	0	0
Decreased appetite(n=148,151)	8.8	7.9
Irritability(n=151,151)	15.2	9.3
Increased sleep(n=150,153)	32	25.5
Decreased sleep(n=151,151)	16.6	15.2
Hives (urticaria)(n=148,151)	1.4	0.7
Antipyretic medication to treat symptom(n=148,151)	1.4	1.3
Any systemic event(n=154,153)	57.8	48.4

Notes
[19] - N= subjects reporting yes for at least 1 day or no for all days for any systemic event.
[20] - N= subjects reporting yes for at least 1 day or no for all days for any systemic event.

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)

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End point title

Percentage of Subjects Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)

End point description

End point type

Other pre-specified

End point timeframe

Within 7 days after Dose 2 of the infant series

End point values	7vPnC + DTaP - Infant Series	DTaP (Catch-up 7vPnC) - Infant Series
Number of subjects analysed	142 ^[21]	153 ^[22]
Units: Percentage of subjects
number (not applicable)
Fever >=37.5 but =<39 degrees C(n=138,149)	25.4	15.4
Fever >39 but =<40.0 degrees C(n=135,147)	2.2	0
Fever >40 degrees C(n=133,147)	0	0.7
Decreased appetite(n=135,147)	11.9	5.4
Irritability(n=134,149)	19.4	12.1
Increased sleep(n=136,148)	19.1	12.8
Decreased sleep(n=140,151)	17.1	15.2
Hives (urticaria)(n=133,147)	3	0
Antipyretic medication to treat symptom(n=134,147)	2.2	2
Any systemic event(n=142,153)	53.5	38.6

Notes
[21] - N= subjects reporting yes for at least 1 day or no for all days for any systemic event.
[22] - N= subjects reporting yes for at least 1 day or no for all days for any systemic event.

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)

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End point title

Percentage of Subjects Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)

End point description

End point type

Other pre-specified

End point timeframe

Within 7 days after Dose 3 of the infant series

End point values	7vPnC + DTaP - Infant Series	DTaP (Catch-up 7vPnC) - Infant Series
Number of subjects analysed	122 ^[23]	143 ^[24]
Units: Percentage of subjects
number (not applicable)
Fever >=37.5 but =<39 degrees C(n=120,141)	19.2	14.9
Fever >39 but =<40.0 degrees C(n=118,138)	1.7	0.7
Fever >40 degrees C(n=118,138)	0	0
Decreased appetite(n=119,138)	8.4	6.5
Irritability(n=118,139)	10.2	7.2
Increased sleep(n=119,141)	16	18.4
Decreased sleep(n=120,140)	6.7	14.3
Hives (urticaria)(n=119,138)	1.7	0
Antipyretic medication to treat symptom(n=119,138)	1.7	2.2
Any systemic event(n=122,143)	39.3	36.4

Notes
[23] - N= subjects reporting yes for at least 1 day or no for all days for any systemic event.
[24] - N= subjects reporting yes for at least 1 day or no for all days for any systemic event.

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)

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End point title

Percentage of Subjects Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)

End point description

End point type

Other pre-specified

End point timeframe

Within 7 days after the toddler dose

End point values	7vPnC + DTaP - Toddler Dose	DTaP (Catch-up 7vPnC) - Toddler Dose
Number of subjects analysed	108 ^[25]	138 ^[26]
Units: Percentage of subjects
number (not applicable)
Fever >=37.5 but =<39 degrees C(n=103,135)	34	22.2
Fever >39 but =<40.0 degrees C(n=99,132)	5.1	2.3
Fever >40 degrees C(n=98,132)	1	0
Decreased appetite(n=100,133)	9	8.3
Irritability(n=100,134)	17	9.7
Increased sleep(n=103,135)	20.4	15.6
Decreased sleep(n=101,133)	10.9	7.5
Hives (urticaria)(n=98,133)	1	0.8
Antipyretic medication to treat symptom(n=98,133)	4.1	4.5
Any systemic event(n=108,138)	52.8	39.9

Notes
[25] - N= subjects reporting yes for at least 1 day or no for all days for any systemic event.
[26] - N= subjects reporting yes for at least 1 day or no for all days for any systemic event.

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)

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End point title

Percentage of Subjects Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)

End point description

End point type

Other pre-specified

End point timeframe

Within 7 days after Catch-up Dose 1

End point values	DTaP (Catch-up 7vPnC) - After the Infant Series
Number of subjects analysed	139 ^[27]
Units: Percentage of subjects
number (not applicable)
Fever >=37.5 but =<39 degrees C(n=139)	32.4
Fever >39 but =<40.0 degrees C(n=135)	2.2
Fever >40 degrees C(n=135)	0
Decreased appetite(n=136)	8.1
Irritability(n=136)	12.5
Increased sleep(n=136)	17.6
Decreased sleep(n=136)	11.8
Hives (urticaria)(n=135)	0.7
Antipyretic medication to treat symptom(n=136)	5.9
Any systemic event(n=139)	49.6

Notes
[27] - N= subjects reporting yes for at least 1 day or no for all days for any systemic event.

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)

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End point title

Percentage of Subjects Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)

End point description

End point type

Other pre-specified

End point timeframe

Within 7 days after Catch-up Dose 2

End point values	DTaP (Catch-up 7vPnC) - After the Infant Series
Number of subjects analysed	141 ^[28]
Units: Percentage of subjects
number (not applicable)
Fever >=37.5 but =<39 degrees C(n=140)	32.1
Fever >39 but =<40.0 degrees C(n=138)	5.1
Fever >40 degrees C(n=138)	0.7
Decreased appetite(n=138)	10.9
Irritability(n=138)	11.6
Increased sleep(n=138)	15.9
Decreased sleep(n=139)	10.1
Hives (urticaria)(n=138)	2.2
Antipyretic medication to treat symptom(n=138)	5.1
Any systemic event(n=141)	47.5

Notes
[28] - N= subjects reporting yes for at least 1 day or no for all days for any systemic event.

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)

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End point title

Percentage of Subjects Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)

End point description

End point type

Other pre-specified

End point timeframe

Within 7 days after Catch-up Dose 3

End point values	DTaP (Catch-up 7vPnC) - After the Toddler Dose
Number of subjects analysed	136 ^[29]
Units: Percentage of subjects
number (not applicable)
Fever >=37.5 but =<39 degrees C(n=134)	26.9
Fever >39 but =<40.0 degrees C(n=130)	0.8
Fever >40 degrees C(n=130)	0
Decreased appetite(n=130)	6.2
Irritability(n=131)	9.2
Increased sleep(n=131)	10.7
Decreased sleep(n=131)	6.9
Hives (urticaria)(n=131)	0.8
Antipyretic medication to treat symptom(n=130)	1.5
Any systemic event(n=136)	39

Notes
[29] - N= subjects reporting yes for at least 1 day or no for all days for any systemic event.

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

AEs: from signing ICF to visit 4(CU Dose 1: 28 to 42 days) for Group 1/visit 6(28 to 42 days)for Group 2 and from visit 7(Dose 4: 28 to 42 days)to visit 8(CU Dose 3: 28 to 42 days) for Group 1/to visit 9(28 to 42 days) for Group 2. SAEs: ICF to last visit

Adverse event reporting additional description

Safety population: subjects who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

15.0

Reporting group title

7vPnC + DTaP - Infant Series

Reporting group description

Subjects who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.

Reporting group title

DTaP (Catch-up 7vPnC)- Infant Series

Reporting group description

Subjects who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed from Infant Dose 1 through the CU Dose 1.

Reporting group title

7vPnC + DTaP - After the Infant Series

Reporting group description

Subjects who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.

Reporting group title

DTaP (Catch-up 7vPnC) - After the Infant Series

Reporting group description

Reporting group title

7vPnC + DTaP - Toddler Dose

Reporting group description

Subjects who received a single 0.5 mL dose of 7vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.

Reporting group title

DTaP (Catch-up 7vPnC) - Toddler Dose

Reporting group description

Subjects who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed from toddler dose through the CU Dose 3.

Reporting group title

DTaP (Catch-up 7vPnC) - After the Toddler Dose

Reporting group description

Serious adverse events	7vPnC + DTaP - Infant Series	DTaP (Catch-up 7vPnC)- Infant Series	7vPnC + DTaP - After the Infant Series	DTaP (Catch-up 7vPnC) - After the Infant Series	7vPnC + DTaP - Toddler Dose	DTaP (Catch-up 7vPnC) - Toddler Dose	DTaP (Catch-up 7vPnC) - After the Toddler Dose
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 159 (1.89%)	7 / 158 (4.43%)	10 / 159 (6.29%)	7 / 158 (4.43%)	0 / 122 (0.00%)	4 / 149 (2.68%)	1 / 149 (0.67%)
number of deaths (all causes)	0	0	0	0	0	0	0
number of deaths resulting from adverse events
Injury, poisoning and procedural complications
Burns second degree
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	1 / 149 (0.67%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	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
Congenital, familial and genetic disorders
Cryptorchism
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	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
Vascular disorders
Kawasaki's disease
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	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
Nervous system disorders
Febrile convulsion
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	4 / 159 (2.52%)	2 / 158 (1.27%)	0 / 122 (0.00%)	1 / 149 (0.67%)	1 / 149 (0.67%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 4	0 / 2	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	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
Gastrointestinal disorders
Inguinal hernia
subjects affected / exposed	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	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
Intussusception
subjects affected / exposed	0 / 159 (0.00%)	1 / 158 (0.63%)	1 / 159 (0.63%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	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
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	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
Apnoea
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	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
Tonsillar hypertrophy
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	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
Infantile asthma
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	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
Respiratory failure
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	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
Infections and infestations
Gastroenteritis viral
subjects affected / exposed	1 / 159 (0.63%)	1 / 158 (0.63%)	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory syncytial virus bronchitis
subjects affected / exposed	1 / 159 (0.63%)	1 / 158 (0.63%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	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
Bronchitis bacterial
subjects affected / exposed	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	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
Respiratory syncytial virus bronchiolitis
subjects affected / exposed	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	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
Bronchitis
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	1 / 159 (0.63%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	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
Adenovirus infection
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	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
Pneumonia
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	2 / 159 (1.26%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	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
Exanthema subitum
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	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
Gastroenteritis adenovirus
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	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
Otitis media
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	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
Pneumonia respiratory syncytial viral
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	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
Pneumonia mycoplasmal
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	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
Upper respiratory tract infection
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	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
Bronchopneumonia
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	2 / 149 (1.34%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Weight gain poor
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	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

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

Non-serious adverse events	7vPnC + DTaP - Infant Series	DTaP (Catch-up 7vPnC)- Infant Series	7vPnC + DTaP - After the Infant Series	DTaP (Catch-up 7vPnC) - After the Infant Series	7vPnC + DTaP - Toddler Dose	DTaP (Catch-up 7vPnC) - Toddler Dose	DTaP (Catch-up 7vPnC) - After the Toddler Dose
Total subjects affected by non serious adverse events
subjects affected / exposed	123 / 159 (77.36%)	126 / 158 (79.75%)	20 / 159 (12.58%)	129 / 158 (81.65%)	72 / 122 (59.02%)	96 / 149 (64.43%)	85 / 149 (57.05%)
General disorders and administration site conditions
Vaccination site erythema
subjects affected / exposed	5 / 159 (3.14%)	10 / 158 (6.33%)	0 / 159 (0.00%)	2 / 158 (1.27%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	9	13	0	2	0	0	0
Pyrexia
subjects affected / exposed	5 / 159 (3.14%)	0 / 158 (0.00%)	0 / 159 (0.00%)	4 / 158 (2.53%)	0 / 122 (0.00%)	1 / 149 (0.67%)	0 / 149 (0.00%)
occurrences all number	5	0	0	4	0	1	0
Vaccination site induration
subjects affected / exposed	1 / 159 (0.63%)	4 / 158 (2.53%)	0 / 159 (0.00%)	2 / 158 (1.27%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	1	4	0	2	0	0	0
Injection site induration
subjects affected / exposed	1 / 159 (0.63%)	1 / 158 (0.63%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	1	2	0	0	0	0	0
Vaccination site swelling
subjects affected / exposed	1 / 159 (0.63%)	1 / 158 (0.63%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	1	1	0	0	0	0	0
Application site erythema
subjects affected / exposed	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	2	0	0	0	0	0
Injection site haemorrhage
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	1	0	0	0	0	0	0
Fever≥37.5°C but≤39°C:Infant Series Dose 1/After Infant Series Dose1/Toddler Dose/After 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[1]	28 / 149 (18.79%)	24 / 152 (15.79%)	0 / 159 (0.00%)	45 / 139 (32.37%)	35 / 103 (33.98%)	30 / 135 (22.22%)	36 / 134 (26.87%)
occurrences all number	28	24	0	45	35	30	36
Fever ≥37.5°C but ≤39°C: Infant Series Dose 2 / After 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[2]	35 / 138 (25.36%)	23 / 149 (15.44%)	0 / 159 (0.00%)	45 / 140 (32.14%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	35	23	0	45	0	0	0
Fever ≥37.5°C but ≤39°C: Infant Series Dose 3
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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[3]	23 / 120 (19.17%)	21 / 141 (14.89%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	23	21	0	0	0	0	0
Fever>39°C but ≤40°C: Infant Series Dose 1/After Infant Series Dose 1/Toddler Dose/After Toddle 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[4]	3 / 148 (2.03%)	3 / 151 (1.99%)	0 / 159 (0.00%)	3 / 135 (2.22%)	5 / 99 (5.05%)	3 / 132 (2.27%)	1 / 130 (0.77%)
occurrences all number	3	3	0	3	5	3	1
Fever>39°C but ≤40°C: Infant Series Dose 2 / After 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[5]	3 / 135 (2.22%)	0 / 147 (0.00%)	0 / 159 (0.00%)	7 / 138 (5.07%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	3	0	0	7	0	0	0
Fever>39°C but ≤40°C: Infant Series Dose 3
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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[6]	2 / 118 (1.69%)	1 / 138 (0.72%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	2	1	0	0	0	0	0
Fever >40.0°C: Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose / After 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[7]	0 / 148 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)	0 / 135 (0.00%)	1 / 98 (1.02%)	0 / 132 (0.00%)	0 / 130 (0.00%)
occurrences all number	0	151	0	0	1	0	0
Fever >40.0°C: Infant Series Dose 2 / After 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[8]	0 / 133 (0.00%)	1 / 147 (0.68%)	0 / 159 (0.00%)	1 / 138 (0.72%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	1	0	1	0	0	0
Decreased appetite- Infant Series Dose 1/After Infant Series Dose 1/Toddler Dose/After 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[9]	13 / 148 (8.78%)	12 / 151 (7.95%)	0 / 159 (0.00%)	11 / 136 (8.09%)	9 / 100 (9.00%)	11 / 133 (8.27%)	8 / 130 (6.15%)
occurrences all number	13	12	0	11	9	11	8
Decreased appetite- Infant Series Dose 2 / After 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[10]	16 / 135 (11.85%)	8 / 147 (5.44%)	0 / 159 (0.00%)	15 / 138 (10.87%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	16	8	0	15	0	0	0
Decreased appetite- Infant Series Dose 3
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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[11]	10 / 119 (8.40%)	9 / 138 (6.52%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	10	9	0	0	0	0	0
Irritability- Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose / After 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[12]	23 / 151 (15.23%)	14 / 151 (9.27%)	0 / 159 (0.00%)	17 / 136 (12.50%)	17 / 100 (17.00%)	13 / 134 (9.70%)	12 / 131 (9.16%)
occurrences all number	23	14	0	17	17	13	12
Irritability- Infant Series Dose 2 / After 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[13]	26 / 134 (19.40%)	18 / 149 (12.08%)	0 / 159 (0.00%)	16 / 138 (11.59%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	26	18	0	16	0	0	0
Irritability- Infant Series Dose 3
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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[14]	12 / 118 (10.17%)	10 / 139 (7.19%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	12	10	0	0	0	0	0
Increased sleep- Infant Series Dose 1 / After Infant Series Dose 1/Toddler Dose/After 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[15]	48 / 150 (32.00%)	39 / 153 (25.49%)	0 / 159 (0.00%)	24 / 136 (17.65%)	21 / 103 (20.39%)	21 / 135 (15.56%)	14 / 131 (10.69%)
occurrences all number	48	39	0	24	21	21	14
Increased sleep- Infant Series Dose 2 / After 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[16]	26 / 136 (19.12%)	19 / 148 (12.84%)	0 / 159 (0.00%)	22 / 138 (15.94%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	26	19	0	22	0	0	0
Increased sleep- Infant Series Dose 3
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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[17]	19 / 119 (15.97%)	26 / 141 (18.44%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	19	26	0	0	0	0	0
Decreased sleep- Infant Series Dose 1/After Infant Series Dose 1/Toddler Dose/After 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[18]	25 / 151 (16.56%)	23 / 151 (15.23%)	0 / 159 (0.00%)	16 / 136 (11.76%)	11 / 101 (10.89%)	10 / 133 (7.52%)	9 / 131 (6.87%)
occurrences all number	25	23	0	16	11	10	9
Decreased sleep- Infant Series Dose 2 / After 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[19]	24 / 140 (17.14%)	23 / 151 (15.23%)	0 / 159 (0.00%)	14 / 139 (10.07%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	24	23	0	14	0	0	0
Decreased sleep- Infant Series Dose 3
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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[20]	8 / 120 (6.67%)	20 / 140 (14.29%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	8	20	0	0	0	0	0
Hives (urticaria)- Infant Series Dose 2 / After 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[21]	4 / 133 (3.01%)	0 / 147 (0.00%)	0 / 159 (0.00%)	3 / 138 (2.17%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	4	0	0	3	0	0	0
Hives (urticaria)- Infant Series Dose 1/After Infant Series Dose 1/Toddler Dose/After 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[22]	2 / 148 (1.35%)	1 / 151 (0.66%)	0 / 159 (0.00%)	1 / 135 (0.74%)	1 / 98 (1.02%)	1 / 133 (0.75%)	1 / 131 (0.76%)
occurrences all number	2	1	0	1	1	1	1
Hives (urticaria)- Infant Series Dose 3
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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[23]	2 / 119 (1.68%)	0 / 138 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	2	0	0	0	0	0	0
Immune system disorders
Food allergy
subjects affected / exposed	2 / 159 (1.26%)	1 / 158 (0.63%)	6 / 159 (3.77%)	6 / 158 (3.80%)	1 / 122 (0.82%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	4	1	6	9	1	0	0
Allergy to arthropod bite
subjects affected / exposed	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	1	0	0	0	0	0
Milk allergy
subjects affected / exposed	0 / 159 (0.00%)	1 / 158 (0.63%)	1 / 159 (0.63%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	1	1	1	0	0	0
Allergy to animal
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	1 / 158 (0.63%)	1 / 122 (0.82%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	0	0	1	1	0	0
Anaphylactic reaction
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Reproductive system and breast disorders
Genital rash
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	1 / 122 (0.82%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	0	0	0	1	0	0
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
subjects affected / exposed	1 / 159 (0.63%)	1 / 158 (0.63%)	1 / 159 (0.63%)	3 / 158 (1.90%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	2	1	1	4	0	0	0
Rhinorrhoea
subjects affected / exposed	1 / 159 (0.63%)	1 / 158 (0.63%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	1	1	0	0	0	0	0
Asthma
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	1 / 149 (0.67%)	1 / 149 (0.67%)
occurrences all number	2	0	0	0	0	1	1
Infantile asthma
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	0	1	0	0	0	0
Rhinitis perennial
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	0	1	0	0	0	0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	2	0	0	0	0	0	0
Aspartate aminotransferase increased
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	2	0	0	0	0	0	0
Blood lactate dehydrogenase increased
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	2	0	0	0	0	0	0
Injury, poisoning and procedural complications
Excoriation
subjects affected / exposed	0 / 159 (0.00%)	2 / 158 (1.27%)	0 / 159 (0.00%)	1 / 158 (0.63%)	1 / 122 (0.82%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	2	0	1	1	0	0
Contusion
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	3 / 149 (2.01%)	1 / 149 (0.67%)
occurrences all number	1	0	0	0	0	3	1
Joint dislocation
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	1	0	0	0	0	0	0
Thermal burn
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	1 / 122 (0.82%)	1 / 149 (0.67%)	2 / 149 (1.34%)
occurrences all number	1	0	0	0	1	1	2
Arthropod bite
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	4 / 158 (2.53%)	1 / 122 (0.82%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	0	0	6	1	0	0
Wound
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Arthropod sting
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	1 / 149 (0.67%)	1 / 149 (0.67%)
occurrences all number	0	0	0	0	0	1	1
Face injury
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	1 / 149 (0.67%)	0 / 149 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Fall
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	1 / 122 (0.82%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	0	0	0	1	0	0
Lip injury
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	0	0	0	0	0	1
Cardiac disorders
Wolff-Parkinson-White syndrome
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	0	1	0	0	0	0
Blood and lymphatic system disorders
Iron deficiency anaemia
subjects affected / exposed	1 / 159 (0.63%)	1 / 158 (0.63%)	2 / 159 (1.26%)	2 / 158 (1.27%)	0 / 122 (0.00%)	1 / 149 (0.67%)	0 / 149 (0.00%)
occurrences all number	2	3	2	4	0	1	0
Eye disorders
Conjunctivitis
subjects affected / exposed	6 / 159 (3.77%)	14 / 158 (8.86%)	0 / 159 (0.00%)	9 / 158 (5.70%)	1 / 122 (0.82%)	4 / 149 (2.68%)	2 / 149 (1.34%)
occurrences all number	6	14	0	12	1	5	2
Eye discharge
subjects affected / exposed	3 / 159 (1.89%)	3 / 158 (1.90%)	0 / 159 (0.00%)	2 / 158 (1.27%)	1 / 122 (0.82%)	0 / 149 (0.00%)	2 / 149 (1.34%)
occurrences all number	3	3	0	2	1	0	2
Keratitis
subjects affected / exposed	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	1	0	0	0	0	0
Ocular hyperaemia
subjects affected / exposed	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	1	0	1	0	0	0
Eyelid oedema
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	0	0	0	0	0	1
Gastrointestinal disorders
Constipation
subjects affected / exposed	8 / 159 (5.03%)	8 / 158 (5.06%)	0 / 159 (0.00%)	6 / 158 (3.80%)	1 / 122 (0.82%)	1 / 149 (0.67%)	0 / 149 (0.00%)
occurrences all number	9	8	0	10	1	1	0
Diarrhoea
subjects affected / exposed	7 / 159 (4.40%)	9 / 158 (5.70%)	1 / 159 (0.63%)	8 / 158 (5.06%)	6 / 122 (4.92%)	6 / 149 (4.03%)	2 / 149 (1.34%)
occurrences all number	9	12	1	8	6	7	2
Haematochezia
subjects affected / exposed	1 / 159 (0.63%)	1 / 158 (0.63%)	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	1	1	0	1	0	0	0
Dyspepsia
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	1	0	0	0	0	0	0
Ileus
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	1	0	0	0	0	0	0
Inguinal hernia
subjects affected / exposed	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	1	0	0	0	0	0
Intussusception
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	2	0	0	0	0	0	0
Upper gastrointestinal haemorrhage
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	1	0	0	0	0	0	0
Vomiting
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	2 / 158 (1.27%)	1 / 122 (0.82%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	1	0	0	2	1	0	0
Stomatitis
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Aphthous stomatitis
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	0	0	0	0	0	1
Skin and subcutaneous tissue disorders
Eczema
subjects affected / exposed	26 / 159 (16.35%)	22 / 158 (13.92%)	2 / 159 (1.26%)	4 / 158 (2.53%)	2 / 122 (1.64%)	3 / 149 (2.01%)	5 / 149 (3.36%)
occurrences all number	35	32	3	5	2	3	5
Eczema infantile
subjects affected / exposed	6 / 159 (3.77%)	8 / 158 (5.06%)	1 / 159 (0.63%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	9	13	1	1	0	0	0
Dermatitis diaper
subjects affected / exposed	16 / 159 (10.06%)	13 / 158 (8.23%)	1 / 159 (0.63%)	13 / 158 (8.23%)	7 / 122 (5.74%)	2 / 149 (1.34%)	4 / 149 (2.68%)
occurrences all number	23	19	2	14	7	2	4
Asteatosis
subjects affected / exposed	5 / 159 (3.14%)	4 / 158 (2.53%)	0 / 159 (0.00%)	1 / 158 (0.63%)	1 / 122 (0.82%)	1 / 149 (0.67%)	1 / 149 (0.67%)
occurrences all number	9	7	0	1	1	1	1
Dry skin
subjects affected / exposed	1 / 159 (0.63%)	6 / 158 (3.80%)	1 / 159 (0.63%)	2 / 158 (1.27%)	1 / 122 (0.82%)	1 / 149 (0.67%)	1 / 149 (0.67%)
occurrences all number	2	14	2	2	1	1	1
Heat rash
subjects affected / exposed	3 / 159 (1.89%)	3 / 158 (1.90%)	0 / 159 (0.00%)	16 / 158 (10.13%)	2 / 122 (1.64%)	1 / 149 (0.67%)	1 / 149 (0.67%)
occurrences all number	3	4	0	24	2	1	1
Dermatitis atopic
subjects affected / exposed	4 / 159 (2.52%)	0 / 158 (0.00%)	3 / 159 (1.89%)	2 / 158 (1.27%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	8	0	3	3	0	0	0
Dermatitis
subjects affected / exposed	1 / 159 (0.63%)	3 / 158 (1.90%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	2	4	0	0	0	0	0
Dermatitis contact
subjects affected / exposed	3 / 159 (1.89%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	1 / 122 (0.82%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	3	0	0	0	1	0	0
Erythema
subjects affected / exposed	2 / 159 (1.26%)	1 / 158 (0.63%)	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	2	1	0	1	0	0	0
Rash generalised
subjects affected / exposed	0 / 159 (0.00%)	3 / 158 (1.90%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	4	0	0	0	0	0
Urticaria
subjects affected / exposed	1 / 159 (0.63%)	1 / 158 (0.63%)	1 / 159 (0.63%)	3 / 158 (1.90%)	0 / 122 (0.00%)	2 / 149 (1.34%)	1 / 149 (0.67%)
occurrences all number	1	1	1	3	0	2	1
Petechiae
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	1	0	0	0	0	0	0
Pruritus
subjects affected / exposed	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 159 (0.00%)	2 / 158 (1.27%)	0 / 122 (0.00%)	0 / 149 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	1	0	2	0	0	1
Rash
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	1 / 158 (0.63%)	2 / 122 (1.64%)	1 / 149 (0.67%)	2 / 149 (1.34%)
occurrences all number	1	0	0	1	2	1	2
Seborrhoeic dermatitis
subjects affected / exposed	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	1	0	1	0	0	0
Generalised erythema
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Dermal cyst
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	1 / 149 (0.67%)	0 / 149 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Eczema asteatotic
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	0	0	0	0	0	1
Erythema (Any)- Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose
Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Dictionary version was not captured, hence 0.0 is mentioned.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[24]	87 / 152 (57.24%)	22 / 152 (14.47%)	0 / 158 (0.00%)	72 / 139 (51.80%)	56 / 108 (51.85%)	44 / 137 (32.12%)	0 / 122 (0.00%)
occurrences all number	87	22	0	72	56	44	0
Erythema (Any)- Infant Series Dose 2 / After 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[25]	91 / 142 (64.08%)	59 / 150 (39.33%)	0 / 159 (0.00%)	73 / 144 (50.69%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	91	59	0	73	0	0	0
Erythema (Any)- Infant Series Dose 3 / After Toddler Dose 3
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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[26]	65 / 123 (52.85%)	44 / 144 (30.56%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	43 / 134 (32.09%)
occurrences all number	65	44	0	0	0	0	43
Erythema (Mild)- Infant Series Dose 2 / After 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[27]	83 / 142 (58.45%)	50 / 150 (33.33%)	0 / 159 (0.00%)	65 / 144 (45.14%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	93	50	0	65	0	0	0
Erythema (Mild)- Infant Series Dose 1 / After Infant Series Dose 1 / 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[28]	80 / 152 (52.63%)	19 / 151 (12.58%)	0 / 159 (0.00%)	63 / 139 (45.32%)	51 / 106 (48.11%)	39 / 137 (28.47%)	0 / 122 (0.00%)
occurrences all number	80	19	0	63	51	39	0
Erythema (Mild)- Infant Series Dose 3 / After Toddler Dose 3
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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[29]	57 / 123 (46.34%)	40 / 143 (27.97%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	36 / 133 (27.07%)
occurrences all number	57	40	0	0	0	0	36
Erythema (Moderate)- Infant Series Dose 1 / After Infant Series Dose 1 / 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[30]	22 / 148 (14.86%)	3 / 152 (1.97%)	0 / 159 (0.00%)	14 / 136 (10.29%)	24 / 102 (23.53%)	10 / 134 (7.46%)	0 / 149 (0.00%)
occurrences all number	22	3	0	14	24	10	0
Erythema (Moderate)- Infant Series Dose 2 / After 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[31]	43 / 134 (32.09%)	10 / 147 (6.80%)	0 / 159 (0.00%)	19 / 140 (13.57%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	43	10	0	19	0	0	0
Erythema (Moderate)- Infant Series Dose 3 / After Toddler Dose 3
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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[32]	24 / 120 (20.00%)	8 / 139 (5.76%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	13 / 131 (9.92%)
occurrences all number	24	8	0	0	0	0	13
Induration (Any)- Infant Series Dose 1 / After Infant Series Dose 1 / 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[33]	60 / 149 (40.27%)	12 / 153 (7.84%)	0 / 159 (0.00%)	48 / 138 (34.78%)	46 / 108 (42.59%)	32 / 137 (23.36%)	0 / 149 (0.00%)
occurrences all number	60	12	0	48	46	32	0
Induration (Any)- Infant Series Dose 2 / After 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[34]	71 / 137 (51.82%)	45 / 150 (30.00%)	0 / 159 (0.00%)	47 / 144 (32.64%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	71	45	0	47	0	0	0
Induration (Any)- Infant Series Dose 3 / After Toddler Dose 3
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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[35]	55 / 124 (44.35%)	28 / 144 (19.44%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	37 / 134 (27.61%)
occurrences all number	55	28	0	0	0	0	37
Induration (Mild)- Infant Series Dose 1 / After Infant Series Dose 1 / 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[36]	57 / 149 (38.26%)	12 / 153 (7.84%)	0 / 159 (0.00%)	45 / 138 (32.61%)	44 / 108 (40.74%)	27 / 137 (19.71%)	0 / 149 (0.00%)
occurrences all number	57	12	0	45	44	27	0
Induration (Mild)- Infant Series Dose 2 / After 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[37]	68 / 137 (49.64%)	43 / 150 (28.67%)	0 / 159 (0.00%)	43 / 143 (30.07%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	68	43	0	43	0	0	0
Induration (Mild)- Infant Series Dose 3 / After Toddler Dose 3
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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[38]	53 / 124 (42.74%)	28 / 144 (19.44%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	33 / 133 (24.81%)
occurrences all number	53	28	0	0	0	0	33
Induration (Moderate)- Infant Series Dose 1 / After Infant Series Dose 1 / 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[39]	15 / 148 (10.14%)	0 / 151 (0.00%)	0 / 158 (0.00%)	11 / 135 (8.15%)	16 / 99 (16.16%)	9 / 133 (6.77%)	0 / 149 (0.00%)
occurrences all number	15	0	0	11	16	9	0
Induration (Moderate)- Infant Series Dose 2 / After 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[40]	32 / 134 (23.88%)	10 / 148 (6.76%)	0 / 158 (0.00%)	21 / 140 (15.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	32	10	0	21	0	0	0
Induration (Moderate)- Infant Series Dose 3 / After Toddler Dose 3
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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[41]	14 / 119 (11.76%)	3 / 139 (2.16%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	13 / 131 (9.92%)
occurrences all number	14	3	0	0	0	0	13
Tenderness (Any)- Infant Series Dose 1 / After Infant Series Dose 1 / 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[42]	18 / 148 (12.16%)	1 / 151 (0.66%)	0 / 159 (0.00%)	11 / 136 (8.09%)	11 / 99 (11.11%)	6 / 136 (4.41%)	0 / 149 (0.00%)
occurrences all number	18	1	0	11	11	6	0
Tenderness (Any)- Infant Series Dose 2 / After 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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[43]	10 / 133 (7.52%)	6 / 147 (4.08%)	0 / 159 (0.00%)	7 / 139 (5.04%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	10	6	0	7	0	0	0
Tenderness (Any)- Infant Series Dose 3 / After Toddler Dose 3
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. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[44]	6 / 119 (5.04%)	5 / 138 (3.62%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	9 / 132 (6.82%)
occurrences all number	6	5	0	0	0	0	9
Infections and infestations
Nasopharyngitis
subjects affected / exposed	49 / 159 (30.82%)	59 / 158 (37.34%)	1 / 159 (0.63%)	63 / 158 (39.87%)	27 / 122 (22.13%)	43 / 149 (28.86%)	42 / 149 (28.19%)
occurrences all number	84	107	1	96	30	45	44
Upper respiratory tract infection
subjects affected / exposed	35 / 159 (22.01%)	22 / 158 (13.92%)	5 / 159 (3.14%)	27 / 158 (17.09%)	17 / 122 (13.93%)	19 / 149 (12.75%)	10 / 149 (6.71%)
occurrences all number	55	31	5	38	18	21	10
Gastroenteritis
subjects affected / exposed	19 / 159 (11.95%)	12 / 158 (7.59%)	0 / 159 (0.00%)	13 / 158 (8.23%)	2 / 122 (1.64%)	4 / 149 (2.68%)	8 / 149 (5.37%)
occurrences all number	24	12	0	14	2	4	8
Bronchitis
subjects affected / exposed	10 / 159 (6.29%)	11 / 158 (6.96%)	0 / 159 (0.00%)	17 / 158 (10.76%)	11 / 122 (9.02%)	12 / 149 (8.05%)	9 / 149 (6.04%)
occurrences all number	11	11	0	25	11	13	9
Influenza
subjects affected / exposed	16 / 159 (10.06%)	12 / 158 (7.59%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	1 / 149 (0.67%)	1 / 149 (0.67%)
occurrences all number	16	12	0	0	0	1	1
Exanthema subitum
subjects affected / exposed	6 / 159 (3.77%)	13 / 158 (8.23%)	0 / 159 (0.00%)	21 / 158 (13.29%)	2 / 122 (1.64%)	7 / 149 (4.70%)	4 / 149 (2.68%)
occurrences all number	7	13	0	23	2	7	4
Gastroenteritis viral
subjects affected / exposed	7 / 159 (4.40%)	3 / 158 (1.90%)	0 / 159 (0.00%)	2 / 158 (1.27%)	0 / 122 (0.00%)	0 / 149 (0.00%)	1 / 149 (0.67%)
occurrences all number	8	3	0	2	0	0	1
Varicella
subjects affected / exposed	5 / 159 (3.14%)	3 / 158 (1.90%)	0 / 159 (0.00%)	2 / 158 (1.27%)	2 / 122 (1.64%)	3 / 149 (2.01%)	2 / 149 (1.34%)
occurrences all number	5	3	0	2	2	3	2
Otitis media
subjects affected / exposed	5 / 159 (3.14%)	2 / 158 (1.27%)	0 / 159 (0.00%)	9 / 158 (5.70%)	4 / 122 (3.28%)	2 / 149 (1.34%)	2 / 149 (1.34%)
occurrences all number	5	2	0	11	4	2	2
Impetigo
subjects affected / exposed	2 / 159 (1.26%)	5 / 158 (3.16%)	0 / 159 (0.00%)	2 / 158 (1.27%)	0 / 122 (0.00%)	1 / 149 (0.67%)	1 / 149 (0.67%)
occurrences all number	3	5	0	3	0	1	1
Respiratory syncytial virus infection
subjects affected / exposed	2 / 159 (1.26%)	5 / 158 (3.16%)	0 / 159 (0.00%)	0 / 158 (0.00%)	2 / 122 (1.64%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	2	5	0	0	2	0	0
Bronchiolitis
subjects affected / exposed	5 / 159 (3.14%)	1 / 158 (0.63%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	1 / 149 (0.67%)	0 / 149 (0.00%)
occurrences all number	5	1	0	0	0	1	0
Otitis media acute
subjects affected / exposed	0 / 159 (0.00%)	5 / 158 (3.16%)	0 / 159 (0.00%)	4 / 158 (2.53%)	0 / 122 (0.00%)	0 / 149 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	6	0	6	0	0	1
Pharyngitis
subjects affected / exposed	1 / 159 (0.63%)	5 / 158 (3.16%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	4 / 149 (2.68%)
occurrences all number	2	6	0	0	0	0	4
Enteritis infectious
subjects affected / exposed	0 / 159 (0.00%)	3 / 158 (1.90%)	0 / 159 (0.00%)	1 / 158 (0.63%)	1 / 122 (0.82%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	5	0	1	1	0	0
Rhinitis
subjects affected / exposed	1 / 159 (0.63%)	2 / 158 (1.27%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	3 / 149 (2.01%)	1 / 149 (0.67%)
occurrences all number	1	2	0	0	0	3	1
Gastroenteritis rotavirus
subjects affected / exposed	2 / 159 (1.26%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	2	0	0	0	0	0	0
Molluscum contagiosum
subjects affected / exposed	0 / 159 (0.00%)	2 / 158 (1.27%)	0 / 159 (0.00%)	2 / 158 (1.27%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	4	0	2	0	0	0
Oral candidiasis
subjects affected / exposed	1 / 159 (0.63%)	1 / 158 (0.63%)	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	2	1	0	1	0	0	0
Otitis externa
subjects affected / exposed	2 / 159 (1.26%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	2	0	0	0	0	0	0
Paronychia
subjects affected / exposed	2 / 159 (1.26%)	0 / 158 (0.00%)	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	2	0	0	2	0	0	0
Respiratory syncytial virus bronchitis
subjects affected / exposed	1 / 159 (0.63%)	1 / 158 (0.63%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	1	1	0	0	0	0	0
Tonsillitis
subjects affected / exposed	1 / 159 (0.63%)	1 / 158 (0.63%)	0 / 159 (0.00%)	1 / 158 (0.63%)	1 / 122 (0.82%)	1 / 149 (0.67%)	0 / 149 (0.00%)
occurrences all number	1	2	0	1	1	1	0
Adenovirus infection
subjects affected / exposed	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	1	0	1	0	0	0
Cellulitis
subjects affected / exposed	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	1	0	1	0	0	0
Conjunctivitis viral
subjects affected / exposed	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	1	0	0	0	0	0
Croup infectious
subjects affected / exposed	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	1 / 149 (0.67%)	0 / 149 (0.00%)
occurrences all number	0	1	0	0	0	1	0
Fungal infection
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	1	0	0	0	0	0	0
Fungal skin infection
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	1	0	0	1	0	0	0
Genital candidiasis
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	2	0	0	0	0	0	0
Hand-foot-and-mouth disease
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	11 / 158 (6.96%)	4 / 122 (3.28%)	6 / 149 (4.03%)	2 / 149 (1.34%)
occurrences all number	2	0	0	13	4	6	2
Mucocutaneous candidiasis
subjects affected / exposed	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	2	0	0	0	0	0
Hordeolum
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	1	0	0	0	0	0	0
Respiratory tract infection
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	1	0	0	0	0	0	0
Rotavirus infection
subjects affected / exposed	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 122 (0.00%)	1 / 149 (0.67%)	0 / 149 (0.00%)
occurrences all number	0	1	0	1	0	1	0
Sinusitis
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	1 / 149 (0.67%)	0 / 149 (0.00%)
occurrences all number	1	0	0	0	0	1	0
Staphylococcal scalded skin syndrome
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	1	0	0	0	0	0	0
Vaccination site infection
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	1	0	0	0	0	0	0
Viral infection
subjects affected / exposed	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	1	0	0	0	0	0
Viral rash
subjects affected / exposed	1 / 159 (0.63%)	0 / 158 (0.00%)	0 / 159 (0.00%)	1 / 158 (0.63%)	1 / 122 (0.82%)	1 / 149 (0.67%)	0 / 149 (0.00%)
occurrences all number	1	0	0	1	1	1	0
Gastroenteritis bacterial
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	2 / 158 (1.27%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	0	0	2	0	0	0
Candidiasis
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Conjunctivitis bacterial
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 122 (0.00%)	1 / 149 (0.67%)	0 / 149 (0.00%)
occurrences all number	0	0	0	1	0	1	0
Herpangina
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	1 / 158 (0.63%)	1 / 122 (0.82%)	0 / 149 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	0	0	2	1	0	1
Herpes simplex
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Localised infection
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Otitis media bacterial
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 122 (0.00%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Candida nappy rash
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	1 / 122 (0.82%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	0	0	0	1	0	0
Bronchopneumonia
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	1 / 149 (0.67%)	0 / 149 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Acute sinusitis
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	0	0	0	0	0	1
Gastroenteritis adenovirus
subjects affected / exposed	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 159 (0.00%)	0 / 158 (0.00%)	0 / 122 (0.00%)	0 / 149 (0.00%)	1 / 149 (0.67%)
occurrences all number	0	0	0	0	0	0	1
Metabolism and nutrition disorders
Lactose intolerance
subjects affected / exposed	0 / 159 (0.00%)	1 / 158 (0.63%)	0 / 159 (0.00%)	1 / 158 (0.63%)	1 / 122 (0.82%)	0 / 149 (0.00%)	0 / 149 (0.00%)
occurrences all number	0	3	0	1	1	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.
[44] - 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 4, Randomized, Open-label Trial Evaluating the Safety, Tolerability, and Immunogenicity of DTaP Vaccine in Healthy Infants Given with a 7-valent Pneumococcal Conjugate Vaccine in Japan.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series

Primary: Percentage of Subjects Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series

Primary: Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series

Primary: Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series

Primary: Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series

Primary: Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series

Primary: Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 microgram per milliliter (mcg/mL) 1 Month After the Infant Series

Primary: Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 microgram per milliliter (mcg/mL) 1 Month After the Infant Series

Primary: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series

Primary: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series

Secondary: Percentage of Subjects Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose

Secondary: Percentage of Subjects Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose

Secondary: Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose

Secondary: Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose

Secondary: Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose

Secondary: Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose

Secondary: Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose

Secondary: Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose

Secondary: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose

Secondary: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose

Secondary: Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose

Secondary: Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose

Secondary: Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Catch-up Dose 3

Secondary: Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Catch-up Dose 3

Secondary: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3

Secondary: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 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 4, Randomized, Open-label Trial Evaluating the Safety, Tolerability, and Immunogenicity of DTaP Vaccine in Healthy Infants Given with a 7-valent Pneumococcal Conjugate Vaccine in Japan.