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Clinical Trial Results:
A Phase 3, Open-label, Single-Arm Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 2 and 3 Doses of 13-valent Pneumococcal Conjugate Vaccine in Human Immunodeficiency Virus-Infected Subjects 6 Years of Age and Older Who Have Not Been Previously Immunized With Pneumococcal Vaccine

Summary
EudraCT number	2009-011564-11
Trial protocol	Outside EU/EEA
Global end of trial date	12 Apr 2013

Results information
Results version number	v1(current)
This version publication date	29 Jun 2016
First version publication date	01 Aug 2015
Other versions

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

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Trial information

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Sponsor protocol code

6115A1-3002-WW

ISRCTN number

US NCT number

NCT00962780

WHO universal trial number (UTN)

Other trial identifiers

Alias: B1851021

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)

Yes

EMA paediatric investigation plan number(s)

EMEA-000036-PIP01-07

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

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

Yes

Analysis stage

Final

Date of interim/final analysis

12 Sep 2013

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

12 Apr 2013

Was the trial ended prematurely?

Main objective of the trial

1. To evaluate the immune responses 1 month after 3 doses of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) compared with the immune responses 1 month after 2 doses of 13vPnC as measured by serotype-specific immunoglobulin G (IgG) geometric mean fold rises (GMFRs) in subjects greater than or equal to (>=) 6 years of age. 2. To evaluate the acceptability of the safety profile of 13vPnC 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 Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

18 Mar 2010

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

6 Months

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Romania: 16

Country: Number of subjects enrolled

South Africa: 285

Worldwide total number of subjects

301

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)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

150

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

Study was initiated on 18 March 2010 and completed on 12 April 2013. Subjects were enrolled from 2 countries(Romania and South Africa). Three hundred and three subjects were randomized in study, out of which 301 subjects received the investigational vaccines (2 subjects were withdrawn prior to vaccination for non safety related reasons).

Period 1 title

Overall Trial (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

13vPnC, 23vPS (Pediatric Subjects)

Arm description

Subjects older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric subjects) received 3 doses of 13-valent pneumococcal conjugate vaccine (13vPnC) 1 month apart, followed by 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) 1 month after 13vPnC Dose 3 (23vPS Dose).

Arm type

Experimental

Investigational medicinal product name

13-valent pneumococcal conjugate vaccine

Investigational medicinal product code

PF-05208760

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Three doses of 0.5 milliliter (mL) of 13vPnC intramuscularly 1 month apart.

Investigational medicinal product name

23-valent pneumococcal polysaccharide

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3.

13vPnC, 23vPS (Adult Subjects)

Arm description

Subjects >=18 years of age (adult subjects) received 3 doses of 13vPnC 1 month apart, followed by 1 dose of 23vPS 1 month after 13vPnC Dose 3 (23vPS Dose).

Arm type

Experimental

Investigational medicinal product name

13-valent pneumococcal conjugate vaccine

Investigational medicinal product code

PF-05208760

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Three doses of 0.5 mL of 13vPnC intramuscularly 1 month apart.

Investigational medicinal product name

23-valent pneumococcal polysaccharide

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3.

Number of subjects in period 1	13vPnC, 23vPS (Pediatric Subjects)	13vPnC, 23vPS (Adult Subjects)
Started	150	151
Vaccinated 13vPnC Dose 1	150	151
Vaccinated 13vPnC Dose 2	145	145
Vaccinated 13vPnC Dose 3	144	142
Vaccinated 23vPS Dose	143	139
Completed	141	138
Not completed	9	13
Consent withdrawn by subject	1	7
Death	-	1
Protocol Violation	8	4
Unspecified	-	1

Baseline characteristics

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Reporting group title

13vPnC, 23vPS (Pediatric Subjects)

Reporting group description

Reporting group title

13vPnC, 23vPS (Adult Subjects)

Reporting group description

Subjects >=18 years of age (adult subjects) received 3 doses of 13vPnC 1 month apart, followed by 1 dose of 23vPS 1 month after 13vPnC Dose 3 (23vPS Dose).

Reporting group values	13vPnC, 23vPS (Pediatric Subjects)	13vPnC, 23vPS (Adult Subjects)	Total
Number of subjects	150	151	301
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	10.3 ± 3.04	41.2 ± 8.45	-
Gender categorical
Units: Subjects
Female	76	88	164
Male	74	63	137

End points

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Reporting group title

13vPnC, 23vPS (Pediatric Subjects)

Reporting group description

Reporting group title

13vPnC, 23vPS (Adult Subjects)

Reporting group description

Subjects >=18 years of age (adult subjects) received 3 doses of 13vPnC 1 month apart, followed by 1 dose of 23vPS 1 month after 13vPnC Dose 3 (23vPS Dose).

Subject analysis set title

13vPnC, 23vPS (All Subjects)

Subject analysis set type

Per protocol

Subject analysis set description

Subjects >=6 years of age (all subjects) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).

Primary: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Subjects

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End point title

Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Subjects ^[1]

End point description

GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all subjects with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. Evaluable immunogenicity population: eligible subjects who received vaccination as assigned; had blood drawn within pre-specified time-frames; had at least 1 valid, determinate assay result; had no major protocol violation. Here, n=subjects evaluable for specified serotype.

End point type

Primary

End point timeframe

1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3

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	13vPnC, 23vPS (All Subjects)
Number of subjects analysed	259 ^[2]
Units: fold rise
geometric mean (confidence interval 95%)
Serotype 1 (n = 248)	1.03 (1.01 to 1.08)
Serotype 3 (n = 238)	1.05 (0.99 to 1.07)
Serotype 4 (n = 257)	1.09 (1 to 1.1)
Serotype 5 (n = 257)	1.01 (1.03 to 1.14)
Serotype 6A (n = 249)	1.02 (0.97 to 1.05)
Serotype 6B (n = 257)	1.04 (0.97 to 1.07)
Serotype 7F (n = 259)	1.1 (1.05 to 1.16)
Serotype 9V (n = 259)	1.05 (1.01 to 1.09)
Serotype 14 (n = 259)	1.04 (1 to 1.09)
Serotype 18C (n = 259)	0.99 (0.96 to 1.02)
Serotype 19A (n = 259)	0.99 (0.96 to 1.03)
Serotype 19F (n = 252)	1.06 (1.01 to 1.11)
Serotype 23F (n = 258)	1.09 (1.03 to 1.15)

Notes
[2] - N (number of subjects analyzed)= subjects evaluable for this measure.

No statistical analyses for this end point

Secondary: Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Subjects

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End point title

Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Subjects

End point description

Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all subjects are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all subjects with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Evaluable immunogenicity population. Here "n" signifies all subjects who were evaluable for specified serotype for each treatment arm, respectively.

End point type

Secondary

End point timeframe

1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3

End point values	13vPnC, 23vPS (Pediatric Subjects)	13vPnC, 23vPS (Adult Subjects)	13vPnC, 23vPS (All Subjects)
Number of subjects analysed	128 ^[3]	131 ^[4]	259 ^[5]
Units: microgram per milliliter (mcg/mL)
geometric mean (confidence interval 95%)
Serotype 1: 13vPnC Dose 2 (n = 120, 128, 248)	3.88 (3.3 to 4.57)	3.95 (3.23 to 4.85)	3.92 (3.44 to 4.46)
Serotype 1: 13vPnC Dose 3 (n = 120, 128, 248)	4.14 (3.56 to 4.83)	3.92 (3.21 to 4.79)	4.03 (3.55 to 4.57)
Serotype 3: 13vPnC Dose 2 (n = 118, 120, 238)	1.47 (1.25 to 1.74)	0.97 (0.81 to 1.16)	1.19 (1.05 to 1.35)
Serotype 3: 13vPnC Dose 3 (n = 118, 120, 238)	1.49 (1.26 to 1.76)	1.06 (0.88 to 1.27)	1.25 (1.11 to 1.42)
Serotype 4: 13vPnC Dose 2 (n = 127, 130, 257)	3.06 (2.54 to 3.69)	2.97 (2.4 to 3.67)	3.01 (2.62 to 3.47)
Serotype 4: 13vPnC Dose 3 (n = 127, 130, 257)	3.36 (2.84 to 3.97)	3.19 (2.59 to 3.91)	3.27 (2.87 to 3.73)
Serotype 5: 13vPnC Dose 2 (n = 126, 131, 257)	4.52 (3.78 to 5.39)	5.77 (4.83 to 6.89)	5.12 (4.51 to 5.8)
Serotype 5: 13vPnC Dose 3 (n = 126, 131, 257)	4.84 (4.12 to 5.7)	5.53 (4.63 to 6.61)	5.18 (4.6 to 5.85)
Serotype 6A: 13vPnC Dose 2 (n = 119, 130, 249)	7.66 (6.46 to 9.08)	7.03 (5.71 to 8.67)	7.33 (6.4 to 8.39)
Serotype 6A: 13vPnC Dose 3 (n = 119, 130, 249)	7.97 (6.81 to 9.33)	7.04 (5.74 to 8.64)	7.47 (6.56 to 8.51)
Serotype 6B: 13vPnC Dose 2 (n = 127, 130, 257)	11.43 (9.45 to 13.84)	7.93 (6.51 to 9.65)	9.5 (8.28 to 10.91)
Serotype 6B: 13vPnC Dose 3 (n = 127, 130, 257)	11.94 (10.01 to 14.24)	8.28 (6.78 to 10.11)	9.92 (8.67 to 11.35)
Serotype 7F: 13vPnC Dose 2 (n = 128, 131, 259)	4.25 (3.67 to 4.92)	5.78 (4.81 to 6.95)	4.96 (4.41 to 5.59)
Serotype 7F: 13vPnC Dose 3 (n = 128, 131, 259)	5.05 (4.38 to 5.82)	5.9 (4.95 to 7.04)	5.46 (4.88 to 6.12)
Serotype 9V: 13vPnC Dose 2 (n = 128, 131, 259)	4.81 (4.18 to 5.54)	5.14 (4.27 to 6.19)	4.98 (4.43 to 5.59)
Serotype 9V: 13vPnC Dose 3 (n = 128, 131, 259)	4.98 (4.35 to 5.7)	5.48 (4.59 to 6.55)	5.23 (4.67 to 5.84)
Serotype 14: 13vPnC Dose 2 (n = 128, 131, 259)	11.6 (8.76 to 15.35)	15.14 (11.64 to 19.71)	13.27 (10.96 to 16.08)
Serotype 14: 13vPnC Dose 3 (n = 128, 131, 259)	12.62 (9.75 to 16.33)	15.13 (11.8 to 19.4)	13.83 (11.57 to 16.53)
Serotype 18C: 13vPnC Dose 2 (n = 128, 131, 259)	3.79 (3.12 to 4.6)	5.33 (4.34 to 6.54)	4.5 (3.91 to 5.19)
Serotype 18C: 13vPnC Dose 3 (n = 128, 131, 259)	3.83 (3.19 to 4.6)	5.18 (4.27 to 6.28)	4.46 (3.9 to 5.1)
Serotype 19A: 13vPnC Dose 2 (n = 128, 131, 259)	14.38 (12.2 to 16.96)	13.19 (11.06 to 15.75)	13.77 (12.21 to 15.53)
Serotype 19A: 13vPnC Dose 3 (n = 128, 131, 259)	14.19 (12.17 to 16.54)	13.18 (11.11 to 15.62)	13.67 (12.2 to 15.32)
Serotype 19F: 13vPnC Dose 2 (n = 124, 128, 252)	5.78 (4.63 to 7.21)	5.34 (4.17 to 6.84)	5.55 (4.71 to 6.55)
Serotype 19F: 13vPnC Dose 3 (n = 124, 128, 252)	6.09 (4.98 to 7.44)	5.67 (4.47 to 7.18)	5.87 (5.03 to 6.85)
Serotype 23F: 13vPnC Dose 2 (n = 127, 131, 258)	6.45 (5.3 to 7.85)	6.1 (4.86 to 7.66)	6.27 (5.4 to 7.28)
Serotype 23F: 13vPnC Dose 3 (n = 127, 131, 258)	6.64 (5.55 to 7.94)	7.06 (5.65 to 8.82)	6.85 (5.94 to 7.9)

Notes
[3] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[4] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[5] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.

No statistical analyses for this end point

Secondary: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Subjects

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End point title

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Subjects

End point description

Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all subjects using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all subjects with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Evaluable immunogenicity population. Here "n" signifies subjects with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively.

End point type

Secondary

End point timeframe

1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3

End point values	13vPnC, 23vPS (Pediatric Subjects)	13vPnC, 23vPS (Adult Subjects)	13vPnC, 23vPS (All Subjects)
Number of subjects analysed	127 ^[6]	129 ^[7]	256 ^[8]
Units: titers
geometric mean (confidence interval 95%)
Serotype 1: 13vPnC Dose 2 (n = 126, 127, 253)	51 (37.2 to 70)	54 (38.7 to 74.2)	52 (41.8 to 65.5)
Serotype 1: 13vPnC Dose 3 (n = 126, 127, 253)	69 (51.6 to 91.4)	69 (51.3 to 92)	69 (56.1 to 84.1)
Serotype 3: 13vPnC Dose 2 (n = 127, 129, 256)	81 (64.1 to 102)	48 (37.9 to 61.5)	62 (52.6 to 73.9)
Serotype 3: 13vPnC Dose 3 (n = 127, 129, 256)	114 (94.5 to 137.8)	79 (62.1 to 99.9)	95 (81.3 to 110.3)
Serotype 4: 13vPnC Dose 2 (n = 117, 126, 243)	2509 (1922.3 to 3274.2)	1620 (1211.2 to 2167.4)	2000 (1639.8 to 2439.1)
Serotype 4: 13vPnC Dose 3 (n = 117, 126, 243)	3246 (2697.1 to 3906.3)	1944 (1465.3 to 2579.7)	2488 (2092.1 to 2959.8)
Serotype 5: 13vPnC Dose 2 (n = 122, 124, 246)	159 (109.2 to 232.2)	104 (69.1 to 156.9)	129 (97.3 to 169.7)
Serotype 5: 13vPnC Dose 3 (n = 122, 124, 246)	267 (191.3 to 371.5)	142 (97.5 to 206.7)	194 (150.8 to 249.7)
Serotype 6A: 13vPnC Dose 2 (n = 125, 124, 249)	5560 (4378.4 to 7060.9)	2425 (1790.7 to 3284.5)	3678 (3016.2 to 4485.6)
Serotype 6A: 13vPnC Dose 3 (n = 125, 124, 249)	7758 (6314.2 to 9531.2)	3239 (2488.5 to 4215.9)	5022 (4216.8 to 5979.9)
Serotype 6B: 13vPnC Dose 2 (n = 121, 128, 249)	5449 (4365.1 to 6801.1)	2724 (2004.8 to 3701)	3815 (3140.9 to 4634.1)
Serotype 6B: 13vPnC Dose 3 (n = 121, 128, 249)	7151 (5828.2 to 8773.9)	3723 (2771.1 to 5002.5)	5113 (4250.1 to 6150.5)
Serotype 7F: 13vPnC Dose 2 (n = 125, 127, 252)	3494 (2772.8 to 4403.3)	2255 (1739.6 to 2923.6)	2802 (2352.6 to 3338)
Serotype 7F: 13vPnC Dose 3 (n = 125, 127, 252)	4638 (3889.7 to 5529.4)	2702 (2130.3 to 3428.2)	3533 (3037.4 to 4108.5)
Serotype 9V: 13vPnC Dose 2 (n = 118, 127, 245)	3339 (2461.4 to 4530.3)	1432 (998.6 to 2054.9)	2153 (1690.3 to 2743.3)
Serotype 9V: 13vPnC Dose 3 (n = 118, 127, 245)	4714 (3731.5 to 5955.4)	2004 (1416.5 to 2836.1)	3026 (2434.3 to 3761.4)
Serotype 14: 13vPnC Dose 2 (n = 117, 127, 244)	3704 (2906.5 to 4719.5)	1342 (1010.1 to 1782.1)	2183 (1792.2 to 2659.6)
Serotype 14: 13vPnC Dose 3 (n = 117, 127, 244)	3963 (3195.8 to 4914.2)	1480 (1150.3 to 1903.9)	2373 (1988.4 to 2832.8)
Serotype 18C: 13vPnC Dose 2 (n = 117, 121, 238)	4635 (3609.7 to 5951.8)	1349 (947 to 1921.5)	2475 (1965.7 to 3115.4)
Serotype 18C: 13vPnC Dose 3 (n = 117, 121, 238)	5579 (4423.7 to 7036.9)	1787 (1272.8 to 2508.5)	3127 (2515.2 to 3888.6)
Serotype 19A: 13vPnC Dose 2 (n = 125, 127, 252)	684 (519.2 to 902.1)	458 (332.5 to 631.2)	559 (452.3 to 690.9)
Serotype 19A: 13vPnC Dose 3 (n = 125, 127, 252)	1002 (814.5 to 1232.3)	613 (465.6 to 806.4)	782 (657.2 to 930.5)
Serotype 19F: 13vPnC Dose 2 (n = 122, 118, 240)	717 (495.6 to 1036.7)	315 (196.7 to 506)	479 (354.4 to 646.9)
Serotype 19F: 13vPnC Dose 3 (n = 122, 118, 240)	1152 (864.2 to 1535)	597 (397.9 to 897.1)	834 (650.1 to 1070.2)
Serotype 23F: 13vPnC Dose 2 (n = 120, 126, 246)	1477 (1086.2 to 2008.2)	409 (271.9 to 614)	765 (585.2 to 999.4)
Serotype 23F: 13vPnC Dose 3 (n = 120, 126, 246)	2327 (1844.2 to 2935.9)	671 (449.8 to 1000.3)	1231 (963 to 1572.5)

Notes
[6] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[7] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[8] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.

No statistical analyses for this end point

Secondary: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Subjects

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End point title

Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Subjects

End point description

GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all subjects with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. Evaluable immunogenicity population. Here "n" signifies subjects with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively.

End point type

Secondary

End point timeframe

1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3

End point values	13vPnC, 23vPS (Pediatric Subjects)	13vPnC, 23vPS (Adult Subjects)	13vPnC, 23vPS (All Subjects)
Number of subjects analysed	127 ^[9]	129 ^[10]	256 ^[11]
Units: fold rise
geometric mean (confidence interval 95%)
Serotype 1 (n = 126, 127, 253)	1.3 (1.13 to 1.61)	1.3 (1.09 to 1.51)	1.3 (1.16 to 1.48)
Serotype 3 (n = 127, 129, 256)	1.4 (1.25 to 1.59)	1.6 (1.45 to 1.83)	1.5 (1.4 to 1.65)
Serotype 4 (n = 117, 126, 243)	1.3 (1.1 to 1.52)	1.2 (1.07 to 1.34)	1.2 (1.13 to 1.37)
Serotype 5 (n = 122, 124, 246)	1.7 (1.36 to 2.06)	1.4 (1.17 to 1.59)	1.5 (1.33 to 1.72)
Serotype 6A (n = 125, 124, 249)	1.4 (1.22 to 1.6)	1.3 (1.15 to 1.55)	1.4 (1.23 to 1.51)
Serotype 6B (n = 121, 128, 249)	1.3 (1.18 to 1.46)	1.4 (1.2 to 1.56)	1.3 (1.23 to 1.46)
Serotype 7F (n = 125, 127, 252)	1.3 (1.15 to 1.53)	1.2 (1.03 to 1.4)	1.3 (1.14 to 1.4)
Serotype 9V (n = 118, 127, 245)	1.4 (1.16 to 1.72)	1.4 (1.18 to 1.65)	1.4 (1.24 to 1.6)
Serotype 14 (n = 117, 127, 244)	1.1 (0.95 to 1.2)	1.1 (0.98 to 1.24)	1.1 (1 to 1.18)
Serotype 18C (n = 117, 121, 238)	1.2 (1.1 to 1.32)	1.3 (1.08 to 1.63)	1.3 (1.13 to 1.42)
Serotype 19A (n = 125, 127, 252)	1.5 (1.27 to 1.68)	1.3 (1.18 to 1.52)	1.4 (1.27 to 1.54)
Serotype 19F (n = 122, 118, 240)	1.6 (1.31 to 1.97)	1.9 (1.45 to 2.48)	1.7 (1.48 to 2.06)
Serotype 23F (n = 120, 126, 246)	1.6 (1.31 to 1.9)	1.6 (1.34 to 2.02)	1.6 (1.4 to 1.85)

Notes
[9] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[10] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[11] - "Number of subjects analyzed" signifies those subjects who were evaluable for this measure.

No statistical analyses for this end point

Secondary: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Subjects

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End point title

Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Subjects

End point description

GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all subjects with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. Evaluable immunogenicity population. Here "n" signifies subjects with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively.

End point type

Secondary

End point timeframe

1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3

End point values	13vPnC, 23vPS (Pediatric Subjects)	13vPnC, 23vPS (Adult Subjects)
Number of subjects analysed	128 ^[12]	131 ^[13]
Units: fold rise
geometric mean (confidence interval 95%)
Serotype 1 (n = 120, 128)	1.07 (1.01 to 1.13)	0.99 (0.93 to 1.06)
Serotype 3 (n = 118, 120)	1.01 (0.95 to 1.08)	1.09 (1.02 to 1.16)
Serotype 4 (n = 127, 130)	1.1 (1.02 to 1.18)	1.07 (1 to 1.16)
Serotype 5 (n = 126, 131)	1.07 (1.01 to 1.14)	0.96 (0.91 to 1.01)
Serotype 6A (n = 119, 130)	1.04 (0.96 to 1.12)	1 (0.95 to 1.06)
Serotype 6B (n = 127, 130)	1.04 (0.99 to 1.1)	1.04 (0.99 to 1.11)
Serotype 7F (n = 128, 131)	1.19 (1.12 to 1.27)	1.02 (0.95 to 1.1)
Serotype 9V (n = 128, 131)	1.03 (0.98 to 1.09)	1.07 (1.02 to 1.12)
Serotype 14 (n = 128, 131)	1.09 (1.02 to 1.16)	1 (0.95 to 1.05)
Serotype 18C (n = 128, 131)	1.01 (0.96 to 1.07)	0.97 (0.93 to 1.01)
Serotype 19A (n = 128, 131)	0.99 (0.93 to 1.04)	1 (0.96 to 1.04)
Serotype 19F (n = 124, 128)	1.05 (0.98 to 1.13)	1.06 (0.99 to 1.14)
Serotype 23F (n = 127, 131)	1.03 (0.96 to 1.11)	1.16 (1.07 to 1.26)

Notes
[12] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[13] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.

No statistical analyses for this end point

Other pre-specified: Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Subjects

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End point title

Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Subjects

End point description

Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all subjects are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all subjects with available data for both the before and after 13vPnC Dose 1 blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Evaluable immunogenicity population. Here "n" signifies subjects with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively.

End point type

Other pre-specified

End point timeframe

Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1

End point values	13vPnC, 23vPS (Pediatric Subjects)	13vPnC, 23vPS (Adult Subjects)	13vPnC, 23vPS (All Subjects)
Number of subjects analysed	133 ^[14]	137 ^[15]	270 ^[16]
Units: mcg/mL
geometric mean (confidence interval 95%)
Serotype 1: Before 13vPnC Dose 1 (n=78,122,200)	1.03 (0.72 to 1.48)	0.82 (0.63 to 1.06)	0.9 (0.73 to 1.1)
Serotype 1: After 13vPnC Dose 1 (n=78,122,200)	3.78 (2.97 to 4.8)	4 (3.19 to 5.01)	3.91 (3.32 to 4.61)
Serotype 3: Before 13vPnC Dose 1 (n=99,127,226)	0.83 (0.62 to 1.11)	0.47 (0.37 to 0.58)	0.6 (0.5 to 0.72)
Serotype 3: After 13vPnC Dose 1 (n=99,127,226)	1.25 (0.99 to 1.58)	0.75 (0.62 to 0.92)	0.94 (0.81 to 1.09)
Serotype 4: Before 13vPnC Dose 1 (n=95,127,222)	0.19 (0.14 to 0.25)	0.35 (0.28 to 0.45)	0.27 (0.22 to 0.33)
Serotype 4: After 13vPnC Dose 1 (n=95,127,222)	2.62 (1.97 to 3.5)	2.91 (2.26 to 3.75)	2.79 (2.31 to 3.36)
Serotype 5: Before 13vPnC Dose 1 (n=122,137,259)	4.18 (3.42 to 5.12)	3.38 (2.84 to 4.02)	3.74 (3.28 to 4.27)
Serotype 5: After 13vPnC Dose 1 (n=122,137,259)	4.81 (3.98 to 5.8)	5.53 (4.63 to 6.61)	5.18 (4.55 to 5.89)
Serotype 6A: Before 13vPnC Dose 1 (n=99,136,235)	6.22 (5.19 to 7.45)	2.67 (2.24 to 3.18)	3.81 (3.32 to 4.37)
Serotype 6A: After 13vPnC Dose 1 (n=99,136,235)	7.31 (6.07 to 8.79)	6.77 (5.38 to 8.51)	6.99 (6 to 8.15)
Serotype 6B: Before 13vPnC Dose 1 (n=131,134,265)	5.52 (4.59 to 6.64)	3.23 (2.69 to 3.88)	4.21 (3.69 to 4.81)
Serotype 6B: After 13vPnC Dose 1 (n=131,134,265)	10.26 (8.37 to 12.58)	7.29 (5.81 to 9.15)	8.63 (7.41 to 10.06)
Serotype 7F: Before 13vPnC Dose 1 (n=111,134,245)	0.85 (0.63 to 1.14)	1.14 (0.94 to 1.37)	1 (0.84 to 1.18)
Serotype 7F: After 13vPnC Dose 1 (n=111,134,245)	4.34 (3.68 to 5.11)	5.57 (4.57 to 6.78)	4.97 (4.36 to 5.67)
Serotype 9V: Before 13vPnC Dose 1 (n=129,137,266)	2.1 (1.74 to 2.54)	1.56 (1.3 to 1.86)	1.8 (1.58 to 2.05)
Serotype 9V: After 13vPnC Dose 1 (n=129,137,266)	4.77 (4.08 to 5.57)	5.16 (4.24 to 6.27)	4.97 (4.38 to 5.63)
Serotype 14: Before 13vPnC Dose 1 (n=113,136,249)	0.76 (0.57 to 1.03)	2.45 (1.94 to 3.09)	1.44 (1.18 to 1.76)
Serotype 14: After 13vPnC Dose 1 (n=113,136,249)	12.04 (8.48 to 17.1)	16.46 (12.38 to 21.9)	14.28 (11.44 to 17.84)
Serotype 18C: Before 13vPnC Dose 1 (n=127,134,261)	0.66 (0.52 to 0.85)	0.85 (0.69 to 1.04)	0.75 (0.64 to 0.88)
Serotype 18C: After 13vPnC Dose 1 (n=127,134,261)	3.92 (3.14 to 4.91)	5.55 (4.51 to 6.84)	4.69 (4.02 to 5.46)
Serotype 19A: Before 13vPnC Dose 1 (n=133,137,270)	7.51 (6.34 to 8.9)	4.78 (4.04 to 5.66)	5.97 (5.29 to 6.74)
Serotype 19A: After 13vPnC Dose 1 (n=133,137,270)	13.28 (11.11 to 15.87)	13.03 (10.75 to 15.8)	13.15 (11.54 to 14.99)
Serotype 19F: Before 13vPnC Dose 1 (n=93,126,219)	1.36 (1.06 to 1.75)	1.36 (1.07 to 1.73)	1.36 (1.14 to 1.62)
Serotype 19F: After 13vPnC Dose 1 (n=93,126,219)	4.62 (3.55 to 6.02)	4.98 (3.74 to 6.62)	4.82 (3.96 to 5.88)
Serotype 23F: Before 13vPnC Dose 1 (n=126,137,263)	2.29 (1.83 to 2.86)	1.61 (1.31 to 1.96)	1.9 (1.64 to 2.21)
Serotype 23F: After 13vPnC Dose 1 (n=126,137,263)	5.65 (4.66 to 6.86)	5.3 (4.16 to 6.75)	5.47 (4.68 to 6.39)

Notes
[14] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[15] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[16] - “Number of subjects analyzed" signifies those subjects who were evaluable for this measure.

No statistical analyses for this end point

Other pre-specified: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Subjects

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End point title

Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Subjects

End point description

GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all subjects with available data from both before 13vPnC Dose and after 13vPnC Dose 1 blood draws. Evaluable immunogenicity population. Here "n" signifies subjects with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively.

End point type

Other pre-specified

End point timeframe

Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1

End point values	13vPnC, 23vPS (Pediatric Subjects)	13vPnC, 23vPS (Adult Subjects)	13vPnC, 23vPS (All Subjects)
Number of subjects analysed	133 ^[17]	137 ^[18]	270 ^[19]
Units: fold rise
geometric mean (confidence interval 95%)
Serotype 1 (n = 78, 122, 200)	3.67 (2.7 to 4.99)	4.88 (3.87 to 6.15)	4.37 (3.63 to 5.25)
Serotype 3 (n = 99, 127, 226)	1.51 (1.27 to 1.79)	1.62 (1.43 to 1.83)	1.57 (1.42 to 1.74)
Serotype 4 (n = 95, 127, 222)	14.02 (10.55 to 18.62)	8.29 (6.55 to 10.49)	10.38 (8.64 to 12.47)
Serotype 5 (n = 122, 137, 259)	1.15 (1.06 to 1.25)	1.64 (1.44 to 1.85)	1.38 (1.28 to 1.5)
Serotype 6A (n = 99, 136, 235)	1.18 (1.02 to 1.35)	2.54 (2.09 to 3.07)	1.83 (1.6 to 2.1)
Serotype 6B (n = 131, 134, 265)	1.86 (1.55 to 2.22)	2.26 (1.87 to 2.72)	2.05 (1.8 to 2.33)
Serotype 7F (n = 111, 134, 245)	5.11 (3.92 to 6.65)	4.9 (3.99 to 6.03)	4.99 (4.24 to 5.88)
Serotype 9V (n = 129, 137, 266)	2.27 (1.97 to 2.61)	3.32 (2.76 to 3.99)	2.76 (2.45 to 3.1)
Serotype 14 (n = 113, 136, 249)	15.79 (11.84 to 21.05)	6.73 (5.17 to 8.76)	9.91 (8.11 to 12.11)
Serotype 18C (n = 127, 134, 261)	5.92 (4.64 to 7.55)	6.55 (5.23 to 8.2)	6.23 (5.29 to 7.35)
Serotype 19A (n = 133, 137, 270)	1.77 (1.55 to 2.02)	2.73 (2.31 to 3.21)	2.2 (1.98 to 2.45)
Serotype 19F (n = 93, 126, 219)	3.39 (2.71 to 4.25)	3.66 (2.96 to 4.52)	3.54 (3.04 to 4.13)
Serotype 23F (n = 126, 137, 263)	2.47 (2.02 to 3.02)	3.3 (2.71 to 4.03)	2.87 (2.49 to 3.31)

Notes
[17] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[18] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[19] - “Number of subjects analyzed" signifies those subjects who were evaluable for this measure.

No statistical analyses for this end point

Other pre-specified: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Subjects

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End point title

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Subjects

End point description

Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all subjects using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all subjects with available data for both the before and after 13vPnC Dose 1 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Evaluable immunogenicity population. Here "n" signifies subjects with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively.

End point type

Other pre-specified

End point timeframe

Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1

End point values	13vPnC, 23vPS (Pediatric Subjects)	13vPnC, 23vPS (Adult Subjects)	13vPnC, 23vPS (All Subjects)
Number of subjects analysed	129 ^[20]	128 ^[21]	257 ^[22]
Units: titers
geometric mean (confidence interval 95%)
Serotype 1: Before 13vPnC Dose 1 (n=129,127,256)	5 (4.3 to 5.8)	5 (4.3 to 5.2)	5 (4.4 to 5.3)
Serotype 1: After 13vPnC Dose 1 (n=129,127,256)	49 (35.3 to 68.1)	57 (41.6 to 79.3)	53 (42.2 to 66.7)
Serotype 3: Before 13vPnC Dose 1 (n=126,128,254)	8 (6.6 to 10.8)	5 (4.5 to 5.8)	7 (5.7 to 7.5)
Serotype 3: After 13vPnC Dose 1 (n=126,128,254)	41 (31.7 to 52.6)	21 (16.3 to 27.1)	29 (24.3 to 35.1)
Serotype 4: Before 13vPnC Dose 1 (n=108,119,227)	25 (15.2 to 41.7)	27 (17 to 42.1)	26 (18.6 to 36.3)
Serotype 4: After 13vPnC Dose 1 (n=108,119,227)	2247 (1611.9 to 3131.4)	1372 (958.8 to 1963.7)	1735 (1356.9 to 2218.3)
Serotype 5: Before 13vPnC Dose 1 (n=125,122,247)	5 (4.5 to 6.7)	6 (4.8 to 6.8)	6 (4.9 to 6.4)
Serotype 5: After 13vPnC Dose 1 (n=125,122,247)	79 (52.5 to 118)	123 (81.8 to 186.3)	98 (73.7 to 131.1)
Serotype 6A: Before 13vPnC Dose 1 (n=99,98,197)	157 (84.4 to 292.5)	61 (35.1 to 106.8)	98 (64.6 to 149.4)
Serotype 6A: After 13vPnC Dose 1 (n=99,98,197)	3480 (2460.1 to 4921.8)	1543 (984.4 to 2418.5)	2322 (1743.1 to 3092.9)
Serotype 6B: Before 13vPnC Dose 1 (n=101,120,221)	279 (155.5 to 501.1)	231 (143.4 to 372.5)	252 (174.1 to 364.6)
Serotype 6B: After 13vPnC Dose 1 (n=101,120,221)	3852 (2888.3 to 5137.8)	2099 (1455.6 to 3028.2)	2771 (2179.2 to 3522.5)
Serotype 7F: Before 13vPnC Dose 1 (n=110,113,223)	416 (253.5 to 682.9)	38 (22.9 to 64.6)	124 (84.3 to 183.8)
Serotype 7F: After 13vPnC Dose 1 (n=110,113,223)	3775 (3019.4 to 4720.1)	2005 (1443.9 to 2783.1)	2739 (2237.5 to 3353.5)
Serotype 9V: Before 13vPnC Dose 1 (n=109,117,226)	152 (87.2 to 266.2)	69 (40.7 to 117.2)	101 (68.8 to 148.6)
Serotype 9V: After 13vPnC Dose 1 (n=109,117,226)	2533 (1822.7 to 3520.3)	1231 (836.1 to 1812.2)	1743 (1347 to 2256.4)
Serotype 14: Before 13vPnC Dose 1 (n=107,126,233)	328 (201.4 to 535.5)	123 (79.6 to 191.4)	193 (139 to 269.2)
Serotype 14: After 13vPnC Dose 1 (n=107,126,233)	3571 (2772.2 to 4600.1)	1277 (944.9 to 1725.8)	2048 (1660.8 to 2524.9)
Serotype 18C: Before 13vPnC Dose 1 (n=95,120,215)	42 (21.9 to 79)	25 (15.5 to 39.6)	31 (21.2 to 45.8)
Serotype 18C: After 13vPnC Dose 1 (n=95,120,215)	2821 (1891.1 to 4208.9)	1031 (671.3 to 1584.6)	1609 (1188.2 to 2178.5)
Serotype 19A: Before 13vPnC Dose 1 (n=129,128,257)	28 (19.1 to 40.8)	23 (16.7 to 32.7)	26 (19.9 to 32.9)
Serotype 19A: After 13vPnC Dose 1 (n=129,128,257)	506 (381.9 to 671.7)	390 (275.2 to 552.8)	445 (355.7 to 555.9)
Serotype 19F: Before 13vPnC Dose 1 (n=123,123,246)	11 (7.6 to 15.5)	14 (9.5 to 20.1)	12 (9.5 to 15.8)
Serotype 19F: After 13vPnC Dose 1 (n=123,123,246)	425 (285.3 to 632.5)	214 (130.4 to 352.3)	302 (219.3 to 415.2)
Serotype 23F: Before 13vPnC Dose 1 (n=118,125,243)	14 (9.3 to 22)	7 (5.3 to 9)	10 (7.6 to 12.7)
Serotype 23F: After 13vPnC Dose 1 (n=118,125,243)	587 (379.3 to 907.7)	140 (86.6 to 227.6)	281 (200.8 to 393.7)

Notes
[20] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[21] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[22] - “Number of subjects analyzed" signifies those subjects who were evaluable for this measure.

No statistical analyses for this end point

Other pre-specified: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Subjects

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End point title

Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Subjects

End point description

End point type

Other pre-specified

End point timeframe

Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1

End point values	13vPnC, 23vPS (Pediatric Subjects)	13vPnC, 23vPS (Adult Subjects)	13vPnC, 23vPS (All Subjects)
Number of subjects analysed	129 ^[23]	128 ^[24]	257 ^[25]
Units: fold rise
geometric mean (confidence interval 95%)
Serotype 1 (n = 129, 127, 256)	9.8 (6.97 to 13.81)	12.2 (8.84 to 16.84)	10.9 (8.65 to 13.81)
Serotype 3 (n = 126, 128, 254)	4.8 (3.72 to 6.3)	4.1 (3.22 to 5.3)	4.5 (3.73 to 5.35)
Serotype 4 (n = 108, 119, 227)	89.4 (51.43 to 155.31)	51.3 (31.16 to 84.59)	66.8 (46.17 to 96.75)
Serotype 5 (n = 125, 122, 247)	14.4 (9.56 to 21.67)	21.7 (14.55 to 32.32)	17.6 (13.25 to 23.44)
Serotype 6A (n = 99, 98, 197)	22.2 (12.61 to 38.9)	25.2 (14.51 to 43.83)	23.6 (15.98 to 34.94)
Serotype 6B (n = 101, 120, 221)	13.8 (8.12 to 23.45)	9.1 (5.91 to 13.95)	11 (7.87 to 15.37)
Serotype 7F (n = 110, 113, 223)	9.1 (5.79 to 14.23)	52.2 (31.42 to 86.57)	22 (15.42 to 31.42)
Serotype 9V (n = 109, 117, 226)	16.6 (9.71 to 28.47)	17.8 (10.53 to 30.18)	17.2 (11.87 to 25.04)
Serotype 14 (n = 107, 126, 233)	10.9 (6.79 to 17.41)	10.3 (6.82 to 15.7)	10.6 (7.76 to 14.44)
Serotype 18C (n = 95, 120, 215)	67.9 (35.25 to 130.73)	41.6 (24.59 to 70.26)	51.6 (34.27 to 77.78)
Serotype 19A (n = 129, 128, 257)	18.1 (12.52 to 26.25)	16.7 (11.78 to 23.61)	17.4 (13.51 to 22.38)
Serotype 19F (n = 123, 123, 246)	39 (24.56 to 62.05)	15.5 (9.77 to 24.65)	24.6 (17.69 to 34.25)
Serotype 23F (n = 118, 125, 243)	41.1 (24.94 to 67.81)	20.2 (12.78 to 32.05)	28.6 (20.34 to 40.1)

Notes
[23] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[24] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[25] - “Number of subjects analyzed" signifies those subjects who were evaluable for this measure.

No statistical analyses for this end point

Other pre-specified: Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Subjects

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End point title

Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Subjects

End point description

Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all subjects are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all subjects with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Evaluable immunogenicity population. Here "n" signifies subjects with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively.

End point type

Other pre-specified

End point timeframe

1 month after 13vPnC Dose 3, 1 month after 23vPS Dose

End point values	13vPnC, 23vPS (Pediatric Subjects)	13vPnC, 23vPS (Adult Subjects)	13vPnC, 23vPS (All Subjects)
Number of subjects analysed	133 ^[26]	130 ^[27]	263 ^[28]
Units: mcg/mL
geometric mean (confidence interval 95%)
Serotype 1: After 13vPnC Dose 3 (n=128,127,255)	4.08 (3.53 to 4.73)	3.94 (3.22 to 4.82)	4.01 (3.54 to 4.54)
Serotype 1: After 23vPS Dose (n=128,127,255)	4.42 (3.8 to 5.14)	4.02 (3.32 to 4.85)	4.21 (3.74 to 4.75)
Serotype 3: After 13vPnC Dose 3 (n=124,118,242)	1.49 (1.27 to 1.75)	1.04 (0.87 to 1.26)	1.25 (1.11 to 1.42)
Serotype 3: After 23vPS Dose (n=124,118,242)	1.65 (1.42 to 1.92)	0.98 (0.82 to 1.17)	1.28 (1.14 to 1.44)
Serotype 4: After 13vPnC Dose 3 (n=133,128,261)	3.29 (2.79 to 3.87)	3.19 (2.59 to 3.93)	3.24 (2.84 to 3.7)
Serotype 4: After 23vPS Dose (n=133,128,261)	3.28 (2.77 to 3.88)	3.01 (2.44 to 3.72)	3.15 (2.75 to 3.59)
Serotype 5: After 13vPnC Dose 3 (n=132,130,262)	4.73 (4.02 to 5.57)	5.54 (4.64 to 6.63)	5.12 (4.54 to 5.78)
Serotype 5: After 23vPS Dose (n=132,130,262)	5.08 (4.33 to 5.95)	6.2 (5.23 to 7.35)	5.61 (4.99 to 6.3)
Serotype 6A: After 13vPnC Dose 3 (n=122,129,251)	8.2 (6.99 to 9.61)	7.07 (5.75 to 8.69)	7.6 (6.67 to 8.66)
Serotype 6A: After 23vPS Dose (n=122,129,251)	7.98 (6.85 to 9.31)	6.71 (5.51 to 8.17)	7.3 (6.44 to 8.27)
Serotype 6B: After 13vPnC Dose 3 (n=133,129,262)	12.25 (10.31 to 14.55)	8.29 (6.78 to 10.13)	10.1 (8.84 to 11.55)
Serotype 6B: After 23vPS Dose (n=133,129,262)	11.1 (9.39 to 13.13)	8.25 (6.8 to 10.01)	9.59 (8.44 to 10.9)
Serotype 7F: After 13vPnC Dose 3 (n=133,130,263)	5.05 (4.39 to 5.81)	5.88 (4.93 to 7.02)	5.44 (4.87 to 6.09)
Serotype 7F: After 23vPS Dose (n=133,130,263)	5.15 (4.5 to 5.9)	5.93 (5.02 to 7)	5.52 (4.96 to 6.14)
Serotype 9V: After 13vPnC Dose 3 (n=133,130,263)	5.02 (4.4 to 5.72)	5.49 (4.59 to 6.57)	5.25 (4.7 to 5.86)
Serotype 9V: After 23vPS Dose (n=133,130,263)	5.27 (4.62 to 6)	5.83 (4.88 to 6.96)	5.54 (4.96 to 6.18)
Serotype 14: After 13vPnC Dose 3 (n=133,130,263)	13.18 (10.19 to 17.05)	15.35 (11.97 to 19.69)	14.21 (11.89 to 16.98)
Serotype 14: After 23vPS Dose (n=133,130,263)	12.98 (10.1 to 16.67)	16.24 (12.82 to 20.57)	14.5 (12.21 to 17.21)
Serotype 18C: After 13vPnC Dose 3 (n=132,130,262)	3.84 (3.21 to 4.59)	5.17 (4.25 to 6.28)	4.45 (3.9 to 5.08)
Serotype 18C: After 23vPS Dose (n=132,130,262)	3.54 (2.98 to 4.2)	4.8 (3.98 to 5.79)	4.12 (3.62 to 4.68)
Serotype 19A: After 13vPnC Dose 3 (n=133,130,263)	14.16 (12.21 to 16.41)	13.21 (11.13 to 15.68)	13.68 (12.22 to 15.31)
Serotype 19A: After 23vPS Dose (n=133,130,263)	13.16 (11.31 to 15.33)	13.28 (11.24 to 15.69)	13.22 (11.82 to 14.79)
Serotype 19F: After 13vPnC Dose 3 (n=130,127,257)	6.15 (5.09 to 7.45)	5.67 (4.47 to 7.19)	5.91 (5.08 to 6.87)
Serotype 19F: After 23vPS Dose (n=130,127,257)	6.78 (5.65 to 8.14)	5.84 (4.62 to 7.39)	6.3 (5.44 to 7.3)
Serotype 23F: After 13vPnC Dose 3 (n=132,129,261)	6.69 (5.6 to 7.98)	7.3 (5.87 to 9.09)	6.98 (6.07 to 8.03)
Serotype 23F: After 23vPS Dose (n=132,129,261)	5.99 (5.05 to 7.11)	7.03 (5.69 to 8.7)	6.49 (5.66 to 7.43)

Notes
[26] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[27] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[28] - “Number of subjects analyzed" signifies those subjects who were evaluable for this measure.

No statistical analyses for this end point

Other pre-specified: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Subjects

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End point title

Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Subjects

End point description

GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 23vPS Dose were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all subjects with available data from both 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws. Evaluable immunogenicity population. Here "n" signifies subjects with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively.

End point type

Other pre-specified

End point timeframe

1 month after 13vPnC Dose 3, 1 month after 23vPS Dose

End point values	13vPnC, 23vPS (Pediatric Subjects)	13vPnC, 23vPS (Adult Subjects)	13vPnC, 23vPS (All Subjects)
Number of subjects analysed	133 ^[29]	130 ^[30]	263 ^[31]
Units: fold rise
geometric mean (confidence interval 95%)
Serotype 1 (n = 128, 127, 255)	1.08 (1.01 to 1.16)	1.02 (0.96 to 1.08)	1.05 (1 to 1.1)
Serotype 3 (n = 124, 118, 242)	1.11 (1.03 to 1.2)	0.94 (0.88 to 1)	1.02 (0.97 to 1.08)
Serotype 4 (n = 133, 128, 261)	1 (0.94 to 1.05)	0.94 (0.9 to 0.99)	0.97 (0.94 to 1.01)
Serotype 5 (n = 132, 130, 262)	1.07 (1.02 to 1.13)	1.12 (1.05 to 1.19)	1.09 (1.05 to 1.14)
Serotype 6A (n = 122, 129, 251)	0.97 (0.92 to 1.04)	0.95 (0.91 to 0.99)	0.96 (0.93 to 1)
Serotype 6B (n = 133, 129, 262)	0.91 (0.87 to 0.95)	1 (0.96 to 1.04)	0.95 (0.92 to 0.98)
Serotype 7F (n = 133, 130, 263)	1.02 (0.97 to 1.07)	1.01 (0.95 to 1.06)	1.01 (0.98 to 1.05)
Serotype 9V (n = 133, 130, 263)	1.05 (1 to 1.1)	1.06 (1.01 to 1.11)	1.06 (1.02 to 1.09)
Serotype 14 (n = 133, 130, 263)	0.98 (0.91 to 1.06)	1.06 (0.99 to 1.13)	1.02 (0.97 to 1.07)
Serotype 18C (n = 132, 130, 262)	0.92 (0.88 to 0.96)	0.93 (0.89 to 0.97)	0.92 (0.9 to 0.95)
Serotype 19A (n = 133, 130, 263)	0.93 (0.89 to 0.97)	1.01 (0.96 to 1.05)	0.97 (0.94 to 1)
Serotype 19F (n = 130, 127, 257)	1.1 (1.04 to 1.17)	1.03 (0.97 to 1.09)	1.07 (1.02 to 1.11)
Serotype 23F (n = 132, 129, 261)	0.9 (0.86 to 0.94)	0.96 (0.91 to 1.02)	0.93 (0.89 to 0.96)

Notes
[29] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[30] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[31] - “Number of subjects analyzed" signifies those subjects who were evaluable for this measure.

No statistical analyses for this end point

Other pre-specified: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Subjects

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End point title

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Subjects

End point description

Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all subjects using a mcOPA assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all subjects with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Evaluable immunogenicity population. Here "n" signifies subjects with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively.

End point type

Other pre-specified

End point timeframe

1 month after 13vPnC Dose 3, 1 month after 23vPS Dose

End point values	13vPnC, 23vPS (Pediatric Subjects)	13vPnC, 23vPS (Adult Subjects)	13vPnC, 23vPS (All Subjects)
Number of subjects analysed	132 ^[32]	128 ^[33]	260 ^[34]
Units: titers
geometric mean (confidence interval 95%)
Serotype 1: After 13vPnC Dose 3 (n=131,125,256)	70 (53.4 to 93)	67 (50.2 to 90.6)	69 (56.4 to 84.3)
Serotype 1: After 23vPS Dose (n=131,125,256)	100 (76.6 to 130.3)	66 (49 to 90.2)	82 (66.9 to 100.2)
Serotype 3: After 13vPnC Dose 3 (n=132,128,260)	114 (94.6 to 136.7)	78 (61.3 to 98.7)	94 (81.1 to 109.7)
Serotype 3: After 23vPS Dose (n=132,128,260)	148 (123.9 to 177.3)	103 (81.6 to 130.9)	124 (107 to 144)
Serotype 4: After 13vPnC Dose 3 (n=127,126,253)	3213 (2698.5 to 3826.6)	1888 (1427.3 to 2498.1)	2466 (2087 to 2913.5)
Serotype 4: After 23vPS Dose (n=127,126,253)	3553 (2984.9 to 4229.7)	1831 (1366 to 2453.7)	2554 (2146.3 to 3038.7)
Serotype 5: After 13vPnC Dose 3 (n=129,124,253)	270 (197 to 370.1)	143 (97.5 to 209.6)	198 (154.2 to 253.5)
Serotype 5: After 23vPS Dose (n=129,124,253)	378 (276.5 to 516.9)	186 (130.9 to 264.4)	267 (210.6 to 338.6)
Serotype 6A: After 13vPnC Dose 3 (n=132,127,259)	8011 (6580 to 9752.1)	2956 (2240.1 to 3900.3)	4913 (4109.7 to 5873.6)
Serotype 6A: After 23vPS Dose (n=132,127,259)	7236 (5936.2 to 8819.4)	2707 (2060.8 to 3556.3)	4468 (3743.3 to 5333.1)
Serotype 6B: After 13vPnC Dose 3 (n=130,126,256)	7102 (5853.9 to 8615.8)	3666 (2720.7 to 4940.5)	5129 (4283.9 to 6141)
Serotype 6B: After 23vPS Dose (n=130,126,256)	6652 (5460.8 to 8102.8)	3324 (2496.6 to 4426.2)	4728 (3961.1 to 5643.2)
Serotype 7F: After 13vPnC Dose 3 (n=131,125,256)	4640 (3915.9 to 5497.9)	2821 (2283.2 to 3484.4)	3639 (3171.6 to 4174.8)
Serotype 7F: After 23vPS Dose (n=131,125,256)	5260 (4470.4 to 6189.9)	3027 (2455.7 to 3731.3)	4016 (3508.3 to 4597.9)
Serotype 9V: After 13vPnC Dose 3 (n=127,125,252)	4501 (3606.4 to 5618)	1980 (1394.6 to 2811.7)	2995 (2424.2 to 3700.8)
Serotype 9V: After 23vPS Dose (n=127,125,252)	5114 (4090.6 to 6393)	2037 (1452.6 to 2857.6)	3240 (2629.5 to 3991.2)
Serotype 14: After 13vPnC Dose 3 (n=127,126,253)	4023 (3317.5 to 4879.5)	1431 (1115.7 to 1836.1)	2405 (2030.8 to 2847.1)
Serotype 14: After 23vPS Dose (n=127,126,253)	4718 (3861.6 to 5764.9)	1620 (1284.5 to 2043)	2771 (2346.9 to 3270.7)
Serotype 18C: After 13vPnC Dose 3 (n=129,121,250)	5455 (4401.5 to 6761.4)	1667 (1172.5 to 2370.8)	3074 (2479.2 to 3810.5)
Serotype 18C: After 23vPS Dose (n=129,121,250)	6468 (5341.1 to 7832.2)	1835 (1328.1 to 2535.5)	3515 (2878.5 to 4292.8)
Serotype 19A: After 13vPnC Dose 3 (n=131,125,256)	1021 (837.5 to 1245.6)	603 (456.7 to 796.3)	790 (665.2 to 937.4)
Serotype 19A: After 23vPS Dose (n=131,125,256)	1244 (1012.1 to 1529.5)	691 (531 to 898.6)	933 (788.2 to 1105.5)
Serotype 19F: After 13vPnC Dose 3 (n=126,117,243)	1166 (884.3 to 1537.7)	564 (375 to 848.1)	822 (642.8 to 1051)
Serotype 19F: After 23vPS Dose (n=126,117,243)	1696 (1296.5 to 2217.5)	790 (547.5 to 1139.7)	1174 (934.2 to 1474.8)
Serotype 23F: After 13vPnC Dose 3 (n=128,126,254)	2346 (1883.3 to 2922.6)	650 (435.3 to 969.9)	1241 (976.6 to 1576.7)
Serotype 23F: After 23vPS Dose (n=128,126,254)	2595 (2143.3 to 3141.5)	580 (386.1 to 871.8)	1234 (970.1 to 1570.3)

Notes
[32] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[33] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[34] - “Number of subjects analyzed" signifies those subjects who were evaluable for this measure.

No statistical analyses for this end point

Other pre-specified: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Subjects

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End point title

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Subjects

End point description

End point type

Other pre-specified

End point timeframe

1 month after 13vPnC Dose 3, 1 month after 23vPS Dose

End point values	13vPnC, 23vPS (Pediatric Subjects)	13vPnC, 23vPS (Adult Subjects)	13vPnC, 23vPS (All Subjects)
Number of subjects analysed	132 ^[35]	128 ^[36]	260 ^[37]
Units: fold rise
geometric mean (confidence interval 95%)
Serotype 1 (n = 131, 125, 256)	1.4 (1.23 to 1.63)	1 (0.86 to 1.13)	1.2 (1.08 to 1.31)
Serotype 3 (n = 132, 128, 260)	1.3 (1.15 to 1.48)	1.3 (1.17 to 1.51)	1.3 (1.2 to 1.44)
Serotype 4 (n = 127, 126, 253)	1.1 (1.04 to 1.18)	1 (0.87 to 1.09)	1 (0.97 to 1.1)
Serotype 5 (n = 129, 124, 253)	1.4 (1.15 to 1.71)	1.3 (1.13 to 1.5)	1.4 (1.2 to 1.53)
Serotype 6A (n = 132, 127, 259)	0.9 (0.85 to 0.96)	0.9 (0.86 to 0.97)	0.9 (0.87 to 0.95)
Serotype 6B (n = 130, 126, 256)	0.9 (0.87 to 1.01)	0.9 (0.79 to 1.04)	0.9 (0.86 to 0.99)
Serotype 7F (n = 131, 125, 256)	1.1 (1.06 to 1.21)	1.1 (0.93 to 1.23)	1.1 (1.02 to 1.19)
Serotype 9V (n = 127, 125, 252)	1.1 (1.05 to 1.23)	1 (0.84 to 1.27)	1.1 (0.97 to 1.21)
Serotype 14 (n = 127, 126, 253)	1.2 (1.07 to 1.28)	1.1 (1.03 to 1.24)	1.2 (1.08 to 1.23)
Serotype 18C (n = 129, 121, 250)	1.2 (1.04 to 1.35)	1.1 (0.92 to 1.31)	1.1 (1.03 to 1.27)
Serotype 19A (n = 131, 125, 256)	1.2 (1.11 to 1.34)	1.1 (1.03 to 1.27)	1.2 (1.1 to 1.27)
Serotype 19F (n = 126, 117, 243)	1.5 (1.25 to 1.69)	1.4 (1.14 to 1.72)	1.4 (1.26 to 1.62)
Serotype 23F (n = 128, 126, 254)	1.1 (0.96 to 1.28)	0.9 (0.81 to 0.98)	1 (0.91 to 1.09)

Notes
[35] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[36] - “Number of subjects analyzed” signifies those subjects who were evaluable for this measure.
[37] - “Number of subjects analyzed" signifies those subjects who were evaluable for this measure.

No statistical analyses for this end point

Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Local Reactions: 13vPnC Dose 1

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End point title

Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Local Reactions: 13vPnC Dose 1

End point description

Specific local reactions were prompted for each day, and reported using an electronic diary (e-diary). Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters (cm) for subjects aged 6 to <12 years and 2.5 to 5.0 cm for subjects aged greater than (>) 12 years); Moderate (2.5 to 7.0 cm for subjects aged 6 to <12 years and 5.1 to 10.0 cm for subjects aged >12 years); Severe (>7 cm for subjects aged 6 to <12 years and >10 cm for subjects aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Report of severe swelling was confirmed as data entry error. Safety population included all enrolled subjects who received at least 1 dose of investigational product. Here “n” signifies subjects with known values for specified local reaction. Subjects may be represented in more than 1 category.

End point type

Other pre-specified

End point timeframe

Within 14 days after 13vPnC Dose 1

End point values	13vPnC, 23vPS (Pediatric Subjects)	13vPnC, 23vPS (Adult Subjects)	13vPnC, 23vPS (All Subjects)
Number of subjects analysed	120 ^[38]	123 ^[39]	243 ^[40]
Units: percentage of subjects
number (not applicable)
Redness: Any (n = 92, 88, 180)	20.7	2.3	11.7
Redness: Mild (n = 91, 88, 179)	19.8	2.3	11.2
Redness: Moderate (n = 85, 88, 173)	2.4	0	1.2
Redness: Severe (n = 84, 88, 172)	0	0	0
Swelling: Any (n = 97, 94, 191)	29.9	9.6	19.9
Swelling: Mild (n = 91, 93, 184)	17.6	8.6	13
Swelling: Moderate (n = 92, 89, 181)	16.3	1.1	8.8
Swelling: Severe (n = 84, 88, 172)	1.2	0	0.6
Pain at Injection Site: Any (n = 117, 121, 238)	68.4	62.8	65.5
Pain at Injection Site: Mild (n = 112, 116, 228)	55.4	56	55.7
Pain at Injection Site: Moderate (n = 94, 94, 188)	28.7	18.1	23.4
Pain at Injection Site: Severe (n = 86, 89, 175)	8.1	2.2	5.1

Notes
[38] - "Number of subjects analyzed" signifies subjects with known values for any local reaction.
[39] - "Number of subjects analyzed" signifies subjects with known values for any local reaction.
[40] - "Number of subjects analyzed" signifies subjects with known values for any local reaction.

No statistical analyses for this end point

Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Local Reactions: 13vPnC Dose 2

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End point title

Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Local Reactions: 13vPnC Dose 2

End point description

Specific local reactions were prompted for each day, and reported using an e-diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for subjects aged 6 to <12 years and 2.5 to 5.0 cm for subjects aged >12 years); Moderate (2.5 to 7.0 cm for subjects aged 6 to <12 years and 5.1 to 10.0 cm for subjects aged >12 years); Severe (>7 cm for subjects aged 6 to <12 years and >10 cm for subjects aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Safety population. Here “n” signifies subjects with known values for specified local reaction. Subjects may be represented in more than 1 category.

End point type

Other pre-specified

End point timeframe

Within 14 days after 13vPnC Dose 2

End point values	13vPnC, 23vPS (Pediatric Subjects)	13vPnC, 23vPS (Adult Subjects)	13vPnC, 23vPS (All Subjects)
Number of subjects analysed	120 ^[41]	119 ^[42]	239 ^[43]
Units: percentage of subjects
number (not applicable)
Redness: Any (n = 101, 86, 187)	13.9	2.3	8.6
Redness: Mild (n = 100, 86, 186)	10	2.3	6.5
Redness: Moderate (n = 95, 85, 180)	4.2	0	2.2
Redness: Severe (n = 93, 85, 178)	1.1	0	0.6
Swelling: Any (n = 103, 88, 191)	25.2	8	17.3
Swelling: Mild (n = 102, 88, 190)	18.6	8	13.7
Swelling: Moderate (n = 99, 85, 184)	12.1	0	6.5
Swelling: Severe (n = 93, 85, 178)	0	0	0
Pain at Injection Site: Any (n = 117, 119, 236)	60.7	79.8	70.3
Pain at Injection Site: Mild (n = 110, 117, 227)	49.1	72.6	61.2
Pain at Injection Site: Moderate (n= 103, 96, 199)	24.3	27.1	25.6
Pain at Injection Site: Severe (n = 93, 86, 179)	5.4	3.5	4.5

Notes
[41] - "Number of subjects analyzed" signifies subjects with known values for any local reaction.
[42] - "Number of subjects analyzed" signifies subjects with known values for any local reaction.
[43] - “Number of subjects analyzed" signifies subjects with known values for any local reaction.

No statistical analyses for this end point

Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Local Reactions: 13vPnC Dose 3

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End point title

Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Local Reactions: 13vPnC Dose 3

End point description

End point type

Other pre-specified

End point timeframe

Within 14 days after 13vPnC Dose 3

End point values	13vPnC, 23vPS (Pediatric Subjects)	13vPnC, 23vPS (Adult Subjects)	13vPnC, 23vPS (All Subjects)
Number of subjects analysed	104 ^[44]	109 ^[45]	213 ^[46]
Units: percentage of subjects
number (not applicable)
Redness: Any (n = 84, 70, 154)	8.3	0	4.5
Redness: Mild (n = 83, 70, 153)	7.2	0	3.9
Redness: Moderate (n = 82, 70, 152)	2.4	0	1.3
Redness: Severe (n = 80, 70, 150)	0	0	0
Swelling: Any (n = 89, 71, 160)	18	4.2	11.9
Swelling: Mild (n = 86, 71, 157)	10.5	4.2	7.6
Swelling: Moderate (n = 84, 70, 154)	9.5	0	5.2
Swelling: Severe (n = 80, 70, 150)	0	0	0
Pain at Injection Site: Any (n = 104, 109, 213)	52.9	69.7	61.5
Pain at Injection Site: Mild (n = 96, 105, 201)	41.7	63.8	53.2
Pain at Injection Site: Moderate (n = 89, 78, 167)	19.1	24.4	21.6
Pain at Injection Site: Severe (n = 83, 73, 156)	4.8	5.5	5.1

Notes
[44] - "Number of subjects analyzed" signifies subjects with known values for any local reaction.
[45] - "Number of subjects analyzed" signifies subjects with known values for any local reaction.
[46] - “Number of subjects analyzed" signifies subjects with known values for any local reaction.

No statistical analyses for this end point

Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Systemic Events: 13vPnC Dose 1

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End point title

Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Systemic Events: 13vPnC Dose 1

End point description

Specific systemic events(fever >=38 degrees Celsius[C],fatigue,headache,vomiting,diarrhea,muscle pain,joint pain,use of medication to treat pain/fever) were prompted for each day, and reported using an e-diary. Fatigue,headache,muscle pain,joint pain were scaled as: Any(symptom present); Mild(did not interfere with activity); Moderate(some interference with activity); Severe(prevented routine daily activity). Vomiting was scaled as: Any(vomiting present); Mild(1-2 times in 24 hours); Moderate(>2 times in 24 hours); Severe(required intravenous hydration). Diarrhea was scaled as: Any(diarrhea present); Mild(2-3 loose stools in 24 hours); Moderate(4-5 loose stools 24 hours); Severe(>=6 loose stools in 24 hours). All reporting of fever >40 degrees C and all reporting of severe vomiting, after 13vPnC Dose 1, were confirmed as data entry errors. Safety population.n=subjects with known values for specified systemic event. Subjects may be represented in more than 1 category.

End point type

Other pre-specified

End point timeframe

Within 14 days after 13vPnC Dose 1

End point values	13vPnC, 23vPS (Pediatric Subjects)	13vPnC, 23vPS (Adult Subjects)	13vPnC, 23vPS (All Subjects)
Number of subjects analysed	128 ^[47]	138 ^[48]	266 ^[49]
Units: percentage of subjects
number (not applicable)
Fever: >=38 degrees C (n= 94, 95, 189)	19.1	17.9	18.5
Fever: >=38, <38.5 degrees C (n = 87, 92, 179)	8	8.7	8.4
Fever: >=38.5, <39 degrees C (n = 85, 89, 174)	2.4	3.4	2.9
Fever: >=39, =<40 degrees C (n = 86, 88, 174)	4.7	2.3	3.4
Fever: >40 degrees C (n = 88, 93, 181)	6.8	8.6	7.7
Fatigue: Any (n = 111, 119, 230)	47.7	58.8	53.5
Fatigue: Mild (n = 105, 113, 218)	33.3	51.3	42.7
Fatigue: Moderate (n = 96, 99, 195)	26	28.3	27.2
Fatigue: Severe (n = 86, 92, 178)	9.3	8.7	9
Headache: Any (n = 107, 113, 220)	39.3	61.1	50.5
Headache: Mild (n = 100, 109, 209)	33	57.8	45.9
Headache: Moderate (n = 94, 97, 191)	18.1	22.7	20.4
Headache: Severe (n = 87, 89, 176)	6.9	9	8
Vomiting: Any (n = 89, 91, 180)	18	7.7	12.8
Vomiting: Mild (n = 89, 91, 180)	14.6	7.7	11.1
Vomiting: Moderate (n = 84, 88, 172)	2.4	0	1.2
Vomiting: Severe (n = 85, 88, 173)	2.4	0	1.2
Diarrhea: Any (n = 94, 105, 199)	25.5	34.3	30.2
Diarrhea: Mild (n = 92, 104, 196)	19.6	29.8	25
Diarrhea: Moderate (n = 86, 91, 177)	8.1	7.7	7.9
Diarrhea: Severe (n = 85, 88, 173)	1.2	1.1	1.2
Muscle Pain: Any (n = 108, 118, 226)	48.1	62.7	55.8
Muscle Pain: Mild (n = 103, 110, 213)	36.9	56.4	46.9
Muscle Pain: Moderate (n = 89, 98, 187)	19.1	19.4	19.3
Muscle Pain: Severe (n = 86, 91, 177)	5.8	5.5	5.6
Joint Pain: Any (n = 100, 105, 205)	34	42.9	38.5
Joint Pain: Mild (n = 98, 101, 199)	26.5	36.6	31.7
Joint Pain: Moderate (n = 89, 95, 184)	12.4	17.9	15.2
Joint Pain: Severe (n = 84, 91, 175)	4.8	4.4	4.6
Use of Medication to Treat Pain (n = 101, 96, 197)	33.7	24	28.9
Use of Medication to Treat Fever (n=112, 107, 219)	44.6	39.3	42

Notes
[47] - "Number of subjects analyzed" signifies subjects with known values for any systemic event.
[48] - "Number of subjects analyzed" signifies subjects with known values for any systemic event.
[49] - “Number of subjects analyzed" signifies subjects with known values for any systemic event.

No statistical analyses for this end point

Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Systemic Events: 13vPnC Dose 2

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End point title

Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Systemic Events: 13vPnC Dose 2

End point description

Specific systemic events(fever >=38 degrees Celsius[C],fatigue,headache,vomiting,diarrhea,muscle pain,joint pain,use of medication to treat pain/fever) were prompted for each day, and reported using an e-diary. Fatigue,headache,muscle pain,joint pain were scaled as: Any(symptom present); Mild(did not interfere with activity); Moderate(some interference with activity); Severe(prevented routine daily activity). Vomiting was scaled as: Any(vomiting present); Mild(1-2 times in 24 hours); Moderate(>2 times in 24 hours); Severe(required intravenous hydration). Diarrhea was scaled as: Any(diarrhea present); Mild(2-3 loose stools in 24 hours); Moderate(4-5 loose stools 24 hours); Severe(>=6 loose stools in 24 hours). All reporting of fever >40 degrees C and all reporting of severe vomiting, after 13vPnC Dose 2, were confirmed as data entry errors. Safety population.n=subjects with known values for specified systemic event. Subjects may be represented in more than 1 category.

End point type

Other pre-specified

End point timeframe

Within 14 days after 13vPnC Dose 2

End point values	13vPnC, 23vPS (Pediatric Subjects)	13vPnC, 23vPS (Adult Subjects)	13vPnC, 23vPS (All Subjects)
Number of subjects analysed	123 ^[50]	120 ^[51]	243 ^[52]
Units: percentage of subjects
number (not applicable)
Fever: >=38 degrees C (n= 102, 88, 190)	16.7	11.4	14.2
Fever: >=38, <38.5 degrees C (n = 96, 87, 183)	7.3	9.2	8.2
Fever: >=38.5, <39 degrees C (n = 98, 85, 183)	6.1	1.2	3.8
Fever: >=39, =<40 degrees C (n = 97, 87, 184)	7.2	3.4	5.4
Fever: >40 degrees C (n = 95, 85, 180)	1.1	1.2	1.1
Fatigue: Any (n = 106, 105, 211)	33	48.6	40.8
Fatigue: Mild (n = 104, 103, 207)	24	42.7	33.3
Fatigue: Moderate (n = 96, 88, 184)	10.4	21.6	15.8
Fatigue: Severe (n = 95, 88, 183)	7.4	5.7	6.6
Headache: Any (n = 101, 106, 207)	28.7	49.1	39.1
Headache: Mild (n = 97, 102, 199)	18.6	40.2	29.6
Headache: Moderate (n = 97, 93, 190)	13.4	28	20.5
Headache: Severe (n = 94, 88, 182)	2.1	3.4	2.7
Vomiting: Any (n = 96, 89, 185)	10.4	10.1	10.3
Vomiting: Mild (n = 94, 89, 183)	6.4	9	7.7
Vomiting: Moderate (n = 94, 85, 179)	3.2	1.2	2.2
Vomiting: Severe (n = 94, 85, 179)	3.2	0	1.7
Diarrhea: Any (n = 95, 95, 190)	10.5	26.3	18.4
Diarrhea: Mild (n = 94, 93, 187)	7.4	24.7	16
Diarrhea: Moderate (n = 93, 87, 180)	3.2	8	5.6
Diarrhea: Severe (n = 94, 85, 179)	4.3	1.2	2.8
Muscle Pain: Any (n = 112, 104, 216)	37.5	52.9	44.9
Muscle Pain: Mild (n = 105, 103, 208)	25.7	46.6	36.1
Muscle Pain: Moderate (n = 100, 91, 191)	15	20.9	17.8
Muscle Pain: Severe (n = 95, 85, 180)	5.3	2.4	3.9
Joint Pain: Any (n = 106, 95, 201)	26.4	34.7	30.3
Joint Pain: Mild (n = 100, 93, 193)	16	29	22.3
Joint Pain: Moderate (n = 99, 89, 188)	11.1	12.4	11.7
Joint Pain: Severe (n = 94, 85, 179)	4.3	2.4	3.4
Use of Medication to Treat Pain (n = 100, 91, 191)	20	17.6	18.8
Use of Medication to Treat Fever (n=102, 96, 198)	28.4	26	27.3

Notes
[50] - "Number of subjects analyzed" signifies subjects with known values for any systemic event.
[51] - "Number of subjects analyzed" signifies subjects with known values for any systemic event.
[52] - “Number of subjects analyzed" signifies subjects with known values for any systemic event.

No statistical analyses for this end point

Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Systemic Events: 13vPnC Dose 3

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End point title

Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Systemic Events: 13vPnC Dose 3

End point description

Specific systemic events(fever >=38 degrees Celsius[C],fatigue,headache,vomiting,diarrhea,muscle pain,joint pain,use of medication to treat pain/fever) were prompted for each day, and reported using an e-diary. Fatigue,headache,muscle pain,joint pain were scaled as: Any(symptom present); Mild(did not interfere with activity); Moderate(some interference with activity); Severe(prevented routine daily activity). Vomiting was scaled as: Any(vomiting present); Mild(1-2 times in 24 hours); Moderate(>2 times in 24 hours); Severe(required intravenous hydration). Diarrhea was scaled as: Any(diarrhea present); Mild(2-3 loose stools in 24 hours); Moderate(4-5 loose stools 24 hours); Severe(>=6 loose stools in 24 hours). All reporting of fever >40 degrees C except 1 subject and all reporting of severe vomiting, after 13vPnC Dose 3, were confirmed as data entry errors. Safety population.n=subjects with known values for specified systemic event. Subjects may be represented in more than 1 category.

End point type

Other pre-specified

End point timeframe

Within 14 days after 13vPnC Dose 3

End point values	13vPnC, 23vPS (Pediatric Subjects)	13vPnC, 23vPS (Adult Subjects)	13vPnC, 23vPS (All Subjects)
Number of subjects analysed	106 ^[53]	113 ^[54]	219 ^[55]
Units: percentage of subjects
number (not applicable)
Fever: >=38 degrees C (n= 85, 73, 158)	10.6	11	10.8
Fever: >=38, <38.5 degrees C (n = 82, 73, 155)	6.1	5.5	5.8
Fever: >=38.5, <39 degrees C (n = 81, 72, 153)	2.5	5.6	3.9
Fever: >=39, =<40 degrees C (n = 82, 70, 152)	2.4	2.9	2.6
Fever: >40 degrees C (n = 83, 70, 153)	3.6	1.4	2.6
Fatigue: Any (n = 92, 91, 183)	25	47.3	36.1
Fatigue: Mild (n = 89, 88, 177)	20.2	39.8	29.9
Fatigue: Moderate (n = 83, 80, 163)	6	25	15.3
Fatigue: Severe (n = 83, 73, 156)	4.8	8.2	6.4
Headache: Any (n = 88, 89, 177)	18.2	46.1	32.2
Headache: Mild (n = 84, 87, 171)	10.7	41.4	26.3
Headache: Moderate (n = 83, 77, 160)	8.4	19.5	13.8
Headache: Severe (n = 82, 72, 154)	3.7	6.9	5.2
Vomiting: Any (n = 85, 74, 159)	8.2	9.5	8.8
Vomiting: Mild (n = 84, 72, 156)	7.1	5.6	6.4
Vomiting: Moderate (n = 82, 73, 155)	2.4	5.5	3.9
Vomiting: Severe (n = 81, 72, 153)	1.2	2.8	2
Diarrhea: Any (n = 81, 81, 162)	4.9	28.4	16.7
Diarrhea: Mild (n = 81, 79, 160)	4.9	25.3	15
Diarrhea: Moderate (n = 80, 73, 153)	1.3	6.8	3.9
Diarrhea: Severe (n = 81, 73, 154)	1.2	4.1	2.6
Muscle Pain: Any (n = 99, 92, 191)	37.4	47.8	42.4
Muscle Pain: Mild (n = 93, 89, 182)	25.8	37.1	31.3
Muscle Pain: Moderate (n = 85, 78, 163)	12.9	24.4	18.4
Muscle Pain: Severe (n = 84, 72, 156)	8.3	5.6	7.1
Joint Pain: Any (n = 91, 83, 174)	24.2	32.5	28.2
Joint Pain: Mild (n = 88, 82, 170)	15.9	28	21.8
Joint Pain: Moderate (n = 82, 77, 159)	7.3	15.6	11.3
Joint Pain: Severe (n = 81, 71, 152)	2.5	2.8	2.6
Use of Medication to Treat Pain (n = 90, 79, 169)	17.8	21.5	19.5
Use of Medication to Treat Fever (n = 89, 75, 164)	20.2	20	20.1

Notes
[53] - "Number of subjects analyzed" signifies subjects with known values for any systemic event.
[54] - "Number of subjects analyzed" signifies subjects with known values for any systemic event.
[55] - “Number of subjects analyzed" signifies subjects with known values for any systemic event.

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions(LRs),systemic events(SEs) assessed within 14 days after: 13vPnC Dose 1(Day 1); 13vPnC Dose 2(28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3(28-42 days after 13vPnC Dose 2)

Adverse event reporting additional description

Adverse Event (AE) may be reported as both serious/non-serious, but are distinct events. AE may=serious for 1 subject, non-serious for another or subject may have experienced both serious, non-serious AE. AEs/SAEs=non-systematic assessment; LRs/SEs=systematic assessment. Here 0.0 is mentioned for dictionary version as version was not captured.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

16.0

Reporting group title

Prior 13vPnC Dose 1

Reporting group description

Subjects >=6 years of age (all subjects) who received at least 1 of 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed between signing of informed consent form and before 13vPnC Dose 1.

Reporting group title

13vPnC Dose 1

Reporting group description

Subjects >=6 years of age (all subjects) who received a single dose of 0.5 mL of 13vPnC intramuscularly on Day 1 (13vPnC Dose 1), assessed between 13vPnC Dose 1 and before 13vPnC Dose 2.

Reporting group title

13vPnC Dose 2

Reporting group description

Subjects >=6 years of age (all subjects) who received a single dose of 0.5 mL of 13vPnC intramuscularly 1 month after 13vPnC Dose 1 (13vPnC Dose 2), assessed between 13vPnC Dose 2 and before 13vPnC Dose 3.

Reporting group title

13vPnC Dose 3

Reporting group description

Subjects >=6 years of age (all subjects) who received a single dose of 0.5 mL of 13vPnC intramuscularly 1 month after 13vPnC Dose 2 (13vPnC Dose 3), assessed between 13vPnC Dose 3 and before 23vPS Dose.

Reporting group title

23vPS Dose

Reporting group description

Subjects >=6 years of age (all subjects) who received a single dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed between 23vPS Dose and before 23vPS Dose blood draw 1 month after 23vPS Dose.

Reporting group title

Follow-up

Reporting group description

Subjects >=6 years of age (all subjects) who received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed from 23vPS blood draw to the 6-month follow-up telephone contact after 13vPnC Dose 3.

Serious adverse events	Prior 13vPnC Dose 1	13vPnC Dose 1	13vPnC Dose 2	13vPnC Dose 3	23vPS Dose	Follow-up
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 301 (0.33%)	1 / 301 (0.33%)	4 / 290 (1.38%)	1 / 286 (0.35%)	0 / 282 (0.00%)	1 / 282 (0.35%)
number of deaths (all causes)	0	0	0	1	0	0
number of deaths resulting from adverse events				0
Injury, poisoning and procedural complications
Road traffic accident
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	1 / 286 (0.35%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
Nervous system disorders
Convulsion
subjects affected / exposed	0 / 301 (0.00%)	1 / 301 (0.33%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences causally related to treatment / all	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
Blood and lymphatic system disorders
Lymphadenopathy
subjects affected / exposed	1 / 301 (0.33%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences causally related to treatment / all	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
Gastrointestinal disorders
Haemorrhoids
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	1 / 290 (0.34%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences causally related to treatment / all	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
Infections and infestations
Lobar pneumonia
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	1 / 290 (0.34%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences causally related to treatment / all	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
Pharyngitis bacterial
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	1 / 290 (0.34%)	0 / 286 (0.00%)	0 / 282 (0.00%)	1 / 282 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tonsillitis
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	1 / 290 (0.34%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences causally related to treatment / all	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
Croup infectious
subjects affected / exposed	1 / 301 (0.33%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences causally related to treatment / all	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

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

Non-serious adverse events	Prior 13vPnC Dose 1	13vPnC Dose 1	13vPnC Dose 2	13vPnC Dose 3	23vPS Dose	Follow-up
Total subjects affected by non serious adverse events
subjects affected / exposed	16 / 301 (5.32%)	216 / 301 (71.76%)	171 / 290 (58.97%)	137 / 286 (47.90%)	31 / 282 (10.99%)	2 / 282 (0.71%)
Vascular disorders
Hypertension
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	1 / 290 (0.34%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	0	1	0	0	0
General disorders and administration site conditions
Fatigue
subjects affected / exposed	0 / 301 (0.00%)	3 / 301 (1.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	3	0	0	0	0
Pyrexia
subjects affected / exposed	0 / 301 (0.00%)	2 / 301 (0.66%)	2 / 290 (0.69%)	0 / 286 (0.00%)	1 / 282 (0.35%)	0 / 282 (0.00%)
occurrences all number	0	3	2	0	1	0
Influenza like illness
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	1 / 290 (0.34%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	0	1	0	0	0
Injection site pain
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	1 / 286 (0.35%)	6 / 282 (2.13%)	0 / 282 (0.00%)
occurrences all number	0	0	0	1	6	0
Injection site reaction
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	2 / 282 (0.71%)	0 / 282 (0.00%)
occurrences all number	0	0	0	0	2	0
Injection site swelling
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	2 / 282 (0.71%)	0 / 282 (0.00%)
occurrences all number	0	0	0	0	2	0
Vaccination site swelling
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	2 / 282 (0.71%)	0 / 282 (0.00%)
occurrences all number	0	0	0	0	2	0
Fever (≥38°C)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative assessment type: Systematic
subjects affected / exposed ^[1]	0 / 301 (0.00%)	35 / 189 (18.52%)	27 / 190 (14.21%)	17 / 158 (10.76%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	35	27	17	0	0
Fever (≥38°C but <38.5°C)
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. LRs and SEs were to be assessed for 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[2]	0 / 301 (0.00%)	15 / 179 (8.38%)	15 / 183 (8.20%)	9 / 155 (5.81%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	15	15	9	0	0
Fever (≥38.5°C but <39°C)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[3]	0 / 301 (0.00%)	5 / 174 (2.87%)	7 / 183 (3.83%)	6 / 153 (3.92%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	5	7	6	0	0
Fever (≥39°C but ≤40°C)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[4]	0 / 301 (0.00%)	6 / 174 (3.45%)	10 / 184 (5.43%)	4 / 152 (2.63%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	6	10	4	0	0
Fever (>40°C)
Additional description: Subjects affected, occurrences for LRs,SEs is same as data collected through e-diaries cannot distinguish 1 occurrence from another within a subject. All temperature >40˚C were confirmed as data entry errors except 1 subject at Dose 3.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[5]	0 / 301 (0.00%)	14 / 181 (7.73%)	2 / 180 (1.11%)	4 / 153 (2.61%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	14	2	4	0	0
Fatigue (Any)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[6]	0 / 301 (0.00%)	123 / 230 (53.48%)	86 / 211 (40.76%)	66 / 183 (36.07%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	123	86	66	0	0
Fatigue (Mild)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[7]	0 / 301 (0.00%)	93 / 218 (42.66%)	69 / 207 (33.33%)	53 / 177 (29.94%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	93	69	53	0	0
Fatigue (Moderate)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[8]	0 / 301 (0.00%)	53 / 195 (27.18%)	29 / 184 (15.76%)	25 / 163 (15.34%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	53	29	25	0	0
Fatigue (Severe)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[9]	0 / 301 (0.00%)	16 / 178 (8.99%)	12 / 183 (6.56%)	10 / 156 (6.41%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	16	12	10	0	0
Headache (Any)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[10]	0 / 301 (0.00%)	111 / 220 (50.45%)	81 / 207 (39.13%)	57 / 177 (32.20%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	111	81	57	0	0
Headache (Mild)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[11]	0 / 301 (0.00%)	96 / 209 (45.93%)	59 / 199 (29.65%)	45 / 171 (26.32%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	96	59	45	0	0
Headache (Moderate)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[12]	0 / 301 (0.00%)	39 / 191 (20.42%)	39 / 190 (20.53%)	22 / 160 (13.75%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	39	39	22	0	0
Headache (Severe)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[13]	0 / 301 (0.00%)	14 / 176 (7.95%)	5 / 182 (2.75%)	8 / 154 (5.19%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	14	5	8	0	0
Vomiting (Any)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[14]	0 / 301 (0.00%)	23 / 180 (12.78%)	19 / 185 (10.27%)	14 / 159 (8.81%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	23	19	14	0	0
Vomiting (Mild)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[15]	0 / 301 (0.00%)	20 / 180 (11.11%)	14 / 183 (7.65%)	10 / 156 (6.41%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	20	14	10	0	0
Vomiting (Moderate)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[16]	0 / 301 (0.00%)	2 / 172 (1.16%)	4 / 179 (2.23%)	6 / 155 (3.87%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	2	4	6	0	0
Vomiting (Severe)
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.All reporting of severe vomiting were confirmed as data entry errors.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[17]	0 / 301 (0.00%)	2 / 173 (1.16%)	3 / 179 (1.68%)	3 / 153 (1.96%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	2	3	3	0	0
Diarrhea (Any)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[18]	0 / 301 (0.00%)	60 / 199 (30.15%)	35 / 190 (18.42%)	27 / 162 (16.67%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	60	35	27	0	0
Diarrhea (Mild)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[19]	0 / 301 (0.00%)	49 / 196 (25.00%)	30 / 187 (16.04%)	24 / 160 (15.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	49	30	24	0	0
Diarrhea (Moderate)
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. LRs and SEs were to be assessed for 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[20]	0 / 301 (0.00%)	14 / 177 (7.91%)	10 / 180 (5.56%)	6 / 153 (3.92%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	14	10	6	0	0
Diarrhea (Severe)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[21]	0 / 301 (0.00%)	2 / 173 (1.16%)	5 / 179 (2.79%)	4 / 154 (2.60%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	2	5	4	0	0
Muscle pain (Any)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[22]	0 / 301 (0.00%)	126 / 226 (55.75%)	97 / 216 (44.91%)	81 / 191 (42.41%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	126	97	81	0	0
Muscle pain (Mild)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[23]	0 / 301 (0.00%)	100 / 213 (46.95%)	75 / 208 (36.06%)	57 / 182 (31.32%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	100	75	57	0	0
Muscle pain (Moderate)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[24]	0 / 301 (0.00%)	36 / 187 (19.25%)	34 / 191 (17.80%)	30 / 163 (18.40%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	36	34	30	0	0
Muscle pain (Severe)
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 ^[25]	0 / 301 (0.00%)	10 / 177 (5.65%)	7 / 180 (3.89%)	11 / 156 (7.05%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	10	7	11	0	0
Joint pain (Any)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[26]	0 / 301 (0.00%)	79 / 205 (38.54%)	61 / 201 (30.35%)	49 / 174 (28.16%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	79	61	49	0	0
Joint pain (Mild)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[27]	0 / 301 (0.00%)	63 / 199 (31.66%)	43 / 193 (22.28%)	37 / 170 (21.76%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	63	43	37	0	0
Joint pain (Moderate)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[28]	0 / 301 (0.00%)	28 / 184 (15.22%)	22 / 188 (11.70%)	18 / 159 (11.32%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	28	22	18	0	0
Joint pain (Severe)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Systemic Events 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[29]	0 / 301 (0.00%)	8 / 175 (4.57%)	6 / 179 (3.35%)	4 / 152 (2.63%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	8	6	4	0	0
Reproductive system and breast disorders
Dysmenorrhoea
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	1 / 290 (0.34%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	0	1	0	0	0
Gynaecomastia
subjects affected / exposed	1 / 301 (0.33%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	1	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	4 / 301 (1.33%)	4 / 301 (1.33%)	3 / 290 (1.03%)	1 / 286 (0.35%)	4 / 282 (1.42%)	0 / 282 (0.00%)
occurrences all number	4	4	3	1	4	0
Oropharyngeal pain
subjects affected / exposed	0 / 301 (0.00%)	1 / 301 (0.33%)	0 / 290 (0.00%)	2 / 286 (0.70%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	1	0	2	0	0
Rhinorrhoea
subjects affected / exposed	0 / 301 (0.00%)	1 / 301 (0.33%)	1 / 290 (0.34%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	1	1	0	0	0
Upper-airway cough syndrome
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	1 / 290 (0.34%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	0	1	0	0	0
Wheezing
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	1 / 290 (0.34%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	0	1	0	0	0
Nasal disorder
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	1 / 286 (0.35%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	0	0	1	0	0
Psychiatric disorders
Abnormal dreams
subjects affected / exposed	1 / 301 (0.33%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	1	0	0	0	0	0
Agitation
subjects affected / exposed	1 / 301 (0.33%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	1	0	0	0	0	0
Depression
subjects affected / exposed	1 / 301 (0.33%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	1	0	0	0	0	0
Injury, poisoning and procedural complications
Radius fracture
subjects affected / exposed	0 / 301 (0.00%)	1 / 301 (0.33%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	1	0	0	0	0
Lip injury
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	1 / 290 (0.34%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	0	1	0	0	0
Procedural pain
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	1 / 290 (0.34%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	0	1	0	0	0
Nervous system disorders
Headache
subjects affected / exposed	0 / 301 (0.00%)	3 / 301 (1.00%)	1 / 290 (0.34%)	1 / 286 (0.35%)	2 / 282 (0.71%)	0 / 282 (0.00%)
occurrences all number	0	3	1	1	2	0
Intercostal neuralgia
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	1 / 286 (0.35%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	0	0	1	0	0
Sciatica
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	1 / 282 (0.35%)	0 / 282 (0.00%)
occurrences all number	0	0	0	0	1	0
Dizziness
subjects affected / exposed	1 / 301 (0.33%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	1	0	0	0	0	0
Blood and lymphatic system disorders
Lymphadenopathy
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	1 / 282 (0.35%)
occurrences all number	0	0	0	0	0	1
Eye disorders
Conjunctivitis
subjects affected / exposed	1 / 301 (0.33%)	1 / 301 (0.33%)	0 / 290 (0.00%)	0 / 286 (0.00%)	1 / 282 (0.35%)	0 / 282 (0.00%)
occurrences all number	1	1	0	0	1	0
Gastrointestinal disorders
Nausea
subjects affected / exposed	0 / 301 (0.00%)	1 / 301 (0.33%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	1	0	0	0	0
Salivary gland enlargement
subjects affected / exposed	0 / 301 (0.00%)	1 / 301 (0.33%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	1	0	0	0	0
Vomiting
subjects affected / exposed	0 / 301 (0.00%)	1 / 301 (0.33%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	1	0	0	0	0
Abdominal pain
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	1 / 286 (0.35%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	0	0	1	0	0
Gastritis
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	1 / 286 (0.35%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	0	0	1	0	0
Stomatitis
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	1 / 286 (0.35%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	0	0	1	0	0
Abdominal pain upper
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	1 / 282 (0.35%)	0 / 282 (0.00%)
occurrences all number	0	0	0	0	1	0
Diarrhoea
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	1 / 282 (0.35%)	0 / 282 (0.00%)
occurrences all number	0	0	0	0	1	0
Gastroduodenitis
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	1 / 282 (0.35%)
occurrences all number	0	0	0	0	0	1
Skin and subcutaneous tissue disorders
Eczema
subjects affected / exposed	0 / 301 (0.00%)	1 / 301 (0.33%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	1	0	0	0	0
Exfoliative rash
subjects affected / exposed	0 / 301 (0.00%)	1 / 301 (0.33%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	1	0	0	0	0
Rash
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	2 / 286 (0.70%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	0	0	2	0	0
Pruritus
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	1 / 282 (0.35%)	0 / 282 (0.00%)
occurrences all number	0	0	0	0	1	0
Urticaria
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	1 / 282 (0.35%)	0 / 282 (0.00%)
occurrences all number	0	0	0	0	1	0
Redness (Any)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[30]	0 / 301 (0.00%)	21 / 180 (11.67%)	16 / 187 (8.56%)	7 / 154 (4.55%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	21	16	7	0	0
Redness (Mild)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[31]	0 / 301 (0.00%)	20 / 179 (11.17%)	12 / 186 (6.45%)	6 / 153 (3.92%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	20	12	6	0	0
Redness (Moderate)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[32]	0 / 301 (0.00%)	2 / 173 (1.16%)	4 / 180 (2.22%)	2 / 152 (1.32%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	2	4	2	0	0
Redness (Severe)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[33]	0 / 301 (0.00%)	0 / 172 (0.00%)	1 / 178 (0.56%)	0 / 150 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	0	1	0	0	0
Swelling (Any)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[34]	0 / 301 (0.00%)	38 / 191 (19.90%)	33 / 191 (17.28%)	19 / 160 (11.88%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	38	33	19	0	0
Swelling (Mild)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[35]	0 / 301 (0.00%)	24 / 184 (13.04%)	26 / 190 (13.68%)	12 / 157 (7.64%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	24	26	12	0	0
Swelling (Moderate)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[36]	0 / 301 (0.00%)	16 / 181 (8.84%)	12 / 184 (6.52%)	8 / 154 (5.19%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	16	12	8	0	0
Swelling (Severe)
Additional description: Subjects affected, occurrences for LRs, SEs is same as data collected through e-diaries cannot be used to distinguish 1 occurrence from another within subject. LRs, SEs were assessed at 13vPnC Dose 1,2 and 3 only. Swelling(severe)= data entry error.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[37]	0 / 301 (0.00%)	1 / 172 (0.58%)	0 / 178 (0.00%)	0 / 150 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	1	0	0	0	0
Pain at injection site (Any)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[38]	0 / 301 (0.00%)	156 / 238 (65.55%)	166 / 236 (70.34%)	131 / 213 (61.50%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	156	166	131	0	0
Pain at injection site (Mild)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[39]	0 / 301 (0.00%)	127 / 228 (55.70%)	139 / 227 (61.23%)	107 / 201 (53.23%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	127	139	107	0	0
Pain at injection site (Moderate)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[40]	0 / 301 (0.00%)	44 / 188 (23.40%)	51 / 199 (25.63%)	36 / 167 (21.56%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	44	51	36	0	0
Pain at injection site (Severe)
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. LRs and SEs were to be assessed at 13vPnC Dose 1, 2 and 3 only.
alternative dictionary used: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[41]	0 / 301 (0.00%)	9 / 175 (5.14%)	8 / 179 (4.47%)	8 / 156 (5.13%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	9	8	8	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 301 (0.00%)	1 / 301 (0.33%)	0 / 290 (0.00%)	2 / 286 (0.70%)	1 / 282 (0.35%)	0 / 282 (0.00%)
occurrences all number	0	1	0	2	1	0
Pain in extremity
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	1 / 290 (0.34%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	0	1	0	0	0
Myalgia
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	1 / 286 (0.35%)	1 / 282 (0.35%)	0 / 282 (0.00%)
occurrences all number	0	0	0	1	1	0
Back pain
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	1 / 282 (0.35%)	0 / 282 (0.00%)
occurrences all number	0	0	0	0	1	0
Spondylolisthesis
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	1 / 282 (0.35%)	0 / 282 (0.00%)
occurrences all number	0	0	0	0	1	0
Scoliosis
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	1 / 282 (0.35%)
occurrences all number	0	0	0	0	0	1
Infections and infestations
Influenza
subjects affected / exposed	0 / 301 (0.00%)	5 / 301 (1.66%)	1 / 290 (0.34%)	8 / 286 (2.80%)	3 / 282 (1.06%)	1 / 282 (0.35%)
occurrences all number	0	5	1	8	3	1
Gastroenteritis
subjects affected / exposed	0 / 301 (0.00%)	3 / 301 (1.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	3	0	0	0	0
Upper respiratory tract infection
subjects affected / exposed	6 / 301 (1.99%)	3 / 301 (1.00%)	4 / 290 (1.38%)	1 / 286 (0.35%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	6	3	4	1	0	0
Sinusitis
subjects affected / exposed	0 / 301 (0.00%)	2 / 301 (0.66%)	1 / 290 (0.34%)	1 / 286 (0.35%)	1 / 282 (0.35%)	1 / 282 (0.35%)
occurrences all number	0	2	1	1	1	1
Cystitis
subjects affected / exposed	0 / 301 (0.00%)	1 / 301 (0.33%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	1	0	0	0	0
Herpes virus infection
subjects affected / exposed	0 / 301 (0.00%)	1 / 301 (0.33%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	1	0	0	0	0
Oral herpes
subjects affected / exposed	0 / 301 (0.00%)	1 / 301 (0.33%)	1 / 290 (0.34%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	1	1	0	0	0
Otitis media
subjects affected / exposed	0 / 301 (0.00%)	1 / 301 (0.33%)	0 / 290 (0.00%)	1 / 286 (0.35%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	1	0	1	0	0
Respiratory tract infection
subjects affected / exposed	0 / 301 (0.00%)	1 / 301 (0.33%)	0 / 290 (0.00%)	1 / 286 (0.35%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	1	0	1	0	0
Rhinitis
subjects affected / exposed	1 / 301 (0.33%)	1 / 301 (0.33%)	2 / 290 (0.69%)	4 / 286 (1.40%)	2 / 282 (0.71%)	0 / 282 (0.00%)
occurrences all number	1	1	2	4	2	0
Subcutaneous abscess
subjects affected / exposed	0 / 301 (0.00%)	1 / 301 (0.33%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	1	0	0	0	0
Tinea capitis
subjects affected / exposed	0 / 301 (0.00%)	1 / 301 (0.33%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	1	0	0	0	0
Tonsillitis
subjects affected / exposed	1 / 301 (0.33%)	1 / 301 (0.33%)	0 / 290 (0.00%)	2 / 286 (0.70%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	1	1	0	2	0	0
Tooth infection
subjects affected / exposed	0 / 301 (0.00%)	1 / 301 (0.33%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	1	0	0	0	0
Viraemia
subjects affected / exposed	0 / 301 (0.00%)	1 / 301 (0.33%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	1	0	0	0	0
Body tinea
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	1 / 290 (0.34%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	0	1	0	0	0
Lower respiratory tract infection
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	1 / 290 (0.34%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	0	1	0	0	0
Pharyngitis
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	1 / 290 (0.34%)	1 / 286 (0.35%)	1 / 282 (0.35%)	1 / 282 (0.35%)
occurrences all number	0	0	1	1	1	1
Pharyngitis bacterial
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	1 / 290 (0.34%)	1 / 286 (0.35%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	0	1	1	0	0
Tooth abscess
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	1 / 286 (0.35%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	0	0	1	0	0
Varicella
subjects affected / exposed	3 / 301 (1.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	1 / 286 (0.35%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	3	0	0	1	0	0
Impetigo
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	1 / 282 (0.35%)	0 / 282 (0.00%)
occurrences all number	0	0	0	0	1	0
Laryngitis
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	1 / 282 (0.35%)	0 / 282 (0.00%)
occurrences all number	0	0	0	0	1	0
Pneumonia
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	1 / 282 (0.35%)	0 / 282 (0.00%)
occurrences all number	0	0	0	0	1	0
Oral candidiasis
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	1 / 282 (0.35%)
occurrences all number	0	0	0	0	0	1
Parotitis
subjects affected / exposed	1 / 301 (0.33%)	0 / 301 (0.00%)	0 / 290 (0.00%)	0 / 286 (0.00%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	1	0	0	0	0	0
Metabolism and nutrition disorders
Hypercholesterolaemia
subjects affected / exposed	0 / 301 (0.00%)	0 / 301 (0.00%)	0 / 290 (0.00%)	1 / 286 (0.35%)	0 / 282 (0.00%)	0 / 282 (0.00%)
occurrences all number	0	0	0	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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.
[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 with known values.

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Were there any global substantial amendments to the protocol? Yes

01 Sep 2010

1. Reference to the 7443-V form was removed from the Safety Evaluation section, Adverse Event (AE) and Serious Adverse Event (SAE) Recording and Reporting section, and Serious Adverse Event Reporting Requirements section. 2. Updated informed consent procedures in Visit 1 (Baseline Visit) to add “If Visit 0 was not applicable, obtain informed consent…” and new text pertaining to determination of AEs or SAEs for subjects who had a Screening Visit was added to Visit 1. 3. Reporting time lines for SAEs were updated to “24 hours” and wordings “instructing sites to follow-up on reported SAEs by phone” and “A business day was defined as any day except weekends, December 25, and January 1” was removed from the Serious Adverse Event Reporting Requirements section. 4. Updated commencement of concomitant medications reporting to “Visit 1” and the text “In addition for subjects undergoing Visit 0 (Screening Visit), concomitant medications received following an AE or SAE was recorded at Visit 0” was added to Concomitant Treatment sections. 5. Subject Discontinuation or Withdrawal section was updated to reflect follow-up for safety reporting applied “If the subject had received at least one dose of investigational product” and that “Subjects who were discontinued prior to Visit 1 were not be followed for safety”.

28 Feb 2012

1. Section of Adverse Events, revised to reflect EU CT-3 (European Union Clinical Trials - 3) requirements and standard Pfizer safety terminology. 2. Section of Reporting of Safety Issues and Serious Breaches of the Protocol or ICH (International Conference on Harmonisation) GCP (Good Clinical Practice), was added to clarify the need for immediate notification should there be a clinical hold or similar issue taken for purposes of safety so that Pfizer can fulfill its reporting obligations as sponsor in accordance with local legislation.

28 Mar 2013

1. In a Protocol Administrative Changes and Clarifications letter, dated 28 March 2013, the participating sites’ requirements to report SAEs after active reporting period in Amendment 3, wording was clarified from “Should an investigator be made aware of any SAE occurring any time after the active reporting period, it must be promptly reported.” This was updated as follows: “Serious adverse events occurring to a subject after the active reporting period has ended should be reported to the Sponsor if the investigator becomes aware of them; at a minimum, all serious adverse events that the investigator believes have at least a reasonable possibility of being related to study drug are to be reported to the Sponsor.”

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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Primary: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Subjects

Primary: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Subjects

Secondary: Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Subjects

Secondary: Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Subjects

Secondary: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Subjects

Secondary: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Subjects

Secondary: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Subjects

Secondary: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Subjects

Secondary: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Subjects

Secondary: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Subjects

Other pre-specified: Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Subjects

Other pre-specified: Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Subjects

Other pre-specified: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Subjects

Other pre-specified: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Subjects

Other pre-specified: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Subjects

Other pre-specified: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Subjects

Other pre-specified: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Subjects

Other pre-specified: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Subjects

Other pre-specified: Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Subjects

Other pre-specified: Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Subjects

Other pre-specified: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Subjects

Other pre-specified: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Subjects

Other pre-specified: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Subjects

Other pre-specified: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Subjects

Other pre-specified: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Subjects

Other pre-specified: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Subjects

Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Local Reactions: 13vPnC Dose 1

Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Local Reactions: 13vPnC Dose 1

Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Local Reactions: 13vPnC Dose 2

Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Local Reactions: 13vPnC Dose 2

Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Local Reactions: 13vPnC Dose 3

Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Local Reactions: 13vPnC Dose 3

Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Systemic Events: 13vPnC Dose 1

Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Systemic Events: 13vPnC Dose 1

Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Systemic Events: 13vPnC Dose 2

Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Systemic Events: 13vPnC Dose 2

Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Systemic Events: 13vPnC Dose 3

Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-Specified Systemic Events: 13vPnC Dose 3

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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