Trial Outcomes & Findings for Study Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose. (NCT NCT01026038)

Last Updated: 2012-02-08

Results Overview

Antibody GMC as measured by microgram/millilitre (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

263 participants

Primary outcome timeframe

One month after vaccination

Results posted on

2012-02-08

Participant Flow

A total of 263 participants who had received a 4-dose vaccination series of pneumococcal conjugate vaccine as part of study 6096A1-008 (NCT00366678) were enrolled for this study. Out of those 1 participant was a screen failure and was not included in results.

Participant milestones

Participant milestones
Measure	13vPnC/13vPnC/13vPnC Single dose (0.5 milliliter \[mL\]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.	7vPnC/7vPnC/13vPnC Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.	7vPnC/13vPnC/13vPnC Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
Overall Study STARTED	130	65	67
Overall Study COMPLETED	129	64	67
Overall Study NOT COMPLETED	1	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	13vPnC/13vPnC/13vPnC Single dose (0.5 milliliter \[mL\]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.	7vPnC/7vPnC/13vPnC Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.	7vPnC/13vPnC/13vPnC Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
Overall Study Lost to Follow-up	1	1	0

Baseline Characteristics

Study Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	13vPnC/13vPnC/13vPnC n=130 Participants Single dose (0.5 milliliter \[mL\]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.	7vPnC/7vPnC/13vPnC n=65 Participants Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.	7vPnC/13vPnC/13vPnC n=67 Participants Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.	Total n=262 Participants Total of all reporting groups
Age Continuous	3.4 Years STANDARD_DEVIATION 0.25 • n=5 Participants	3.4 Years STANDARD_DEVIATION 0.24 • n=7 Participants	3.5 Years STANDARD_DEVIATION 0.25 • n=5 Participants	3.4 Years STANDARD_DEVIATION 0.25 • n=4 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	29 Participants n=7 Participants	40 Participants n=5 Participants	139 Participants n=4 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	36 Participants n=7 Participants	27 Participants n=5 Participants	123 Participants n=4 Participants

PRIMARY outcome

Timeframe: One month after vaccination

Population: Evaluable immunogenicity population: eligible participants, randomized, blood drawn within required timeframes, at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. N= number of participants with determinate IgG antibody concentration to serotype.

Outcome measures

Outcome measures
Measure	13vPnC/13vPnC/13vPnC n=120 Participants Single dose (0.5 milliliter \[mL\]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.	7vPnC/7vPnC/13vPnC n=57 Participants Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.	7vPnC/13vPnC/13vPnC n=58 Participants Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine 4	10.34 mcg/mL Interval 8.94 to 11.97	12.79 mcg/mL Interval 10.0 to 16.35	8.98 mcg/mL Interval 6.98 to 11.56
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine 6B	31.62 mcg/mL Interval 27.02 to 37.01	51.07 mcg/mL Interval 38.65 to 67.49	35.38 mcg/mL Interval 27.25 to 45.93
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine 9V	6.76 mcg/mL Interval 5.9 to 7.73	6.50 mcg/mL Interval 5.31 to 7.95	6.19 mcg/mL Interval 5.04 to 7.61
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine 14	21.55 mcg/mL Interval 18.41 to 25.24	21.15 mcg/mL Interval 16.89 to 26.48	20.73 mcg/mL Interval 16.45 to 26.12
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine 18C	4.56 mcg/mL Interval 3.93 to 5.29	6.12 mcg/mL Interval 4.89 to 7.65	5.35 mcg/mL Interval 4.27 to 6.71
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine 19F	16.59 mcg/mL Interval 13.57 to 20.28	12.07 mcg/mL Interval 9.35 to 15.59	15.09 mcg/mL Interval 11.17 to 20.39
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine 23F	8.68 mcg/mL Interval 7.5 to 10.03	10.87 mcg/mL Interval 8.3 to 14.22	9.10 mcg/mL Interval 7.34 to 11.28
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine 1	10.72 mcg/mL Interval 9.17 to 12.52	2.96 mcg/mL Interval 2.45 to 3.59	20.69 mcg/mL Interval 16.14 to 26.53
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine 3	1.81 mcg/mL Interval 1.46 to 2.23	1.60 mcg/mL Interval 1.19 to 2.17	2.07 mcg/mL Interval 1.66 to 2.59
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine 5	10.00 mcg/mL Interval 8.63 to 11.58	2.86 mcg/mL Interval 2.37 to 3.46	19.20 mcg/mL Interval 14.93 to 24.7
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine 6A	23.09 mcg/mL Interval 19.5 to 27.33	14.38 mcg/mL Interval 10.53 to 19.64	18.60 mcg/mL Interval 13.87 to 24.93
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine 7F	8.23 mcg/mL Interval 7.11 to 9.52	5.04 mcg/mL Interval 4.16 to 6.11	8.02 mcg/mL Interval 6.66 to 9.67
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine 19A	17.10 mcg/mL Interval 14.54 to 20.11	8.58 mcg/mL Interval 6.7 to 10.99	16.46 mcg/mL Interval 13.42 to 20.19

PRIMARY outcome

Timeframe: Seven days after vaccination

Population: Safety population: all participants who received the single dose of 13vPnC vaccination. "n" is signifying number of participants reporting yes for at least 1 day or no for all days, for each group, respectively.

Local reactions (redness, swelling and pain) were reported using electronic diary. Redness and swelling were recorded in caliper units (range 1 to 14+), each caliper unit represented 0.5 cm. Categorized as any, absent (no redness or swelling present; 0 caliper units), mild (0.5 to 2.0 cm; 1 to 4 caliper units); moderate (2.5 to 7.0 cm; 5 to 14 caliper units); or severe (\>7.0 cm; \>14 caliper units). Pain was categorized as any, mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity. Participants may be reported in more than 1 category.

Outcome measures

Outcome measures
Measure	13vPnC/13vPnC/13vPnC n=130 Participants Single dose (0.5 milliliter \[mL\]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.	7vPnC/7vPnC/13vPnC n=64 Participants Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.	7vPnC/13vPnC/13vPnC n=64 Participants Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
Percentage of Participants With Prespecified Local Reactions Pain: Any (n= 112, 52, 53)	55.4 Percentage of Participants	55.8 Percentage of Participants	64.2 Percentage of Participants
Percentage of Participants With Prespecified Local Reactions Pain: Mild (n= 109, 51, 51)	50.5 Percentage of Participants	49.0 Percentage of Participants	56.9 Percentage of Participants
Percentage of Participants With Prespecified Local Reactions Pain: Moderate (n= 95, 47, 48)	17.9 Percentage of Participants	25.5 Percentage of Participants	20.8 Percentage of Participants
Percentage of Participants With Prespecified Local Reactions Pain: Severe (n= 90, 43, 45)	1.1 Percentage of Participants	2.3 Percentage of Participants	2.2 Percentage of Participants
Percentage of Participants With Prespecified Local Reactions Swelling: Any (101, 48, 47)	39.6 Percentage of Participants	41.7 Percentage of Participants	27.7 Percentage of Participants
Percentage of Participants With Prespecified Local Reactions Swelling: Mild (n= 96, 48, 47)	28.1 Percentage of Participants	35.4 Percentage of Participants	23.4 Percentage of Participants
Percentage of Participants With Prespecified Local Reactions Swelling: Moderate (n= 97, 44, 46)	24.7 Percentage of Participants	20.5 Percentage of Participants	10.9 Percentage of Participants
Percentage of Participants With Prespecified Local Reactions Swelling: Severe (n= 90, 43, 45)	0.0 Percentage of Participants	2.3 Percentage of Participants	0.0 Percentage of Participants
Percentage of Participants With Prespecified Local Reactions Redness: Any (n= 105, 50, 50)	48.6 Percentage of Participants	54.0 Percentage of Participants	46.0 Percentage of Participants
Percentage of Participants With Prespecified Local Reactions Redness: Mild (n= 101, 49, 48)	38.6 Percentage of Participants	40.8 Percentage of Participants	37.5 Percentage of Participants
Percentage of Participants With Prespecified Local Reactions Redness: Moderate (n= 95, 45, 47)	22.1 Percentage of Participants	31.1 Percentage of Participants	17.0 Percentage of Participants
Percentage of Participants With Prespecified Local Reactions Redness: Severe (n= 90, 43, 45)	0.0 Percentage of Participants	2.3 Percentage of Participants	0.0 Percentage of Participants

PRIMARY outcome

Timeframe: Seven days after vaccination

Systemic events (any fever \>= 38 degree celsius \[C\], vomiting, diarrhea, and fatigue) were reported using electronic diary. Fever categorized as \>=38 to \<=39 degree C; \>39 to \<=40 degree C; \>40 degree C. Vomiting: mild (1-2 times/day ); moderate (\>2 times/day); severe (requires intravenous hydration). Diarrhea: mild (2-3 loose stools/day); moderate (4-5 stools/day); severe (\>=6 loose stools/day). Fatigue: mild (does not interfere with activity); moderate (some interference with activity); severe (prevents daily routine activity). Participants may be reported in more than 1 category.

Outcome measures

Outcome measures
Measure	13vPnC/13vPnC/13vPnC n=130 Participants Single dose (0.5 milliliter \[mL\]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.	7vPnC/7vPnC/13vPnC n=64 Participants Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.	7vPnC/13vPnC/13vPnC n=64 Participants Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
Percentage of Participants With Prespecified Systemic Events Fever >=38 to <=39 degree C (n= 93, 49, 46)	15.1 Percentage of Participants	28.6 Percentage of Participants	19.6 Percentage of Participants
Percentage of Participants With Prespecified Systemic Events Fever >39 to <=40 degree C (n= 92, 43, 46)	2.2 Percentage of Participants	4.7 Percentage of Participants	2.2 Percentage of Participants
Percentage of Participants With Prespecified Systemic Events Fever >40 degree C (n= 90, 43, 45)	0.0 Percentage of Participants	0.0 Percentage of Participants	2.2 Percentage of Participants
Percentage of Participants With Prespecified Systemic Events Vomiting: Any (n= 91, 44, 45)	3.3 Percentage of Participants	9.1 Percentage of Participants	6.7 Percentage of Participants
Percentage of Participants With Prespecified Systemic Events Vomiting: Mild (n= 91, 44, 45)	3.3 Percentage of Participants	9.1 Percentage of Participants	6.7 Percentage of Participants
Percentage of Participants With Prespecified Systemic Events Vomiting: Moderate (n= 90, 43, 45)	0.0 Percentage of Participants	0.0 Percentage of Participants	0.0 Percentage of Participants
Percentage of Participants With Prespecified Systemic Events Vomiting: Severe (n= 90, 43, 45)	0.0 Percentage of Participants	0.0 Percentage of Participants	0.0 Percentage of Participants
Percentage of Participants With Prespecified Systemic Events Diarrhea: Any (n= 90, 45, 47)	8.9 Percentage of Participants	17.8 Percentage of Participants	8.5 Percentage of Participants
Percentage of Participants With Prespecified Systemic Events Diarrhea: Mild (n= 90, 45, 47)	8.9 Percentage of Participants	17.8 Percentage of Participants	8.5 Percentage of Participants
Percentage of Participants With Prespecified Systemic Events Diarrhea: Moderate (n= 90, 43, 45)	1.1 Percentage of Participants	0.0 Percentage of Participants	0.0 Percentage of Participants
Percentage of Participants With Prespecified Systemic Events Diarrhea: Severe (n= 90, 43, 45)	0.0 Percentage of Participants	0.0 Percentage of Participants	0.0 Percentage of Participants
Percentage of Participants With Prespecified Systemic Events Fatigue: Any (n= 103, 54, 48)	40.8 Percentage of Participants	51.9 Percentage of Participants	31.3 Percentage of Participants
Percentage of Participants With Prespecified Systemic Events Fatigue: Mild (n= 100, 49, 48)	34.0 Percentage of Participants	34.7 Percentage of Participants	20.8 Percentage of Participants
Percentage of Participants With Prespecified Systemic Events Fatigue: Moderate (n= 96, 49, 46)	16.7 Percentage of Participants	30.6 Percentage of Participants	15.2 Percentage of Participants
Percentage of Participants With Prespecified Systemic Events Fatigue: Severe (n= 92, 43, 45)	3.3 Percentage of Participants	2.3 Percentage of Participants	2.2 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 7 days before vaccination

IgG GMC to 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 all the participants using a standardized anti-pneumococcal IgG enzymelinked immunosorbent assay (ELISA). CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Outcome measures

Outcome measures
Measure	13vPnC/13vPnC/13vPnC n=120 Participants Single dose (0.5 milliliter \[mL\]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.	7vPnC/7vPnC/13vPnC n=57 Participants Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.	7vPnC/13vPnC/13vPnC n=58 Participants Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine 4	0.17 mcg/mL Interval 0.15 to 0.21	0.23 mcg/mL Interval 0.18 to 0.3	0.18 mcg/mL Interval 0.15 to 0.22
Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine 6B	2.86 mcg/mL Interval 2.35 to 3.48	4.10 mcg/mL Interval 2.96 to 5.68	3.21 mcg/mL Interval 2.37 to 4.36
Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine 9V	0.72 mcg/mL Interval 0.6 to 0.85	0.92 mcg/mL Interval 0.72 to 1.17	0.71 mcg/mL Interval 0.58 to 0.87
Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine 14	0.77 mcg/mL Interval 0.61 to 0.98	0.74 mcg/mL Interval 0.52 to 1.06	0.59 mcg/mL Interval 0.42 to 0.83
Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine 18C	0.21 mcg/mL Interval 0.17 to 0.25	0.36 mcg/mL Interval 0.28 to 0.47	0.23 mcg/mL Interval 0.18 to 0.28
Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine 19F	2.22 mcg/mL Interval 1.67 to 2.95	2.11 mcg/mL Interval 1.43 to 3.11	1.44 mcg/mL Interval 1.04 to 2.02
Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine 23F	1.26 mcg/mL Interval 1.0 to 1.58	1.56 mcg/mL Interval 1.19 to 2.05	1.18 mcg/mL Interval 0.92 to 1.52
Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine 1	0.35 mcg/mL Interval 0.29 to 0.43	0.14 mcg/mL Interval 0.09 to 0.2	0.28 mcg/mL Interval 0.23 to 0.34
Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine 3	0.50 mcg/mL Interval 0.35 to 0.71	0.47 mcg/mL Interval 0.29 to 0.75	0.42 mcg/mL Interval 0.3 to 0.58
Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine 5	1.28 mcg/mL Interval 1.07 to 1.53	1.12 mcg/mL Interval 0.89 to 1.41	1.41 mcg/mL Interval 1.19 to 1.67
Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine 6A	4.05 mcg/mL Interval 3.25 to 5.04	1.89 mcg/mL Interval 1.5 to 2.38	2.47 mcg/mL Interval 1.91 to 3.21
Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine 7F	0.65 mcg/mL Interval 0.55 to 0.78	0.21 mcg/mL Interval 0.15 to 0.3	0.77 mcg/mL Interval 0.62 to 0.96
Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine 19A	6.16 mcg/mL Interval 4.88 to 7.79	3.38 mcg/mL Interval 2.6 to 4.41	4.63 mcg/mL Interval 3.43 to 6.26

SECONDARY outcome

Timeframe: Four to seven days after vaccination

IgG GMC to 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 all the participants using a standardized anti-pneumococcal IgG ELISA. CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Outcome measures

Outcome measures
Measure	13vPnC/13vPnC/13vPnC n=44 Participants Single dose (0.5 milliliter \[mL\]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.	7vPnC/7vPnC/13vPnC n=18 Participants Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.	7vPnC/13vPnC/13vPnC n=22 Participants Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine 4	2.96 mcg/mL Interval 1.67 to 5.24	4.66 mcg/mL Interval 2.01 to 10.82	3.85 mcg/mL Interval 1.7 to 8.74
Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine 6B	17.78 mcg/mL Interval 12.5 to 25.3	19.15 mcg/mL Interval 8.84 to 41.48	16.26 mcg/mL Interval 8.1 to 32.66
Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine 9V	3.49 mcg/mL Interval 2.39 to 5.09	3.15 mcg/mL Interval 1.75 to 5.66	3.20 mcg/mL Interval 1.86 to 5.5
Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine 14	5.55 mcg/mL Interval 3.32 to 9.3	5.67 mcg/mL Interval 2.29 to 13.99	4.52 mcg/mL Interval 2.14 to 9.52
Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine 18C	2.31 mcg/mL Interval 1.36 to 3.91	3.34 mcg/mL Interval 1.66 to 6.72	2.51 mcg/mL Interval 1.33 to 4.73
Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine 19F	11.70 mcg/mL Interval 7.21 to 19.0	6.88 mcg/mL Interval 2.98 to 15.86	8.51 mcg/mL Interval 4.38 to 16.55
Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine 23F	5.24 mcg/mL Interval 3.49 to 7.87	5.82 mcg/mL Interval 2.97 to 11.4	6.28 mcg/mL Interval 3.5 to 11.26
Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine 1	4.24 mcg/mL Interval 2.48 to 7.26	0.56 mcg/mL Interval 0.27 to 1.18	8.00 mcg/mL Interval 3.51 to 18.23
Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine 3	1.24 mcg/mL Interval 0.79 to 1.95	1.12 mcg/mL Interval 0.56 to 2.25	1.24 mcg/mL Interval 0.9 to 1.72
Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine 5	6.00 mcg/mL Interval 4.16 to 8.66	1.43 mcg/mL Interval 0.99 to 2.06	9.81 mcg/mL Interval 5.29 to 18.19
Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine 6A	13.86 mcg/mL Interval 9.69 to 19.83	4.46 mcg/mL Interval 2.18 to 9.12	7.37 mcg/mL Interval 3.95 to 13.78
Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine 7F	3.55 mcg/mL Interval 2.35 to 5.36	1.23 mcg/mL Interval 0.69 to 2.21	3.08 mcg/mL Interval 1.72 to 5.51
Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine 19A	13.07 mcg/mL Interval 9.63 to 17.74	5.09 mcg/mL Interval 3.17 to 8.19	10.50 mcg/mL Interval 7.12 to 15.5

SECONDARY outcome

Timeframe: Up to 7 days before vaccination

Population: Evaluable immunogenicity population. N= number of participants analyzed within a given treatment group. n= number of participants with a determinate OPA antibody titer to the given serotype.

Pneumococcal OPA GMTs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

Outcome measures

Outcome measures
Measure	13vPnC/13vPnC/13vPnC n=44 Participants Single dose (0.5 milliliter \[mL\]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.	7vPnC/7vPnC/13vPnC n=18 Participants Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.	7vPnC/13vPnC/13vPnC n=22 Participants Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine 4 (n= 40, 14, 19)	8 Geometric mean titers Interval 4.4 to 13.1	46 Geometric mean titers Interval 7.8 to 268.5	45 Geometric mean titers Interval 10.6 to 190.6
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine 6B (n= 38, 16, 21)	245 Geometric mean titers Interval 92.6 to 646.9	247 Geometric mean titers Interval 49.1 to 1241.8	332 Geometric mean titers Interval 84.4 to 1304.3
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine 9V (n= 40, 18, 21)	43 Geometric mean titers Interval 16.3 to 111.9	36 Geometric mean titers Interval 8.6 to 149.1	52 Geometric mean titers Interval 14.6 to 187.8
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine 14 (n= 39, 16, 20)	98 Geometric mean titers Interval 39.7 to 242.9	40 Geometric mean titers Interval 9.2 to 174.2	49 Geometric mean titers Interval 14.4 to 163.9
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine 18C (n= 42, 17, 19)	14 Geometric mean titers Interval 6.9 to 27.7	76 Geometric mean titers Interval 15.7 to 363.0	28 Geometric mean titers Interval 7.2 to 109.7
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine 19F (n= 43, 17, 21)	48 Geometric mean titers Interval 20.8 to 112.5	49 Geometric mean titers Interval 13.0 to 182.6	40 Geometric mean titers Interval 14.0 to 112.5
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine 23F (n= 43, 16, 21)	52 Geometric mean titers Interval 22.5 to 120.3	61 Geometric mean titers Interval 13.1 to 284.3	178 Geometric mean titers Interval 54.6 to 578.7
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine 1 (n= 44, 18, 22)	6 Geometric mean titers Interval 4.5 to 7.5	5 Geometric mean titers Interval 3.4 to 6.5	10 Geometric mean titers Interval 6.9 to 15.0
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine 3 (n= 42, 17, 21)	20 Geometric mean titers Interval 11.8 to 34.6	10 Geometric mean titers Interval 4.4 to 22.2	18 Geometric mean titers Interval 12.1 to 28.0
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine 5 (n= 44, 18, 22)	4 Geometric mean titers Since all values for serotype 5 in 13v/13v/13v treatment arm was less than lower limit of quantification (LLOQ), values was set to 0.5\*limit of detection (LOD \[8\]) = 4. Hence variability (standard error) could not be estimated; CI was not estimable.	4 Geometric mean titers Since all values for serotype 5 in 7v/7v/13v treatment arm was less than LLOQ, values was set to 0.5\*LOD (8) = 4. Hence variability (standard error) could not be estimated; CI was not estimable.	4 Geometric mean titers Interval 3.6 to 5.6
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine 6A (n= 44, 16, 21)	170 Geometric mean titers Interval 72.8 to 395.5	10 Geometric mean titers Interval 3.4 to 31.4	75 Geometric mean titers Interval 22.3 to 253.9
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine 7F (n= 39, 16, 21)	60 Geometric mean titers Interval 22.5 to 157.8	47 Geometric mean titers Interval 10.0 to 225.2	389 Geometric mean titers Interval 112.0 to 1351.1
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine 19A (n= 41, 18, 20)	118 Geometric mean titers Interval 58.2 to 239.7	25 Geometric mean titers Interval 7.4 to 82.0	124 Geometric mean titers Interval 46.4 to 330.2

SECONDARY outcome

Timeframe: One month after vaccination

Serotype-specific pneumococcal 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 all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

Outcome measures

Outcome measures
Measure	13vPnC/13vPnC/13vPnC n=120 Participants Single dose (0.5 milliliter \[mL\]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.	7vPnC/7vPnC/13vPnC n=57 Participants Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.	7vPnC/13vPnC/13vPnC n=58 Participants Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine 14 (n= 115, 54, 55)	2780 Geometric mean titers Interval 2374.7 to 3254.6	3079 Geometric mean titers Interval 2450.6 to 3869.4	2979 Geometric mean titers Interval 2232.9 to 3973.4
Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine 18C (n= 117, 54, 57)	7711 Geometric mean titers Interval 6589.6 to 9023.3	7091 Geometric mean titers Interval 5655.9 to 8889.9	8431 Geometric mean titers Interval 6740.3 to 10545.7
Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine 19F (n= 118, 57, 57)	1319 Geometric mean titers Interval 1030.5 to 1689.5	1721 Geometric mean titers Interval 1316.8 to 2250.3	1914 Geometric mean titers Interval 1350.6 to 2712.5
Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine 23F (n= 118, 53, 56)	2427 Geometric mean titers Interval 2063.6 to 2855.0	2411 Geometric mean titers Interval 1792.5 to 3242.4	2673 Geometric mean titers Interval 2091.2 to 3417.3
Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine 1 (n= 119, 56, 57)	613 Geometric mean titers Interval 525.2 to 715.7	197 Geometric mean titers Interval 161.4 to 239.4	1212 Geometric mean titers Interval 968.0 to 1516.9
Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine 3 (n= 118, 56, 58)	244 Geometric mean titers Interval 214.7 to 276.4	173 Geometric mean titers Interval 139.5 to 214.5	291 Geometric mean titers Interval 239.4 to 353.7
Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine 5 (n= 118, 55, 54)	455 Geometric mean titers Interval 358.7 to 537.9	390 Geometric mean titers Interval 281.2 to 541.8	728 Geometric mean titers Interval 545.0 to 972.2
Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine 6A (n= 117, 55, 55)	5580 Geometric mean titers Interval 4593.6 to 6777.0	5596 Geometric mean titers Interval 4276.6 to 7321.2	5982 Geometric mean titers Interval 4450.7 to 8041.1
Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine 4 (n= 117, 53, 55)	5465 Geometric mean titers Interval 4698.9 to 6356.4	5208 Geometric mean titers Interval 4301.7 to 6304.2	5487 Geometric mean titers Interval 4236.9 to 7106.4
Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine 6B (n= 117, 57, 56)	6684 Geometric mean titers Interval 5638.4 to 7924.4	10042 Geometric mean titers Interval 7697.5 to 13101.6	8983 Geometric mean titers Interval 7006.9 to 11516.8
Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine 9V (n= 116, 54, 55)	5120 Geometric mean titers Interval 4456.1 to 5882.6	4052 Geometric mean titers Interval 3291.0 to 4989.7	5221 Geometric mean titers Interval 4110.4 to 6630.7
Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine 7F (n= 118, 56, 54)	4323 Geometric mean titers Interval 3794.4 to 4925.1	8048 Geometric mean titers Interval 6500.9 to 9962.2	4056 Geometric mean titers Interval 3092.2 to 5321.2
Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine 19A (n= 116, 53, 54)	1212 Geometric mean titers Interval 1048.1 to 1400.7	1249 Geometric mean titers Interval 956.5 to 1632.3	1568 Geometric mean titers Interval 1249.7 to 1966.1

SECONDARY outcome

Timeframe: One month after vaccination

Population: The data was not collected as planned as the additional, more stringent qualification and validation of the improved mcOPA assays used in this study did not support 1/8 for the quantitation of a serum response and thus the established LLOQ was used for the mcOPA assay.

Percentage of participants with at least 1/8 serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) determined in the blood samples of all participants.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One month after vaccination

Population: The data was not collected as planned as the additional, more stringent qualification and validation of the improved mcOPA assays used in this study did not support 1/2048 for serotype 7F for the quantitation of a serum response and thus the established LLOQ was used for the mcOPA assay.

Percentage of participants with at least 1/2048 serotype-specific pneumococcal OPA GMTs for serotype 7F determined in the blood samples of all participants.

Outcome measures

Outcome data not reported

POST_HOC outcome

Timeframe: One month after vaccination

Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using mcOPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. LOD established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5\*LOD for analysis.

Outcome measures

Outcome measures
Measure	13vPnC/13vPnC/13vPnC n=120 Participants Single dose (0.5 milliliter \[mL\]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.	7vPnC/7vPnC/13vPnC n=57 Participants Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.	7vPnC/13vPnC/13vPnC n=58 Participants Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine 1 (n= 119, 56, 57)	100.0 Percentage of Participants Interval 96.9 to 100.0	100.0 Percentage of Participants Interval 93.6 to 100.0	100.0 Percentage of Participants Interval 93.7 to 100.0
Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine 3 (n= 118, 56, 58)	100.0 Percentage of Participants Interval 96.9 to 100.0	98.2 Percentage of Participants Interval 90.4 to 100.0	100.0 Percentage of Participants Interval 93.8 to 100.0
Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine 5 (n= 118, 55, 54)	99.2 Percentage of Participants Interval 95.4 to 100.0	96.4 Percentage of Participants Interval 87.5 to 99.6	100.0 Percentage of Participants Interval 93.4 to 100.0
Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine 6A (n= 117, 55, 55)	100.0 Percentage of Participants Interval 96.9 to 100.0	100.0 Percentage of Participants Interval 93.5 to 100.0	100.0 Percentage of Participants Interval 93.5 to 100.0
Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine 7F (n= 118, 56, 54)	100.0 Percentage of Participants Interval 96.9 to 100.0	100.0 Percentage of Participants Interval 93.6 to 100.0	100.0 Percentage of Participants Interval 93.4 to 100.0
Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine 19A (n= 116, 53, 54)	100.0 Percentage of Participants Interval 96.9 to 100.0	100.0 Percentage of Participants Interval 93.3 to 100.0	100.0 Percentage of Participants Interval 93.4 to 100.0
Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine 4 (n= 117, 53, 55)	100.0 Percentage of Participants Interval 96.9 to 100.0	100.0 Percentage of Participants Interval 93.3 to 100.0	100.0 Percentage of Participants Interval 93.5 to 100.0
Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine 6B (n= 117, 57, 56)	100.0 Percentage of Participants Interval 96.9 to 100.0	100.0 Percentage of Participants Interval 93.7 to 100.0	100.0 Percentage of Participants Interval 93.6 to 100.0
Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine 9V (n= 116, 54, 55)	100.0 Percentage of Participants Interval 96.9 to 100.0	100.0 Percentage of Participants Interval 93.4 to 100.0	100.0 Percentage of Participants Interval 93.5 to 100.0
Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine 14 (n= 115, 54, 55)	100.0 Percentage of Participants Interval 96.8 to 100.0	100.0 Percentage of Participants Interval 93.4 to 100.0	100.0 Percentage of Participants Interval 93.5 to 100.0
Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine 18C (n= 117, 54, 57)	100.0 Percentage of Participants Interval 96.9 to 100.0	100.0 Percentage of Participants Interval 93.4 to 100.0	100.0 Percentage of Participants Interval 93.7 to 100.0
Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine 19F (n= 118, 57, 57)	98.3 Percentage of Participants Interval 94.0 to 99.8	100.0 Percentage of Participants Interval 93.7 to 100.0	98.2 Percentage of Participants Interval 90.6 to 100.0
Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine 23F (n= 118, 53, 56)	100.0 Percentage of Participants Interval 96.9 to 100.0	100.0 Percentage of Participants Interval 93.3 to 100.0	100.0 Percentage of Participants Interval 93.6 to 100.0

Adverse Events

13vPnC/13vPnC/13vPnC

Serious events: 0 serious events

Other events: 82 other events

Deaths: 0 deaths

7vPnC/7vPnC/13vPnC

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

7vPnC/13vPnC/13vPnC

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	13vPnC/13vPnC/13vPnC n=130 participants at risk Single dose (0.5 milliliter \[mL\]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.	7vPnC/7vPnC/13vPnC n=64 participants at risk Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.	7vPnC/13vPnC/13vPnC n=64 participants at risk Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
Skin and subcutaneous tissue disorders Pain (Any)	55.4% 62/112 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	55.8% 29/52 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	64.2% 34/53 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Skin and subcutaneous tissue disorders Pain (Mild)	50.5% 55/109 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	49.0% 25/51 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	56.9% 29/51 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Skin and subcutaneous tissue disorders Pain (Moderate)	17.9% 17/95 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	25.5% 12/47 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	20.8% 10/48 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Skin and subcutaneous tissue disorders Pain (Severe)	1.1% 1/90 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	2.3% 1/43 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	2.2% 1/45 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Skin and subcutaneous tissue disorders Swelling (Any)	39.6% 40/101 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	41.7% 20/48 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	27.7% 13/47 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Skin and subcutaneous tissue disorders Swelling (Mild)	28.1% 27/96 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	35.4% 17/48 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	23.4% 11/47 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Skin and subcutaneous tissue disorders Swelling (Moderate)	24.7% 24/97 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	20.5% 9/44 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	10.9% 5/46 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Skin and subcutaneous tissue disorders Swelling (Severe)	0.00% 0/90 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	2.3% 1/43 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/45 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Skin and subcutaneous tissue disorders Redness (Any)	48.6% 51/105 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	54.0% 27/50 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	46.0% 23/50 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Skin and subcutaneous tissue disorders Redness (Mild)	38.6% 39/101 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	40.8% 20/49 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	37.5% 18/48 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Skin and subcutaneous tissue disorders Redness (Moderate)	22.1% 21/95 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	31.1% 14/45 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	17.0% 8/47 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Skin and subcutaneous tissue disorders Redness (Severe)	0.00% 0/90 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	2.3% 1/43 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/45 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
General disorders Fever >= 38.0 degree C but <=39.0 degree C	15.1% 14/93 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	28.6% 14/49 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	19.6% 9/46 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
General disorders Fever >39.0 to <=40.0 degree C	2.2% 2/92 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	4.7% 2/43 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	2.2% 1/46 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
General disorders Fever >40.0 degree C	0.00% 0/90 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/43 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	2.2% 1/45 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
General disorders Vomiting (Any)	3.3% 3/91 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	9.1% 4/44 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	6.7% 3/45 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
General disorders Vomiting (Mild)	3.3% 3/91 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	9.1% 4/44 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	6.7% 3/45 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
General disorders Vomiting (Moderate)	0.00% 0/90 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/43 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/45 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
General disorders Vomiting (Severe)	0.00% 0/90 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/43 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/45 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
General disorders Diarrhea (Any)	8.9% 8/90 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	17.8% 8/45 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	8.5% 4/47 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
General disorders Diarrhea (Mild)	8.9% 8/90 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	17.8% 8/45 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	8.5% 4/47 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
General disorders Diarrhea (Moderate)	1.1% 1/90 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/43 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/45 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
General disorders Diarrhea (Severe)	0.00% 0/90 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/43 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/45 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
General disorders Fatigue (Any)	40.8% 42/103 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	51.9% 28/54 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	31.2% 15/48 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
General disorders Fatigue (Mild)	34.0% 34/100 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	34.7% 17/49 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	20.8% 10/48 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
General disorders Fatigue (Moderate)	16.7% 16/96 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	30.6% 15/49 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	15.2% 7/46 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
General disorders Fatigue (Severe)	3.3% 3/92 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	2.3% 1/43 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	2.2% 1/45 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
General disorders Injection site erythema	0.77% 1/130 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Acute tonsillitis	0.77% 1/130 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Bronchitis	1.5% 2/130 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Ear infection	0.00% 0/130 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	1.6% 1/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	1.6% 1/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Gastroenteritis	0.77% 1/130 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	1.6% 1/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	1.6% 1/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Nasopharyngitis	2.3% 3/130 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Pharyngitis	1.5% 2/130 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	1.6% 1/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Rhinitis	0.00% 0/130 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	1.6% 1/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Tonsillitis	1.5% 2/130 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	1.6% 1/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	1.6% 1/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Urinary tract infection	0.77% 1/130 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Varicella	1.5% 2/130 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	1.6% 1/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Viral infection	1.5% 2/130 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	1.6% 1/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
Injury, poisoning and procedural complications Radius fracture	0.00% 0/130 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).	1.6% 1/64 • AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC). SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).