Trial Outcomes & Findings for 13-valent Pneumococcal Conjugate Vaccine Study in Adults => 50 Years of Age in Mexico (NCT NCT01432262)

NCT ID: NCT01432262

Last Updated: 2013-01-25

Results Overview

Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a quantitative functional OPA assay. Confidence intervals (CIs) for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Individual OPA assay values below the assay LLOQ (lower limit of quantification) were set at a titer of 0.5\*limit of detection (LOD \[8\]) = (titer of 4) for the purpose of calculating the OPA GMT.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 324 participants
• Primary outcome timeframe: One month (28 to 42 days) after vaccination
• Results posted on: 2013-01-25

Participant Flow

Participant milestones

Measure	13vPnC, Cohort 1 Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.	13vPnC, Cohort 2 Participants greater than or equal to (\>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
Overall Study STARTED	162	162
Overall Study Vaccinated	162	161
Overall Study COMPLETED	160	161
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	13vPnC, Cohort 1 Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.	13vPnC, Cohort 2 Participants greater than or equal to (\>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

13-valent Pneumococcal Conjugate Vaccine Study in Adults => 50 Years of Age in Mexico

Baseline characteristics by cohort

Measure	13vPnC, Cohort 1 n=162 Participants Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.	13vPnC, Cohort 2 n=161 Participants Participants greater than or equal to (\>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.	Total n=323 Participants Total of all reporting groups
Age Continuous	55.7 years STANDARD_DEVIATION 4.0 • n=5 Participants	73.4 years STANDARD_DEVIATION 5.8 • n=7 Participants	64.5 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	96 Participants n=5 Participants	84 Participants n=7 Participants	180 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants	77 Participants n=7 Participants	143 Participants n=5 Participants

PRIMARY outcome

Timeframe: One month (28 to 42 days) after vaccination

Population: Evaluable Immunogenicity Population (EIP): eligible participants who received vaccine, had blood drawn within the pre-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, and had no other major protocol violations.

Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a quantitative functional OPA assay. Confidence intervals (CIs) for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Individual OPA assay values below the assay LLOQ (lower limit of quantification) were set at a titer of 0.5*limit of detection (LOD [8]) = (titer of 4) for the purpose of calculating the OPA GMT.

Outcome measures

Measure	13vPnC, Cohort 1 n=155 Participants Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.	13vPnC, Cohort 2 n=159 Participants Participants greater than or equal to (\>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 14	1569 titer Interval 1267.9 to 1940.3	1316 titer Interval 1068.9 to 1619.3
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	120 titer Interval 92.3 to 155.3	84 titer Interval 62.8 to 112.5
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 3	88 titer Interval 72.4 to 106.9	89 titer Interval 70.8 to 111.5
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 4	1729 titer Interval 1377.6 to 2170.9	1209 titer Interval 977.1 to 1495.9
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 5	288 titer Interval 208.6 to 398.3	285 titer Interval 208.7 to 388.9
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 6A	3380 titer Interval 2732.9 to 4179.6	3343 titer Interval 2625.2 to 4256.6
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 6B	3982 titer Interval 3273.2 to 4845.0	3384 titer Interval 2708.6 to 4227.2
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 7F	3130 titer Interval 2660.9 to 3681.4	1929 titer Interval 1564.7 to 2378.1
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 9V	2416 titer Interval 1901.0 to 3071.4	1402 titer Interval 1030.8 to 1906.8
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 18C	3063 titer Interval 2405.9 to 3900.7	2197 titer Interval 1727.2 to 2794.8
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 19A	1542 titer Interval 1257.9 to 1889.0	1196 titer Interval 990.6 to 1443.1
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 19F	1104 titer Interval 828.1 to 1473.1	1188 titer Interval 905.0 to 1558.6
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 23F	879 titer Interval 650.3 to 1187.7	930 titer Interval 667.1 to 1296.2

PRIMARY outcome

Timeframe: Within 14 days after vaccination

Population: Safety Population included all participants who received vaccine. N (Number of Participants Analyzed)=participants reporting yes for at least 1 day or no for all 14 days and n=participants reporting yes for at least 1 day or no for all 14 days for specified local reaction for each group respectively. Participants may be represented in \>1 category.

Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present), Mild (2.5 to 5.0 centimeters [cm]), Moderate (5.1 to 10.0 cm), Severe (>10 cm). Pain at injection site scaled as Any (pain present), Mild (does not interfere with activity), Moderate (interferes with activity), Severe (prevents daily activity).

Outcome measures

Measure	13vPnC, Cohort 1 n=152 Participants Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.	13vPnC, Cohort 2 n=139 Participants Participants greater than or equal to (\>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination Pain at injection site: Mild (n=151, 136)	74.2 percentage of participants Interval 66.4 to 80.9	60.3 percentage of participants Interval 51.6 to 68.6
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination Redness: Any (n=125, 120)	14.4 percentage of participants Interval 8.8 to 21.8	15.8 percentage of participants Interval 9.8 to 23.6
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination Redness: Mild (n=124, 120)	9.7 percentage of participants Interval 5.1 to 16.3	13.3 percentage of participants Interval 7.8 to 20.7
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination Redness: Moderate (n=125, 115)	8.8 percentage of participants Interval 4.5 to 15.2	7.0 percentage of participants Interval 3.1 to 13.2
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination Redness: Severe (n=125, 112)	2.4 percentage of participants Interval 0.5 to 6.9	0.0 percentage of participants Interval 0.0 to 3.2
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination Swelling: Any (n=130, 120)	21.5 percentage of participants Interval 14.8 to 29.6	13.3 percentage of participants Interval 7.8 to 20.7
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination Swelling: Mild (n=127, 120)	18.1 percentage of participants Interval 11.8 to 25.9	11.7 percentage of participants Interval 6.5 to 18.8
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination Swelling: Moderate (n=127, 114)	8.7 percentage of participants Interval 4.4 to 15.0	4.4 percentage of participants Interval 1.4 to 9.9
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination Swelling: Severe (n=125, 113)	2.4 percentage of participants Interval 0.5 to 6.9	0.9 percentage of participants Interval 0.0 to 4.8
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination Pain at injection site: Any (n=151, 137)	75.5 percentage of participants Interval 67.8 to 82.1	60.6 percentage of participants Interval 51.9 to 68.8
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination Pain at injection site: Moderate (n=130, 117)	21.5 percentage of participants Interval 14.8 to 29.6	8.5 percentage of participants Interval 4.2 to 15.2
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination Pain at injection site: Severe (n=125, 113)	3.2 percentage of participants Interval 0.9 to 8.0	3.5 percentage of participants Interval 1.0 to 8.8

PRIMARY outcome

Timeframe: Within 14 days after vaccination

Population: Safety Population included all participants who received vaccine. N (Number of Participants Analyzed)=participants reporting yes for at least 1 day or no for all 14 days and n=participants reporting yes for at least 1 day or no for all 14 days for specified systemic event for each group respectively. Participants may be represented in \>1 category.

Systemic events reported using electronic diary. Fever-Any:>=38 degrees Celsius (C), Mild (M):>=38 to <38.5 degrees C, Moderate(Mod):>=38.5 to <39 degrees C, Severe (S):>=39 to <=40 degrees C, Potentially life threatening:>40 degrees C. Headache, fatigue, muscle pain, joint pain- Any: present, M:did not interfere with activity, Mod:some interference, S:activity prevented. Vomiting- Any:present, M:1-2 times/day (d), Mod:>2/d, S:required intravenous hydration. Diarrhoea- Any:present, M:2-3 loose stools/d, Mod:4-5/d, S:>=6/d. All reports of fever >40 degrees C were confirmed as data entry errors.

Outcome measures

Measure	13vPnC, Cohort 1 n=155 Participants Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.	13vPnC, Cohort 2 n=145 Participants Participants greater than or equal to (\>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Fever: Severe (n=124, 113)	0.8 percentage of participants Interval 0.0 to 4.4	1.8 percentage of participants Interval 0.2 to 6.2
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Fatigue: Moderate (n=134, 125)	26.9 percentage of participants Interval 19.6 to 35.2	20.0 percentage of participants Interval 13.4 to 28.1
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Diarrhea: Mild (n=129, 120)	23.3 percentage of participants Interval 16.3 to 31.5	14.2 percentage of participants Interval 8.5 to 21.7
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Joint pain: Mild (n=137, 127)	30.7 percentage of participants Interval 23.1 to 39.1	29.9 percentage of participants Interval 22.1 to 38.7
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Use of medication to treat fever (n=129, 118)	11.6 percentage of participants Interval 6.7 to 18.5	13.6 percentage of participants Interval 8.0 to 21.1
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Fever: Any (n=126, 118)	2.4 percentage of participants Interval 0.5 to 6.8	10.2 percentage of participants Interval 5.4 to 17.1
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Fever: Mild (n=126, 113)	1.6 percentage of participants Interval 0.2 to 5.6	3.5 percentage of participants Interval 1.0 to 8.8
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Fever: Moderate (n=125, 113)	0.8 percentage of participants Interval 0.0 to 4.4	1.8 percentage of participants Interval 0.2 to 6.2
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Fever: Potentially life threatening (n=124, 116)	0.0 percentage of participants Interval 0.0 to 2.9	4.3 percentage of participants Interval 1.4 to 9.8
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Fatigue: Any (n=144, 132)	47.2 percentage of participants Interval 38.9 to 55.7	38.6 percentage of participants Interval 30.3 to 47.5
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Fatigue: Mild (n=142, 130)	39.4 percentage of participants Interval 31.3 to 48.0	36.2 percentage of participants Interval 27.9 to 45.0
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Fatigue: Severe (n=126, 113)	6.3 percentage of participants Interval 2.8 to 12.1	5.3 percentage of participants Interval 2.0 to 11.2
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Headache: Any (n=140, 129)	44.3 percentage of participants Interval 35.9 to 52.9	32.6 percentage of participants Interval 24.6 to 41.4
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Headache: Mild (n=140, 128)	39.3 percentage of participants Interval 31.1 to 47.9	30.5 percentage of participants Interval 22.6 to 39.2
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Headache: Moderate (n=129, 119)	18.6 percentage of participants Interval 12.3 to 26.4	16.0 percentage of participants Interval 9.9 to 23.8
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Headache: Severe (n=126, 115)	4.0 percentage of participants Interval 1.3 to 9.0	5.2 percentage of participants Interval 1.9 to 11.0
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Vomiting: Any (n=125, 113)	4.0 percentage of participants Interval 1.3 to 9.1	1.8 percentage of participants Interval 0.2 to 6.2
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Vomiting: Mild (n=125, 113)	3.2 percentage of participants Interval 0.9 to 8.0	1.8 percentage of participants Interval 0.2 to 6.2
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Vomiting: Moderate (n=124, 113)	1.6 percentage of participants Interval 0.2 to 5.7	0.9 percentage of participants Interval 0.0 to 4.8
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Vomiting: Severe (n=124, 112)	0.0 percentage of participants Interval 0.0 to 2.9	0.0 percentage of participants Interval 0.0 to 3.2
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Diarrhea: Any (n=134, 120)	26.1 percentage of participants Interval 18.9 to 34.4	15.0 percentage of participants Interval 9.1 to 22.7
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Diarrhea: Moderate (n=129, 113)	6.2 percentage of participants Interval 2.7 to 11.9	1.8 percentage of participants Interval 0.2 to 6.2
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Diarrhea: Severe (n=125, 112)	0.8 percentage of participants Interval 0.0 to 4.4	0.9 percentage of participants Interval 0.0 to 4.9
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Muscle pain: Any (n=147, 132)	60.5 percentage of participants Interval 52.2 to 68.5	43.9 percentage of participants Interval 35.3 to 52.8
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Muscle pain: Mild (n=146, 129)	59.6 percentage of participants Interval 51.2 to 67.6	40.3 percentage of participants Interval 31.8 to 49.3
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Muscle pain: Moderate (n=132, 123)	23.5 percentage of participants Interval 16.5 to 31.6	19.5 percentage of participants Interval 12.9 to 27.6
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Muscle pain: Severe (n=125, 116)	5.6 percentage of participants Interval 2.3 to 11.2	6.0 percentage of participants Interval 2.5 to 12.0
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Joint pain: Any (n=139, 129)	35.3 percentage of participants Interval 27.3 to 43.8	33.3 percentage of participants Interval 25.3 to 42.2
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Joint pain: Moderate (n=130, 123)	13.1 percentage of participants Interval 7.8 to 20.1	17.1 percentage of participants Interval 10.9 to 24.9
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Joint pain: Severe (n=125, 116)	4.0 percentage of participants Interval 1.3 to 9.1	5.2 percentage of participants Interval 1.9 to 10.9
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination Use of medication to treat pain (n=130, 121)	13.8 percentage of participants Interval 8.4 to 21.0	12.4 percentage of participants Interval 7.1 to 19.6

PRIMARY outcome

Timeframe: Baseline up to 1 Month (28 to 42 days) after vaccination

Population: Safety Population included all participants who received the vaccine.

An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between vaccination and up to 1 month (28 to 42 days) after vaccination that were absent before treatment or that worsened relative to pre-treatment state.

Outcome measures

Measure	13vPnC, Cohort 1 n=162 Participants Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.	13vPnC, Cohort 2 n=161 Participants Participants greater than or equal to (\>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) AEs	11.1 percentage of participants Interval 6.7 to 17.0	6.2 percentage of participants Interval 3.0 to 11.1
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) SAEs	0.0 percentage of participants Interval 0.0 to 2.3	1.2 percentage of participants Interval 0.2 to 4.4

SECONDARY outcome

Timeframe: One month (28 to 42 days) after vaccination

Population: EIP: eligible participants who received vaccine, had blood drawn within the pre-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, and had no other major protocol violations.

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 microcolony OPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.

Outcome measures

Measure	13vPnC, Cohort 1 n=155 Participants Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.	13vPnC, Cohort 2 n=159 Participants Participants greater than or equal to (\>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	90.3 percentage of participants Interval 84.5 to 94.5	81.0 percentage of participants Interval 74.0 to 86.8
Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 3	94.8 percentage of participants Interval 90.0 to 97.7	90.1 percentage of participants Interval 84.2 to 94.4
Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 4	97.4 percentage of participants Interval 93.4 to 99.3	98.7 percentage of participants Interval 95.3 to 99.8
Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 5	89.2 percentage of participants Interval 83.0 to 93.7	90.8 percentage of participants Interval 85.0 to 94.9
Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 6A	98.7 percentage of participants Interval 95.4 to 99.8	98.1 percentage of participants Interval 94.6 to 99.6
Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 6B	99.4 percentage of participants Interval 96.4 to 100.0	98.7 percentage of participants Interval 95.5 to 99.8
Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 7F	99.4 percentage of participants Interval 96.5 to 100.0	97.5 percentage of participants Interval 93.6 to 99.3
Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 9V	96.8 percentage of participants Interval 92.6 to 98.9	92.3 percentage of participants Interval 86.9 to 95.9
Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 14	98.1 percentage of participants Interval 94.4 to 99.6	98.1 percentage of participants Interval 94.5 to 99.6
Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 18C	98.1 percentage of participants Interval 94.4 to 99.6	98.7 percentage of participants Interval 95.4 to 99.8
Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 19A	99.3 percentage of participants Interval 96.4 to 100.0	99.4 percentage of participants Interval 96.5 to 100.0
Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 19F	95.4 percentage of participants Interval 90.7 to 98.1	96.0 percentage of participants Interval 91.5 to 98.5
Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 23F	94.2 percentage of participants Interval 89.2 to 97.3	91.7 percentage of participants Interval 86.2 to 95.5

SECONDARY outcome

Timeframe: Pre-vaccination to 1 month (28 to 42 days) after vaccination

Population: EIP: eligible participants who received vaccine, had blood drawn within the pre-specified time frames, had at least 1 valid and determinate assay result, received no prohibited vaccines, and had no other major protocol violations. Here "N" signifies participants with valid and determinate assay results at both pre-vaccination and post-vaccination.

Geometric mean fold rises (GMFRs) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from pre-vaccination to 1 month post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

Outcome measures

Measure	13vPnC, Cohort 1 n=153 Participants Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.	13vPnC, Cohort 2 n=158 Participants Participants greater than or equal to (\>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination 1	21.3 fold rise Interval 16.17 to 28.16	11.7 fold rise Interval 8.7 to 15.82
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination 6A	62.3 fold rise Interval 39.0 to 99.36	28.7 fold rise Interval 19.76 to 41.7
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination 18C	44.3 fold rise Interval 28.19 to 69.51	13.9 fold rise Interval 9.21 to 21.09
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination 19A	30.0 fold rise Interval 21.19 to 42.5	11.2 fold rise Interval 7.99 to 15.69
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination 3	12.5 fold rise Interval 9.77 to 16.05	7.8 fold rise Interval 6.03 to 10.02
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination 4	57.7 fold rise Interval 36.4 to 91.36	19.9 fold rise Interval 13.23 to 29.88
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination 5	37.3 fold rise Interval 26.06 to 53.47	26.2 fold rise Interval 18.74 to 36.72
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination 6B	18.1 fold rise Interval 11.61 to 28.15	9.4 fold rise Interval 6.61 to 13.45
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination 7F	43.2 fold rise Interval 26.94 to 69.17	15.5 fold rise Interval 10.05 to 23.8
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination 9V	8.8 fold rise Interval 5.72 to 13.43	7.2 fold rise Interval 4.72 to 10.98
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination 14	5.3 fold rise Interval 3.73 to 7.56	3.4 fold rise Interval 2.58 to 4.56
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination 19F	42.8 fold rise Interval 28.33 to 64.67	20.8 fold rise Interval 13.38 to 32.29
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination 23F	63.6 fold rise Interval 43.16 to 93.75	35.8 fold rise Interval 24.16 to 52.95

Adverse Events

13vPnC, Cohort 1

Serious events: 0 serious events

Other events: 119 other events

Deaths: 0 deaths

13vPnC, Cohort 2

Serious events: 2 serious events

Other events: 88 other events

Deaths: 0 deaths

Serious adverse events

Measure	13vPnC, Cohort 1 n=162 participants at risk Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.	13vPnC, Cohort 2 n=161 participants at risk Participants greater than or equal to (\>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
Gastrointestinal disorders Gastric ulcer	0.00% 0/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	0.62% 1/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).
Gastrointestinal disorders Gastritis	0.00% 0/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	0.62% 1/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	0.62% 1/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).

Other adverse events

Measure	13vPnC, Cohort 1 n=162 participants at risk Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.	13vPnC, Cohort 2 n=161 participants at risk Participants greater than or equal to (\>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	0.62% 1/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).
Gastrointestinal disorders Constipation	0.00% 0/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	0.62% 1/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).
Gastrointestinal disorders Nausea	1.2% 2/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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% 0/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Asthenia	0.62% 1/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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% 0/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Influenza like illness	0.00% 0/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	0.62% 1/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Any	2.4% 3/126 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	10.2% 12/118 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Mild	1.6% 2/126 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	3.5% 4/113 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Moderate	0.80% 1/125 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	1.8% 2/113 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Severe	0.81% 1/124 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	1.8% 2/113 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Potentially life threatening	0.00% 0/124 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	4.3% 5/116 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	47.2% 68/144 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	38.6% 51/132 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	39.4% 56/142 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	36.2% 47/130 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	26.9% 36/134 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	20.0% 25/125 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	6.3% 8/126 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	5.3% 6/113 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Headache Any	44.3% 62/140 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	32.6% 42/129 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Headache Mild	39.3% 55/140 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	30.2% 39/129 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Headache Moderate	18.6% 24/129 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	16.0% 19/119 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Headache Severe	4.0% 5/126 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	5.2% 6/115 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	4.0% 5/125 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	1.8% 2/113 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	3.2% 4/125 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	1.8% 2/113 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	1.6% 2/124 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	0.88% 1/113 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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% 0/124 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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% 0/112 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	26.1% 35/134 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	15.0% 18/120 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	23.3% 30/129 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	14.2% 17/120 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	6.2% 8/129 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	1.8% 2/113 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	0.80% 1/125 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	0.89% 1/112 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Muscle pain Any	60.5% 89/147 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	43.9% 58/132 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Muscle pain Mild	59.6% 87/146 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	40.3% 52/129 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Muscle pain Moderate	23.5% 31/132 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	19.5% 24/123 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Muscle pain Severe	5.6% 7/125 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	6.0% 7/116 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Joint pain Any	35.3% 49/139 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	33.3% 43/129 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Joint pain Mild	30.7% 42/137 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	29.9% 38/127 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Joint pain Moderate	13.1% 17/130 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	17.1% 21/123 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Joint pain Severe	4.0% 5/125 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	5.2% 6/116 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	0.62% 1/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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% 0/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Gastrointestinal infection	0.00% 0/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	0.62% 1/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Influenza	0.62% 1/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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% 0/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Laryngitis	0.62% 1/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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% 0/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	1.9% 3/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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% 0/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Otitis media acute	0.00% 0/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	0.62% 1/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	1.2% 2/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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% 0/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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% 0/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	0.62% 1/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Upper respiratory tract infection	0.62% 1/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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% 0/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	0.62% 1/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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% 0/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 Limb injury	0.62% 1/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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% 0/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	0.62% 1/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).
Musculoskeletal and connective tissue disorders Neck pain	0.62% 1/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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% 0/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	1.2% 2/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).
Nervous system disorders Dizziness	0.62% 1/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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% 0/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).
Nervous system disorders Headache	0.62% 1/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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% 0/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).
Psychiatric disorders Libido decreased	0.62% 1/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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% 0/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).
Renal and urinary disorders Urethral pain	0.00% 0/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	0.62% 1/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).
Reproductive system and breast disorders Vaginal haemorrhage	0.62% 1/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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% 0/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	0.62% 1/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	14.4% 18/125 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	15.8% 19/120 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	9.7% 12/124 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	13.3% 16/120 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	8.8% 11/125 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	7.0% 8/115 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	2.4% 3/125 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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% 0/112 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	21.5% 28/130 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	13.3% 16/120 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	18.1% 23/127 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	11.7% 14/120 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	8.7% 11/127 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	4.4% 5/114 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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	2.4% 3/125 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	0.88% 1/113 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 at injection site Any	75.5% 114/151 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	60.6% 83/137 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 at injection site Mild	74.2% 112/151 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	60.3% 82/136 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 at injection site Moderate	21.5% 28/130 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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% 10/117 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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 at injection site Severe	3.2% 4/125 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).	3.5% 4/113 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).
Vascular disorders Hypertension	0.62% 1/162 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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% 0/161 • Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 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).

Additional Information

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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.
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Restriction type: OTHER