Trial Outcomes & Findings for 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants (NCT NCT04530838)

Last Updated: 2023-04-21

Results Overview

Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 centimeter (cm). Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: \>0 to 2.0 cm; moderate \>2.0 to 7.0 cm; and severe: \>7.0 cm.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

668 participants

Primary outcome timeframe

Within 7 Days after Dose 1

Results posted on

2023-04-21

Participant Flow

A total of 668 participants were enrolled and randomized in the study. One participant did not receive any study vaccine. One participant receive vaccination through route which was not as per randomization. Hence, data of these participants were excluded from analysis.

Participant milestones

Participant milestones
Measure	20vPnC (SC) Participants received 4 doses of 0.5 milliliter (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) subcutaneously (SC) into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) Participants received 4 doses of 0.5 mL 13-valent Pneumococcal Conjugate Vaccine (13vPnC) SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) Participants received 4 doses of 0.5 mL 20vPnC intramuscularly (IM) into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Overall Study STARTED	225	224	217
Overall Study COMPLETED	217	220	211
Overall Study NOT COMPLETED	8	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	20vPnC (SC) Participants received 4 doses of 0.5 milliliter (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) subcutaneously (SC) into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) Participants received 4 doses of 0.5 mL 13-valent Pneumococcal Conjugate Vaccine (13vPnC) SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) Participants received 4 doses of 0.5 mL 20vPnC intramuscularly (IM) into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Overall Study Other	2	1	0
Overall Study Physician Decision	0	0	1
Overall Study Death	0	0	1
Overall Study Adverse Event	0	1	0
Overall Study No longer meets eligibility criteria	1	0	2
Overall Study Withdrawal by parent/guardian	5	2	2

Baseline Characteristics

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	20vPnC (SC) n=225 Participants Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) n=224 Participants Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) n=217 Participants Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Total n=666 Participants Total of all reporting groups
Age, Continuous	2.4 Months STANDARD_DEVIATION 0.33 • n=5 Participants	2.4 Months STANDARD_DEVIATION 0.40 • n=7 Participants	2.4 Months STANDARD_DEVIATION 0.42 • n=5 Participants	2.4 Months STANDARD_DEVIATION 0.39 • n=4 Participants
Sex: Female, Male Female	117 Participants n=5 Participants	114 Participants n=7 Participants	106 Participants n=5 Participants	337 Participants n=4 Participants
Sex: Female, Male Male	108 Participants n=5 Participants	110 Participants n=7 Participants	111 Participants n=5 Participants	329 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	225 Participants n=5 Participants	224 Participants n=7 Participants	217 Participants n=5 Participants	666 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	225 Participants n=5 Participants	224 Participants n=7 Participants	217 Participants n=5 Participants	666 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Within 7 Days after Dose 1

Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after Dose 1.

Outcome measures

Outcome measures
Measure	20vPnC (SC) n=225 Participants Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) n=224 Participants Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) n=217 Participants Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 Swelling: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7
Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 Pain at the injection site: Mild	15.6 Percentage of participants 95% Confidence Interval 11.1 • Interval 11.1 to 21.0	13.4 Percentage of participants 95% Confidence Interval 9.2 • Interval 9.2 to 18.6	12.4 Percentage of participants 95% Confidence Interval 8.4 • Interval 8.4 to 17.6
Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 Redness: Mild	58.2 Percentage of participants 95% Confidence Interval 51.5 • Interval 51.5 to 64.7	51.3 Percentage of participants 95% Confidence Interval 44.6 • Interval 44.6 to 58.1	26.3 Percentage of participants 95% Confidence Interval 20.5 • Interval 20.5 to 32.7
Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 Redness: Moderate	20.0 Percentage of participants 95% Confidence Interval 15.0 • Interval 15.0 to 25.8	23.7 Percentage of participants 95% Confidence Interval 18.3 • Interval 18.3 to 29.8	11.1 Percentage of participants 95% Confidence Interval 7.2 • Interval 7.2 to 16.0
Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 Redness: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7
Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 Swelling: Mild	48.9 Percentage of participants 95% Confidence Interval 42.2 • Interval 42.2 to 55.6	42.9 Percentage of participants 95% Confidence Interval 36.3 • Interval 36.3 to 49.6	17.5 Percentage of participants 95% Confidence Interval 12.7 • Interval 12.7 to 23.2
Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 Swelling: Moderate	19.6 Percentage of participants 95% Confidence Interval 14.6 • Interval 14.6 to 25.3	23.2 Percentage of participants 95% Confidence Interval 17.9 • Interval 17.9 to 29.3	11.1 Percentage of participants 95% Confidence Interval 7.2 • Interval 7.2 to 16.0
Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 Pain at the injection site: Moderate	1.8 Percentage of participants 95% Confidence Interval 0.5 • Interval 0.5 to 4.5	2.7 Percentage of participants 95% Confidence Interval 1.0 • Interval 1.0 to 5.7	3.2 Percentage of participants 95% Confidence Interval 1.3 • Interval 1.3 to 6.5
Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 Pain at the injection site: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0.5 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.5

PRIMARY outcome

Timeframe: Within 7 Days after Dose 2

Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after Dose 2. Here, "Number of Participants Analyzed" = number of participants with any e-diary data reported after Dose 2.

Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: \>0 to 2.0 cm; moderate \>2.0 to 7.0 cm; and severe: \>7.0 cm.

Outcome measures

Outcome measures
Measure	20vPnC (SC) n=223 Participants Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) n=222 Participants Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) n=215 Participants Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Redness: Mild	52.9 Percentage of participants 95% Confidence Interval 46.1 • Interval 46.1 to 59.6	53.2 Percentage of participants 95% Confidence Interval 46.4 • Interval 46.4 to 59.9	24.7 Percentage of participants 95% Confidence Interval 19.0 • Interval 19.0 to 31.0
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Redness: Moderate	23.3 Percentage of participants 95% Confidence Interval 17.9 • Interval 17.9 to 29.4	31.1 Percentage of participants 95% Confidence Interval 25.1 • Interval 25.1 to 37.6	7.0 Percentage of participants 95% Confidence Interval 4.0 • Interval 4.0 to 11.2
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Redness: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Swelling: Mild	46.2 Percentage of participants 95% Confidence Interval 39.5 • Interval 39.5 to 53.0	46.8 Percentage of participants 95% Confidence Interval 40.1 • Interval 40.1 to 53.6	18.1 Percentage of participants 95% Confidence Interval 13.2 • Interval 13.2 to 24.0
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Swelling: Moderate	22.4 Percentage of participants 95% Confidence Interval 17.1 • Interval 17.1 to 28.5	26.6 Percentage of participants 95% Confidence Interval 20.9 • Interval 20.9 to 32.9	7.9 Percentage of participants 95% Confidence Interval 4.7 • Interval 4.7 to 12.4
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Swelling: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Pain at the injection site: Mild	13.0 Percentage of participants 95% Confidence Interval 8.9 • Interval 8.9 to 18.1	16.7 Percentage of participants 95% Confidence Interval 12.0 • Interval 12.0 to 22.2	9.3 Percentage of participants 95% Confidence Interval 5.8 • Interval 5.8 to 14.0
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Pain at the injection site: Moderate	3.6 Percentage of participants 95% Confidence Interval 1.6 • Interval 1.6 to 6.9	0.5 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.5	2.3 Percentage of participants 95% Confidence Interval 0.8 • Interval 0.8 to 5.3
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Pain at the injection site: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7

PRIMARY outcome

Timeframe: Within 7 Days after Dose 3

Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after Dose 3. Here, "Overall Number of Participants Analyzed" = number of participants with any e-diary data reported after Dose 3.

Outcome measures

Outcome measures
Measure	20vPnC (SC) n=222 Participants Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) n=221 Participants Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) n=215 Participants Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Redness: Mild	45.0 Percentage of participants Interval 38.4 to 51.8	51.1 Percentage of participants Interval 44.3 to 57.9	23.3 Percentage of participants Interval 17.8 to 29.5
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Redness: Moderate	33.8 Percentage of participants Interval 27.6 to 40.4	34.8 Percentage of participants Interval 28.6 to 41.5	8.4 Percentage of participants Interval 5.0 to 12.9
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Redness: Severe	0 Percentage of participants Interval 0.0 to 1.6	0 Percentage of participants Interval 0.0 to 1.7	0 Percentage of participants Interval 0.0 to 1.7
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Swelling: Mild	38.7 Percentage of participants Interval 32.3 to 45.5	39.8 Percentage of participants Interval 33.3 to 46.6	17.7 Percentage of participants Interval 12.8 to 23.4
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Swelling: Moderate	30.2 Percentage of participants Interval 24.2 to 36.7	35.3 Percentage of participants Interval 29.0 to 42.0	9.8 Percentage of participants Interval 6.1 to 14.5
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Swelling: Severe	0 Percentage of participants Interval 0.0 to 1.6	0 Percentage of participants Interval 0.0 to 1.7	0 Percentage of participants Interval 0.0 to 1.7
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Pain at the injection site: Mild	10.8 Percentage of participants Interval 7.1 to 15.7	14.5 Percentage of participants Interval 10.1 to 19.8	8.8 Percentage of participants Interval 5.4 to 13.5
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Pain at the injection site: Moderate	3.6 Percentage of participants Interval 1.6 to 7.0	1.4 Percentage of participants Interval 0.3 to 3.9	0.9 Percentage of participants Interval 0.1 to 3.3
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Pain at the injection site: Severe	0 Percentage of participants Interval 0.0 to 1.6	0 Percentage of participants Interval 0.0 to 1.7	0.5 Percentage of participants Interval 0.0 to 2.6

PRIMARY outcome

Timeframe: Within 7 Days after Dose 4

Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after Dose 4. Here, "Number of Participants Analyzed" = number of participants with any e-diary data reported after Dose 4.

Outcome measures

Outcome measures
Measure	20vPnC (SC) n=218 Participants Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) n=220 Participants Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) n=212 Participants Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Pain at the injection site: Moderate	1.4 Percentage of participants Interval 0.3 to 4.0	3.2 Percentage of participants Interval 1.3 to 6.4	3.3 Percentage of participants Interval 1.3 to 6.7
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Redness: Mild	37.2 Percentage of participants Interval 30.7 to 43.9	36.4 Percentage of participants Interval 30.0 to 43.1	20.8 Percentage of participants Interval 15.5 to 26.8
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Redness: Moderate	49.1 Percentage of participants Interval 42.3 to 55.9	49.1 Percentage of participants Interval 42.3 to 55.9	11.8 Percentage of participants Interval 7.8 to 16.9
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Redness: Severe	0.5 Percentage of participants Interval 0.0 to 2.5	0.5 Percentage of participants Interval 0.0 to 2.5	0 Percentage of participants Interval 0.0 to 1.7
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Swelling: Mild	37.6 Percentage of participants Interval 31.2 to 44.4	35.9 Percentage of participants Interval 29.6 to 42.6	13.2 Percentage of participants Interval 9.0 to 18.5
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Swelling: Moderate	42.2 Percentage of participants Interval 35.6 to 49.1	41.8 Percentage of participants Interval 35.2 to 48.6	10.8 Percentage of participants Interval 7.0 to 15.8
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Swelling: Severe	0.5 Percentage of participants Interval 0.0 to 2.5	0 Percentage of participants Interval 0.0 to 1.7	0 Percentage of participants Interval 0.0 to 1.7
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Pain at the injection site: Mild	19.7 Percentage of participants Interval 14.7 to 25.6	19.1 Percentage of participants Interval 14.1 to 24.9	10.4 Percentage of participants Interval 6.6 to 15.3
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Pain at the injection site: Severe	0 Percentage of participants Interval 0.0 to 1.7	0 Percentage of participants Interval 0.0 to 1.7	0 Percentage of participants Interval 0.0 to 1.7

PRIMARY outcome

Timeframe: Within 7 Days After Dose 1

Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up Dose 1.

Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature greater than or equal to (\>=) 37.5 degree Celsius (C), and categorized as \>=37.5 to 38.4 degree C, greater than (\>)38.4 to 38.9 degree C,\>38.9 to 40.0 degree C and \>40.0 degree C; decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed); drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity); Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

Outcome measures

Outcome measures
Measure	20vPnC (SC) n=225 Participants Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) n=224 Participants Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) n=217 Participants Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Irritability: Severe	1.3 Percentage of participants 95% Confidence Interval 0.3 • Interval 0.3 to 3.8	1.8 Percentage of participants 95% Confidence Interval 0.5 • Interval 0.5 to 4.5	0.5 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.5
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Fever: >=37.5 degree C	9.8 Percentage of participants 95% Confidence Interval 6.2 • Interval 6.2 to 14.4	12.9 Percentage of participants 95% Confidence Interval 8.8 • Interval 8.8 to 18.1	9.7 Percentage of participants 95% Confidence Interval 6.1 • Interval 6.1 to 14.4
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Fever: >=37.5°C to 38.4 degree C	9.3 Percentage of participants 95% Confidence Interval 5.9 • Interval 5.9 to 13.9	12.5 Percentage of participants 95% Confidence Interval 8.5 • Interval 8.5 to 17.6	9.7 Percentage of participants 95% Confidence Interval 6.1 • Interval 6.1 to 14.4
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Fever: >38.4°C to 38.9 degree C	0.4 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.5	0.4 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.5	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Fever: >38.9 to 40.0 degree C	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Fever: >40.0 degree C	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Decreased appetite: Mild	3.6 Percentage of participants 95% Confidence Interval 1.5 • Interval 1.5 to 6.9	7.1 Percentage of participants 95% Confidence Interval 4.1 • Interval 4.1 to 11.3	3.2 Percentage of participants 95% Confidence Interval 1.3 • Interval 1.3 to 6.5
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Decreased appetite: Moderate	1.8 Percentage of participants 95% Confidence Interval 0.5 • Interval 0.5 to 4.5	3.1 Percentage of participants 95% Confidence Interval 1.3 • Interval 1.3 to 6.3	3.2 Percentage of participants 95% Confidence Interval 1.3 • Interval 1.3 to 6.5
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Decreased appetite: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0.4 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.5	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Drowsiness: Mild	40.4 Percentage of participants 95% Confidence Interval 34.0 • Interval 34.0 to 47.2	42.0 Percentage of participants 95% Confidence Interval 35.4 • Interval 35.4 to 48.7	42.9 Percentage of participants 95% Confidence Interval 36.2 • Interval 36.2 to 49.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Drowsiness: Moderate	0.9 Percentage of participants 95% Confidence Interval 0.1 • Interval 0.1 to 3.2	2.2 Percentage of participants 95% Confidence Interval 0.7 • Interval 0.7 to 5.1	4.1 Percentage of participants 95% Confidence Interval 1.9 • Interval 1.9 to 7.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Drowsiness: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0.4 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.5	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Irritability: Mild	13.8 Percentage of participants 95% Confidence Interval 9.6 • Interval 9.6 to 19.0	11.2 Percentage of participants 95% Confidence Interval 7.4 • Interval 7.4 to 16.0	12.9 Percentage of participants 95% Confidence Interval 8.7 • Interval 8.7 to 18.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Irritability: Moderate	12.0 Percentage of participants 95% Confidence Interval 8.1 • Interval 8.1 to 17.0	13.4 Percentage of participants 95% Confidence Interval 9.2 • Interval 9.2 to 18.6	11.5 Percentage of participants 95% Confidence Interval 7.6 • Interval 7.6 to 16.5

PRIMARY outcome

Timeframe: Within 7 Days After Dose 2

Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after Dose 2. Here, "Overall Number of Participants Analyzed" = number of participants with any e-diary data reported after Dose 2.

Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature \>=37.5 degree C and categorized as \>=37.5 to 38.4 degree C,\>38.4 to 38.9 degree C,\>38.9 to 40.0 degree C and \>40.0 degree C; decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed); drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity); Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

Outcome measures

Outcome measures
Measure	20vPnC (SC) n=223 Participants Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) n=222 Participants Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) n=215 Participants Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Fever: >=37.5 degree C	20.2 Percentage of participants 95% Confidence Interval 15.1 • Interval 15.1 to 26.1	21.2 Percentage of participants 95% Confidence Interval 16.0 • Interval 16.0 to 27.1	18.1 Percentage of participants 95% Confidence Interval 13.2 • Interval 13.2 to 24.0
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Fever: >=37.5 to 38.4 degree C	15.2 Percentage of participants 95% Confidence Interval 10.8 • Interval 10.8 to 20.6	17.6 Percentage of participants 95% Confidence Interval 12.8 • Interval 12.8 to 23.2	14.9 Percentage of participants 95% Confidence Interval 10.4 • Interval 10.4 to 20.4
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Fever: >38.4 to 38.9 degree C	3.1 Percentage of participants 95% Confidence Interval 1.3 • Interval 1.3 to 6.4	2.3 Percentage of participants 95% Confidence Interval 0.7 • Interval 0.7 to 5.2	1.9 Percentage of participants 95% Confidence Interval 0.5 • Interval 0.5 to 4.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Fever: >38.9 to 40.0 degree C	1.8 Percentage of participants 95% Confidence Interval 0.5 • Interval 0.5 to 4.5	1.4 Percentage of participants 95% Confidence Interval 0.3 • Interval 0.3 to 3.9	1.4 Percentage of participants 95% Confidence Interval 0.3 • Interval 0.3 to 4.0
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Fever: >40.0 degree C	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Decreased appetite: Mild	4.5 Percentage of participants 95% Confidence Interval 2.2 • Interval 2.2 to 8.1	6.8 Percentage of participants 95% Confidence Interval 3.8 • Interval 3.8 to 10.9	5.1 Percentage of participants 95% Confidence Interval 2.6 • Interval 2.6 to 9.0
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Decreased appetite: Moderate	5.8 Percentage of participants 95% Confidence Interval 3.1 • Interval 3.1 to 9.8	5.0 Percentage of participants 95% Confidence Interval 2.5 • Interval 2.5 to 8.7	4.7 Percentage of participants 95% Confidence Interval 2.3 • Interval 2.3 to 8.4
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Decreased appetite: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Drowsiness: Mild	39.9 Percentage of participants 95% Confidence Interval 33.4 • Interval 33.4 to 46.7	48.6 Percentage of participants 95% Confidence Interval 41.9 • Interval 41.9 to 55.4	39.5 Percentage of participants 95% Confidence Interval 33.0 • Interval 33.0 to 46.4
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Drowsiness: Moderate	3.1 Percentage of participants 95% Confidence Interval 1.3 • Interval 1.3 to 6.4	4.1 Percentage of participants 95% Confidence Interval 1.9 • Interval 1.9 to 7.6	2.3 Percentage of participants 95% Confidence Interval 0.8 • Interval 0.8 to 5.3
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Drowsiness: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Irritability: Mild	12.6 Percentage of participants 95% Confidence Interval 8.5 • Interval 8.5 to 17.6	16.7 Percentage of participants 95% Confidence Interval 12.0 • Interval 12.0 to 22.2	10.2 Percentage of participants 95% Confidence Interval 6.5 • Interval 6.5 to 15.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Irritability: Moderate	12.1 Percentage of participants 95% Confidence Interval 8.1 • Interval 8.1 to 17.1	14.9 Percentage of participants 95% Confidence Interval 10.5 • Interval 10.5 to 20.2	15.3 Percentage of participants 95% Confidence Interval 10.8 • Interval 10.8 to 20.9
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Irritability: Severe	1.3 Percentage of participants 95% Confidence Interval 0.3 • Interval 0.3 to 3.9	0.5 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.5	1.4 Percentage of participants 95% Confidence Interval 0.3 • Interval 0.3 to 4.0

PRIMARY outcome

Timeframe: Within 7 Days After Dose 3

Outcome measures

Outcome measures
Measure	20vPnC (SC) n=222 Participants Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) n=221 Participants Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) n=215 Participants Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Fever: >=37.5 degree C	15.3 Percentage of participants 95% Confidence Interval 10.8 • Interval 10.8 to 20.7	19.9 Percentage of participants 95% Confidence Interval 14.9 • Interval 14.9 to 25.8	15.3 Percentage of participants 95% Confidence Interval 10.8 • Interval 10.8 to 20.9
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Fever: >=37.5 to 38.4 degree C	13.5 Percentage of participants 95% Confidence Interval 9.3 • Interval 9.3 to 18.7	16.3 Percentage of participants 95% Confidence Interval 11.7 • Interval 11.7 to 21.8	12.6 Percentage of participants 95% Confidence Interval 8.4 • Interval 8.4 to 17.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Fever: >38.4 to 38.9 degree C	1.4 Percentage of participants 95% Confidence Interval 0.3 • Interval 0.3 to 3.9	2.7 Percentage of participants 95% Confidence Interval 1.0 • Interval 1.0 to 5.8	1.9 Percentage of participants 95% Confidence Interval 0.5 • Interval 0.5 to 4.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Fever: >38.9 to 40.0 degree C	0.5 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.5	0.9 Percentage of participants 95% Confidence Interval 0.1 • Interval 0.1 to 3.2	0.9 Percentage of participants 95% Confidence Interval 0.1 • Interval 0.1 to 3.3
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Fever: >40.0 degree C	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Decreased appetite: Mild	5.0 Percentage of participants 95% Confidence Interval 2.5 • Interval 2.5 to 8.7	7.2 Percentage of participants 95% Confidence Interval 4.2 • Interval 4.2 to 11.5	4.2 Percentage of participants 95% Confidence Interval 1.9 • Interval 1.9 to 7.8
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Decreased appetite: Moderate	2.7 Percentage of participants 95% Confidence Interval 1.0 • Interval 1.0 to 5.8	3.6 Percentage of participants 95% Confidence Interval 1.6 • Interval 1.6 to 7.0	3.7 Percentage of participants 95% Confidence Interval 1.6 • Interval 1.6 to 7.2
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Decreased appetite: Severe	0.5 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.5	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Drowsiness: Mild	24.8 Percentage of participants 95% Confidence Interval 19.2 • Interval 19.2 to 31.0	32.6 Percentage of participants 95% Confidence Interval 26.4 • Interval 26.4 to 39.2	32.6 Percentage of participants 95% Confidence Interval 26.3 • Interval 26.3 to 39.3
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Drowsiness: Moderate	1.4 Percentage of participants 95% Confidence Interval 0.3 • Interval 0.3 to 3.9	1.8 Percentage of participants 95% Confidence Interval 0.5 • Interval 0.5 to 4.6	1.4 Percentage of participants 95% Confidence Interval 0.3 • Interval 0.3 to 4.0
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Drowsiness: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Irritability: Mild	16.7 Percentage of participants 95% Confidence Interval 12.0 • Interval 12.0 to 22.2	10.9 Percentage of participants 95% Confidence Interval 7.1 • Interval 7.1 to 15.7	14.0 Percentage of participants 95% Confidence Interval 9.6 • Interval 9.6 to 19.3
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Irritability: Moderate	8.6 Percentage of participants 95% Confidence Interval 5.2 • Interval 5.2 to 13.0	9.0 Percentage of participants 95% Confidence Interval 5.6 • Interval 5.6 to 13.6	13.0 Percentage of participants 95% Confidence Interval 8.8 • Interval 8.8 to 18.3
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Irritability: Severe	0.5 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.5	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7	0.9 Percentage of participants 95% Confidence Interval 0.1 • Interval 0.1 to 3.3

PRIMARY outcome

Timeframe: Within 7 Days After Dose 4

Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after Dose 4. Here, "Overall Number of Participants Analyzed" = number of participants with any e-diary data reported after Dose 4.

Outcome measures

Outcome measures
Measure	20vPnC (SC) n=218 Participants Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) n=220 Participants Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) n=212 Participants Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Fever: >=37.5 degree C	42.7 Percentage of participants 95% Confidence Interval 36.0 • Interval 36.0 to 49.5	39.5 Percentage of participants 95% Confidence Interval 33.0 • Interval 33.0 to 46.3	38.2 Percentage of participants 95% Confidence Interval 31.6 • Interval 31.6 to 45.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Fever: >=37.5 to 38.4 degree C	25.7 Percentage of participants 95% Confidence Interval 20.0 • Interval 20.0 to 32.0	29.1 Percentage of participants 95% Confidence Interval 23.2 • Interval 23.2 to 35.6	24.1 Percentage of participants 95% Confidence Interval 18.5 • Interval 18.5 to 30.4
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Fever: >38.4 to 38.9 degree C	10.1 Percentage of participants 95% Confidence Interval 6.4 • Interval 6.4 to 14.9	5.9 Percentage of participants 95% Confidence Interval 3.2 • Interval 3.2 to 9.9	6.1 Percentage of participants 95% Confidence Interval 3.3 • Interval 3.3 to 10.3
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Fever: >38.9 to 40.0 degree C	6.4 Percentage of participants 95% Confidence Interval 3.6 • Interval 3.6 to 10.5	4.5 Percentage of participants 95% Confidence Interval 2.2 • Interval 2.2 to 8.2	8.0 Percentage of participants 95% Confidence Interval 4.7 • Interval 4.7 to 12.5
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Fever: >40.0 degree C	0.5 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.5	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Decreased appetite: Mild	6.4 Percentage of participants 95% Confidence Interval 3.6 • Interval 3.6 to 10.5	6.8 Percentage of participants 95% Confidence Interval 3.9 • Interval 3.9 to 11.0	6.1 Percentage of participants 95% Confidence Interval 3.3 • Interval 3.3 to 10.3
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Decreased appetite: Moderate	7.3 Percentage of participants 95% Confidence Interval 4.3 • Interval 4.3 to 11.6	7.7 Percentage of participants 95% Confidence Interval 4.6 • Interval 4.6 to 12.1	5.7 Percentage of participants 95% Confidence Interval 3.0 • Interval 3.0 to 9.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Decreased appetite: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7	0.9 Percentage of participants 95% Confidence Interval 0.1 • Interval 0.1 to 3.4
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Drowsiness: Mild	24.3 Percentage of participants 95% Confidence Interval 18.8 • Interval 18.8 to 30.6	23.6 Percentage of participants 95% Confidence Interval 18.2 • Interval 18.2 to 29.8	29.7 Percentage of participants 95% Confidence Interval 23.7 • Interval 23.7 to 36.4
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Drowsiness: Moderate	1.4 Percentage of participants 95% Confidence Interval 0.3 • Interval 0.3 to 4.0	2.3 Percentage of participants 95% Confidence Interval 0.7 • Interval 0.7 to 5.2	1.9 Percentage of participants 95% Confidence Interval 0.5 • Interval 0.5 to 4.8
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Drowsiness: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Irritability: Mild	14.2 Percentage of participants 95% Confidence Interval 9.9 • Interval 9.9 to 19.6	15.5 Percentage of participants 95% Confidence Interval 10.9 • Interval 10.9 to 20.9	15.1 Percentage of participants 95% Confidence Interval 10.6 • Interval 10.6 to 20.6
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Irritability: Moderate	7.3 Percentage of participants 95% Confidence Interval 4.3 • Interval 4.3 to 11.6	11.4 Percentage of participants 95% Confidence Interval 7.5 • Interval 7.5 to 16.3	9.4 Percentage of participants 95% Confidence Interval 5.9 • Interval 5.9 to 14.2
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Irritability: Severe	0.9 Percentage of participants 95% Confidence Interval 0.1 • Interval 0.1 to 3.3	0.9 Percentage of participants 95% Confidence Interval 0.1 • Interval 0.1 to 3.2	0.5 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.6

PRIMARY outcome

Timeframe: Day 1 of Dose 1 to 1 Month after Dose 3

Population: Safety population included all the participants who received at least 1 dose of the IP and had safety data after any dose.

An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Outcome measures

Outcome measures
Measure	20vPnC (SC) n=225 Participants Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) n=224 Participants Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) n=217 Participants Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3	47.6 Percentage of participants 95% Confidence Interval 40.9 • Interval 40.9 to 54.3	55.4 Percentage of participants 95% Confidence Interval 48.6 • Interval 48.6 to 62.0	58.5 Percentage of participants 95% Confidence Interval 51.7 • Interval 51.7 to 65.2

PRIMARY outcome

Timeframe: From Dose 4 to 1 Month after Dose 4

Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. Here, "Number of Participants Analyzed" = number of participants who received Dose 4.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Outcome measures

Outcome measures
Measure	20vPnC (SC) n=218 Participants Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) n=220 Participants Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) n=212 Participants Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4	40.4 Percentage of participants 95% Confidence Interval 33.8 • Interval 33.8 to 47.2	43.2 Percentage of participants 95% Confidence Interval 36.5 • Interval 36.5 to 50.0	43.9 Percentage of participants 95% Confidence Interval 37.1 • Interval 37.1 to 50.8

PRIMARY outcome

Timeframe: From Dose 1 to 1 Month after Dose 4

Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose.

A serious AE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events.

Outcome measures

Outcome measures
Measure	20vPnC (SC) n=225 Participants Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) n=224 Participants Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) n=217 Participants Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 4	6.2 Percentage of participants 95% Confidence Interval 3.4 • Interval 3.4 to 10.2	4.0 Percentage of participants 95% Confidence Interval 1.9 • Interval 1.9 to 7.5	7.4 Percentage of participants 95% Confidence Interval 4.3 • Interval 4.3 to 11.7

PRIMARY outcome

Timeframe: From Dose 1 to 1 Month after Dose 4

Population: Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.

An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or was otherwise long-lasting in its effects.

Outcome measures

Outcome measures
Measure	20vPnC (SC) n=225 Participants Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) n=224 Participants Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) n=217 Participants Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 1 Month After Dose 4	10.7 Percentage of participants 95% Confidence Interval 7.0 • Interval 7.0 to 15.5	8.9 Percentage of participants 95% Confidence Interval 5.5 • Interval 5.5 to 13.5	8.3 Percentage of participants 95% Confidence Interval 5.0 • Interval 5.0 to 12.8

PRIMARY outcome

Timeframe: 1 Month after Dose 3

Population: Dose 3 evaluable immunogenicity population included eligible participants who were 2 to 6 months of age at first vaccination, received first 3 doses as randomized, had at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, had no other major protocol deviations per clinician.Here, "N" = participants with an IgG concentration greater than or equal to(\>=)predefined level for given serotype,"n" =participants with valid assay results for specified serotype.

Pneumococcal serotype-specific IgG Concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5\*LLOQ. The predefined levels, \>=0.35 micrograms/mL for all serotypes except for serotypes 5 (\>=0.23 micrograms/mL), 6B (\>=0.10 micrograms/mL) and 19A (\>=0.12 micrograms/mL).

Outcome measures

Outcome measures
Measure	20vPnC (SC) n=221 Participants Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) n=220 Participants Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) n=213 Participants Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype: 1	97.7 Percentage of participants Interval 94.8 to 99.3	99.1 Percentage of participants Interval 96.8 to 99.9	92.0 Percentage of participants Interval 87.5 to 95.3
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype: 3	96.4 Percentage of participants Interval 93.0 to 98.4	99.1 Percentage of participants Interval 96.8 to 99.9	95.3 Percentage of participants Interval 91.5 to 97.7
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype: 4	96.8 Percentage of participants Interval 93.6 to 98.7	99.1 Percentage of participants Interval 96.8 to 99.9	94.8 Percentage of participants Interval 90.9 to 97.4
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype: 5	92.3 Percentage of participants Interval 88.0 to 95.5	97.3 Percentage of participants Interval 94.2 to 99.0	93.0 Percentage of participants Interval 88.7 to 96.0
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype: 6A	90.0 Percentage of participants Interval 85.3 to 93.7	98.2 Percentage of participants Interval 95.4 to 99.5	94.8 Percentage of participants Interval 90.9 to 97.4
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype: 6B	87.8 Percentage of participants Interval 82.7 to 91.8	96.4 Percentage of participants Interval 93.0 to 98.4	82.2 Percentage of participants Interval 76.3 to 87.1
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype: 7F	95.9 Percentage of participants Interval 92.4 to 98.1	99.1 Percentage of participants Interval 96.8 to 99.9	94.8 Percentage of participants Interval 90.9 to 97.4
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype: 9V	95.9 Percentage of participants Interval 92.4 to 98.1	98.6 Percentage of participants Interval 96.1 to 99.7	93.0 Percentage of participants Interval 88.7 to 96.0
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype: 14	96.8 Percentage of participants Interval 93.6 to 98.7	97.7 Percentage of participants Interval 94.8 to 99.3	96.2 Percentage of participants Interval 92.7 to 98.4
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype: 18C	96.8 Percentage of participants Interval 93.6 to 98.7	99.1 Percentage of participants Interval 96.8 to 99.9	94.8 Percentage of participants Interval 90.9 to 97.4
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype: 19A	99.5 Percentage of participants Interval 97.5 to 100.0	99.5 Percentage of participants Interval 97.5 to 100.0	99.1 Percentage of participants Interval 96.6 to 99.9
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype: 19F	100.0 Percentage of participants Interval 98.3 to 100.0	100.0 Percentage of participants Interval 98.3 to 100.0	100.0 Percentage of participants Interval 98.3 to 100.0
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype: 23F	89.6 Percentage of participants Interval 84.8 to 93.3	93.6 Percentage of participants Interval 89.6 to 96.5	88.7 Percentage of participants Interval 83.7 to 92.6
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype: 8	99.5 Percentage of participants Interval 97.5 to 100.0	0.9 Percentage of participants Interval 0.1 to 3.3	99.5 Percentage of participants Interval 97.4 to 100.0
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype: 10A	60.2 Percentage of participants Interval 53.4 to 66.7	1.8 Percentage of participants Interval 0.5 to 4.6	59.6 Percentage of participants Interval 52.7 to 66.3
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype: 11A	100.0 Percentage of participants Interval 98.3 to 100.0	2.7 Percentage of participants Interval 1.0 to 5.8	100.0 Percentage of participants Interval 98.3 to 100.0
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype: 12F	74.7 Percentage of participants Interval 68.4 to 80.3	0.9 Percentage of participants Interval 0.1 to 3.2	74.6 Percentage of participants Interval 68.3 to 80.3
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype: 15B	99.1 Percentage of participants Interval 96.8 to 99.9	8.2 Percentage of participants Interval 4.9 to 12.6	98.6 Percentage of participants Interval 95.9 to 99.7
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype: 22F	100.0 Percentage of participants Interval 98.3 to 100.0	0.9 Percentage of participants Interval 0.1 to 3.2	100.0 Percentage of participants Interval 98.3 to 100.0
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype: 33F	95.0 Percentage of participants Interval 91.2 to 97.5	3.2 Percentage of participants Interval 1.3 to 6.4	92.5 Percentage of participants Interval 88.0 to 95.6

SECONDARY outcome

Timeframe: 1 Month after Dose 3

Population: Dose 3 evaluable immunogenicity population included eligible participants who were 2 to 6 months of age at first vaccination, received first 3 doses as randomized, had at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, and had no other major protocol deviations per clinician. Here, "N" = participants with an IgG concentration \>= predefined level for given serotype and "n" =participants with valid assay results for specified serotype.

Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the LLOQ were set to 0.5\*LLOQ.

Outcome measures

Outcome measures
Measure	20vPnC (SC) n=221 Participants Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) n=220 Participants Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) n=213 Participants Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 Serotype 1	1.37 Micrograms per milliliter Interval 1.25 to 1.51	2.21 Micrograms per milliliter Interval 1.98 to 2.47	1.17 Micrograms per milliliter Interval 1.04 to 1.31
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 Serotype 3	1.29 Micrograms per milliliter Interval 1.18 to 1.41	1.81 Micrograms per milliliter Interval 1.66 to 1.98	1.10 Micrograms per milliliter Interval 0.99 to 1.22
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 Serotype 4	1.76 Micrograms per milliliter Interval 1.57 to 1.97	2.96 Micrograms per milliliter Interval 2.64 to 3.32	1.73 Micrograms per milliliter Interval 1.52 to 1.97
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 Serotype 5	1.01 Micrograms per milliliter Interval 0.89 to 1.16	1.72 Micrograms per milliliter Interval 1.51 to 1.96	1.00 Micrograms per milliliter Interval 0.87 to 1.14
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 Serotype 6A	1.38 Micrograms per milliliter Interval 1.21 to 1.57	2.34 Micrograms per milliliter Interval 2.09 to 2.62	1.64 Micrograms per milliliter Interval 1.42 to 1.88
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 Serotype 6B	0.42 Micrograms per milliliter Interval 0.35 to 0.5	0.83 Micrograms per milliliter Interval 0.71 to 0.97	0.39 Micrograms per milliliter Interval 0.32 to 0.48
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 Serotype 7F	1.58 Micrograms per milliliter Interval 1.43 to 1.75	2.19 Micrograms per milliliter Interval 1.95 to 2.46	1.52 Micrograms per milliliter Interval 1.35 to 1.71
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 Serotype 9V	1.46 Micrograms per milliliter Interval 1.32 to 1.61	2.11 Micrograms per milliliter Interval 1.88 to 2.36	1.45 Micrograms per milliliter Interval 1.29 to 1.64
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 Serotype 14	2.79 Micrograms per milliliter Interval 2.45 to 3.18	3.31 Micrograms per milliliter Interval 2.9 to 3.78	2.43 Micrograms per milliliter Interval 2.13 to 2.76
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 Serotype 18C	1.67 Micrograms per milliliter Interval 1.51 to 1.86	2.52 Micrograms per milliliter Interval 2.26 to 2.82	1.54 Micrograms per milliliter Interval 1.38 to 1.72
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 Serotype 19A	2.41 Micrograms per milliliter Interval 2.19 to 2.65	3.19 Micrograms per milliliter Interval 2.86 to 3.56	2.36 Micrograms per milliliter Interval 2.11 to 2.64
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 Serotype 19F	2.81 Micrograms per milliliter Interval 2.6 to 3.04	3.73 Micrograms per milliliter Interval 3.41 to 4.08	2.76 Micrograms per milliliter Interval 2.53 to 3.02
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 Serotype 23F	1.32 Micrograms per milliliter Interval 1.15 to 1.51	2.05 Micrograms per milliliter Interval 1.79 to 2.34	1.29 Micrograms per milliliter Interval 1.13 to 1.48
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 Serotype 8	3.32 Micrograms per milliliter Interval 3.05 to 3.61	0.01 Micrograms per milliliter Interval 0.01 to 0.01	3.29 Micrograms per milliliter Interval 2.97 to 3.64
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 Serotype 10A	0.50 Micrograms per milliliter Interval 0.42 to 0.6	0.01 Micrograms per milliliter Interval 0.01 to 0.02	0.47 Micrograms per milliliter Interval 0.39 to 0.56
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 Serotype 11A	5.63 Micrograms per milliliter Interval 5.17 to 6.14	0.02 Micrograms per milliliter Interval 0.02 to 0.02	5.22 Micrograms per milliliter Interval 4.73 to 5.77
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 Serotype 12F	0.79 Micrograms per milliliter Interval 0.67 to 0.93	0.01 Micrograms per milliliter Interval 0.01 to 0.01	0.72 Micrograms per milliliter Interval 0.6 to 0.85
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 Serotype 15B	6.77 Micrograms per milliliter Interval 6.04 to 7.6	0.04 Micrograms per milliliter Interval 0.03 to 0.05	6.80 Micrograms per milliliter Interval 6.03 to 7.67
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 Serotype 22F	4.94 Micrograms per milliliter Interval 4.54 to 5.38	0.01 Micrograms per milliliter Interval 0.0 to 0.01	4.41 Micrograms per milliliter Interval 3.99 to 4.88
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 Serotype 33F	1.70 Micrograms per milliliter Interval 1.51 to 1.92	0.02 Micrograms per milliliter Interval 0.02 to 0.03	1.62 Micrograms per milliliter Interval 1.4 to 1.87

SECONDARY outcome

Timeframe: 1 Month after Dose 4

Population: Dose 4 evaluable immunogenicity population included eligible participants who were 2 to 6 months of age at Dose 1 and 12 to 15 months of age at Dose 4, received all 4 doses as randomized, had at least 1 valid assay result from the blood collection within 27 to 56 days after Dose 4, and had no other major protocol deviations per clinician. Here,"N" = participants with an IgG concentration \>= predefined level for given serotype and "n"=participants with valid assay results for specified serotype.

Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.

Outcome measures

Outcome measures
Measure	20vPnC (SC) n=217 Participants Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) n=220 Participants Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) n=211 Participants Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 Serotype 1	2.79 Micrograms per milliliter Interval 2.5 to 3.12	4.62 Micrograms per milliliter Interval 4.11 to 5.19	2.78 Micrograms per milliliter Interval 2.47 to 3.12
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 Serotype 3	0.97 Micrograms per milliliter Interval 0.87 to 1.08	1.44 Micrograms per milliliter Interval 1.3 to 1.59	1.08 Micrograms per milliliter Interval 0.96 to 1.21
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 Serotype 4	6.93 Micrograms per milliliter Interval 6.14 to 7.83	10.01 Micrograms per milliliter Interval 8.89 to 11.27	7.31 Micrograms per milliliter Interval 6.51 to 8.2
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 Serotype 5	2.96 Micrograms per milliliter Interval 2.63 to 3.34	4.64 Micrograms per milliliter Interval 4.13 to 5.21	2.94 Micrograms per milliliter Interval 2.59 to 3.33
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 Serotype 6A	11.90 Micrograms per milliliter Interval 10.61 to 13.34	17.25 Micrograms per milliliter Interval 15.66 to 18.99	13.92 Micrograms per milliliter Interval 12.43 to 15.59
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 Serotype 6B	7.18 Micrograms per milliliter Interval 6.3 to 8.18	10.48 Micrograms per milliliter Interval 9.46 to 11.61	7.50 Micrograms per milliliter Interval 6.58 to 8.55
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 Serotype 7F	4.46 Micrograms per milliliter Interval 4.04 to 4.92	6.62 Micrograms per milliliter Interval 5.95 to 7.38	4.85 Micrograms per milliliter Interval 4.34 to 5.42
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 Serotype 9V	4.54 Micrograms per milliliter Interval 4.04 to 5.09	6.62 Micrograms per milliliter Interval 5.93 to 7.39	5.38 Micrograms per milliliter Interval 4.81 to 6.02
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 Serotype 14	8.23 Micrograms per milliliter Interval 7.27 to 9.31	10.30 Micrograms per milliliter Interval 9.25 to 11.47	9.19 Micrograms per milliliter Interval 8.1 to 10.43
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 Serotype 18C	3.95 Micrograms per milliliter Interval 3.5 to 4.45	5.97 Micrograms per milliliter Interval 5.27 to 6.75	3.81 Micrograms per milliliter Interval 3.38 to 4.3
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 Serotype 19A	7.62 Micrograms per milliliter Interval 6.82 to 8.52	8.97 Micrograms per milliliter Interval 8.08 to 9.95	7.92 Micrograms per milliliter Interval 7.06 to 8.89
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 Serotype 19F	8.74 Micrograms per milliliter Interval 7.84 to 9.73	11.02 Micrograms per milliliter Interval 9.96 to 12.2	8.56 Micrograms per milliliter Interval 7.66 to 9.56
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 Serotype 23F	7.01 Micrograms per milliliter Interval 6.16 to 7.97	11.76 Micrograms per milliliter Interval 10.42 to 13.28	7.39 Micrograms per milliliter Interval 6.49 to 8.42
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 Serotype 8	5.84 Micrograms per milliliter Interval 5.23 to 6.53	0.02 Micrograms per milliliter Interval 0.02 to 0.03	5.88 Micrograms per milliliter Interval 5.23 to 6.62
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 Serotype 10A	6.98 Micrograms per milliliter Interval 6.13 to 7.93	0.01 Micrograms per milliliter Interval 0.01 to 0.01	8.02 Micrograms per milliliter Interval 7.02 to 9.16
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 Serotype 11A	5.73 Micrograms per milliliter Interval 5.08 to 6.46	0.02 Micrograms per milliliter Interval 0.01 to 0.02	5.78 Micrograms per milliliter Interval 5.14 to 6.5
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 Serotype 12F	2.73 Micrograms per milliliter Interval 2.41 to 3.09	0.01 Micrograms per milliliter Interval 0.01 to 0.01	2.69 Micrograms per milliliter Interval 2.36 to 3.06
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 Serotype 15B	18.45 Micrograms per milliliter Interval 16.73 to 20.36	0.03 Micrograms per milliliter Interval 0.03 to 0.04	21.83 Micrograms per milliliter Interval 19.53 to 24.41
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 Serotype 22F	14.07 Micrograms per milliliter Interval 12.67 to 15.63	0.00 Micrograms per milliliter Interval 0.0 to 0.01	14.21 Micrograms per milliliter Interval 12.61 to 16.0
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 Serotype 33F	10.29 Micrograms per milliliter Interval 9.28 to 11.4	0.02 Micrograms per milliliter Interval 0.01 to 0.02	11.13 Micrograms per milliliter Interval 9.99 to 12.39

SECONDARY outcome

Timeframe: 1 Month after Dose 3, before Dose 4 and 1 Month after Dose 4

Population: For 1 month after Dose 3 and before Dose 4: Dose 3 evaluable immunogenicity population set were analyzed and for 1 month after Dose 4: Dose 4 evaluable immunogenicity population for 1 month after Dose 4 OPA GMTs were analyzed. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure and "Number Analyzed"= participants with valid results for the specified serotype.

20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. OPA titers were determined in randomly selected subsets of sera from each vaccine group.

Outcome measures

Outcome measures
Measure	20vPnC (SC) n=73 Participants Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) n=75 Participants Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) n=72 Participants Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 1:1 Month after Dose 3	55 Titers Interval 43.0 to 71.0	126 Titers Interval 104.0 to 152.0	56 Titers Interval 45.0 to 70.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 1:Before Dose. 4	11 Titers Interval 10.0 to 12.0	13 Titers Interval 11.0 to 16.0	10 Titers Interval 9.0 to 11.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 1:1 Month after Dose 4	162 Titers Interval 125.0 to 210.0	386 Titers Interval 306.0 to 486.0	194 Titers Interval 150.0 to 251.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 3:1 Month after Dose 3	107 Titers Interval 86.0 to 134.0	170 Titers Interval 147.0 to 196.0	120 Titers Interval 103.0 to 139.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 3:Before Dose 4	16 Titers Interval 13.0 to 20.0	20 Titers Interval 16.0 to 25.0	16 Titers Interval 12.0 to 20.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 3: 1 Month after Dose 4	131 Titers Interval 114.0 to 150.0	193 Titers Interval 165.0 to 226.0	150 Titers Interval 126.0 to 179.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 4:1 Month after Dose 3	1864 Titers Interval 1565.0 to 2219.0	1768 Titers Interval 1393.0 to 2245.0	1617 Titers Interval 1298.0 to 2015.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 4: Before Dose 4	25 Titers Interval 18.0 to 37.0	44 Titers Interval 29.0 to 66.0	21 Titers Interval 15.0 to 28.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 4:1 Month after Dose 4	1627 Titers Interval 1232.0 to 2148.0	2038 Titers Interval 1471.0 to 2825.0	1544 Titers Interval 1224.0 to 1948.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 5:1 Month after Dose 3	95 Titers Interval 79.0 to 114.0	154 Titers Interval 131.0 to 183.0	91 Titers Interval 77.0 to 109.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 5:Before Dose 4	16 Titers Interval 15.0 to 17.0	18 Titers Interval 16.0 to 19.0	15 Titers Interval 14.0 to 16.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 5:1 Month after Dose 4	172 Titers Interval 140.0 to 212.0	248 Titers Interval 204.0 to 303.0	141 Titers Interval 112.0 to 179.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 6A:1 Month after Dose 3	2709 Titers Interval 2283.0 to 3213.0	3339 Titers Interval 2777.0 to 4013.0	3120 Titers Interval 2562.0 to 3799.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 6A:Before Dose 4	83 Titers Interval 56.0 to 122.0	173 Titers Interval 116.0 to 258.0	95 Titers Interval 62.0 to 147.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 6A:1 Month after Dose 4	3249 Titers Interval 2686.0 to 3928.0	5455 Titers Interval 4379.0 to 6795.0	3489 Titers Interval 2831.0 to 4300.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 6B:1 Month after Dose 3	1548 Titers Interval 1247.0 to 1921.0	2489 Titers Interval 2005.0 to 3088.0	1563 Titers Interval 1215.0 to 2010.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 6B:Before Dose 4	40 Titers Interval 29.0 to 54.0	75 Titers Interval 49.0 to 115.0	44 Titers Interval 31.0 to 63.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 6B:1 Month after Dose 4	2304 Titers Interval 1811.0 to 2933.0	4319 Titers Interval 3478.0 to 5362.0	2552 Titers Interval 2006.0 to 3247.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 7F:1 Month after Dose 3	4160 Titers Interval 3406.0 to 5081.0	4428 Titers Interval 3821.0 to 5131.0	4491 Titers Interval 3675.0 to 5490.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 7F:Before Dose 4	626 Titers Interval 436.0 to 899.0	761 Titers Interval 579.0 to 1000.0	689 Titers Interval 487.0 to 975.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 7F:1 Month after Dose 4	4735 Titers Interval 3824.0 to 5863.0	6361 Titers Interval 5024.0 to 8054.0	4703 Titers Interval 3704.0 to 5972.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 9V:1 Month after Dose 3	1807 Titers Interval 1432.0 to 2279.0	2388 Titers Interval 1986.0 to 2870.0	1929 Titers Interval 1554.0 to 2394.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 9V:Before Dose 4	183 Titers Interval 134.0 to 251.0	204 Titers Interval 151.0 to 274.0	212 Titers Interval 149.0 to 302.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 9V:1 Month after Dose 4	4199 Titers Interval 3322.0 to 5309.0	5162 Titers Interval 4349.0 to 6127.0	4201 Titers Interval 3418.0 to 5164.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 14:1 Month after Dose 3	1922 Titers Interval 1429.0 to 2585.0	2593 Titers Interval 1999.0 to 3362.0	2103 Titers Interval 1527.0 to 2897.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 14:Before Dose 4	426 Titers Interval 307.0 to 592.0	469 Titers Interval 346.0 to 634.0	357 Titers Interval 251.0 to 509.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 14:1 Month after Dose 4	1673 Titers Interval 1331.0 to 2102.0	1706 Titers Interval 1385.0 to 2102.0	2005 Titers Interval 1631.0 to 2463.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 18C:1 Month after Dose 3	5124 Titers Interval 4381.0 to 5992.0	5355 Titers Interval 4617.0 to 6212.0	4908 Titers Interval 4037.0 to 5967.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 18C:Before Dose 4	122 Titers Interval 76.0 to 198.0	173 Titers Interval 112.0 to 267.0	89 Titers Interval 56.0 to 143.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 18C:1 Month after Dose 4	4477 Titers Interval 3528.0 to 5681.0	6315 Titers Interval 5081.0 to 7848.0	4249 Titers Interval 3355.0 to 5381.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 19A:1 Month after Dose 3	638 Titers Interval 535.0 to 762.0	676 Titers Interval 551.0 to 830.0	553 Titers Interval 441.0 to 693.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 19A:Before Dose 4	13 Titers Interval 10.0 to 18.0	20 Titers Interval 14.0 to 28.0	12 Titers Interval 10.0 to 16.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 19A:1 Month after Dose 4	1860 Titers Interval 1530.0 to 2261.0	2534 Titers Interval 2044.0 to 3143.0	1722 Titers Interval 1379.0 to 2151.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 19F:1 Month after Dose 3	449 Titers Interval 356.0 to 566.0	624 Titers Interval 494.0 to 788.0	488 Titers Interval 411.0 to 580.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 19F:Before Dose 4	26 Titers Interval 24.0 to 29.0	25 Titers Interval 24.0 to 26.0	26 Titers Interval 23.0 to 29.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 19F:1 Month after Dose 4	1071 Titers Interval 846.0 to 1356.0	1783 Titers Interval 1364.0 to 2331.0	962 Titers Interval 753.0 to 1230.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 23F:1 Month after Dose 3	1580 Titers Interval 1211.0 to 2061.0	1849 Titers Interval 1499.0 to 2281.0	1402 Titers Interval 1103.0 to 1782.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 23F:Before Dose 4	42 Titers Interval 24.0 to 73.0	62 Titers Interval 36.0 to 107.0	24 Titers Interval 15.0 to 39.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 23F:1 Month after Dose 4	2609 Titers Interval 2015.0 to 3377.0	3772 Titers Interval 2966.0 to 4796.0	2052 Titers Interval 1668.0 to 2523.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 8:1 Month after Dose 3	1532 Titers Interval 1215.0 to 1933.0	16 Titers Interval 15.0 to 18.0	1541 Titers Interval 1220.0 to 1946.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 8:Before Dose 4	166 Titers Interval 119.0 to 230.0	20 Titers Interval 17.0 to 24.0	147 Titers Interval 105.0 to 205.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 8:1 Month after Dose 4	2970 Titers Interval 2412.0 to 3658.0	27 Titers Interval 20.0 to 36.0	3208 Titers Interval 2525.0 to 4077.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 10A:1 Month after Dose 3	6977 Titers Interval 5204.0 to 9354.0	40 Titers Interval 33.0 to 47.0	6780 Titers Interval 5436.0 to 8456.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 10A:Before Dose 4	1985 Titers Interval 1422.0 to 2772.0	78 Titers Interval 51.0 to 118.0	2066 Titers Interval 1439.0 to 2967.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 10A:1 Month after Dose 4	9030 Titers Interval 6855.0 to 11893.0	87 Titers Interval 56.0 to 136.0	8269 Titers Interval 6252.0 to 10937.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 11A:1 Month after Dose 3	1894 Titers Interval 1540.0 to 2330.0	58 Titers Interval 47.0 to 71.0	1838 Titers Interval 1451.0 to 2327.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 11A:Before Dose 4	416 Titers Interval 258.0 to 670.0	95 Titers Interval 64.0 to 142.0	247 Titers Interval 150.0 to 405.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 11A: 1 Month after Dose 4	3958 Titers Interval 2973.0 to 5269.0	90 Titers Interval 62.0 to 132.0	4200 Titers Interval 3187.0 to 5534.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 12F:1 Month after Dose 3	35278 Titers Interval 23575.0 to 52790.0	24 Titers Interval 24.0 to 25.0	21475 Titers Interval 14378.0 to 32074.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 12F:Before Dose 4	3984 Titers Interval 3017.0 to 5261.0	35 Titers Interval 26.0 to 47.0	4904 Titers Interval 3909.0 to 6153.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 12F:1 Month after Dose 4	15611 Titers Interval 11336.0 to 21499.0	43 Titers Interval 31.0 to 60.0	18899 Titers Interval 14215.0 to 25125.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 15B:1 Month after Dose 3	6981 Titers Interval 5726.0 to 8511.0	17 Titers Interval 15.0 to 20.0	5707 Titers Interval 4129.0 to 7889.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 15B:Before Dose 4	578 Titers Interval 345.0 to 969.0	26 Titers Interval 18.0 to 39.0	609 Titers Interval 331.0 to 1121.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 15B:1 Month after Dose 4	7280 Titers Interval 5594.0 to 9475.0	32 Titers Interval 20.0 to 50.0	7770 Titers Interval 6448.0 to 9363.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 22F:1 Month after Dose 3	21864 Titers Interval 16413.0 to 29125.0	10 Titers Interval 8.0 to 11.0	19276 Titers Interval 14969.0 to 24822.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 22F:Before Dose 4	2562 Titers Interval 1869.0 to 3512.0	16 Titers Interval 11.0 to 24.0	2014 Titers Interval 1477.0 to 2745.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 22F:1 Month after Dose 4	28435 Titers Interval 19414.0 to 41649.0	18 Titers Interval 12.0 to 27.0	23480 Titers Interval 17229.0 to 31998.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 33F:1 Month after Dose 3	20162 Titers Interval 13581.0 to 29930.0	177 Titers Interval 160.0 to 195.0	15931 Titers Interval 11550.0 to 21974.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 33F:Before Dose 4	5678 Titers Interval 4403.0 to 7321.0	539 Titers Interval 391.0 to 742.0	6835 Titers Interval 5080.0 to 9198.0
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 Serotype 33F:1 Month after Dose 4	18997 Titers Interval 13140.0 to 27463.0	658 Titers Interval 480.0 to 904.0	26963 Titers Interval 18722.0 to 38830.0

SECONDARY outcome

Timeframe: 1 Month after Dose 4

Population: Dose 4 evaluable immunogenicity population included participants who were eligible randomized aged 2 to 6 months of age at first dose, received all 4 randomized doses with Dose 4 received within defined window 12 to 15 months of age, had at least 1 immunogenicity results within 27 to 56 days, inclusive, after Dose 4,and had no other major protocol deviations per clinician. Here, N=participants evaluable for this outcome measure and n=participants with valid results for specified serotype.

Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The predefined levels, \>=0.35 micrograms/mL for all serotypes except for serotypes 5 (\>=0.23 micrograms/mL), 6B (\>=0.10 micrograms/mL) and 19A (\>=0.12 micrograms/mL).

Outcome measures

SECONDARY outcome

Timeframe: 1 Month after Dose 3 to before Dose 4

Population: Dose 3 evaluable immunogenicity population was included. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure and "Number Analyzed"= participants with valid IgG concentration at both timepoints for the specified serotype.

GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from 1 month after Dose 3 to before Dose 4 was reported from participants in Dose 3 evaluable immunogenicity population.

Outcome measures

SECONDARY outcome

Timeframe: From 1 Month after Dose 3 to 1 Month after Dose 4

Population: Dose 3 and Dose 4 evaluable immunogenicity populations were included. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure and "Number Analyzed"= participants with valid IgG concentrations at both timepoints for the specified serotype.

GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from 1 month after Dose 3 to 1 month after Dose 4 was reported from participants in both the Dose 3 and Dose 4 evaluable immunogenicity population.

Outcome measures

Outcome measures
Measure	20vPnC (SC) n=218 Participants Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) n=219 Participants Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) n=212 Participants Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 Serotype 6A	8.6 Fold rise Interval 7.5 to 9.8	7.3 Fold rise Interval 6.5 to 8.3	8.6 Fold rise Interval 7.6 to 9.8
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 Serotype 1	2.0 Fold rise Interval 1.8 to 2.2	2.1 Fold rise Interval 1.9 to 2.3	2.4 Fold rise Interval 2.2 to 2.7
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 Serotype 3	0.7 Fold rise Interval 0.7 to 0.8	0.8 Fold rise Interval 0.7 to 0.9	1.0 Fold rise Interval 0.9 to 1.1
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 Serotype 4	3.9 Fold rise Interval 3.4 to 4.4	3.4 Fold rise Interval 3.0 to 3.8	4.3 Fold rise Interval 3.7 to 4.8
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 Serotype 5	2.9 Fold rise Interval 2.6 to 3.3	2.7 Fold rise Interval 2.4 to 3.0	3.0 Fold rise Interval 2.6 to 3.4
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 Serotype 6B	17.1 Fold rise Interval 14.3 to 20.4	12.6 Fold rise Interval 10.8 to 14.7	19.5 Fold rise Interval 16.2 to 23.5
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 Serotype 7F	2.8 Fold rise Interval 2.6 to 3.1	3.0 Fold rise Interval 2.7 to 3.3	3.3 Fold rise Interval 2.9 to 3.6
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 Serotype 9V	3.1 Fold rise Interval 2.8 to 3.5	3.1 Fold rise Interval 2.8 to 3.5	3.8 Fold rise Interval 3.4 to 4.2
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 Serotype 14	2.9 Fold rise Interval 2.6 to 3.4	3.1 Fold rise Interval 2.7 to 3.6	3.9 Fold rise Interval 3.3 to 4.5
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 Serotype 18C	2.3 Fold rise Interval 2.1 to 2.6	2.4 Fold rise Interval 2.1 to 2.6	2.5 Fold rise Interval 2.3 to 2.8
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 Serotype 19A	3.2 Fold rise Interval 2.8 to 3.6	2.8 Fold rise Interval 2.5 to 3.1	3.4 Fold rise Interval 3.0 to 3.8
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 Serotype 19F	3.1 Fold rise Interval 2.8 to 3.4	2.9 Fold rise Interval 2.6 to 3.3	3.1 Fold rise Interval 2.8 to 3.5
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 Serotype 23F	5.3 Fold rise Interval 4.6 to 6.1	5.7 Fold rise Interval 5.0 to 6.5	5.8 Fold rise Interval 5.1 to 6.6
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 Serotype 8	1.8 Fold rise Interval 1.6 to 2.0	1.7 Fold rise Interval 1.5 to 2.0	1.8 Fold rise Interval 1.6 to 2.0
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 Serotype 10A	14.0 Fold rise Interval 11.8 to 16.5	0.8 Fold rise Interval 0.7 to 1.0	17.5 Fold rise Interval 14.7 to 20.7
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 Serotype 11A	1.0 Fold rise Interval 0.9 to 1.1	0.8 Fold rise Interval 0.7 to 1.0	1.1 Fold rise Interval 1.0 to 1.2
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 Serotype 12F	3.4 Fold rise Interval 3.0 to 3.9	1.0 Fold rise Interval 1.0 to 1.1	3.9 Fold rise Interval 3.4 to 4.4
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 Serotype 15B	2.7 Fold rise Interval 2.4 to 3.1	0.9 Fold rise Interval 0.7 to 1.1	3.3 Fold rise Interval 2.9 to 3.7
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 Serotype 22F	2.9 Fold rise Interval 2.6 to 3.1	0.7 Fold rise Interval 0.6 to 0.9	3.2 Fold rise Interval 2.9 to 3.6
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 Serotype 33F	6.0 Fold rise Interval 5.3 to 6.7	0.7 Fold rise Interval 0.6 to 0.9	7.1 Fold rise Interval 6.2 to 8.1

SECONDARY outcome

Timeframe: From before Dose 4 to 1 Month after Dose 4

Population: Dose 4 evaluable immunogenicity population was included. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure and "Number Analyzed" =participants with valid IgG concentrations at both timepoints for the specified serotype.

GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from before Dose 4 to 1 month after Dose 4 was reported from participants in the Dose 4 evaluable immunogenicity population.

Outcome measures

Outcome measures
Measure	20vPnC (SC) n=217 Participants Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) n=220 Participants Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) n=211 Participants Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 Serotype 1	10.7 Fold rise Interval 9.6 to 11.9	12.1 Fold rise Interval 11.0 to 13.3	12.6 Fold rise Interval 11.3 to 14.0
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 Serotype 3	7.5 Fold rise Interval 6.6 to 8.4	7.9 Fold rise Interval 7.1 to 8.8	8.9 Fold rise Interval 8.0 to 10.0
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 Serotype 4	15.0 Fold rise Interval 13.2 to 17.1	14.3 Fold rise Interval 12.7 to 16.0	16.5 Fold rise Interval 14.8 to 18.5
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 Serotype 5	10.8 Fold rise Interval 9.8 to 12.0	11.8 Fold rise Interval 10.7 to 13.1	12.2 Fold rise Interval 11.0 to 13.6
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 Serotype 6A	17.6 Fold rise Interval 15.7 to 19.6	18.4 Fold rise Interval 16.6 to 20.5	22.1 Fold rise Interval 19.8 to 24.7
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 Serotype 6B	22.3 Fold rise Interval 19.9 to 24.9	24.3 Fold rise Interval 21.9 to 27.0	26.9 Fold rise Interval 23.9 to 30.2
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 Serotype 7F	6.0 Fold rise Interval 5.5 to 6.6	7.2 Fold rise Interval 6.5 to 8.0	6.8 Fold rise Interval 6.2 to 7.5
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 Serotype 9V	11.8 Fold rise Interval 10.5 to 13.2	12.0 Fold rise Interval 10.8 to 13.3	13.9 Fold rise Interval 12.4 to 15.6
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 Serotype 14	4.3 Fold rise Interval 3.8 to 4.9	4.4 Fold rise Interval 3.9 to 5.0	5.7 Fold rise Interval 5.0 to 6.6
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 Serotype 18C	11.7 Fold rise Interval 10.5 to 12.9	14.0 Fold rise Interval 12.7 to 15.4	12.7 Fold rise Interval 11.5 to 14.1
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 Serotype 19A	34.2 Fold rise Interval 30.0 to 38.9	37.6 Fold rise Interval 33.2 to 42.6	38.3 Fold rise Interval 33.4 to 44.0
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 Serotype 19F	18.8 Fold rise Interval 16.6 to 21.4	21.4 Fold rise Interval 19.0 to 24.2	19.9 Fold rise Interval 17.6 to 22.4
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 Serotype 23F	22.6 Fold rise Interval 20.1 to 25.5	22.6 Fold rise Interval 19.8 to 25.7	22.7 Fold rise Interval 20.1 to 25.7
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 Serotype 8	10.8 Fold rise Interval 9.6 to 12.1	1.3 Fold rise Interval 1.2 to 1.4	11.2 Fold rise Interval 9.9 to 12.7
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 Serotype 10A	6.3 Fold rise Interval 5.6 to 7.1	1.1 Fold rise Interval 1.0 to 1.1	7.4 Fold rise Interval 6.6 to 8.3
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 Serotype 11A	7.0 Fold rise Interval 6.2 to 7.9	1.1 Fold rise Interval 1.0 to 1.2	8.1 Fold rise Interval 7.2 to 9.1
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 Serotype 12F	8.5 Fold rise Interval 7.6 to 9.4	1.0 Fold rise Interval 1.0 to 1.1	9.9 Fold rise Interval 8.9 to 10.9
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 Serotype 15B	6.8 Fold rise Interval 6.0 to 7.7	1.5 Fold rise Interval 1.3 to 1.6	8.7 Fold rise Interval 7.6 to 10.0
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 Serotype 22F	7.9 Fold rise Interval 7.1 to 8.8	1.2 Fold rise Interval 1.1 to 1.3	8.9 Fold rise Interval 8.1 to 9.9
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 Serotype 33F	5.7 Fold rise Interval 5.1 to 6.3	1.2 Fold rise Interval 1.1 to 1.3	6.9 Fold rise Interval 6.2 to 7.8

Adverse Events

20vPnC (SC)

Serious events: 14 serious events

Other events: 222 other events

Deaths: 0 deaths

13vPnC (SC)

Serious events: 9 serious events

Other events: 223 other events

Deaths: 0 deaths

20vPnC (IM)

Serious events: 16 serious events

Other events: 211 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	20vPnC (SC) n=225 participants at risk Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) n=224 participants at risk Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) n=217 participants at risk Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
General disorders Injection site erythema (REDNESS)	96.4% 217/225 • Number of events 762 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	96.9% 217/224 • Number of events 784 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	59.9% 130/217 • Number of events 297 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
General disorders Injection site pain (PAIN)	37.3% 84/225 • Number of events 167 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	37.9% 85/224 • Number of events 166 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	30.0% 65/217 • Number of events 118 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
General disorders Injection site swelling (SWELLING)	91.6% 206/225 • Number of events 723 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	94.2% 211/224 • Number of events 729 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	54.8% 119/217 • Number of events 251 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
General disorders Pyrexia (FEVER)	60.4% 136/225 • Number of events 219 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	60.3% 135/224 • Number of events 219 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	50.7% 110/217 • Number of events 197 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
Infections and infestations Bronchitis	3.6% 8/225 • Number of events 10 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	3.6% 8/224 • Number of events 9 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	5.1% 11/217 • Number of events 11 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
Infections and infestations Nasopharyngitis	21.8% 49/225 • Number of events 72 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	28.6% 64/224 • Number of events 85 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	30.4% 66/217 • Number of events 96 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
Infections and infestations Upper respiratory tract infection	5.3% 12/225 • Number of events 22 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	3.6% 8/224 • Number of events 10 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	3.7% 8/217 • Number of events 14 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
Metabolism and nutrition disorders Decreased appetite (DECREASED APPETITE)	27.6% 62/225 • Number of events 99 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	30.4% 68/224 • Number of events 118 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	25.3% 55/217 • Number of events 94 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
Nervous system disorders Hypersomnia (INCREASED SLEEP)	65.3% 147/225 • Number of events 343 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	71.9% 161/224 • Number of events 410 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	71.0% 154/217 • Number of events 389 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
Psychiatric disorders Irritability (IRRITABILITY)	48.9% 110/225 • Number of events 291 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	53.1% 119/224 • Number of events 295 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	49.3% 107/217 • Number of events 282 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	8.0% 18/225 • Number of events 22 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	4.9% 11/224 • Number of events 14 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	6.9% 15/217 • Number of events 19 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
Skin and subcutaneous tissue disorders Eczema infantile	2.7% 6/225 • Number of events 6 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	7.1% 16/224 • Number of events 18 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	6.0% 13/217 • Number of events 14 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
Skin and subcutaneous tissue disorders Eczema	9.8% 22/225 • Number of events 25 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	8.5% 19/224 • Number of events 19 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study	14.7% 32/217 • Number of events 33 • LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study

Additional Information

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Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from the 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

Measure	20vPnC (SC) n=217 Participants Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) n=220 Participants Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) n=211 Participants Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 Serotype 9V	99.5 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 Serotype 6A	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 Serotype 6B	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 Serotype 7F	99.5 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 Serotype 1	99.1 Percentage of participants	100.0 Percentage of participants	98.6 Percentage of participants
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 Serotype 3	91.7 Percentage of participants	98.6 Percentage of participants	91.5 Percentage of participants
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 Serotype 4	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 Serotype 5	99.5 Percentage of participants	100.0 Percentage of participants	99.5 Percentage of participants
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 Serotype 14	99.1 Percentage of participants	99.5 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 Serotype 18C	99.5 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 Serotype 19A	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 Serotype 19F	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 Serotype 23F	99.5 Percentage of participants	100.0 Percentage of participants	99.5 Percentage of participants
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 Serotype 8	100.0 Percentage of participants	3.2 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 Serotype 10A	99.1 Percentage of participants	0.9 Percentage of participants	99.5 Percentage of participants
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 Serotype 11A	100.0 Percentage of participants	5.9 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 Serotype 12F	98.2 Percentage of participants	0.0 Percentage of participants	98.6 Percentage of participants
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 Serotype 15B	100.0 Percentage of participants	8.6 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 Serotype 22F	100.0 Percentage of participants	1.8 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 Serotype 33F	100.0 Percentage of participants	2.7 Percentage of participants	100.0 Percentage of participants

Measure	20vPnC (SC) n=218 Participants Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	13vPnC (SC) n=219 Participants Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	20vPnC (IM) n=212 Participants Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 Serotype 1	0.2 Fold rise Interval 0.2 to 0.2	0.2 Fold rise Interval 0.2 to 0.2	0.2 Fold rise Interval 0.2 to 0.2
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 Serotype 3	0.1 Fold rise Interval 0.1 to 0.1	0.1 Fold rise Interval 0.1 to 0.1	0.1 Fold rise Interval 0.1 to 0.1
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 Serotype 4	0.3 Fold rise Interval 0.2 to 0.3	0.2 Fold rise Interval 0.2 to 0.3	0.3 Fold rise Interval 0.2 to 0.3
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 Serotype 5	0.3 Fold rise Interval 0.2 to 0.3	0.2 Fold rise Interval 0.2 to 0.3	0.2 Fold rise Interval 0.2 to 0.3
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 Serotype 6A	0.5 Fold rise Interval 0.4 to 0.6	0.4 Fold rise Interval 0.4 to 0.4	0.4 Fold rise Interval 0.3 to 0.4
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 Serotype 6B	0.8 Fold rise Interval 0.6 to 0.9	0.5 Fold rise Interval 0.4 to 0.6	0.7 Fold rise Interval 0.6 to 0.8
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 Serotype 7F	0.5 Fold rise Interval 0.4 to 0.5	0.4 Fold rise Interval 0.4 to 0.5	0.5 Fold rise Interval 0.4 to 0.5
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 Serotype 9V	0.3 Fold rise Interval 0.2 to 0.3	0.3 Fold rise Interval 0.2 to 0.3	0.3 Fold rise Interval 0.2 to 0.3
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 Serotype 14	0.7 Fold rise Interval 0.6 to 0.8	0.7 Fold rise Interval 0.6 to 0.8	0.7 Fold rise Interval 0.6 to 0.8
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 Serotype 18C	0.2 Fold rise Interval 0.2 to 0.2	0.2 Fold rise Interval 0.2 to 0.2	0.2 Fold rise Interval 0.2 to 0.2
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 Serotype 19A	0.1 Fold rise Interval 0.1 to 0.1	0.1 Fold rise Interval 0.1 to 0.1	0.1 Fold rise Interval 0.1 to 0.1
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 Serotype 19F	0.2 Fold rise Interval 0.1 to 0.2	0.1 Fold rise Interval 0.1 to 0.2	0.2 Fold rise Interval 0.1 to 0.2
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 Serotype 23F	0.2 Fold rise Interval 0.2 to 0.3	0.3 Fold rise Interval 0.2 to 0.3	0.3 Fold rise Interval 0.2 to 0.3
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 Serotype 8	0.2 Fold rise Interval 0.1 to 0.2	1.4 Fold rise Interval 1.2 to 1.6	0.2 Fold rise Interval 0.1 to 0.2
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 Serotype 10A	2.2 Fold rise Interval 1.9 to 2.6	0.8 Fold rise Interval 0.6 to 0.9	2.3 Fold rise Interval 1.9 to 2.7
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 Serotype 11A	0.1 Fold rise Interval 0.1 to 0.2	0.8 Fold rise Interval 0.6 to 0.9	0.1 Fold rise Interval 0.1 to 0.2
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 Serotype 12F	0.4 Fold rise Interval 0.3 to 0.5	1.0 Fold rise Interval 0.9 to 1.1	0.4 Fold rise Interval 0.3 to 0.4
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 Serotype 15B	0.4 Fold rise Interval 0.4 to 0.5	0.6 Fold rise Interval 0.5 to 0.7	0.4 Fold rise Interval 0.3 to 0.4
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 Serotype 22F	0.4 Fold rise Interval 0.3 to 0.4	0.6 Fold rise Interval 0.5 to 0.8	0.4 Fold rise Interval 0.3 to 0.4
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 Serotype 33F	1.1 Fold rise Interval 0.9 to 1.2	0.6 Fold rise Interval 0.5 to 0.7	1.0 Fold rise Interval 0.9 to 1.2