Trial Outcomes & Findings for Study of 10-valent Pneumococcal Conjugate Vaccine (Pneumosil) Administered in a 2+1 Schedule to Healthy Infants (NCT NCT03896477)

Last Updated: 2022-04-20

Results Overview

The IgG antibody concentration to each of the 10 serotypes contained in Pneumosil was measured by enzyme-linked immunosorbent assay (ELISA) in serum samples collected 4 weeks after the booster dose (Visit 6). The pneumococcal serotype-specific IgG ELISAs were performed using the World Health Organisation (WHO) reference assay at the WHO Pneumococcal Serology Reference Laboratory, at the Institute of Child Health, University College London, United Kingdom (UK), where the assay was validated.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

660 participants

Primary outcome timeframe

4 weeks post booster dose

Results posted on

2022-04-20

Participant Flow

Healthy, Gambian male and female, pneumococcal conjugate vaccine (PCV)-naïve infants were screened and enrolled at the Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine (MRCG at LSHTM).

Eligible participants were randomized equally (in a 1:1:1 ratio), based on a pre-established randomization scheme, to receive either Pneumosil, Synflorix or Prevenar 13. Participants were to receive two primary vaccinations plus a booster vaccination at 9-10 months of age. The booster vaccination window was extended up to 18 months of age due to a pause in the study due to the COVID-19 pandemic; actual mean age of booster administration was 12.5 months and ranged from 9 to 16 months.

Participant milestones

Participant milestones
Measure	Pneumosil Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Synflorix Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Prevenar 13 Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Overall Study STARTED	220	220	220
Overall Study Received First Vaccination	220	220	220
Overall Study Received Second Vaccination	217	213	213
Overall Study Received Booster Vaccination	208	206	206
Overall Study COMPLETED	203	200	200
Overall Study NOT COMPLETED	17	20	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Pneumosil Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Synflorix Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Prevenar 13 Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Overall Study Met Ineligibility Criteria During the Study	1	1	2
Overall Study Parent Requested Withdrawal	8	12	9
Overall Study Adverse Event	0	0	1
Overall Study Death	1	0	0
Overall Study Other	5	6	7
Overall Study Lost to Follow-up	2	1	1

Baseline Characteristics

Study of 10-valent Pneumococcal Conjugate Vaccine (Pneumosil) Administered in a 2+1 Schedule to Healthy Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pneumosil n=220 Participants Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Synflorix n=220 Participants Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Prevenar 13 n=220 Participants Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Total n=660 Participants Total of all reporting groups
Age, Continuous	47.3 days STANDARD_DEVIATION 3.86 • n=5 Participants	46.8 days STANDARD_DEVIATION 3.96 • n=7 Participants	46.7 days STANDARD_DEVIATION 3.74 • n=5 Participants	46.9 days STANDARD_DEVIATION 3.86 • n=4 Participants
Sex: Female, Male Female	125 Participants n=5 Participants	108 Participants n=7 Participants	109 Participants n=5 Participants	342 Participants n=4 Participants
Sex: Female, Male Male	95 Participants n=5 Participants	112 Participants n=7 Participants	111 Participants n=5 Participants	318 Participants n=4 Participants
Race/Ethnicity, Customized African	220 Participants n=5 Participants	220 Participants n=7 Participants	220 Participants n=5 Participants	660 Participants n=4 Participants
Ethnicity Mandinka	109 Participants n=5 Participants	118 Participants n=7 Participants	124 Participants n=5 Participants	351 Participants n=4 Participants
Ethnicity Wolof	21 Participants n=5 Participants	17 Participants n=7 Participants	22 Participants n=5 Participants	60 Participants n=4 Participants
Ethnicity Fula	26 Participants n=5 Participants	25 Participants n=7 Participants	25 Participants n=5 Participants	76 Participants n=4 Participants
Ethnicity Jola	28 Participants n=5 Participants	31 Participants n=7 Participants	15 Participants n=5 Participants	74 Participants n=4 Participants
Ethnicity Serahule	9 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	27 Participants n=4 Participants
Ethnicity Serere	9 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	25 Participants n=4 Participants
Ethnicity Manjago	5 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity Other	13 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants	37 Participants n=4 Participants
Primary Cooking Fuel Source Wood/charcoal	218 Participants n=5 Participants	219 Participants n=7 Participants	219 Participants n=5 Participants	656 Participants n=4 Participants
Primary Cooking Fuel Source Gas/electricity	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Primary Water Source for Cooking/Drinking Private tap, well or borehole	168 Participants n=5 Participants	180 Participants n=7 Participants	178 Participants n=5 Participants	526 Participants n=4 Participants
Primary Water Source for Cooking/Drinking Community tap, well or borehole	52 Participants n=5 Participants	40 Participants n=7 Participants	42 Participants n=5 Participants	134 Participants n=4 Participants
Weight	4.64 kg STANDARD_DEVIATION 0.55 • n=5 Participants	4.68 kg STANDARD_DEVIATION 0.58 • n=7 Participants	4.67 kg STANDARD_DEVIATION 0.65 • n=5 Participants	4.66 kg STANDARD_DEVIATION 0.59 • n=4 Participants
Length	55.44 cm STANDARD_DEVIATION 1.91 • n=5 Participants	55.48 cm STANDARD_DEVIATION 2.02 • n=7 Participants	55.29 cm STANDARD_DEVIATION 2.11 • n=5 Participants	55.40 cm STANDARD_DEVIATION 2.02 • n=4 Participants

PRIMARY outcome

Timeframe: 4 weeks post booster dose

Population: Primary Per Protocol Immunogenicity Population (PP\_IMM) includes all randomized participants who received all 3 study vaccinations (including booster), contributed post-booster immunogenicity measurements, and with no major protocol deviations that were determined to potentially interfere with immunogenicity assessment. Participants with available data for each serotype are included in the analysis.

Outcome measures

Outcome measures
Measure	Pneumosil n=202 Participants Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Synflorix n=200 Participants Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Prevenar 13 n=200 Participants Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster Serotype 19F	11.11 μg/mL Interval 9.7 to 12.73	17.31 μg/mL Interval 14.83 to 20.2	14.99 μg/mL Interval 13.25 to 16.96
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster Serotype 1	8.45 μg/mL Interval 7.54 to 9.48	2.90 μg/mL Interval 2.57 to 3.28	5.87 μg/mL Interval 5.26 to 6.56
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster Serotype 6B	12.46 μg/mL Interval 11.07 to 14.01	4.96 μg/mL Interval 4.44 to 5.53	15.54 μg/mL Interval 13.71 to 17.6
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster Serotype 7F	6.66 μg/mL Interval 5.96 to 7.44	3.15 μg/mL Interval 2.87 to 3.45	6.31 μg/mL Interval 5.75 to 6.93
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster Serotype 14	8.28 μg/mL Interval 6.97 to 9.82	5.02 μg/mL Interval 4.22 to 5.97	9.17 μg/mL Interval 8.06 to 10.45
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster Serotype 19A	8.82 μg/mL Interval 7.65 to 10.15	2.39 μg/mL Interval 1.97 to 2.89	12.21 μg/mL Interval 10.83 to 13.76
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster Serotype 5	1.54 μg/mL Interval 1.38 to 1.73	0.80 μg/mL Interval 0.72 to 0.88	2.04 μg/mL Interval 1.86 to 2.24
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster Serotype 6A	9.56 μg/mL Interval 8.26 to 11.05	0.60 μg/mL Interval 0.5 to 0.71	10.95 μg/mL Interval 9.57 to 12.54
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster Serotype 9V	3.46 μg/mL Interval 3.08 to 3.88	2.45 μg/mL Interval 2.21 to 2.72	3.87 μg/mL Interval 3.47 to 4.32
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster Serotype 23F	4.95 μg/mL Interval 4.28 to 5.73	2.16 μg/mL Interval 1.92 to 2.44	4.97 μg/mL Interval 4.34 to 5.69

PRIMARY outcome

Timeframe: Day 0 to Day 6 after each vaccination

Population: The Safety Analysis Set (Safety Population) included all participants who were randomized, received a study vaccination, and provided post-vaccination safety data.

Solicited local reactions included tenderness, erythema/redness and induration/swelling at the study vaccine injection site. Solicited systemic reactions included cutaneous rash, fever (based on axillary temperature), irritability, drowsiness, and decreased appetite. The severity of all solicited AEs was graded from mild (Grade 1) to potentially life threatening (Grade 4), based on protocol-defined criteria that were derived from Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (Version 2.0, November 2014).

Outcome measures

Outcome measures
Measure	Pneumosil n=220 Participants Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Synflorix n=220 Participants Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Prevenar 13 n=220 Participants Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination Any local reaction	72 Participants	84 Participants	63 Participants
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination Fever	98 Participants	105 Participants	108 Participants
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination Cutaneous Rash Grade 3 or higher	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination Any local reaction Grade 3 or higher	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination Tenderness	70 Participants	83 Participants	61 Participants
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination Erythema/Redness	1 Participants	3 Participants	1 Participants
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination Induration/Swelling	3 Participants	5 Participants	1 Participants
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination Any systemic reaction	160 Participants	167 Participants	160 Participants
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination Any systemic reaction Grade 3 or higher	3 Participants	0 Participants	2 Participants
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination Fever Grade 3 or higher	3 Participants	0 Participants	2 Participants
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination Cutaneous Rash	16 Participants	7 Participants	6 Participants
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination Irritability	105 Participants	110 Participants	101 Participants
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination Irritability Grade 3 or higher	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination Drowsiness	12 Participants	15 Participants	18 Participants
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination Drowsiness Grade 3 or higher	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination Decreased Appetite	25 Participants	18 Participants	28 Participants
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination Decreased Appetite Grade 3 or higher	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post vaccination; approximately 8.5 months overall.

Population: Safety analysis set

AEs include any intercurrent illness or injury during the study, clinically significant worsening of a preexisting condition, and any solicited AE that occurred or was ongoing 6 days after study vaccine administration. A TEAE is an event that was not present prior to administration of the study vaccine, or increased in intensity after administration of the study vaccine. Unsolicited AEs were graded using the scale below: Grade 1: Mild; asymptomatic or mild symptoms; intervention not indicated. Grade 2: Moderate; minimal, local, or noninvasive intervention indicated. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. Related AEs are AEs where the Investigator determined a reasonable causal relationship between the vaccine administered and the AE based on medical judgement.

Outcome measures

Outcome measures
Measure	Pneumosil n=220 Participants Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Synflorix n=220 Participants Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Prevenar 13 n=220 Participants Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) Vaccine related Grade 5 TEAE	0 Participants	0 Participants	0 Participants
Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) Any treatment-emergent adverse event (TEAE)	198 Participants	197 Participants	189 Participants
Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) Grade 4 TEAE	0 Participants	0 Participants	0 Participants
Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) Grade 5 TEAE	1 Participants	0 Participants	1 Participants
Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) Any vaccine-related TEAE	1 Participants	2 Participants	0 Participants
Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) TEAEs leading to study discontinuation	0 Participants	0 Participants	1 Participants
Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) Grade 1 TEAE	196 Participants	195 Participants	186 Participants
Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) Vaccine-related Grade 1 TEAE	1 Participants	1 Participants	0 Participants
Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) Grade 2 TEAE	22 Participants	20 Participants	17 Participants
Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) Vaccine-related Grade 2 TEAE	0 Participants	0 Participants	0 Participants
Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) Grade 3 TEAE	11 Participants	10 Participants	6 Participants
Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) Vaccine-related Grade 3 TEAE	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall.

Population: Safety analysis set

An SAE was a specific AE that: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of an existing hospitalization. * Resulted in a persistent or significant disability or incapacity. * Resulted in a congenital anomaly or birth defect

Outcome measures

Outcome measures
Measure	Pneumosil n=220 Participants Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Synflorix n=220 Participants Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Prevenar 13 n=220 Participants Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Number of Participants With Serious Adverse Events (SAEs) Any serious adverse event	12 Participants	10 Participants	7 Participants
Number of Participants With Serious Adverse Events (SAEs) Vaccine-related serious adverse events	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 weeks post booster dose

Population: Primary Per Protocol Immunogenicity population with available serotype data; OPA assays were conducted on the first 50 samples from each treatment group.

The functional activity of the antibody response to the 10 serotypes contained in Pneumosil was determined in serum samples collected 4 weeks after the booster dose in a subset of 50 participants per group. This activity was determined using the 4-fold multiplexed opsonophagocytic assay (MOPA) developed at the University of Alabama at Birmingham, and performed at the WHO Pneumococcal Serology Reference Laboratory, at the Institute of Child Health, University College London, UK, where the assay was validated. A higher titer indicates increased antibody-mediated opsonophagocytosis.

Outcome measures

Outcome measures
Measure	Pneumosil n=50 Participants Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Synflorix n=50 Participants Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Prevenar 13 n=50 Participants Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster Serotype 6A	3651.54 titer Interval 2593.53 to 5141.16	53.86 titer Interval 25.1 to 115.56	6464.88 titer Interval 5120.52 to 8162.19
Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster Serotype 6B	3931.21 titer Interval 2969.79 to 5203.89	1294.61 titer Interval 929.52 to 1803.11	6012.88 titer Interval 4130.89 to 8752.29
Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster Serotype 7F	7053.37 titer Interval 5904.91 to 8425.18	4401.18 titer Interval 3593.44 to 5390.5	8288.88 titer Interval 6756.83 to 10168.3
Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster Serotype 9V	1408.68 titer Interval 1092.33 to 1816.64	845.47 titer Interval 631.39 to 1132.13	2464.43 titer Interval 1957.36 to 3102.85
Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster Serotype 1	631.29 titer Interval 467.98 to 851.59	282.35 titer Interval 190.44 to 418.6	429.13 titer Interval 310.99 to 592.14
Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster Serotype 5	885.98 titer Interval 662.2 to 1185.37	484.66 titer Interval 361.73 to 649.38	703.15 titer Interval 556.01 to 889.24
Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster Serotype 14	2622.36 titer Interval 1845.88 to 3725.47	1381.52 titer Interval 883.3 to 2160.74	3131.96 titer Interval 2245.73 to 4367.91
Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster Serotype 19A	1620.76 titer Interval 1200.51 to 2188.13	305.46 titer Interval 177.87 to 524.57	3679.06 titer Interval 2920.79 to 4634.19
Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster Serotype 19F	1384.38 titer Interval 937.18 to 2044.98	2541.40 titer Interval 1666.99 to 3874.49	2094.57 titer Interval 1410.71 to 3109.94
Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster Serotype 23F	2998.53 titer Interval 2272.86 to 3955.89	1427.66 titer Interval 1110.72 to 1835.05	5687.60 titer Interval 3891.57 to 8312.54

SECONDARY outcome

Timeframe: 4 weeks post booster dose

Population: Primary Per Protocol Immunogenicity population with available serotype data

The seroresponse rate was defined as the percentage of infants with serotype-specific IgG antibody concentrations of at least 0.35 μg/mL, which is the reference concentration for assessment of vaccine efficacy against invasive pneumococcal diseases (IPDs). The IgG concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected 4 weeks after the booster dose.

Outcome measures

Outcome measures
Measure	Pneumosil n=202 Participants Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Synflorix n=200 Participants Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Prevenar 13 n=200 Participants Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster Serotype 19A	100 percentage of participants Interval 98.2 to 100.0	91.5 percentage of participants Interval 86.7 to 94.9	100 percentage of participants Interval 98.2 to 100.0
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster Serotype 1	100 percentage of participants Interval 98.2 to 100.0	100 percentage of participants Interval 98.1 to 100.0	99.5 percentage of participants Interval 97.3 to 100.0
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster Serotype 5	97.5 percentage of participants Interval 94.3 to 99.2	89.9 percentage of participants Interval 84.9 to 93.8	99.0 percentage of participants Interval 96.4 to 99.9
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster Serotype 6A	98.0 percentage of participants Interval 95.0 to 99.5	66.2 percentage of participants Interval 59.1 to 72.8	99.0 percentage of participants Interval 96.4 to 99.9
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster Serotype 6B	100 percentage of participants Interval 98.2 to 100.0	99.5 percentage of participants Interval 97.3 to 100.0	99.5 percentage of participants Interval 97.3 to 100.0
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster Serotype 7F	100 percentage of participants Interval 98.2 to 100.0	99.5 percentage of participants Interval 97.3 to 100.0	100 percentage of participants Interval 98.2 to 100.0
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster Serotype 9V	99.0 percentage of participants Interval 96.5 to 99.9	99.5 percentage of participants Interval 97.3 to 100.0	100 percentage of participants Interval 98.2 to 100.0
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster Serotype 14	98.5 percentage of participants Interval 95.7 to 99.7	97.5 percentage of participants Interval 94.3 to 99.2	99.5 percentage of participants Interval 97.3 to 100.0
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster Serotype 19F	100 percentage of participants Interval 98.2 to 100.0	100 percentage of participants Interval 98.1 to 100.0	100 percentage of participants Interval 98.1 to 100.0
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster Serotype 23F	98.0 percentage of participants Interval 95.0 to 99.5	98.0 percentage of participants Interval 95.0 to 99.5	98.5 percentage of participants Interval 95.6 to 99.7

SECONDARY outcome

Timeframe: 4 weeks post booster dose

Population: Primary Per Protocol Immunogenicity population with available data

Seroresponse rate was also defined as the percentage of infants with serotype-specific IgG antibody concentrations of at least 1.0 μg/mL. The IgG concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected 4 weeks after the booster dose.

Outcome measures

Outcome measures
Measure	Pneumosil n=202 Participants Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Synflorix n=200 Participants Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Prevenar 13 n=200 Participants Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster Serotype 23F	94.6 percentage of participants Interval 90.5 to 97.3	83.0 percentage of participants Interval 77.1 to 87.9	96.0 percentage of participants Interval 92.2 to 98.2
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster Serotype 1	98.5 percentage of participants Interval 95.7 to 99.7	88.3 percentage of participants Interval 83.0 to 92.5	97.5 percentage of participants Interval 94.3 to 99.2
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster Serotype 5	68.6 percentage of participants Interval 61.9 to 75.1	37.7 percentage of participants Interval 30.9 to 44.8	87.5 percentage of participants Interval 82.1 to 91.7
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster Serotype 6A	96.5 percentage of participants Interval 93.0 to 98.6	37.9 percentage of participants Interval 31.1 to 45.2	98.0 percentage of participants Interval 94.9 to 99.5
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster Serotype 6B	100 percentage of participants Interval 98.2 to 100.0	96.5 percentage of participants Interval 92.9 to 98.6	99.5 percentage of participants Interval 97.3 to 100.0
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster Serotype 7F	98.0 percentage of participants Interval 95.0 to 99.5	95.0 percentage of participants Interval 91.0 to 97.6	99.5 percentage of participants Interval 97.3 to 100.0
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster Serotype 9V	94.6 percentage of participants Interval 90.5 to 97.3	89.5 percentage of participants Interval 84.4 to 93.4	95.5 percentage of participants Interval 91.6 to 97.9
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster Serotype 14	95.0 percentage of participants Interval 91.1 to 97.6	90.0 percentage of participants Interval 85.0 to 93.8	99.0 percentage of participants Interval 96.4 to 99.9
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster Serotype 19A	96.0 percentage of participants Interval 92.3 to 98.3	77.4 percentage of participants Interval 70.9 to 83.0	99.5 percentage of participants Interval 97.2 to 100.0
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster Serotype 19F	98.5 percentage of participants Interval 95.7 to 99.7	96.9 percentage of participants Interval 93.4 to 98.9	99.0 percentage of participants Interval 96.4 to 99.9

SECONDARY outcome

Timeframe: 4 weeks post booster dose

Population: Primary Per Protocol Immunogenicity population with available serotype data; OPA assays were conducted on the first 50 samples from each treatment group.

The OPA seroresponse rate was defined as the percentage of infants with an OPA titer of at least 8. Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA) from serum samples taken 4 weeks after the booster vaccination.

Outcome measures

Outcome measures
Measure	Pneumosil n=50 Participants Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Synflorix n=50 Participants Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Prevenar 13 n=50 Participants Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster Serotype 6A	100 percentage of participants Interval 92.9 to 100.0	55.6 percentage of participants Interval 40.0 to 70.4	100 percentage of participants Interval 92.9 to 100.0
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster Serotype 6B	100 percentage of participants Interval 92.9 to 100.0	98.0 percentage of participants Interval 89.4 to 100.0	98.0 percentage of participants Interval 89.4 to 100.0
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster Serotype 23F	100 percentage of participants Interval 92.9 to 100.0	100 percentage of participants Interval 92.9 to 100.0	100 percentage of participants Interval 92.9 to 100.0
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster Serotype 1	100 percentage of participants Interval 92.9 to 100.0	96.0 percentage of participants Interval 86.3 to 99.5	98.0 percentage of participants Interval 89.2 to 100.0
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster Serotype 5	100 percentage of participants Interval 92.9 to 100.0	100 percentage of participants Interval 92.9 to 100.0	100 percentage of participants Interval 92.9 to 100.0
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster Serotype 7F	100 percentage of participants Interval 92.9 to 100.0	100 percentage of participants Interval 92.9 to 100.0	100 percentage of participants Interval 92.9 to 100.0
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster Serotype 9V	100 percentage of participants Interval 92.9 to 100.0	100 percentage of participants Interval 92.8 to 100.0	100 percentage of participants Interval 92.9 to 100.0
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster Serotype 14	100 percentage of participants Interval 92.9 to 100.0	96.0 percentage of participants Interval 86.3 to 99.5	100 percentage of participants Interval 92.9 to 100.0
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster Serotype 19A	100 percentage of participants Interval 92.9 to 100.0	90.0 percentage of participants Interval 78.2 to 96.7	100 percentage of participants Interval 92.9 to 100.0
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster Serotype 19F	98.0 percentage of participants Interval 89.4 to 100.0	98.0 percentage of participants Interval 89.4 to 100.0	98.0 percentage of participants Interval 89.4 to 100.0

SECONDARY outcome

Timeframe: 4 weeks after completion of primary vaccinations (at age 18 weeks)

Population: Primary Per Protocol Immunogenicity population with available serotype data

Outcome measures

Outcome measures
Measure	Pneumosil n=216 Participants Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Synflorix n=212 Participants Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Prevenar 13 n=212 Participants Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations Serotype 7F	99.5 percentage of participants Interval 97.5 to 100.0	97.2 percentage of participants Interval 93.9 to 99.0	100 percentage of participants Interval 98.3 to 100.0
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations Seroytpe 9V	94.9 percentage of participants Interval 91.1 to 97.4	91.0 percentage of participants Interval 86.4 to 94.5	98.1 percentage of participants Interval 95.2 to 99.5
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations Serotype 23F	95.8 percentage of participants Interval 92.2 to 98.1	63.2 percentage of participants Interval 56.3 to 69.7	89.6 percentage of participants Interval 84.7 to 93.4
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations Serotype 1	99.5 percentage of participants Interval 97.5 to 100.0	96.2 percentage of participants Interval 92.7 to 98.4	100 percentage of participants Interval 98.3 to 100.0
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations Serotype 5	96.8 percentage of participants Interval 93.4 to 98.7	92.0 percentage of participants Interval 87.5 to 95.3	96.2 percentage of participants Interval 92.7 to 98.4
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations Serotype 6A	83.3 percentage of participants Interval 77.7 to 88.1	12.8 percentage of participants Interval 8.6 to 18.1	91.5 percentage of participants Interval 86.9 to 94.9
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations Serotype 6B	84.7 percentage of participants Interval 79.2 to 89.2	71.2 percentage of participants Interval 64.6 to 77.2	89.0 percentage of participants Interval 84.0 to 92.9
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations Serotype 14	98.6 percentage of participants Interval 96.0 to 99.7	95.3 percentage of participants Interval 91.5 to 97.7	97.2 percentage of participants Interval 93.9 to 99.0
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations Serotype 19A	97.7 percentage of participants Interval 94.7 to 99.2	75.2 percentage of participants Interval 68.8 to 80.9	97.6 percentage of participants Interval 94.6 to 99.2
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations Serotype 19F	100 percentage of participants Interval 98.3 to 100.0	99.5 percentage of participants Interval 97.4 to 100.0	100 percentage of participants Interval 98.3 to 100.0

SECONDARY outcome

Timeframe: 4 weeks after completion of primary vaccinations (at age 18 weeks)

Population: Primary Per Protocol Immunogenicity Population with available serotype data

The IgG antibody concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected 4 weeks after the second primary vaccination dose.

Outcome measures

Outcome measures
Measure	Pneumosil n=216 Participants Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Synflorix n=212 Participants Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Prevenar 13 n=212 Participants Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations Serotype 1	3.63 μg/mL Interval 3.32 to 3.98	1.36 μg/mL Interval 1.23 to 1.51	3.40 μg/mL Interval 3.1 to 3.74
Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations Serotype 7F	3.46 μg/mL Interval 3.09 to 3.88	1.73 μg/mL Interval 1.55 to 1.92	4.67 μg/mL Interval 4.19 to 5.2
Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations Serotype 5	1.19 μg/mL Interval 1.1 to 1.28	0.87 μg/mL Interval 0.79 to 0.96	1.81 μg/mL Interval 1.62 to 2.01
Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations Serotype 6A	1.19 μg/mL Interval 1.0 to 1.41	0.14 μg/mL Interval 0.13 to 0.16	2.62 μg/mL Interval 2.24 to 3.08
Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations Serotype 6B	1.82 μg/mL Interval 1.48 to 2.23	0.91 μg/mL Interval 0.75 to 1.1	1.75 μg/mL Interval 1.49 to 2.07
Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations Serotype 9V	1.93 μg/mL Interval 1.74 to 2.16	1.31 μg/mL Interval 1.17 to 1.46	2.56 μg/mL Interval 2.28 to 2.88
Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations Serotype 14	4.03 μg/mL Interval 3.5 to 4.64	2.58 μg/mL Interval 2.18 to 3.04	3.27 μg/mL Interval 2.7 to 3.96
Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations Serotype 19A	1.75 μg/mL Interval 1.57 to 1.96	0.65 μg/mL Interval 0.57 to 0.73	4.38 μg/mL Interval 3.73 to 5.15
Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations Serotype 19F	5.45 μg/mL Interval 4.94 to 6.01	8.86 μg/mL Interval 7.71 to 10.17	9.06 μg/mL Interval 7.97 to 10.3
Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations Serotype 23F	2.21 μg/mL Interval 1.92 to 2.56	0.57 μg/mL Interval 0.48 to 0.68	1.64 μg/mL Interval 1.39 to 1.93

SECONDARY outcome

Timeframe: 4 weeks after completion of primary vaccinations (at age 18 weeks)

Population: Primary Per Protocol Immunogenicity population with available serotype data; OPA assays were conducted on the first 50 samples from each treatment group.

The OPA seroresponse rate was defined as the percentage of infants with an OPA titer of at least 8. Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA).

Outcome measures

Outcome measures
Measure	Pneumosil n=50 Participants Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Synflorix n=50 Participants Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Prevenar 13 n=50 Participants Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations Serotype 1	98.0 percentage of participants Interval 89.4 to 100.0	73.5 percentage of participants Interval 58.9 to 85.1	96.0 percentage of participants Interval 86.3 to 99.5
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations Serotype 5	98.0 percentage of participants Interval 89.4 to 100.0	96.0 percentage of participants Interval 86.3 to 99.5	100 percentage of participants Interval 92.9 to 100.0
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations Serotype 6A	92.0 percentage of participants Interval 80.8 to 97.8	10.2 percentage of participants Interval 3.4 to 22.2	98.0 percentage of participants Interval 89.4 to 100.0
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations Serotype 6B	96.0 percentage of participants Interval 86.3 to 99.5	69.4 percentage of participants Interval 54.6 to 81.8	92.0 percentage of participants Interval 80.8 to 97.8
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations Serotype 7F	100 percentage of participants Interval 92.9 to 100.0	100 percentage of participants Interval 92.9 to 100.0	100 percentage of participants Interval 92.9 to 100.0
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations Serotype 9V	100 percentage of participants Interval 92.5 to 100.0	100 percentage of participants Interval 92.9 to 100.0	100 percentage of participants Interval 92.9 to 100.0
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations Serotype 14	94.0 percentage of participants Interval 83.5 to 98.8	97.9 percentage of participants Interval 88.9 to 100.0	90.0 percentage of participants Interval 78.2 to 96.7
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations Serotype 19A	91.8 percentage of participants Interval 80.4 to 97.7	56.5 percentage of participants Interval 41.1 to 71.1	96.0 percentage of participants Interval 86.3 to 99.5
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations Serotype 19F	96.0 percentage of participants Interval 86.3 to 99.5	95.9 percentage of participants Interval 86.0 to 99.5	98.0 percentage of participants Interval 89.4 to 100.0
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations Serotype 23F	100 percentage of participants Interval 92.6 to 100.0	100 percentage of participants Interval 92.5 to 100.0	100 percentage of participants Interval 92.8 to 100.0

SECONDARY outcome

Timeframe: 4 weeks after completion of primary vaccinations (at age 18 weeks)

Population: Primary Per Protocol Immunogenicity population with available serotype data; OPA assays were conducted on the first 50 samples from each treatment group.

Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA).

Outcome measures

Outcome measures
Measure	Pneumosil n=50 Participants Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Synflorix n=50 Participants Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Prevenar 13 n=50 Participants Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations Serotype 6A	400.49 titer Interval 238.4 to 672.79	5.35 titer Interval 4.04 to 7.08	1524.31 titer Interval 1066.28 to 2179.09
Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations Serotype 6B	923.86 titer Interval 589.56 to 1447.73	166.74 titer Interval 88.71 to 313.43	920.43 titer Interval 573.35 to 1477.61
Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations Serotype 14	669.79 titer Interval 383.93 to 1168.5	577.98 titer Interval 376.06 to 888.33	489.56 titer Interval 224.0 to 1069.94
Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations Serotype 19A	69.15 titer Interval 46.95 to 101.85	22.40 titer Interval 13.27 to 37.83	324.64 titer Interval 204.39 to 515.65
Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations Serotype 19F	381.46 titer Interval 269.27 to 540.4	690.36 titer Interval 461.1 to 1033.61	647.79 titer Interval 460.5 to 911.24
Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations Serotype 1	99.67 titer Interval 71.83 to 138.3	26.70 titer Interval 17.72 to 40.22	98.63 titer Interval 70.61 to 137.78
Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations Serotype 5	182.18 titer Interval 134.53 to 246.7	85.09 titer Interval 58.98 to 122.75	291.98 titer Interval 221.91 to 384.18
Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations Serotype 7F	2069.84 titer Interval 1622.83 to 2639.98	1096.84 titer Interval 853.88 to 1408.93	3069.95 titer Interval 2435.98 to 3868.91
Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations Serotype 9V	134.50 titer Interval 87.35 to 207.1	58.24 titer Interval 38.29 to 88.58	331.79 titer Interval 241.48 to 455.89
Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations Serotype 23F	806.12 titer Interval 584.18 to 1112.39	180.97 titer Interval 106.19 to 308.44	748.96 titer Interval 458.35 to 1223.84

SECONDARY outcome

Timeframe: Prior to the booster dose at approximately 9 to 16 months of age

Population: Primary Per Protocol Immunogenicity population with available serotype data

The seroresponse rate was defined as the percentage of infants with serotype-specific IgG concentrations of at least 0.35 μg/mL, which is the reference concentration for assessment of vaccine efficacy against invasive pneumococcal diseases (IPDs). The IgG concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected immediately prior to the booster vaccination dose.

Outcome measures

Outcome measures
Measure	Pneumosil n=208 Participants Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Synflorix n=206 Participants Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Prevenar 13 n=206 Participants Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster Serotype 1	50.2 percentage of participants Interval 43.2 to 57.3	17.2 percentage of participants Interval 12.3 to 23.2	53.4 percentage of participants Interval 46.3 to 60.4
Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster Serotype 5	13.7 percentage of participants Interval 9.3 to 19.1	16.4 percentage of participants Interval 11.6 to 22.3	33.8 percentage of participants Interval 27.4 to 40.8
Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster Serotype 6A	76.0 percentage of participants Interval 69.6 to 81.6	32.7 percentage of participants Interval 26.3 to 39.6	70.4 percentage of participants Interval 63.7 to 76.5
Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster Serotype 6B	89.9 percentage of participants Interval 85.0 to 93.6	74.6 percentage of participants Interval 68.1 to 80.4	60.7 percentage of participants Interval 53.7 to 67.4
Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster Serotype 7F	74.5 percentage of participants Interval 68.0 to 80.3	65.4 percentage of participants Interval 58.4 to 71.9	84.5 percentage of participants Interval 78.8 to 89.1
Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster Serotype 9V	35.1 percentage of participants Interval 28.6 to 42.1	36.1 percentage of participants Interval 29.5 to 43.1	37.7 percentage of participants Interval 31.1 to 44.8
Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster Serotype 14	69.6 percentage of participants Interval 62.8 to 75.8	59.3 percentage of participants Interval 52.2 to 66.1	86.3 percentage of participants Interval 80.9 to 90.7
Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster Serotype 19A	58.1 percentage of participants Interval 51.0 to 65.0	54.9 percentage of participants Interval 47.8 to 61.9	65.7 percentage of participants Interval 58.7 to 72.2
Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster Serotype 19F	84.1 percentage of participants Interval 78.4 to 88.8	95.1 percentage of participants Interval 91.2 to 97.6	80.6 percentage of participants Interval 74.5 to 85.8
Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster Serotype 23F	46.2 percentage of participants Interval 39.2 to 53.2	19.4 percentage of participants Interval 14.3 to 25.5	24.9 percentage of participants Interval 19.1 to 31.4

SECONDARY outcome

Timeframe: Prior to the booster dose at approximately 9 to 16 months of age

Population: Primary Per Protocol Immunogenicity population with available serotype data

The IgG antibody concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected immediately prior to the booster vaccination dose.

Outcome measures

Outcome measures
Measure	Pneumosil n=208 Participants Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Synflorix n=206 Participants Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Prevenar 13 n=206 Participants Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster Serotype 9V	0.25 μg/mL Interval 0.23 to 0.28	0.29 μg/mL Interval 0.26 to 0.32	0.28 μg/mL Interval 0.25 to 0.31
Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster Serotype 14	0.71 μg/mL Interval 0.6 to 0.83	0.48 μg/mL Interval 0.41 to 0.56	1.16 μg/mL Interval 1.0 to 1.35
Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster Serotype 1	0.36 μg/mL Interval 0.33 to 0.41	0.16 μg/mL Interval 0.15 to 0.18	0.37 μg/mL Interval 0.33 to 0.41
Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster Serotype 5	0.17 μg/mL Interval 0.15 to 0.18	0.16 μg/mL Interval 0.14 to 0.17	0.24 μg/mL Interval 0.22 to 0.27
Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster Serotype 6A	0.62 μg/mL Interval 0.55 to 0.7	0.22 μg/mL Interval 0.19 to 0.25	0.50 μg/mL Interval 0.45 to 0.56
Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster Serotype 6B	0.97 μg/mL Interval 0.87 to 1.08	0.56 μg/mL Interval 0.5 to 0.62	0.45 μg/mL Interval 0.39 to 0.5
Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster Serotype 7F	0.60 μg/mL Interval 0.53 to 0.68	0.43 μg/mL Interval 0.39 to 0.48	0.72 μg/mL Interval 0.64 to 0.8
Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster Serotype 19A	0.49 μg/mL Interval 0.42 to 0.56	0.40 μg/mL Interval 0.35 to 0.45	0.53 μg/mL Interval 0.46 to 0.62
Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster Serotype 19F	0.83 μg/mL Interval 0.73 to 0.94	1.25 μg/mL Interval 1.11 to 1.4	0.72 μg/mL Interval 0.63 to 0.83
Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster Serotype 23F	0.32 μg/mL Interval 0.27 to 0.37	0.16 μg/mL Interval 0.15 to 0.19	0.17 μg/mL Interval 0.15 to 0.2

SECONDARY outcome

Timeframe: Prior to the booster dose at approximately 9 to 16 months of age

Population: Primary Per Protocol Immunogenicity population with available serotype data; OPA assays were conducted on the first 50 samples from each treatment group.

Outcome measures

Outcome measures
Measure	Pneumosil n=50 Participants Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Synflorix n=50 Participants Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Prevenar 13 n=50 Participants Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster Serotype 1	22.4 percentage of participants Interval 11.8 to 36.6	16.0 percentage of participants Interval 7.2 to 29.1	25.5 percentage of participants Interval 13.9 to 40.3
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster Serotype 5	58.3 percentage of participants Interval 43.2 to 72.4	49.0 percentage of participants Interval 34.4 to 63.7	63.3 percentage of participants Interval 48.3 to 76.6
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster Serotype 6A	76.6 percentage of participants Interval 62.0 to 87.7	14.0 percentage of participants Interval 5.8 to 26.7	63.8 percentage of participants Interval 48.5 to 77.3
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster Serotype 6B	87.5 percentage of participants Interval 74.8 to 95.3	62.5 percentage of participants Interval 47.3 to 76.1	54.2 percentage of participants Interval 39.2 to 68.6
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster Serotype 7F	100 percentage of participants Interval 92.8 to 100.0	100 percentage of participants Interval 92.8 to 100.0	100 percentage of participants Interval 92.6 to 100.0
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster Serotype 9V	100 percentage of participants Interval 92.0 to 100.0	100 percentage of participants Interval 91.8 to 100.0	100 percentage of participants Interval 92.1 to 100.0
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster Serotype 14	75.5 percentage of participants Interval 61.1 to 86.7	52.1 percentage of participants Interval 37.2 to 66.7	72.9 percentage of participants Interval 58.2 to 84.7
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster Serotype 19A	35.4 percentage of participants Interval 22.2 to 50.5	40.8 percentage of participants Interval 27.0 to 55.8	63.3 percentage of participants Interval 48.3 to 76.6
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster Serotype 19F	60.4 percentage of participants Interval 45.3 to 74.2	79.6 percentage of participants Interval 65.7 to 89.8	36.7 percentage of participants Interval 23.4 to 51.7
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster Serotype 23F	100 percentage of participants Interval 91.8 to 100.0	100 percentage of participants Interval 91.6 to 100.0	100 percentage of participants Interval 91.6 to 100.0

SECONDARY outcome

Timeframe: Prior to the booster dose at approximately 9 to 16 months of age

Population: Primary Per Protocol Immunogenicity population with available serotype data; OPA assays were conducted on the first 50 samples from each treatment group.

Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA) from serum samples collected immediately prior to the booster vaccination dose.

Outcome measures

Outcome measures
Measure	Pneumosil n=50 Participants Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Synflorix n=50 Participants Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Prevenar 13 n=50 Participants Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster Serotype 1	5.57 titer Interval 4.56 to 6.8	5.19 titer Interval 4.27 to 6.3	5.45 titer Interval 4.57 to 6.49
Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster Serotype 5	12.53 titer Interval 9.03 to 17.37	12.01 titer Interval 8.28 to 17.43	16.03 titer Interval 10.95 to 23.45
Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster Serotype 6A	42.59 titer Interval 26.46 to 68.55	6.41 titer Interval 4.49 to 9.15	40.66 titer Interval 22.34 to 74.0
Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster Serotype 6B	121.60 titer Interval 78.09 to 189.36	40.08 titer Interval 25.2 to 63.72	32.27 titer Interval 19.77 to 52.68
Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster Serotype 7F	1756.80 titer Interval 1234.91 to 2499.24	1725.63 titer Interval 1206.66 to 2467.79	1688.30 titer Interval 1160.23 to 2456.74
Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster Serotype 9V	27.60 titer Interval 15.8 to 48.21	27.95 titer Interval 17.48 to 44.67	48.64 titer Interval 29.08 to 81.36
Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster Serotype 14	60.53 titer Interval 32.55 to 112.55	17.67 titer Interval 10.31 to 30.29	62.77 titer Interval 33.95 to 116.08
Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster Serotype 19A	13.43 titer Interval 7.8 to 23.11	12.88 titer Interval 8.25 to 20.12	28.20 titer Interval 16.96 to 46.89
Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster Serotype 19F	24.09 titer Interval 13.9 to 41.77	57.66 titer Interval 33.74 to 98.52	12.27 titer Interval 7.34 to 20.5
Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster Serotype 23F	65.62 titer Interval 38.19 to 112.74	41.99 titer Interval 23.29 to 75.68	81.42 titer Interval 44.08 to 150.4

SECONDARY outcome

Timeframe: 4 weeks after completion of primary vaccinations (at age 18 weeks) and 4 weeks post booster

Population: Primary Per Protocol Immunogenicity population with available data for each serotype at both time points

Booster response was measured by the ratio of IgG GMCs measured at the post-booster visit to those measured 4 weeks after completion of primary vaccinations.

Outcome measures

Outcome measures
Measure	Pneumosil n=202 Participants Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Synflorix n=200 Participants Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Prevenar 13 n=200 Participants Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations Serotype 6A	7.86 ratio Interval 6.54 to 9.44	4.30 ratio Interval 3.61 to 5.12	4.14 ratio Interval 3.49 to 4.91
Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations Serotype 6B	6.71 ratio Interval 5.48 to 8.21	5.32 ratio Interval 4.46 to 6.35	8.92 ratio Interval 7.47 to 10.66
Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations Serotype 5	1.29 ratio Interval 1.15 to 1.44	0.90 ratio Interval 0.81 to 1.01	1.15 ratio Interval 1.02 to 1.3
Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations Serotype 7F	1.91 ratio Interval 1.69 to 2.17	1.84 ratio Interval 1.64 to 2.05	1.36 ratio Interval 1.22 to 1.52
Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations Serotype 9V	1.76 ratio Interval 1.55 to 1.98	1.86 ratio Interval 1.65 to 2.09	1.55 ratio Interval 1.34 to 1.79
Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations Serotype 14	1.98 ratio Interval 1.69 to 2.33	1.93 ratio Interval 1.61 to 2.33	2.80 ratio Interval 2.29 to 3.43
Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations Serotype 1	2.31 ratio Interval 2.1 to 2.55	2.09 ratio Interval 1.86 to 2.34	1.74 ratio Interval 1.54 to 1.97
Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations Serotype 19A	4.98 ratio Interval 4.33 to 5.74	3.69 ratio Interval 3.08 to 4.42	2.69 ratio Interval 2.25 to 3.22
Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations Serotype 19F	1.98 ratio Interval 1.74 to 2.26	1.96 ratio Interval 1.68 to 2.29	1.68 ratio Interval 1.46 to 1.94
Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations Serotype 23F	2.24 ratio Interval 1.95 to 2.58	3.67 ratio Interval 3.1 to 4.36	3.00 ratio Interval 2.55 to 3.52

SECONDARY outcome

Timeframe: 4 weeks after completion of primary vaccinations (at age 18 weeks) and 4 weeks post booster

Population: Primary Per Protocol Immunogenicity population with available data for each serotype at both time points; OPA assays were conducted on the first 50 samples from each treatment group.

OPA booster response was measured by the ratio of OPA GMTs measured at the post-booster visit to those measured 4 weeks after completion of primary vaccinations.

Outcome measures

Outcome measures
Measure	Pneumosil n=50 Participants Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Synflorix n=50 Participants Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Prevenar 13 n=50 Participants Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations Serotype 1	6.70 ratio Interval 5.07 to 8.86	9.35 ratio Interval 6.5 to 13.46	4.45 ratio Interval 2.94 to 6.74
Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations Serotype 5	4.91 ratio Interval 3.71 to 6.49	5.36 ratio Interval 3.78 to 7.61	2.46 ratio Interval 1.86 to 3.25
Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations Serotype 6A	10.36 ratio Interval 6.54 to 16.41	10.12 ratio Interval 4.98 to 20.53	3.89 ratio Interval 2.7 to 5.61
Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations Serotype 6B	4.62 ratio Interval 2.84 to 7.53	7.70 ratio Interval 4.4 to 13.46	6.54 ratio Interval 4.03 to 10.6
Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations Serotype 7F	3.51 ratio Interval 2.67 to 4.62	4.03 ratio Interval 2.93 to 5.54	2.71 ratio Interval 2.08 to 3.53
Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations Serotype 9V	10.24 ratio Interval 6.36 to 16.5	14.90 ratio Interval 9.12 to 24.35	7.64 ratio Interval 5.58 to 10.45
Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations Serotype 14	4.27 ratio Interval 2.38 to 7.64	2.25 ratio Interval 1.32 to 3.83	5.73 ratio Interval 2.84 to 11.6
Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations Serotype 19A	23.79 ratio Interval 15.61 to 36.25	12.25 ratio Interval 6.86 to 21.87	11.63 ratio Interval 7.59 to 17.81
Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations Serotype 19F	3.74 ratio Interval 2.47 to 5.65	3.30 ratio Interval 2.32 to 4.68	3.55 ratio Interval 2.35 to 5.39
Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations Serotype 23F	3.81 ratio Interval 2.69 to 5.4	8.71 ratio Interval 5.63 to 13.45	7.41 ratio Interval 4.32 to 12.72

Adverse Events

Pneumosil

Serious events: 12 serious events

Other events: 212 other events

Deaths: 1 deaths

Synflorix

Serious events: 10 serious events

Other events: 213 other events

Deaths: 0 deaths

Prevenar 13

Serious events: 7 serious events

Other events: 211 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Pneumosil n=220 participants at risk Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Synflorix n=220 participants at risk Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.	Prevenar 13 n=220 participants at risk Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Infections and infestations Gastroenteritis	2.3% 5/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.91% 2/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.00% 0/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.
Infections and infestations Bronchiolitis	1.4% 3/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.45% 1/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.91% 2/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.
Infections and infestations Periorbital cellulitis	0.00% 0/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	1.4% 3/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.91% 2/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.
Infections and infestations Cellulitis	0.45% 1/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.00% 0/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.91% 2/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.
Infections and infestations Pneumonia	0.00% 0/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.91% 2/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.45% 1/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.
Infections and infestations Infected dermal cyst	0.00% 0/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.45% 1/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.00% 0/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.
Infections and infestations Meningitis bacterial	0.45% 1/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.00% 0/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.00% 0/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.
Infections and infestations Vulval cellulitis	0.45% 1/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.00% 0/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.00% 0/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.
Congenital, familial and genetic disorders Atrioventricular septal defect	0.00% 0/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.00% 0/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.45% 1/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.
Congenital, familial and genetic disorders Dermoid cyst	0.00% 0/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.45% 1/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.00% 0/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.
Congenital, familial and genetic disorders Sickle cell anaemia	0.45% 1/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.00% 0/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.00% 0/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.
Gastrointestinal disorders Incarcerated umbilical hernia	0.00% 0/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.45% 1/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.00% 0/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.
Gastrointestinal disorders Intussusception	0.45% 1/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.00% 0/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.00% 0/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.
Nervous system disorders Seizure	0.45% 1/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.00% 0/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.	0.00% 0/220 • All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall. Data reported Include both solicited and unsolicited events.

Other adverse events

Additional Information

Mark Alderson

PATH

Phone: + 206.302.4859

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place