Trial Outcomes & Findings for Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™ (NCT NCT01641133)

Last Updated: 2021-03-02

Results Overview

The number of subjects with Grade 3 AEs (solicited and unsolicited), during the 31-day post-vaccination period following each primary dose is reported.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

457 participants

Primary outcome timeframe

Within 31-day (Day 0-Day 30) after any dose of primary vaccination

Results posted on

2021-03-02

Participant Flow

457 subjects were enrolled in the study. Of these, 5 subjects were not included in the Total Vaccinated Cohort, as the study vaccine was not administered. In addition, 157 subjects enrolled at one center were excluded from analysis because of GCP deficiencies, and 1 subject from another center because of invalid Informed Consent form.

Participant milestones

Participant milestones
Measure	Synflorix Group Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.	Prevnar 1 Group Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.	Prevnar 2 Group Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
Overall Study STARTED	97	99	98
Overall Study COMPLETED	87	90	90
Overall Study NOT COMPLETED	10	9	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Synflorix Group Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.	Prevnar 1 Group Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.	Prevnar 2 Group Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
Overall Study Protocol Violation	0	1	1
Overall Study Migrated/moved from study area	5	3	1
Overall Study Adverse Event	0	0	1
Overall Study Withdrawal by Subject	5	3	3
Overall Study Lost to Follow-up	0	2	2

Baseline Characteristics

Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Synflorix Group n=97 Participants Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.	Prevnar 1 Group n=99 Participants Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.	Prevnar 2 Group n=98 Participants Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.	Total n=294 Participants Total of all reporting groups
Age, Continuous	7.4 Weeks STANDARD_DEVIATION 1.3 • n=5 Participants	7.4 Weeks STANDARD_DEVIATION 1.5 • n=7 Participants	7.4 Weeks STANDARD_DEVIATION 1.6 • n=5 Participants	7.4 Weeks STANDARD_DEVIATION 1.47 • n=4 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	47 Participants n=7 Participants	53 Participants n=5 Participants	155 Participants n=4 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	52 Participants n=7 Participants	45 Participants n=5 Participants	139 Participants n=4 Participants

PRIMARY outcome

Timeframe: Within 31-day (Day 0-Day 30) after any dose of primary vaccination

Population: The analysis was performed on the Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented and the symptom sheet filled in.

The number of subjects with Grade 3 AEs (solicited and unsolicited), during the 31-day post-vaccination period following each primary dose is reported.

Outcome measures

Outcome measures
Measure	Synflorix Group n=90 Participants Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.	Prevnar 1 Group n=94 Participants Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.	Prevnar 2 Group n=94 Participants Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period Any AEs Dose 1	18 Participants	10 Participants	10 Participants
Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period Any AEs Dose 2	12 Participants	11 Participants	6 Participants
Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period General AEs Dose 1	5 Participants	3 Participants	2 Participants
Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period General AEs Dose 2	8 Participants	4 Participants	2 Participants
Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period Local AEs Dose 1	17 Participants	8 Participants	9 Participants
Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period Local AEs Dose 2	7 Participants	9 Participants	4 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period following each primary dose

Population: The analysis was performed on The Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented and the symptom sheet filled in.

Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.

Outcome measures

Outcome measures
Measure	Synflorix Group n=90 Participants Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.	Prevnar 1 Group n=94 Participants Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.	Prevnar 2 Group n=94 Participants Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period Grade 3 Pain Dose 1	14 Participants	8 Participants	9 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period Any Swelling Dose 1	16 Participants	12 Participants	10 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period Any Swelling Dose 2	5 Participants	9 Participants	11 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period Any Pain Dose 1	61 Participants	49 Participants	55 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period Any Redness Dose 1	9 Participants	11 Participants	7 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period Grade 3 Redness Dose 1	1 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period Grade 3 Swelling Dose 1	3 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period Any Pain Dose 2	48 Participants	49 Participants	42 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period Grade 3 Pain Dose 2	6 Participants	9 Participants	4 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period Any Redness Dose 2	5 Participants	9 Participants	12 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period Grade 3 Redness Dose 2	1 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period Grade 3 Swelling Dose 2	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-booster vaccination period

Population: The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented and the symptom sheet filled in.

Outcome measures

Outcome measures
Measure	Synflorix Group n=86 Participants Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.	Prevnar 1 Group n=87 Participants Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.	Prevnar 2 Group n=85 Participants Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period Grade 3 Pain	2 Participants	6 Participants	9 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period Any Redness	20 Participants	10 Participants	17 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period Any Swelling	12 Participants	14 Participants	19 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period Grade 3 Swelling	1 Participants	3 Participants	4 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period Any Pain	44 Participants	44 Participants	45 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period Grade 3 Redness	4 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period following each primary dose

Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (\>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.

Outcome measures

Outcome measures
Measure	Synflorix Group n=90 Participants Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.	Prevnar 1 Group n=94 Participants Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.	Prevnar 2 Group n=94 Participants Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Any Drowsiness Dose 1	35 Participants	36 Participants	45 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Related Drowsiness Dose 1	35 Participants	32 Participants	42 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Any Irritability Dose 1	48 Participants	46 Participants	53 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Any Loss of appetite Dose 1	21 Participants	20 Participants	19 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Grade 3 Fever Dose 1	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Related Fever Dose 1	17 Participants	11 Participants	10 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Related Drowsiness Dose 2	25 Participants	23 Participants	31 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Grade 3 Irritability Dose 2	4 Participants	1 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Grade 3 Loss of appetite Dose 2	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Related Loss of appetite Dose 2	12 Participants	17 Participants	18 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Any Fever Dose 2	15 Participants	14 Participants	17 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Grade 3 Fever Dose 2	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Related Fever Dose 2	15 Participants	14 Participants	16 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Grade 3 Drowsiness Dose 1	1 Participants	1 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Grade 3 Irritability Dose 1	5 Participants	2 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Related Irritability Dose 1	46 Participants	41 Participants	49 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Grade 3 Loss of appetite Dose 1	1 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Related Loss of appetite Dose 1	20 Participants	18 Participants	16 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Any Fever Dose 1	18 Participants	12 Participants	11 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Any Drowsiness Dose 2	27 Participants	24 Participants	31 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Grade 3 Drowsiness Dose 2	1 Participants	1 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Any Irritability Dose 2	39 Participants	52 Participants	41 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Related Irritability Dose 2	37 Participants	51 Participants	39 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period Any Loss of appetite Dose 2	12 Participants	17 Participants	19 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-booster vaccination period

Population: The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented and the symptom sheet filled in.

Outcome measures

Outcome measures
Measure	Synflorix Group n=86 Participants Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.	Prevnar 1 Group n=87 Participants Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.	Prevnar 2 Group n=84 Participants Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period Grade 3 Drowsiness	1 Participants	0 Participants	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period Related Drowsiness	25 Participants	24 Participants	26 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period Any Irritability	33 Participants	39 Participants	45 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period Grade 3 Irritability	1 Participants	2 Participants	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period Related Irritability	33 Participants	36 Participants	44 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period Any Loss of appetite	24 Participants	22 Participants	17 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period Grade 3 Loss of appetite	0 Participants	1 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period Any Drowsiness	25 Participants	27 Participants	26 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period Related Loss of appetite	22 Participants	21 Participants	17 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period Any Fever	9 Participants	11 Participants	11 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period Grade 3 Fever	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period Related Fever	9 Participants	8 Participants	10 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) post-booster vaccination period

Population: The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented and the symptom sheet filled in.

The number of subjects with any and grade 3 symptoms (solicited and unsolicited), during the 31-day post-booster vaccination period is reported.

Outcome measures

Outcome measures
Measure	Synflorix Group n=86 Participants Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.	Prevnar 1 Group n=87 Participants Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.	Prevnar 2 Group n=85 Participants Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period Any Grade 3 symptom	10 Participants	12 Participants	14 Participants
Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period Local symptom	50 Participants	47 Participants	47 Participants
Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period Grade 3 local symptom	6 Participants	9 Participants	13 Participants
Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period Any symptom	66 Participants	70 Participants	67 Participants
Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period General symptom	57 Participants	66 Participants	61 Participants
Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period Grade 3 general symptom	4 Participants	5 Participants	4 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) post-primary vaccination period

Population: The analysis was performed on the Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented.

An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

Outcome measures

Outcome measures
Measure	Synflorix Group n=97 Participants Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.	Prevnar 1 Group n=99 Participants Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.	Prevnar 2 Group n=98 Participants Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
Number of Subjects With Unsolicited AEs - Primary Period	55 Participants	58 Participants	61 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) post-booster vaccination period

Population: The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented.

Outcome measures

Outcome measures
Measure	Synflorix Group n=86 Participants Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.	Prevnar 1 Group n=88 Participants Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.	Prevnar 2 Group n=87 Participants Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
Number of Subjects With Unsolicited AEs - Booster Period	25 Participants	27 Participants	28 Participants

SECONDARY outcome

Timeframe: From first vaccination (Month 0) up to study end (11-14 months)

Population: The analysis was performed on the Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented.

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Synflorix Group n=97 Participants Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.	Prevnar 1 Group n=99 Participants Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.	Prevnar 2 Group n=98 Participants Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
Number of Subjects With Serious Adverse Events (SAEs)	3 Participants	4 Participants	1 Participants

SECONDARY outcome

Timeframe: At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination)

Population: The analysis was performed on the ATP cohort for immunogenicity adapted for each epoch, which included all evaluable subjects for whom data concerning primary or booster immunogenicity outcome measures were available.

Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.

Outcome measures

Outcome measures
Measure	Synflorix Group n=86 Participants Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.	Prevnar 1 Group n=89 Participants Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.	Prevnar 2 Group n=86 Participants Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
Antibody Concentrations Against Pneumococcal Serotypes Anti-4 Month 11	6.76 µg/mL Interval 5.87 to 7.79	4.7 µg/mL Interval 3.94 to 5.6	8.77 µg/mL Interval 7.26 to 10.59
Antibody Concentrations Against Pneumococcal Serotypes Anti-6A Month 10	0.25 µg/mL Interval 0.2 to 0.31	0.28 µg/mL Interval 0.22 to 0.36	0.67 µg/mL Interval 0.55 to 0.82
Antibody Concentrations Against Pneumococcal Serotypes Anti-6A Month 3	0.22 µg/mL Interval 0.16 to 0.29	0.36 µg/mL Interval 0.3 to 0.45	3.35 µg/mL Interval 2.53 to 4.42
Antibody Concentrations Against Pneumococcal Serotypes Anti-1 Month 3	2.74 µg/mL Interval 2.32 to 3.24	3.12 µg/mL Interval 2.63 to 3.7	4 µg/mL Interval 3.44 to 4.65
Antibody Concentrations Against Pneumococcal Serotypes Anti-6B Month 10	0.48 µg/mL Interval 0.39 to 0.59	0.3 µg/mL Interval 0.23 to 0.37	0.24 µg/mL Interval 0.19 to 0.3
Antibody Concentrations Against Pneumococcal Serotypes Anti-7F Month 10	1.16 µg/mL Interval 0.99 to 1.37	1 µg/mL Interval 0.84 to 1.19	1.24 µg/mL Interval 1.07 to 1.45
Antibody Concentrations Against Pneumococcal Serotypes Anti-9V Month 3	2.67 µg/mL Interval 2.28 to 3.13	1.34 µg/mL Interval 1.12 to 1.59	2.96 µg/mL Interval 2.49 to 3.51
Antibody Concentrations Against Pneumococcal Serotypes Anti-9V Month 10	0.86 µg/mL Interval 0.7 to 1.04	0.49 µg/mL Interval 0.42 to 0.56	0.53 µg/mL Interval 0.45 to 0.62
Antibody Concentrations Against Pneumococcal Serotypes Anti-14 Month 11	10.04 µg/mL Interval 8.44 to 11.95	8.1 µg/mL Interval 6.68 to 9.83	7.62 µg/mL Interval 6.3 to 9.22
Antibody Concentrations Against Pneumococcal Serotypes Anti-18C Month 3	3.3 µg/mL Interval 2.54 to 4.28	3.22 µg/mL Interval 2.5 to 4.14	3.24 µg/mL Interval 2.62 to 4.0
Antibody Concentrations Against Pneumococcal Serotypes Anti-18C Month 10	0.81 µg/mL Interval 0.67 to 0.98	0.65 µg/mL Interval 0.53 to 0.81	0.56 µg/mL Interval 0.47 to 0.66
Antibody Concentrations Against Pneumococcal Serotypes Anti-19A Month 11	1.64 µg/mL Interval 1.2 to 2.23	1.67 µg/mL Interval 1.17 to 2.38	2.17 µg/mL Interval 1.64 to 2.86
Antibody Concentrations Against Pneumococcal Serotypes Anti-19F Month 3	4.62 µg/mL Interval 3.76 to 5.69	5.67 µg/mL Interval 4.63 to 6.95	4.17 µg/mL Interval 3.69 to 4.72
Antibody Concentrations Against Pneumococcal Serotypes Anti-19F Month 10	1.19 µg/mL Interval 0.96 to 1.48	1.39 µg/mL Interval 1.14 to 1.71	0.53 µg/mL Interval 0.43 to 0.65
Antibody Concentrations Against Pneumococcal Serotypes Anti-19F Month 11	14.43 µg/mL Interval 12.02 to 17.32	13.57 µg/mL Interval 11.29 to 16.32	13.81 µg/mL Interval 11.63 to 16.4
Antibody Concentrations Against Pneumococcal Serotypes Anti-23F Month 10	0.53 µg/mL Interval 0.41 to 0.67	0.24 µg/mL Interval 0.19 to 0.3	0.36 µg/mL Interval 0.29 to 0.45
Antibody Concentrations Against Pneumococcal Serotypes Anti-23F Month 11	4.16 µg/mL Interval 3.23 to 5.36	1.76 µg/mL Interval 1.42 to 2.18	2.76 µg/mL Interval 2.29 to 3.34
Antibody Concentrations Against Pneumococcal Serotypes Anti-19A Month 10	0.19 µg/mL Interval 0.15 to 0.25	0.36 µg/mL Interval 0.27 to 0.5	0.34 µg/mL Interval 0.25 to 0.46
Antibody Concentrations Against Pneumococcal Serotypes Anti-23F Month 3	1.43 µg/mL Interval 1.11 to 1.85	0.53 µg/mL Interval 0.41 to 0.68	1.74 µg/mL Interval 1.28 to 2.37
Antibody Concentrations Against Pneumococcal Serotypes Anti-1 Month 10	0.34 µg/mL Interval 0.29 to 0.4	0.53 µg/mL Interval 0.44 to 0.64	0.62 µg/mL Interval 0.52 to 0.74
Antibody Concentrations Against Pneumococcal Serotypes Anti-1 Month 11	4.61 µg/mL Interval 3.93 to 5.41	4.2 µg/mL Interval 3.6 to 4.9	5.22 µg/mL Interval 4.52 to 6.03
Antibody Concentrations Against Pneumococcal Serotypes Anti-3 Month 3	0.06 µg/mL Interval 0.05 to 0.08	0.84 µg/mL Interval 0.73 to 0.97	2.48 µg/mL Interval 2.21 to 2.78
Antibody Concentrations Against Pneumococcal Serotypes Anti-3 Month 10	0.09 µg/mL Interval 0.07 to 0.12	0.21 µg/mL Interval 0.18 to 0.25	0.37 µg/mL Interval 0.3 to 0.44
Antibody Concentrations Against Pneumococcal Serotypes Anti-3 Month 11	0.1 µg/mL Interval 0.07 to 0.14	0.21 µg/mL Interval 0.18 to 0.25	0.33 µg/mL Interval 0.27 to 0.41
Antibody Concentrations Against Pneumococcal Serotypes Anti-4 Month 3	3.54 µg/mL Interval 3.12 to 4.02	2.73 µg/mL Interval 2.22 to 3.34	2.74 µg/mL Interval 2.34 to 3.21
Antibody Concentrations Against Pneumococcal Serotypes Anti-4 Month 10	0.57 µg/mL Interval 0.49 to 0.66	0.56 µg/mL Interval 0.46 to 0.68	0.39 µg/mL Interval 0.32 to 0.48
Antibody Concentrations Against Pneumococcal Serotypes Anti-5 Month 3	4.55 µg/mL Interval 3.95 to 5.24	2.59 µg/mL Interval 2.1 to 3.18	4.89 µg/mL Interval 4.11 to 5.8
Antibody Concentrations Against Pneumococcal Serotypes Anti-5 Month 10	0.96 µg/mL Interval 0.79 to 1.17	0.77 µg/mL Interval 0.64 to 0.92	1.05 µg/mL Interval 0.88 to 1.25
Antibody Concentrations Against Pneumococcal Serotypes Anti-5 Month 11	8.31 µg/mL Interval 7.08 to 9.77	5.27 µg/mL Interval 4.33 to 6.41	6.15 µg/mL Interval 5.17 to 7.32
Antibody Concentrations Against Pneumococcal Serotypes Anti-6A Month 11	1.3 µg/mL Interval 0.98 to 1.72	0.93 µg/mL Interval 0.69 to 1.24	1.97 µg/mL Interval 1.52 to 2.55
Antibody Concentrations Against Pneumococcal Serotypes Anti-6B Month 3	0.96 µg/mL Interval 0.78 to 1.18	0.21 µg/mL Interval 0.17 to 0.27	0.38 µg/mL Interval 0.29 to 0.51
Antibody Concentrations Against Pneumococcal Serotypes Anti-6B Month 11	3.53 µg/mL Interval 2.96 to 4.2	1.92 µg/mL Interval 1.53 to 2.42	3.03 µg/mL Interval 2.56 to 3.57
Antibody Concentrations Against Pneumococcal Serotypes Anti-7F Month 3	3.36 µg/mL Interval 2.96 to 3.81	2.74 µg/mL Interval 2.35 to 3.19	4.83 µg/mL Interval 4.32 to 5.4
Antibody Concentrations Against Pneumococcal Serotypes Anti-7F Month 11	7.63 µg/mL Interval 6.69 to 8.71	5.07 µg/mL Interval 4.38 to 5.87	5.83 µg/mL Interval 5.07 to 6.69
Antibody Concentrations Against Pneumococcal Serotypes Anti-9V Month 11	7.04 µg/mL Interval 5.99 to 8.26	2.48 µg/mL Interval 2.11 to 2.92	2.84 µg/mL Interval 2.42 to 3.34
Antibody Concentrations Against Pneumococcal Serotypes Anti-14 Month 3	4.74 µg/mL Interval 3.87 to 5.81	3.45 µg/mL Interval 2.79 to 4.25	4.99 µg/mL Interval 3.89 to 6.42
Antibody Concentrations Against Pneumococcal Serotypes Anti-14 Month 10	1.15 µg/mL Interval 0.89 to 1.49	1.05 µg/mL Interval 0.86 to 1.29	1.78 µg/mL Interval 1.45 to 2.19
Antibody Concentrations Against Pneumococcal Serotypes Anti-18C Month 11	25.18 µg/mL Interval 20.92 to 30.31	19.39 µg/mL Interval 15.36 to 24.48	19.27 µg/mL Interval 15.57 to 23.85
Antibody Concentrations Against Pneumococcal Serotypes Anti-19A Month 3	0.24 µg/mL Interval 0.18 to 0.32	0.72 µg/mL Interval 0.6 to 0.87	2.43 µg/mL Interval 1.91 to 3.1

SECONDARY outcome

Timeframe: At study Month 3 (one month after primary vaccination) and at study Month 11 (one month after booster vaccination)

Anti-PD antibody concentrations were measured by Enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL.

Outcome measures

Outcome measures
Measure	Synflorix Group n=45 Participants Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.	Prevnar 1 Group n=50 Participants Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.	Prevnar 2 Group n=37 Participants Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
Concentrations of Antibodies Against Protein D (Anti-PD) Anti-PD Month 3 (N=45,50,37)	2025.1 EL.U/mL Interval 1601.0 to 2561.4	117.2 EL.U/mL Interval 90.4 to 152.1	143.2 EL.U/mL Interval 106.8 to 192.1
Concentrations of Antibodies Against Protein D (Anti-PD) Anti-PD Month 11 (N=45,42,37)	3658.5 EL.U/mL Interval 2741.1 to 4882.8	791 EL.U/mL Interval 576.2 to 1085.8	219.7 EL.U/mL Interval 156.2 to 309.1

SECONDARY outcome

Timeframe: At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination)

The immunogenicity assessment was based on multiplex opsonophagocytic activity assay (MOPA). Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a serotype specific titer for opsonophagocytic activity higher than or equal to (≥) the Lower Limit of Quantification (LLOQ) i.e.: 14 for OPA-1, 11 for OPA-3; 40 for OPA-4; 15 for OPA-5; 45 for OPA-6A; 29 for OPA-6B; 28 for OPA-7F; 39 for OPA-9V; 16 for OPA-14; 40 for OPA-18C; 13 for OPA-19A; 33 for OPA-19F and 40 for OPA-23F.

Outcome measures

Outcome measures
Measure	Synflorix Group n=45 Participants Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.	Prevnar 1 Group n=50 Participants Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.	Prevnar 2 Group n=40 Participants Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-1 Month 3	58.9 Titers Interval 39.4 to 87.9	51.5 Titers Interval 35.6 to 74.5	96.4 Titers Interval 69.4 to 134.1
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-1 Month 10	10.3 Titers Interval 8.1 to 13.2	8.8 Titers Interval 7.3 to 10.6	9.4 Titers Interval 7.6 to 11.6
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-1 Month 11	311.6 Titers Interval 224.6 to 432.5	139.3 Titers Interval 97.7 to 198.8	240.3 Titers Interval 186.5 to 309.7
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-3 Month 3	5.7 Titers Interval 5.4 to 6.1	50.5 Titers Interval 39.5 to 64.6	190.7 Titers Interval 164.2 to 221.6
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-3 Month 10	18.0 Titers Interval 12.7 to 25.6	33.2 Titers Interval 24.7 to 44.6	41.3 Titers Interval 29.4 to 58.0
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-3 Month 11	11.2 Titers Interval 8.6 to 14.6	22.7 Titers Interval 17.3 to 29.9	29.7 Titers Interval 22.1 to 39.8
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-4 Month 3	1327.9 Titers Interval 1127.4 to 1563.9	812.1 Titers Interval 623.2 to 1058.2	1391.5 Titers Interval 1135.4 to 1705.4
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-4 Month 10	128.1 Titers Interval 75.5 to 217.5	123.5 Titers Interval 75.0 to 203.6	91.4 Titers Interval 56.4 to 148.1
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-4 Month 11	2729.6 Titers Interval 2191.8 to 3399.3	1583.4 Titers Interval 1297.1 to 1932.9	3033.2 Titers Interval 2333.0 to 3943.5
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-5 Month 3	335.9 Titers Interval 258.5 to 436.5	132.0 Titers Interval 91.8 to 189.8	250.2 Titers Interval 177.3 to 353.1
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-5 Month 10	68.7 Titers Interval 47.0 to 100.3	29.3 Titers Interval 21.3 to 40.3	37.3 Titers Interval 26.5 to 52.5
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-6A Month 3	60.4 Titers Interval 38.6 to 94.6	91.9 Titers Interval 59.5 to 142.1	1185.5 Titers Interval 781.5 to 1798.2
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-6A Month 10	96.1 Titers Interval 56.2 to 164.3	73.5 Titers Interval 41.7 to 129.5	112.1 Titers Interval 68.3 to 183.9
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-6A Month 11	480.2 Titers Interval 315.8 to 730.1	216.8 Titers Interval 120.5 to 390.2	363.5 Titers Interval 227.8 to 580.1
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-6B Month 3	603.6 Titers Interval 393.5 to 925.8	107.4 Titers Interval 66.4 to 173.6	331.6 Titers Interval 192.2 to 572.0
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-6B Month 10	182.8 Titers Interval 100.7 to 331.6	131.3 Titers Interval 70.8 to 243.7	60.1 Titers Interval 35.1 to 102.9
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-6B Month 11	1868.1 Titers Interval 1373.4 to 2540.8	958.5 Titers Interval 654.5 to 1403.7	1202.2 Titers Interval 946.7 to 1526.7
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-7F Month 3	2595.4 Titers Interval 2133.8 to 3156.9	1702.1 Titers Interval 1330.8 to 2176.8	4654.8 Titers Interval 3739.1 to 5794.8
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-7F Month 10	654.5 Titers Interval 430.9 to 994.1	676.6 Titers Interval 499.3 to 916.8	858.3 Titers Interval 582.1 to 1265.4
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-7F Month 11	3557.9 Titers Interval 2936.0 to 4311.6	2337.9 Titers Interval 1901.8 to 2874.2	2178.5 Titers Interval 1671.3 to 2839.7
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-9V Month 3	1904.8 Titers Interval 1457.9 to 2488.7	1141.6 Titers Interval 809.2 to 1610.7	2916.6 Titers Interval 2422.6 to 3511.3
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-9V Month 10	424.8 Titers Interval 295.2 to 611.1	441.3 Titers Interval 302.3 to 644.2	353.9 Titers Interval 235.9 to 531.0
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-9V Month 11	5130.2 Titers Interval 4255.2 to 6185.2	2391.0 Titers Interval 1944.4 to 2940.3	1720.7 Titers Interval 1407.4 to 2103.8
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-14 Month 3	1497.1 Titers Interval 1102.1 to 2033.6	924.2 Titers Interval 624.0 to 1368.8	1391.5 Titers Interval 807.6 to 2397.5
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-14 Month 10	303.4 Titers Interval 181.6 to 506.9	270.2 Titers Interval 165.2 to 442.0	342.3 Titers Interval 217.3 to 539.0
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-14 Month 11	3132.1 Titers Interval 2355.4 to 4164.8	2043.1 Titers Interval 1539.0 to 2712.3	1413.9 Titers Interval 1103.9 to 1811.0
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-18C Month 3	965.3 Titers Interval 636.3 to 1464.6	685.5 Titers Interval 473.4 to 992.7	1114.7 Titers Interval 835.1 to 1488.1
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-18C Month 10	116.5 Titers Interval 68.6 to 197.8	72.3 Titers Interval 48.6 to 107.5	61.8 Titers Interval 39.5 to 96.8
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-18C Month 11	6271.0 Titers Interval 5032.6 to 7814.2	4731.5 Titers Interval 3739.3 to 5987.0	4358.6 Titers Interval 3271.4 to 5807.2
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-19A Month 3	85.2 Titers Interval 44.3 to 163.9	173.4 Titers Interval 111.5 to 269.8	677.2 Titers Interval 425.5 to 1077.8
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-19A Month 10	37.2 Titers Interval 20.0 to 69.3	71.7 Titers Interval 39.6 to 129.9	69.5 Titers Interval 33.7 to 143.6
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-19A Month 11	748.8 Titers Interval 446.0 to 1257.3	642.2 Titers Interval 401.2 to 1028.0	1061.6 Titers Interval 663.1 to 1699.6
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-19F Month 3	1306.1 Titers Interval 1016.4 to 1678.3	1492.8 Titers Interval 1157.3 to 1925.6	842.3 Titers Interval 706.0 to 1005.0
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-19F Month 10	127.6 Titers Interval 82.7 to 196.9	158.8 Titers Interval 106.3 to 237.2	42.0 Titers Interval 28.6 to 61.8
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-19F Month 11	2900.7 Titers Interval 2180.8 to 3858.1	2749.9 Titers Interval 2133.7 to 3544.1	3696.9 Titers Interval 2753.6 to 4963.1
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-23F Month 3	633.3 Titers Interval 405.4 to 989.3	143.9 Titers Interval 94.3 to 219.4	1089.4 Titers Interval 735.9 to 1612.8
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-23F Month 10	234.9 Titers Interval 134.8 to 409.3	199.1 Titers Interval 105.6 to 375.3	164.3 Titers Interval 91.8 to 294.2
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-23F Month 11	1500.7 Titers Interval 1023.4 to 2200.6	1005.7 Titers Interval 653.4 to 1548.0	1097.8 Titers Interval 774.6 to 1555.9
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-5 Month 11	669.2 Titers Interval 504.7 to 887.3	266.2 Titers Interval 198.0 to 357.8	379.4 Titers Interval 280.2 to 513.8

Adverse Events

Synflorix Group

Serious events: 3 serious events

Other events: 85 other events

Deaths: 0 deaths

Prevnar 1 Group

Serious events: 4 serious events

Other events: 88 other events

Deaths: 0 deaths

Prevnar 2 Group

Serious events: 1 serious events

Other events: 86 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Synflorix Group n=97 participants at risk Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.	Prevnar 1 Group n=99 participants at risk Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.	Prevnar 2 Group n=98 participants at risk Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
Nervous system disorders Convulsion	0.00% 0/97 • Solicited local and general symptoms: during the 4-day post primary and booster vaccination period; Unsolicited AEs: during the 31-day post primary and booster vaccination period; SAEs: from first vaccination (Month 0) up to study end (11-14 months).	1.0% 1/99 • Solicited local and general symptoms: during the 4-day post primary and booster vaccination period; Unsolicited AEs: during the 31-day post primary and booster vaccination period; SAEs: from first vaccination (Month 0) up to study end (11-14 months).	0.00% 0/98 • Solicited local and general symptoms: during the 4-day post primary and booster vaccination period; Unsolicited AEs: during the 31-day post primary and booster vaccination period; SAEs: from first vaccination (Month 0) up to study end (11-14 months).
Infections and infestations Bronchiolitis	0.00% 0/97 • Solicited local and general symptoms: during the 4-day post primary and booster vaccination period; Unsolicited AEs: during the 31-day post primary and booster vaccination period; SAEs: from first vaccination (Month 0) up to study end (11-14 months).	1.0% 1/99 • Solicited local and general symptoms: during the 4-day post primary and booster vaccination period; Unsolicited AEs: during the 31-day post primary and booster vaccination period; SAEs: from first vaccination (Month 0) up to study end (11-14 months).	1.0% 1/98 • Solicited local and general symptoms: during the 4-day post primary and booster vaccination period; Unsolicited AEs: during the 31-day post primary and booster vaccination period; SAEs: from first vaccination (Month 0) up to study end (11-14 months).
Infections and infestations Gastroenteritis	2.1% 2/97 • Solicited local and general symptoms: during the 4-day post primary and booster vaccination period; Unsolicited AEs: during the 31-day post primary and booster vaccination period; SAEs: from first vaccination (Month 0) up to study end (11-14 months).	0.00% 0/99 • Solicited local and general symptoms: during the 4-day post primary and booster vaccination period; Unsolicited AEs: during the 31-day post primary and booster vaccination period; SAEs: from first vaccination (Month 0) up to study end (11-14 months).	0.00% 0/98 • Solicited local and general symptoms: during the 4-day post primary and booster vaccination period; Unsolicited AEs: during the 31-day post primary and booster vaccination period; SAEs: from first vaccination (Month 0) up to study end (11-14 months).
Infections and infestations Pneumonia	0.00% 0/97 • Solicited local and general symptoms: during the 4-day post primary and booster vaccination period; Unsolicited AEs: during the 31-day post primary and booster vaccination period; SAEs: from first vaccination (Month 0) up to study end (11-14 months).	1.0% 1/99 • Solicited local and general symptoms: during the 4-day post primary and booster vaccination period; Unsolicited AEs: during the 31-day post primary and booster vaccination period; SAEs: from first vaccination (Month 0) up to study end (11-14 months).	0.00% 0/98 • Solicited local and general symptoms: during the 4-day post primary and booster vaccination period; Unsolicited AEs: during the 31-day post primary and booster vaccination period; SAEs: from first vaccination (Month 0) up to study end (11-14 months).
Infections and infestations Respiratory syncytial virus bronchiolitis	1.0% 1/97 • Solicited local and general symptoms: during the 4-day post primary and booster vaccination period; Unsolicited AEs: during the 31-day post primary and booster vaccination period; SAEs: from first vaccination (Month 0) up to study end (11-14 months).	0.00% 0/99 • Solicited local and general symptoms: during the 4-day post primary and booster vaccination period; Unsolicited AEs: during the 31-day post primary and booster vaccination period; SAEs: from first vaccination (Month 0) up to study end (11-14 months).	0.00% 0/98 • Solicited local and general symptoms: during the 4-day post primary and booster vaccination period; Unsolicited AEs: during the 31-day post primary and booster vaccination period; SAEs: from first vaccination (Month 0) up to study end (11-14 months).
Infections and infestations Urinary tract infection	0.00% 0/97 • Solicited local and general symptoms: during the 4-day post primary and booster vaccination period; Unsolicited AEs: during the 31-day post primary and booster vaccination period; SAEs: from first vaccination (Month 0) up to study end (11-14 months).	1.0% 1/99 • Solicited local and general symptoms: during the 4-day post primary and booster vaccination period; Unsolicited AEs: during the 31-day post primary and booster vaccination period; SAEs: from first vaccination (Month 0) up to study end (11-14 months).	0.00% 0/98 • Solicited local and general symptoms: during the 4-day post primary and booster vaccination period; Unsolicited AEs: during the 31-day post primary and booster vaccination period; SAEs: from first vaccination (Month 0) up to study end (11-14 months).

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER