Trial Outcomes & Findings for Dose-Finding Study of S.Pneumoniae Whole Cell Vaccine Adsorbed to Alum (PATH-wSP) in Healthy Kenyan Adults and Toddlers (NCT NCT02097472)

NCT ID: NCT02097472

Last Updated: 2019-10-10

Results Overview

Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 304 participants
• Primary outcome timeframe: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
• Results posted on: 2019-10-10

Participant Flow

Recruitment period: approximately 12 months Site: Single center at Kenya Medical Research Institute/Walter Reed Project (KEMRI/WRP) Kombewa Clinical Research Center (CRC)

Participant milestones

Measure	Adult Cohort 1: PATH-wSP (600 mcg) A single injection of 600 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 600 mcg PATH-wSP in the alternate arm.	Adult Cohort 2: PATH-wSP (1000 mcg) A single injection of 1000 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 1000 mcg PATH-wSP in the alternate arm.	Adult Cohort: Saline A single injection of saline in one arm, followed 4 weeks later by a single injection of saline in the alternate arm.	Toddler Cohort 1: PATH-wSP (300 mcg)+Active Control A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.	Toddler Cohort 1: PATH-wSP (300 mcg)+Saline A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.	Toddler Cohort 2: PATH-wSP (600 mcg)+Active Control A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.	Toddler Cohort 2: PATH-wSP (600 mcg)+Saline A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.	Toddler Cohort: Active Control Only A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines in the right thigh. These 3 injections are followed by a single injection of saline in the left thigh 8 weeks later.
Received Vaccination 1 STARTED	18	18	18	50	50	50	50	50
Received Vaccination 1 COMPLETED	18	18	18	50	50	50	50	50
Received Vaccination 1 NOT COMPLETED	0	0	0	0	0	0	0	0
Received Vaccination 2 STARTED	18	18	18	50	50	50	50	50
Received Vaccination 2 COMPLETED	18	18	18	50	50	50	49	50
Received Vaccination 2 NOT COMPLETED	0	0	0	0	0	0	1	0
Assessed for Immunogenicity STARTED	18	18	18	50	50	50	49	50
Assessed for Immunogenicity COMPLETED	18	18	17	48	50	48	47	49
Assessed for Immunogenicity NOT COMPLETED	0	0	1	2	0	2	2	1

Reasons for withdrawal

Measure	Adult Cohort 1: PATH-wSP (600 mcg) A single injection of 600 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 600 mcg PATH-wSP in the alternate arm.	Adult Cohort 2: PATH-wSP (1000 mcg) A single injection of 1000 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 1000 mcg PATH-wSP in the alternate arm.	Adult Cohort: Saline A single injection of saline in one arm, followed 4 weeks later by a single injection of saline in the alternate arm.	Toddler Cohort 1: PATH-wSP (300 mcg)+Active Control A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.	Toddler Cohort 1: PATH-wSP (300 mcg)+Saline A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.	Toddler Cohort 2: PATH-wSP (600 mcg)+Active Control A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.	Toddler Cohort 2: PATH-wSP (600 mcg)+Saline A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.	Toddler Cohort: Active Control Only A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines in the right thigh. These 3 injections are followed by a single injection of saline in the left thigh 8 weeks later.
Received Vaccination 2 Adverse Event	0	0	0	0	0	0	1	0

Baseline Characteristics

Dose-Finding Study of S.Pneumoniae Whole Cell Vaccine Adsorbed to Alum (PATH-wSP) in Healthy Kenyan Adults and Toddlers

Baseline characteristics by cohort

Measure	Adult Cohort: PATH-wSP (600 mcg) n=18 Participants A single injection of 600 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 600 mcg PATH-wSP in the alternate arm.	Adult Cohort: PATH-wSP (1000 mcg) n=18 Participants A single injection of 1000 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 1000 mcg PATH-wSP in the alternate arm.	Adult Cohort: Saline n=18 Participants A single injection of saline in one arm, followed 4 weeks later by a single injection of saline in the alternate arm.	Toddler Cohort: PATH-wSP (300 mcg)+Active Control n=50 Participants A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.	Toddler Cohort: PATH-wSP (300 mcg)+Saline n=50 Participants A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.	Toddler Cohort: PATH-wSP (600 mcg)+Active Control n=50 Participants A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.	Toddler Cohort: PATH-wSP (600 mcg)+Saline n=50 Participants A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.	Toddler Cohort: Active Control Only n=50 Participants A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines in the right thigh. These 3 injections are followed by a single injection of saline in the left thigh 8 weeks later.	Total n=304 Participants Total of all reporting groups
Age, Continuous	26.94 years STANDARD_DEVIATION 5.98 • n=5 Participants	28.56 years STANDARD_DEVIATION 8.61 • n=7 Participants	30.39 years STANDARD_DEVIATION 7.71 • n=5 Participants	1.10 years STANDARD_DEVIATION 0.09 • n=4 Participants	1.09 years STANDARD_DEVIATION 0.09 • n=21 Participants	1.11 years STANDARD_DEVIATION 0.09 • n=8 Participants	1.13 years STANDARD_DEVIATION 0.10 • n=8 Participants	1.09 years STANDARD_DEVIATION 0.09 • n=24 Participants	5.99 years STANDARD_DEVIATION 11.00 • n=42 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	32 Participants n=4 Participants	26 Participants n=21 Participants	23 Participants n=8 Participants	24 Participants n=8 Participants	23 Participants n=24 Participants	148 Participants n=42 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	18 Participants n=4 Participants	24 Participants n=21 Participants	27 Participants n=8 Participants	26 Participants n=8 Participants	27 Participants n=24 Participants	156 Participants n=42 Participants
Region of Enrollment Kenya	18 Participants n=5 Participants	18 Participants n=7 Participants	18 Participants n=5 Participants	50 Participants n=4 Participants	50 Participants n=21 Participants	50 Participants n=8 Participants	50 Participants n=8 Participants	50 Participants n=24 Participants	304 Participants n=42 Participants

PRIMARY outcome

Timeframe: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=18 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=18 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=18 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=18 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination No fatigue/malaise	15 Participants	15 Participants	18 Participants	—	16 Participants	13 Participants	15 Participants	—	—	—	—	—	—	—	—
Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination Grade 1: no interference with activity	3 Participants	3 Participants	0 Participants	—	2 Participants	2 Participants	3 Participants	—	—	—	—	—	—	—	—
Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination Grade 2: Some interference with activity	0 Participants	0 Participants	0 Participants	—	0 Participants	3 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=18 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=18 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=18 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=18 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination No myalgia	11 Participants	16 Participants	17 Participants	—	15 Participants	16 Participants	15 Participants	—	—	—	—	—	—	—	—
Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination Grade 1: no interference with activity	6 Participants	1 Participants	1 Participants	—	3 Participants	1 Participants	3 Participants	—	—	—	—	—	—	—	—
Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination Grade 2: Some interference with activity	1 Participants	1 Participants	0 Participants	—	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

Grade 2 includes repeated use of non-narcotic pain reliever for more than 24 hours.

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=18 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=18 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=18 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=18 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Number/Percent of Adult Subjects Experiencing Headache Following Vaccination No headache	16 Participants	12 Participants	13 Participants	—	15 Participants	11 Participants	12 Participants	—	—	—	—	—	—	—	—
Number/Percent of Adult Subjects Experiencing Headache Following Vaccination Grade 1: no interference with activity	1 Participants	6 Participants	5 Participants	—	3 Participants	6 Participants	6 Participants	—	—	—	—	—	—	—	—
Number/Percent of Adult Subjects Experiencing Headache Following Vaccination Grade 2: Some interference with activity	1 Participants	0 Participants	0 Participants	—	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

Grade 2 includes use of non-narcotic pain reliever for more than 24 hours.

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=18 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=18 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=18 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=18 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination No pain at injection site	4 Participants	3 Participants	14 Participants	—	9 Participants	5 Participants	16 Participants	—	—	—	—	—	—	—	—
Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination Grade 1: no interference with activity	11 Participants	13 Participants	4 Participants	—	8 Participants	11 Participants	2 Participants	—	—	—	—	—	—	—	—
Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination Grade 2: Some interference limiting limb use	3 Participants	2 Participants	0 Participants	—	1 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=18 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=18 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=18 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=18 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination No tenderness	3 Participants	4 Participants	11 Participants	—	7 Participants	7 Participants	16 Participants	—	—	—	—	—	—	—	—
Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination Grade 1: no interference with activity	12 Participants	12 Participants	7 Participants	—	10 Participants	8 Participants	2 Participants	—	—	—	—	—	—	—	—
Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination Grade 2: pain limiting limb use	3 Participants	2 Participants	0 Participants	—	1 Participants	3 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

Grade 1: does not interfere with activity Grade 2: interferes with activity

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=18 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=18 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=18 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=18 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination No induration/swelling	13 Participants	17 Participants	17 Participants	—	18 Participants	16 Participants	18 Participants	—	—	—	—	—	—	—	—
Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination Grade 1: 2.5-5cm	4 Participants	1 Participants	1 Participants	—	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination Grade 2: 5.1-10cm	1 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=18 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=18 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=18 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=18 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination No fever	18 Participants	18 Participants	18 Participants	—	18 Participants	17 Participants	18 Participants	—	—	—	—	—	—	—	—
Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination Grade 3: ≥39.0 to ≤40.0 degrees Celsius	0 Participants	0 Participants	0 Participants	—	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=50 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=50 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=50 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=50 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=50 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=95 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=94 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=48 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination No fever	26 Participants	40 Participants	31 Participants	—	42 Participants	37 Participants	87 Participants	78 Participants	42 Participants	—	—	—	—	—	—
Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination Grade 1: ≥37.5 to ≤38.0 deg. Celsius	11 Participants	6 Participants	13 Participants	—	4 Participants	9 Participants	5 Participants	11 Participants	2 Participants	—	—	—	—	—	—
Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination Grade 2: ≥38.1 to ≤39.0 deg. Celsius	9 Participants	3 Participants	3 Participants	—	2 Participants	3 Participants	2 Participants	5 Participants	2 Participants	—	—	—	—	—	—
Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination Grade 3: ≥39.1 to ≤40.0 deg. Celsius	3 Participants	1 Participants	3 Participants	—	2 Participants	1 Participants	1 Participants	0 Participants	2 Participants	—	—	—	—	—	—
Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination Grade 4: >40.0 deg. Celsius	1 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

Grade 2: includes diffuse macular/maculopapular/morbilliform rash

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=50 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=50 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=50 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=50 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=50 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=95 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=94 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=48 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination No cutaneous rash	41 Participants	44 Participants	43 Participants	—	39 Participants	40 Participants	83 Participants	72 Participants	38 Participants	—	—	—	—	—	—
Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination Grade 1: localized macular rash	7 Participants	4 Participants	5 Participants	—	6 Participants	8 Participants	9 Participants	16 Participants	7 Participants	—	—	—	—	—	—
Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination Grade 2: Diffuse rash or target lesions	2 Participants	2 Participants	2 Participants	—	5 Participants	2 Participants	3 Participants	6 Participants	3 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=50 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=50 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=50 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=50 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=50 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=95 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=94 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=48 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination No irritability	31 Participants	46 Participants	36 Participants	—	49 Participants	40 Participants	90 Participants	89 Participants	47 Participants	—	—	—	—	—	—
Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination Grade 1: crying >usual/normal activity	16 Participants	4 Participants	9 Participants	—	1 Participants	9 Participants	4 Participants	5 Participants	1 Participants	—	—	—	—	—	—
Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination Grade 2: crying>usual/interferes w/normal activity	3 Participants	0 Participants	5 Participants	—	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=50 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=50 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=50 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=50 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=50 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=95 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=94 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=48 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination No drowsiness	48 Participants	49 Participants	47 Participants	—	50 Participants	50 Participants	95 Participants	94 Participants	47 Participants	—	—	—	—	—	—
Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination Grade 1: drowsiness easily tolerated	2 Participants	1 Participants	2 Participants	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination Grade 2: interferes with normal activity	0 Participants	0 Participants	1 Participants	—	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=50 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=50 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=50 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=50 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=50 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=95 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=94 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=48 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination No loss of appetite	32 Participants	42 Participants	30 Participants	—	47 Participants	31 Participants	85 Participants	88 Participants	45 Participants	—	—	—	—	—	—
Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination Grade 1: eating <usual/normal activity	17 Participants	7 Participants	19 Participants	—	3 Participants	19 Participants	10 Participants	6 Participants	3 Participants	—	—	—	—	—	—
Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination Gr. 2: eating <usual/interferes w/ normal activity	1 Participants	1 Participants	1 Participants	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=100 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=100 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=50 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=50 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=50 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=95 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=94 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=48 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination No pain/tenderness at injection site	33 Participants	43 Participants	17 Participants	—	21 Participants	20 Participants	72 Participants	81 Participants	42 Participants	—	—	—	—	—	—
Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination Grade 1: minor reactions to touch	61 Participants	52 Participants	32 Participants	—	28 Participants	30 Participants	22 Participants	13 Participants	6 Participants	—	—	—	—	—	—
Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination Grade 2: cries/protests to touch	6 Participants	5 Participants	1 Participants	—	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=100 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=100 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=50 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=50 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=50 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=95 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=94 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=48 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination No induration/swelling	93 Participants	98 Participants	45 Participants	—	48 Participants	49 Participants	93 Participants	89 Participants	47 Participants	—	—	—	—	—	—
Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination Grade 1: Induration or edema <2.5cm	5 Participants	2 Participants	4 Participants	—	2 Participants	1 Participants	2 Participants	5 Participants	1 Participants	—	—	—	—	—	—
Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination G2: Induration OR edema ≥2.5cm but <50% surface ar	2 Participants	0 Participants	1 Participants	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Measured with enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=17 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=16 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=46 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=47 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=48 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=48 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay Baseline	2083.27 titer Interval 1638.67 to 2648.49	1569.91 titer Interval 1102.09 to 2236.3	1998.33 titer Interval 1356.41 to 2944.02	—	400.00 titer Interval 289.99 to 551.74	311.30 titer Interval 209.43 to 462.71	755.10 titer Interval 541.85 to 1052.27	848.61 titer Interval 612.56 to 1175.62	455.52 titer Interval 318.02 to 652.45	—	—	—	—	—	—
Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay Post-vaccination 1	2619.99 titer Interval 2015.16 to 3406.36	2394.59 titer Interval 1669.66 to 3434.28	1945.09 titer Interval 1329.56 to 2845.58	—	516.79 titer Interval 367.08 to 727.54	506.45 titer Interval 351.03 to 730.68	897.97 titer Interval 664.86 to 1212.82	1647.90 titer Interval 1208.09 to 2247.81	489.62 titer Interval 355.16 to 674.99	—	—	—	—	—	—
Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay Post-vaccination 2	3752.62 titer Interval 2860.91 to 4922.26	2933.71 titer Interval 2049.42 to 4199.55	1961.47 titer Interval 1301.64 to 2955.8	—	800.00 titer Interval 563.29 to 1136.18	732.25 titer Interval 509.87 to 1051.63	1510.20 titer Interval 1101.94 to 2069.72	2211.06 titer Interval 1592.51 to 3069.87	526.28 titer Interval 386.3 to 716.99	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Measured with enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=17 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=17 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=46 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=47 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=48 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=48 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay Baseline	1899.32 titer Interval 1393.87 to 2588.06	2042.68 titer Interval 1679.25 to 2484.75	1793.44 titer Interval 1404.9 to 2289.43	—	410.23 titer Interval 298.75 to 563.3	361.41 titer Interval 268.84 to 485.85	550.02 titer Interval 423.69 to 714.03	674.04 titer Interval 509.7 to 891.36	456.64 titer Interval 349.76 to 596.17	—	—	—	—	—	—
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay Post-vaccination 1	2425.50 titer Interval 1929.04 to 3049.73	3083.33 titer Interval 2532.19 to 3754.44	1922.47 titer Interval 1514.36 to 2440.56	—	565.40 titer Interval 431.64 to 740.62	557.07 titer Interval 408.19 to 760.24	637.63 titer Interval 495.23 to 820.97	1126.67 titer Interval 831.35 to 1526.9	417.09 titer Interval 309.03 to 562.93	—	—	—	—	—	—
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay Post-vaccination 2	3192.07 titer Interval 2609.98 to 3903.97	3901.23 titer Interval 2943.11 to 5171.26	2031.31 titer Interval 1566.67 to 2633.75	—	724.42 titer Interval 563.05 to 932.03	541.73 titer Interval 399.29 to 734.98	889.48 titer Interval 707.12 to 1118.86	1264.22 titer Interval 925.59 to 1726.74	487.03 titer Interval 359.4 to 659.99	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Population: Insufficient sample

Measured using meso scale discovery (MSD).

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=18 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=17 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=48 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=50 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=48 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=49 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein Baseline	861.27 titer Interval 661.13 to 1121.99	820.92 titer Interval 629.25 to 1070.97	908.51 titer Interval 582.64 to 1416.63	—	263.85 titer Interval 206.73 to 336.74	210.15 titer Interval 160.3 to 275.48	309.74 titer Interval 246.74 to 388.83	331.08 titer Interval 270.14 to 405.77	216.45 titer Interval 173.79 to 269.58	—	—	—	—	—	—
Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein Post-vaccination 1	1127.59 titer Interval 869.68 to 1461.99	998.09 titer Interval 777.32 to 1281.56	886.15 titer Interval 614.08 to 1278.77	—	329.38 titer Interval 255.01 to 425.44	328.35 titer Interval 253.48 to 425.33	386.92 titer Interval 316.53 to 472.97	602.20 titer Interval 489.74 to 740.49	247.77 titer Interval 194.9 to 314.98	—	—	—	—	—	—
Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein Post-vaccination 2	1391.66 titer Interval 1065.65 to 1817.41	1410.11 titer Interval 1014.73 to 1959.55	963.25 titer Interval 701.06 to 1323.49	—	462.54 titer Interval 351.01 to 609.51	408.40 titer Interval 318.02 to 524.46	631.63 titer Interval 506.72 to 787.32	803.61 titer Interval 630.84 to 1023.69	279.43 titer Interval 221.59 to 352.36	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Population: The number analyzed may differ between periods because of insufficient samples.

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=18 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=17 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=48 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=50 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=48 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=49 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay Baseline	2124.32 titer Interval 1533.58 to 2942.62	2129.61 titer Interval 1574.0 to 2881.35	2049.33 titer Interval 1457.58 to 2881.3	—	175.80 titer Interval 122.62 to 252.03	174.35 titer Interval 119.81 to 253.71	202.89 titer Interval 145.92 to 282.09	217.24 titer Interval 154.08 to 306.29	177.29 titer Interval 127.64 to 246.25	—	—	—	—	—	—
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay Post-vaccination 1	3149.80 titer Interval 2268.5 to 4373.47	3442.17 titer Interval 2582.7 to 4587.64	2105.22 titer Interval 1473.42 to 3007.94	—	283.38 titer Interval 203.73 to 394.15	294.98 titer Interval 203.95 to 426.66	272.19 titer Interval 204.41 to 362.44	420.45 titer Interval 285.84 to 618.44	167.21 titer Interval 112.78 to 247.89	—	—	—	—	—	—
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay Post-vaccination 2	3469.35 titer Interval 2725.55 to 4416.14	4607.95 titer Interval 3491.22 to 6081.9	2323.41 titer Interval 1752.55 to 3080.21	—	367.01 titer Interval 265.16 to 507.99	338.19 titer Interval 230.39 to 496.43	371.56 titer Interval 279.5 to 493.95	518.77 titer Interval 365.33 to 736.65	186.84 titer Interval 126.04 to 276.97	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Population: The number analyzed may differ between periods because of insufficient samples.

Measured using Meso Scale Discovery (MSD) Assay

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=18 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=17 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=48 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=50 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=48 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=49 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein Baseline	841.63 titer Interval 626.89 to 1129.94	784.56 titer Interval 606.58 to 1014.75	775.26 titer Interval 531.41 to 1130.99	—	426.11 titer Interval 313.4 to 579.35	403.13 titer Interval 289.64 to 561.09	466.20 titer Interval 337.37 to 644.21	497.28 titer Interval 383.3 to 645.15	434.86 titer Interval 331.26 to 570.85	—	—	—	—	—	—
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein Post-vaccination 1	839.14 titer Interval 576.12 to 1222.24	868.55 titer Interval 655.4 to 1151.03	775.29 titer Interval 535.14 to 1123.21	—	563.55 titer Interval 429.28 to 739.83	491.70 titer Interval 361.58 to 668.64	577.47 titer Interval 434.14 to 768.11	654.21 titer Interval 512.33 to 835.39	513.83 titer Interval 390.75 to 675.68	—	—	—	—	—	—
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein Post-vaccination 2	890.67 titer Interval 627.43 to 1264.34	982.10 titer Interval 710.87 to 1356.82	872.62 titer Interval 603.52 to 1261.71	—	804.59 titer Interval 612.11 to 1057.6	704.46 titer Interval 552.58 to 898.09	767.31 titer Interval 578.07 to 1018.48	1074.36 titer Interval 844.35 to 1367.04	679.80 titer Interval 519.1 to 890.25	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Population: The number analyzed may differ between periods because of insufficient samples.

Measured using Meso Scale Discovery (MSD) Assay

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=18 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=17 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=48 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=50 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=48 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=49 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein Baseline	1566.50 titer Interval 1035.43 to 2369.96	1145.05 titer Interval 909.05 to 1442.33	1236.11 titer Interval 819.09 to 1865.46	—	400.58 titer Interval 294.1 to 545.61	271.66 titer Interval 200.93 to 367.3	281.66 titer Interval 209.24 to 379.16	372.53 titer Interval 277.67 to 499.79	288.13 titer Interval 206.26 to 402.5	—	—	—	—	—	—
Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein Post-vaccination 1	1665.26 titer Interval 1070.16 to 2591.29	1367.52 titer Interval 1050.0 to 1781.04	1224.22 titer Interval 787.13 to 1904.02	—	504.49 titer Interval 372.64 to 682.99	364.39 titer Interval 279.71 to 474.72	373.57 titer Interval 288.65 to 483.48	526.34 titer Interval 385.99 to 717.73	328.03 titer Interval 238.52 to 451.14	—	—	—	—	—	—
Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein Post-vaccination 2	1808.37 titer Interval 1220.45 to 2679.52	1713.83 titer Interval 1263.06 to 2325.47	1340.75 titer Interval 972.21 to 1849.0	—	561.60 titer Interval 408.05 to 772.93	480.18 titer Interval 373.03 to 618.11	470.01 titer Interval 350.35 to 630.53	716.82 titer Interval 538.77 to 953.71	394.37 titer Interval 288.87 to 538.41	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Population: The number analyzed may differ between periods because of insufficient samples.

Measured using Meso Scale Discovery (MSD) Assay

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=18 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=17 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=48 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=50 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=48 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=49 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein Baseline	1406.04 titer Interval 901.16 to 2193.77	1140.55 titer Interval 863.69 to 1506.15	1263.61 titer Interval 819.76 to 1947.76	—	204.58 titer Interval 146.61 to 285.48	130.62 titer Interval 98.14 to 173.85	157.58 titer Interval 113.59 to 218.61	229.15 titer Interval 169.0 to 310.7	161.89 titer Interval 119.32 to 219.65	—	—	—	—	—	—
Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein Post-vaccination 1	1632.87 titer Interval 1003.67 to 2656.52	1311.45 titer Interval 973.06 to 1767.52	1308.29 titer Interval 825.65 to 2073.06	—	278.64 titer Interval 204.21 to 380.18	164.27 titer Interval 124.79 to 216.24	187.67 titer Interval 140.6 to 250.51	295.14 titer Interval 219.22 to 397.35	180.93 titer Interval 132.2 to 247.63	—	—	—	—	—	—
Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein Post-vaccination 2	1753.89 titer Interval 1138.27 to 2702.47	1620.05 titer Interval 1203.93 to 2180.01	1430.78 titer Interval 985.89 to 2076.42	—	351.25 titer Interval 255.61 to 482.66	230.51 titer Interval 183.42 to 289.68	273.84 titer Interval 205.92 to 364.16	396.24 titer Interval 297.85 to 527.14	217.32 titer Interval 162.69 to 290.28	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Population: The number analyzed may differ between periods because of insufficient samples.

Measured using Meso Scale Discovery (MSD) Assay

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=18 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=17 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=48 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=50 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=48 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=49 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein Baseline	1677.20 titer Interval 1248.67 to 2252.8	1016.49 titer Interval 757.2 to 1364.57	1436.97 titer Interval 996.44 to 2072.26	—	316.39 titer Interval 202.24 to 494.97	350.52 titer Interval 218.29 to 562.87	355.69 titer Interval 206.59 to 612.41	356.24 titer Interval 224.23 to 565.95	254.77 titer Interval 152.06 to 426.85	—	—	—	—	—	—
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein Post-vaccination 1	1523.84 titer Interval 1045.11 to 2221.85	904.99 titer Interval 670.76 to 1221.03	1461.34 titer Interval 1064.83 to 2005.48	—	354.49 titer Interval 222.21 to 565.5	327.75 titer Interval 203.97 to 526.65	473.66 titer Interval 290.78 to 771.55	344.10 titer Interval 211.0 to 561.19	297.33 titer Interval 181.65 to 486.68	—	—	—	—	—	—
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein Post-vaccination 2	1497.72 titer Interval 1127.58 to 1989.36	950.83 titer Interval 668.08 to 1353.25	1728.30 titer Interval 1234.67 to 2419.29	—	375.72 titer Interval 234.9 to 600.97	342.08 titer Interval 216.65 to 540.12	441.77 titer Interval 265.98 to 733.75	434.85 titer Interval 259.39 to 729.01	392.99 titer Interval 236.6 to 652.75	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Population: The number analyzed may differ between periods because of insufficient samples.

MSD Assay

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=18 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=17 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=48 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=50 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=48 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=49 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein Baseline	1707.99 titer Interval 1209.54 to 2411.84	1398.09 titer Interval 969.28 to 2016.6	1321.49 titer Interval 1075.42 to 1623.87	—	664.34 titer Interval 580.83 to 759.85	632.54 titer Interval 552.55 to 724.12	615.81 titer Interval 530.49 to 714.86	665.59 titer Interval 596.55 to 742.63	652.61 titer Interval 581.79 to 732.04	—	—	—	—	—	—
Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein Post-vaccination 1	1660.20 titer Interval 1310.34 to 2103.47	1359.27 titer Interval 1049.52 to 1760.45	1263.81 titer Interval 1026.75 to 1555.61	—	778.54 titer Interval 680.41 to 890.82	717.62 titer Interval 649.35 to 793.07	728.65 titer Interval 639.5 to 830.22	771.90 titer Interval 682.33 to 873.22	682.37 titer Interval 601.34 to 774.32	—	—	—	—	—	—
Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein Post-vaccination 2	1709.46 titer Interval 1373.92 to 2126.94	1685.31 titer Interval 1318.7 to 2153.85	1493.37 titer Interval 1144.92 to 1947.88	—	844.62 titer Interval 736.1 to 969.13	764.02 titer Interval 687.93 to 848.52	820.14 titer Interval 739.9 to 909.08	939.58 titer Interval 808.92 to 1091.35	765.74 titer Interval 674.9 to 868.81	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Population: The number analyzed may differ between periods because of insufficient samples.

MSD Assay

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=18 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=17 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=48 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=50 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=48 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=49 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein Baseline	1401.11 titer Interval 895.6 to 2191.93	1524.31 titer Interval 968.09 to 2400.1	1625.92 titer Interval 923.1 to 2863.84	—	677.28 titer Interval 535.39 to 856.78	575.24 titer Interval 449.63 to 735.94	556.30 titer Interval 442.49 to 699.38	679.07 titer Interval 530.85 to 868.68	601.79 titer Interval 474.76 to 762.8	—	—	—	—	—	—
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein Post-vaccination 1	1471.39 titer Interval 981.61 to 2205.56	1668.22 titer Interval 1077.75 to 2582.2	1603.96 titer Interval 1003.56 to 2563.53	—	837.32 titer Interval 659.76 to 1062.66	732.41 titer Interval 597.09 to 898.41	702.78 titer Interval 577.6 to 855.08	860.69 titer Interval 672.04 to 1102.3	671.40 titer Interval 526.98 to 855.41	—	—	—	—	—	—
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein Post-vaccination 2	1582.79 titer Interval 1021.39 to 2452.74	1898.28 titer Interval 1189.21 to 3030.13	1769.43 titer Interval 1111.95 to 2815.66	—	937.83 titer Interval 730.15 to 1204.57	815.05 titer Interval 662.34 to 1002.96	961.01 titer Interval 804.64 to 1147.77	1108.83 titer Interval 880.94 to 1395.67	763.13 titer Interval 612.16 to 951.33	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Population: The number analyzed may differ between periods because of insufficient samples.

MSD Assay

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=18 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=17 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=48 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=50 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=48 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=49 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein Baseline	1933.77 titer Interval 1248.16 to 2995.98	2027.06 titer Interval 1481.1 to 2774.27	1897.23 titer Interval 1211.22 to 2971.8	—	650.98 titer Interval 503.48 to 841.69	503.78 titer Interval 373.57 to 679.38	609.28 titer Interval 476.06 to 779.79	892.24 titer Interval 715.63 to 1112.42	542.93 titer Interval 430.61 to 684.54	—	—	—	—	—	—
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein Post-vaccination 1	2299.24 titer Interval 1449.89 to 3646.14	2396.09 titer Interval 1745.84 to 3288.52	1853.17 titer Interval 1231.25 to 2789.21	—	759.91 titer Interval 605.92 to 953.04	622.89 titer Interval 485.14 to 799.76	721.16 titer Interval 578.45 to 899.08	1197.63 titer Interval 951.41 to 1507.56	602.56 titer Interval 476.3 to 762.28	—	—	—	—	—	—
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein Post-vaccination 2	2471.44 titer Interval 1620.81 to 3768.5	2875.72 titer Interval 2003.45 to 4127.76	2218.47 titer Interval 1548.56 to 3178.18	—	926.53 titer Interval 714.91 to 1200.79	833.02 titer Interval 653.96 to 1061.12	880.18 titer Interval 718.66 to 1078.02	1493.50 titer Interval 1179.45 to 1891.16	750.60 titer Interval 580.03 to 971.33	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Population: The number analyzed may differ between periods because of insufficient samples.

Measured using ELISA

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=46 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=47 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=48 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Post-vaccination 1	1.29 fold change Interval 1.1 to 1.52	1.63 fold change Interval 1.34 to 1.98	1.19 fold change Interval 1.03 to 1.37	—	1.94 fold change Interval 1.63 to 2.31	1.07 fold change Interval 0.89 to 1.29	—	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Post-vaccination 2	2.00 fold change Interval 1.6 to 2.49	2.35 fold change Interval 1.86 to 2.98	2.00 fold change Interval 1.57 to 2.54	—	2.48 fold change Interval 1.88 to 3.28	1.16 fold change Interval 0.98 to 1.36	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Population: The number analyzed may differ between periods because of insufficient samples.

Measured using ELISA

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=46 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=47 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=48 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Post-vaccination 1	1.38 fold change Interval 1.09 to 1.75	1.54 fold change Interval 1.28 to 1.85	1.16 fold change Interval 0.96 to 1.4	—	1.67 fold change Interval 1.26 to 2.21	0.91 fold change Interval 0.79 to 1.06	—	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Post-vaccination 2	1.77 fold change Interval 1.39 to 2.24	1.50 fold change Interval 1.2 to 1.87	1.62 fold change Interval 1.29 to 2.03	—	1.83 fold change Interval 1.34 to 2.49	1.07 fold change Interval 0.83 to 1.37	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Population: The number analyzed may differ between periods because of insufficient samples.

Measured using MSD

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD Post-vaccination 1	1.25 fold change Interval 1.11 to 1.4	1.56 fold change Interval 1.37 to 1.77	1.25 fold change Interval 1.14 to 1.37	—	1.82 fold change Interval 1.57 to 2.11	1.14 fold change Interval 1.01 to 1.3	—	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD Post-vaccination 2	1.72 fold change Interval 1.47 to 2.01	1.96 fold change Interval 1.66 to 2.31	2.04 fold change Interval 1.72 to 2.42	—	2.40 fold change Interval 1.98 to 2.92	1.28 fold change Interval 1.11 to 1.48	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Population: The number analyzed may differ between periods because of insufficient samples.

Measured using ELISA

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: MSD Post-vaccination 1	1.61 fold change Interval 1.24 to 2.09	1.74 fold change Interval 1.48 to 2.04	1.34 fold change Interval 1.1 to 1.64	—	1.94 fold change Interval 1.44 to 2.6	0.94 fold change Interval 0.8 to 1.11	—	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: MSD Post-vaccination 2	2.09 fold change Interval 1.58 to 2.77	1.97 fold change Interval 1.57 to 2.47	1.83 fold change Interval 1.46 to 2.29	—	2.38 fold change Interval 1.71 to 3.31	1.03 fold change Interval 0.8 to 1.33	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Population: The number analyzed may differ between periods because of insufficient samples.

Measured using MSD

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Fold Change of IgG Antibodies Against PhtD Pneumococcal Protein Post-vaccination 1	1.32 fold change Interval 1.16 to 1.51	1.25 fold change Interval 1.11 to 1.42	1.24 fold change Interval 0.94 to 1.63	—	1.32 fold change Interval 1.11 to 1.55	1.18 fold change Interval 1.04 to 1.34	—	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of IgG Antibodies Against PhtD Pneumococcal Protein Post-vaccination 2	1.79 fold change Interval 1.53 to 2.09	1.90 fold change Interval 1.55 to 2.32	1.65 fold change Interval 1.29 to 2.11	—	2.10 fold change Interval 1.73 to 2.56	1.60 fold change Interval 1.28 to 1.99	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Population: The number analyzed may differ between periods because of insufficient samples.

Measured using MSD

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Fold Change of IgG Antibodies Against BCH0785 Pneumococcal Protein Post-vaccination 1	1.26 fold change Interval 1.1 to 1.44	1.30 fold change Interval 1.12 to 1.51	1.33 fold change Interval 1.08 to 1.63	—	1.41 fold change Interval 1.17 to 1.71	1.14 fold change Interval 1.0 to 1.3	—	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of IgG Antibodies Against BCH0785 Pneumococcal Protein Post-vaccination 2	1.36 fold change Interval 1.14 to 1.63	1.70 fold change Interval 1.41 to 2.05	1.67 fold change Interval 1.34 to 2.07	—	1.93 fold change Interval 1.53 to 2.42	1.31 fold change Interval 1.05 to 1.64	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Population: The number analyzed may differ between periods because of insufficient samples.

Measured using MSD

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Fold Change of IgG Antibodies Against StkP Pneumococcal Protein Post-vaccination 1	1.36 fold change Interval 1.19 to 1.56	1.26 fold change Interval 1.09 to 1.46	1.19 fold change Interval 1.0 to 1.42	—	1.29 fold change Interval 1.12 to 1.48	1.12 fold change Interval 1.0 to 1.25	—	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of IgG Antibodies Against StkP Pneumococcal Protein Post-vaccination 2	1.69 fold change Interval 1.44 to 1.99	1.79 fold change Interval 1.52 to 2.12	1.74 fold change Interval 1.4 to 2.15	—	1.67 fold change Interval 1.4 to 2.0	1.29 fold change Interval 1.12 to 1.48	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Population: The number analyzed may differ between periods because of insufficient samples.

Measured using MSD

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Fold Change of IgG Antibodies Against PcpA Pneumococcal Protein Post-vaccination 1	1.12 fold change Interval 0.91 to 1.39	0.95 fold change Interval 0.83 to 1.1	1.33 fold change Interval 0.95 to 1.87	—	0.97 fold change Interval 0.73 to 1.28	1.17 fold change Interval 0.96 to 1.42	—	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of IgG Antibodies Against PcpA Pneumococcal Protein Post-vaccination 2	1.17 fold change Interval 0.91 to 1.5	1.07 fold change Interval 0.82 to 1.39	1.24 fold change Interval 0.92 to 1.68	—	1.17 fold change Interval 0.8 to 1.72	1.43 fold change Interval 1.03 to 1.99	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Population: The number analyzed may differ between periods because of insufficient samples.

Measured using MSD

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Fold Change of IgG Antibodies Against SPWCA Pneumococcal Protein Post-vaccination 1	1.17 fold change Interval 1.06 to 1.3	1.14 fold change Interval 1.02 to 1.27	1.18 fold change Interval 1.05 to 1.34	—	1.16 fold change Interval 1.03 to 1.3	1.05 fold change Interval 0.94 to 1.16	—	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of IgG Antibodies Against SPWCA Pneumococcal Protein Post-vaccination 2	1.26 fold change Interval 1.11 to 1.43	1.23 fold change Interval 1.1 to 1.38	1.33 fold change Interval 1.17 to 1.52	—	1.43 fold change Interval 1.24 to 1.66	1.17 fold change Interval 1.04 to 1.31	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Population: The number analyzed may differ between periods because of insufficient samples.

Measured using MSD

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Fold Change of IgG Antibodies Against PiuA Pneumococcal Protein Post-vaccination 1	1.24 fold change Interval 1.08 to 1.42	1.26 fold change Interval 1.08 to 1.47	1.26 fold change Interval 1.05 to 1.52	—	1.27 fold change Interval 1.11 to 1.45	1.12 fold change Interval 1.01 to 1.23	—	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of IgG Antibodies Against PiuA Pneumococcal Protein Post-vaccination 2	1.35 fold change Interval 1.14 to 1.6	1.45 fold change Interval 1.23 to 1.74	1.73 fold change Interval 1.38 to 2.16	—	1.64 fold change Interval 1.37 to 1.96	1.24 fold change Interval 1.07 to 1.42	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Population: The number analyzed may differ between periods because of insufficient samples.

Measured using MSD

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Fold Change of IgG Antibodies Against PiaA Pneumococcal Protein Post-vaccination 1	1.17 fold change Interval 1.01 to 1.36	1.23 fold change Interval 1.03 to 1.47	1.18 fold change Interval 1.03 to 1.37	—	1.34 fold change Interval 1.15 to 1.57	1.11 fold change Interval 0.98 to 1.26	—	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of IgG Antibodies Against PiaA Pneumococcal Protein Post-vaccination 2	1.40 fold change Interval 1.15 to 1.7	1.69 fold change Interval 1.32 to 2.16	1.44 fold change Interval 1.2 to 1.73	—	1.66 fold change Interval 1.34 to 2.05	1.34 fold change Interval 1.11 to 1.62	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Measured using ELISA

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=46 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=47 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 n=48 Participants A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=48 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=46 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=48 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 n=45 Participants A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) <2-Fold	28 Participants	23 Participants	32 Participants	34 Participants	16 Participants	36 Participants	18 Participants	14 Participants	20 Participants	14 Participants	—	—	—	—	—
Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) ≥2-Fold	18 Participants	24 Participants	16 Participants	14 Participants	31 Participants	12 Participants	28 Participants	33 Participants	28 Participants	31 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Measured using ELISA

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=46 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=47 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 n=48 Participants A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=48 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=46 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=48 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 n=46 Participants A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Fold Change in IgG Response to PspA-Fam1 (ELISA) <2-Fold	36 Participants	29 Participants	42 Participants	34 Participants	29 Participants	44 Participants	30 Participants	28 Participants	31 Participants	25 Participants	—	—	—	—	—
Fold Change in IgG Response to PspA-Fam1 (ELISA) ≥2-Fold	10 Participants	18 Participants	6 Participants	14 Participants	18 Participants	4 Participants	16 Participants	19 Participants	17 Participants	21 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Measured using MSD

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=46 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=47 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 n=48 Participants A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=48 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=46 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=48 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 n=46 Participants A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) <2-Fold	37 Participants	31 Participants	43 Participants	38 Participants	26 Participants	39 Participants	23 Participants	23 Participants	18 Participants	6 Participants	—	—	—	—	—
Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) ≥2-Fold, <3-Fold	8 Participants	9 Participants	4 Participants	8 Participants	13 Participants	5 Participants	18 Participants	14 Participants	18 Participants	22 Participants	—	—	—	—	—
Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) ≥3-Fold, <4-Fold	1 Participants	4 Participants	1 Participants	1 Participants	3 Participants	2 Participants	0 Participants	4 Participants	3 Participants	6 Participants	—	—	—	—	—
Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) ≥4-Fold	0 Participants	3 Participants	0 Participants	1 Participants	5 Participants	2 Participants	5 Participants	6 Participants	9 Participants	12 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Measured using MSD

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 n=48 Participants A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=46 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=48 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 n=46 Participants A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) <2-Fold	29 Participants	26 Participants	35 Participants	30 Participants	18 Participants	40 Participants	16 Participants	16 Participants	20 Participants	4 Participants	—	—	—	—	—
Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) ≥2-Fold, <3-Fold	12 Participants	11 Participants	8 Participants	11 Participants	15 Participants	6 Participants	16 Participants	21 Participants	15 Participants	21 Participants	—	—	—	—	—
Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) ≥3-Fold, <4-Fold	2 Participants	7 Participants	1 Participants	3 Participants	5 Participants	2 Participants	5 Participants	1 Participants	4 Participants	5 Participants	—	—	—	—	—
Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) ≥4-Fold	5 Participants	5 Participants	4 Participants	4 Participants	9 Participants	1 Participants	9 Participants	9 Participants	9 Participants	16 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Measured using MSD

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 n=48 Participants A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=46 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=48 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 n=46 Participants A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Fold Change in IgG Response to PhtD Pneumococcal Protein <2-Fold	37 Participants	39 Participants	43 Participants	26 Participants	34 Participants	42 Participants	20 Participants	20 Participants	22 Participants	20 Participants	—	—	—	—	—
Fold Change in IgG Response to PhtD Pneumococcal Protein ≥2-Fold, <3-Fold	8 Participants	7 Participants	3 Participants	15 Participants	7 Participants	2 Participants	18 Participants	18 Participants	15 Participants	15 Participants	—	—	—	—	—
Fold Change in IgG Response to PhtD Pneumococcal Protein ≥3-Fold, <4-Fold	2 Participants	2 Participants	0 Participants	4 Participants	5 Participants	3 Participants	6 Participants	1 Participants	4 Participants	3 Participants	—	—	—	—	—
Fold Change in IgG Response to PhtD Pneumococcal Protein ≥4-Fold	1 Participants	1 Participants	2 Participants	3 Participants	1 Participants	2 Participants	2 Participants	8 Participants	7 Participants	8 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Measured using MSD

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 n=48 Participants A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=46 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=48 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 n=46 Participants A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Fold Change in IgG Response to BCH0785 Pneumococcal Protein <2-Fold	36 Participants	35 Participants	35 Participants	32 Participants	36 Participants	42 Participants	31 Participants	27 Participants	26 Participants	20 Participants	—	—	—	—	—
Fold Change in IgG Response to BCH0785 Pneumococcal Protein ≥2-Fold, <3-Fold	9 Participants	11 Participants	8 Participants	11 Participants	6 Participants	4 Participants	7 Participants	8 Participants	14 Participants	17 Participants	—	—	—	—	—
Fold Change in IgG Response to BCH0785 Pneumococcal Protein ≥3-Fold, <4-Fold	1 Participants	0 Participants	0 Participants	1 Participants	4 Participants	2 Participants	5 Participants	6 Participants	2 Participants	1 Participants	—	—	—	—	—
Fold Change in IgG Response to BCH0785 Pneumococcal Protein ≥4-Fold	2 Participants	3 Participants	5 Participants	4 Participants	1 Participants	1 Participants	3 Participants	6 Participants	6 Participants	8 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Measured using MSD

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 n=48 Participants A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=46 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=48 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 n=46 Participants A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Fold Change in IgG Response to StkP Pneumococcal Protein <2-Fold	38 Participants	35 Participants	42 Participants	35 Participants	38 Participants	41 Participants	22 Participants	21 Participants	22 Participants	24 Participants	—	—	—	—	—
Fold Change in IgG Response to StkP Pneumococcal Protein ≥2-Fold, <3-Fold	6 Participants	9 Participants	4 Participants	9 Participants	7 Participants	6 Participants	16 Participants	15 Participants	18 Participants	14 Participants	—	—	—	—	—
Fold Change in IgG Response to StkP Pneumococcal Protein ≥3-Fold, <4-Fold	2 Participants	0 Participants	0 Participants	2 Participants	2 Participants	2 Participants	3 Participants	4 Participants	0 Participants	4 Participants	—	—	—	—	—
Fold Change in IgG Response to StkP Pneumococcal Protein ≥4-Fold	2 Participants	5 Participants	2 Participants	2 Participants	0 Participants	0 Participants	5 Participants	7 Participants	8 Participants	4 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Measured using MSD

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 n=48 Participants A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=46 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=48 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 n=46 Participants A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Fold Change in IgG Response to PcpA Pneumococcal Protein <2-Fold	37 Participants	42 Participants	40 Participants	23 Participants	39 Participants	33 Participants	30 Participants	32 Participants	35 Participants	26 Participants	—	—	—	—	—
Fold Change in IgG Response to PcpA Pneumococcal Protein ≥2-Fold, <3-Fold	7 Participants	3 Participants	4 Participants	15 Participants	5 Participants	10 Participants	9 Participants	7 Participants	7 Participants	9 Participants	—	—	—	—	—
Fold Change in IgG Response to PcpA Pneumococcal Protein ≥3-Fold, <4-Fold	1 Participants	3 Participants	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants	3 Participants	3 Participants	3 Participants	—	—	—	—	—
Fold Change in IgG Response to PcpA Pneumococcal Protein ≥4-Fold	3 Participants	1 Participants	4 Participants	9 Participants	2 Participants	6 Participants	5 Participants	5 Participants	3 Participants	8 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Measured using MSD

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 n=48 Participants A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=46 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=48 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 n=46 Participants A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Fold Change in IgG Response to SPWCA Pneumococcal Protein <2-Fold	45 Participants	42 Participants	42 Participants	41 Participants	45 Participants	44 Participants	38 Participants	40 Participants	36 Participants	31 Participants	—	—	—	—	—
Fold Change in IgG Response to SPWCA Pneumococcal Protein ≥2-Fold, <3-Fold	2 Participants	6 Participants	4 Participants	6 Participants	1 Participants	4 Participants	6 Participants	6 Participants	10 Participants	12 Participants	—	—	—	—	—
Fold Change in IgG Response to SPWCA Pneumococcal Protein ≥3-Fold, <4-Fold	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—
Fold Change in IgG Response to SPWCA Pneumococcal Protein ≥4-Fold	1 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	3 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Measured using MSD

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 n=48 Participants A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=46 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=48 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 n=46 Participants A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Fold Change in IgG Response to PiuA Pneumococcal Protein <2-Fold	39 Participants	35 Participants	37 Participants	39 Participants	37 Participants	46 Participants	30 Participants	27 Participants	23 Participants	24 Participants	—	—	—	—	—
Fold Change in IgG Response to PiuA Pneumococcal Protein ≥2-Fold, <3-Fold	5 Participants	7 Participants	6 Participants	5 Participants	9 Participants	0 Participants	11 Participants	14 Participants	18 Participants	14 Participants	—	—	—	—	—
Fold Change in IgG Response to PiuA Pneumococcal Protein ≥3-Fold, <4-Fold	3 Participants	5 Participants	2 Participants	2 Participants	1 Participants	3 Participants	3 Participants	2 Participants	0 Participants	2 Participants	—	—	—	—	—
Fold Change in IgG Response to PiuA Pneumococcal Protein ≥4-Fold	1 Participants	2 Participants	3 Participants	2 Participants	0 Participants	0 Participants	2 Participants	4 Participants	7 Participants	6 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Measured using MSD

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 n=48 Participants A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=46 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=48 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 n=46 Participants A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Fold Change in IgG Response to PiaA Pneumococcal Protein ≥2-Fold, <3-Fold	7 Participants	8 Participants	6 Participants	8 Participants	8 Participants	4 Participants	12 Participants	12 Participants	18 Participants	13 Participants	—	—	—	—	—
Fold Change in IgG Response to PiaA Pneumococcal Protein <2-Fold	39 Participants	36 Participants	39 Participants	32 Participants	35 Participants	41 Participants	25 Participants	25 Participants	22 Participants	24 Participants	—	—	—	—	—
Fold Change in IgG Response to PiaA Pneumococcal Protein ≥3-Fold, <4-Fold	0 Participants	3 Participants	2 Participants	3 Participants	2 Participants	2 Participants	4 Participants	4 Participants	2 Participants	4 Participants	—	—	—	—	—
Fold Change in IgG Response to PiaA Pneumococcal Protein ≥4-Fold	2 Participants	2 Participants	1 Participants	5 Participants	2 Participants	2 Participants	5 Participants	6 Participants	6 Participants	5 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Functional antibody responses to Ply (pneumolysin) were assessed using a toxin neutralization assay based on the ability of antibodies to neutralize wild-type Ply-induced lysis of rabbit red blood cells. Briefly, serial 2-fold dilutions (starting at 1/5 dilution) of human serum samples were added together with wild-type Ply in 96-well plates. Rabbit red blood cells were then added and following incubation supernatants removed and transferred to new 96-well plates and absorbance measured at 540 nm using a spectrophotometer plate reader. The mean A450 nm blank value was subtracted by 10% to obtain the Plate Specific Cut Point for each plate. Each sample was categorized as negative (<1/20) or positive (with titer between 1/20 and 1/320).

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=18 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=18 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=17 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=18 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=18 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=18 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=17 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=17 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 n=17 Participants A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin <1:20	3 Participants	3 Participants	2 Participants	—	5 Participants	3 Participants	3 Participants	2 Participants	3 Participants	4 Participants	—	—	—	—	—
Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin 1:20	7 Participants	4 Participants	2 Participants	—	7 Participants	8 Participants	3 Participants	10 Participants	7 Participants	6 Participants	—	—	—	—	—
Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin 1:40	5 Participants	5 Participants	4 Participants	—	5 Participants	5 Participants	8 Participants	5 Participants	7 Participants	7 Participants	—	—	—	—	—
Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin 1:80	3 Participants	5 Participants	6 Participants	—	1 Participants	2 Participants	4 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin 1:160	0 Participants	1 Participants	3 Participants	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Functional antibody responses to Ply (pneumolysin) were assessed using a toxin neutralization assay based on the ability of antibodies to neutralize wild-type Ply-induced lysis of rabbit red blood cells. Briefly, serial 2-fold dilutions (starting at 1/5 dilution) of human serum samples were added together with wild-type Ply in 96-well plates. Rabbit red blood cells were then added and following incubation supernatants removed and transferred to new 96-well plates and absorbance measured at 540 nm using a spectrophotometer plate reader. The mean A450 nm blank value was subtracted by 10% to obtain the Plate Specific Cut Point for each plate. Each sample was categorized as negative (<1/20) or positive (with titer between 1/20 and 1/320).

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=46 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=46 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=46 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 n=47 Participants A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=47 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=47 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 n=48 Participants A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 n=48 Participants A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 n=47 Participants Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 n=46 Participants Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline n=48 Participants Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 n=48 Participants Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 n=48 Participants Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin <1:20	20 Participants	19 Participants	14 Participants	14 Participants	18 Participants	10 Participants	11 Participants	17 Participants	14 Participants	6 Participants	7 Participants	6 Participants	27 Participants	21 Participants	19 Participants
Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin 1:20	11 Participants	9 Participants	10 Participants	12 Participants	15 Participants	15 Participants	10 Participants	13 Participants	13 Participants	11 Participants	12 Participants	6 Participants	10 Participants	13 Participants	17 Participants
Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin 1:40	10 Participants	8 Participants	9 Participants	14 Participants	8 Participants	14 Participants	14 Participants	13 Participants	14 Participants	16 Participants	10 Participants	13 Participants	6 Participants	11 Participants	6 Participants
Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin 1:80	2 Participants	8 Participants	8 Participants	6 Participants	5 Participants	5 Participants	7 Participants	3 Participants	5 Participants	10 Participants	11 Participants	13 Participants	4 Participants	3 Participants	5 Participants
Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin 1:160	1 Participants	2 Participants	4 Participants	1 Participants	0 Participants	2 Participants	5 Participants	2 Participants	1 Participants	3 Participants	6 Participants	5 Participants	1 Participants	0 Participants	0 Participants
Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin 1:320	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	3 Participants	0 Participants	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks (Cohort 1) and 4 weeks (Cohort 2) post-vaccination 1

Population: The number analyzed may differ between proteins because of insufficient samples.

GMCs of these IgG proteins were measured to assess potential interference of PATH-wSP with 10-valent pneumococcal conjugate vaccine (Synflorix). GMCs of Cohort 1 were measured at a different time point than those in Cohort 2, so results are presented separately.

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=46 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=47 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=23 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 n=25 Participants A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects PnC-IgG-ELISA type 1	0.87 ug/mL Interval 0.72 to 1.06	0.18 ug/mL Interval 0.14 to 0.21	3.09 ug/mL Interval 2.5 to 3.83	—	0.25 ug/mL Interval 0.21 to 0.3	0.83 ug/mL Interval 0.64 to 1.08	2.47 ug/mL Interval 1.81 to 3.38	—	—	—	—	—	—	—	—
Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects PnC-IgG-ELISA type 4	1.22 ug/mL Interval 1.01 to 1.47	0.28 ug/mL Interval 0.22 to 0.34	3.41 ug/mL Interval 2.93 to 3.96	—	0.36 ug/mL Interval 0.29 to 0.46	1.15 ug/mL Interval 0.89 to 1.5	2.59 ug/mL Interval 2.08 to 3.22	—	—	—	—	—	—	—	—
Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects PnC-IgG-ELISA type 5	0.38 ug/mL Interval 0.32 to 0.45	0.17 ug/mL Interval 0.14 to 0.2	0.77 ug/mL Interval 0.64 to 0.92	—	0.19 ug/mL Interval 0.16 to 0.23	0.44 ug/mL Interval 0.33 to 0.58	0.77 ug/mL Interval 0.65 to 0.9	—	—	—	—	—	—	—	—
Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects PnC-IgG-ELISA type 6B	1.60 ug/mL Interval 1.33 to 1.92	0.69 ug/mL Interval 0.54 to 0.88	4.28 ug/mL Interval 3.48 to 5.27	—	0.95 ug/mL Interval 0.76 to 1.18	2.19 ug/mL Interval 1.62 to 2.94	3.68 ug/mL Interval 2.68 to 5.06	—	—	—	—	—	—	—	—
Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects PnC-IgG-ELISA type 7F	1.79 ug/mL Interval 1.48 to 2.16	0.60 ug/mL Interval 0.5 to 0.72	4.32 ug/mL Interval 3.63 to 5.13	—	0.72 ug/mL Interval 0.59 to 0.89	1.36 ug/mL Interval 1.04 to 1.79	3.57 ug/mL Interval 2.97 to 4.28	—	—	—	—	—	—	—	—
Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects PnC-IgG-ELISA type 9V	0.77 ug/mL Interval 0.65 to 0.91	0.26 ug/mL Interval 0.2 to 0.33	2.03 ug/mL Interval 1.73 to 2.38	—	0.29 ug/mL Interval 0.24 to 0.35	0.71 ug/mL Interval 0.51 to 0.97	1.57 ug/mL Interval 1.25 to 1.97	—	—	—	—	—	—	—	—
Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects PnC-IgG-ELISA type 14	3.16 ug/mL Interval 2.54 to 3.92	0.63 ug/mL Interval 0.5 to 0.78	8.62 ug/mL Interval 7.02 to 10.57	—	1.02 ug/mL Interval 0.79 to 1.33	3.20 ug/mL Interval 2.36 to 4.34	7.40 ug/mL Interval 5.37 to 10.2	—	—	—	—	—	—	—	—
Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects PnC-IgG-ELISA type 18C	1.51 ug/mL Interval 1.25 to 1.82	0.28 ug/mL Interval 0.22 to 0.35	3.52 ug/mL Interval 3.0 to 4.13	—	0.33 ug/mL Interval 0.27 to 0.41	1.31 ug/mL Interval 1.0 to 1.71	3.05 ug/mL Interval 2.43 to 3.82	—	—	—	—	—	—	—	—
Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects PnC-IgG-ELISA type 19F	4.62 ug/mL Interval 3.78 to 5.63	1.48 ug/mL Interval 1.08 to 2.02	10.93 ug/mL Interval 8.92 to 13.38	—	1.50 ug/mL Interval 1.17 to 1.93	4.76 ug/mL Interval 3.33 to 6.8	7.59 ug/mL Interval 5.1 to 11.29	—	—	—	—	—	—	—	—
Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects PnC-IgG-ELISA type 23F	0.98 ug/mL Interval 0.77 to 1.25	0.27 ug/mL Interval 0.21 to 0.35	2.76 ug/mL Interval 2.22 to 3.44	—	0.28 ug/mL Interval 0.21 to 0.37	0.97 ug/mL Interval 0.7 to 1.34	3.50 ug/mL Interval 2.6 to 4.7	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks post vaccination 1

Population: The number analyzed may differ between proteins because of insufficient samples.

GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Concentration (GMC) Ratio of Diptheria Booster Immune Response Among Toddler Subjects	7.73 IU/mL Interval 6.38 to 9.36	0.25 IU/mL Interval 0.2 to 0.32	7.71 IU/mL Interval 6.48 to 9.19	—	0.27 IU/mL Interval 0.22 to 0.33	9.39 IU/mL Interval 7.9 to 11.15	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks post vaccination 1

Population: The number analyzed may differ between proteins because of insufficient samples.

GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Concentration (GMC) Ratio of Hepatitis B Booster Immune Response Among Toddler Subjects	784.78 mIU/mL Interval 532.71 to 11156.12	149.86 mIU/mL Interval 83.65 to 268.47	695.14 mIU/mL Interval 546.72 to 883.84	—	135.79 mIU/mL Interval 84.93 to 217.11	815.39 mIU/mL Interval 705.76 to 942.04	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks post vaccination 1

Population: The number analyzed may differ between proteins because of insufficient samples.

GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Concentration (GMC) Ratio of Haemophilus Influenzae Type b (Hib) Booster Immune Response Among Toddler Subjects	41.05 ug/mL Interval 29.61 to 56.92	1.68 ug/mL Interval 1.2 to 2.34	39.06 ug/mL Interval 30.7 to 49.68	—	1.23 ug/mL Interval 0.81 to 1.88	37.45 ug/mL Interval 25.82 to 54.32	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks post vaccination 1

Population: The number analyzed may differ between proteins because of insufficient samples.

GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Concentration (GMC) Ratio of Pertussis FHA and Pertussis Toxin Immune Response Among Toddler Subjects Pertussis FHA	85.12 IU/mL Interval 73.07 to 99.17	6.70 IU/mL Interval 5.48 to 8.21	68.23 IU/mL Interval 57.45 to 81.05	—	10.47 IU/mL Interval 8.4 to 13.05	90.65 IU/mL Interval 73.87 to 111.23	—	—	—	—	—	—	—	—	—
Geometric Mean Concentration (GMC) Ratio of Pertussis FHA and Pertussis Toxin Immune Response Among Toddler Subjects Pertussis Toxin	145.11 IU/mL Interval 121.66 to 173.08	19.38 IU/mL Interval 15.13 to 24.81	131.23 IU/mL Interval 105.83 to 162.73	—	18.79 IU/mL Interval 13.55 to 26.07	124.39 IU/mL Interval 96.63 to 160.11	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks post vaccination 1

Population: The number analyzed may differ between proteins because of insufficient samples.

GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Concentration (GMC) Ratio of Pertussis Fimbriae Immune Response Among Toddler Subjects	753.63 U/mL Interval 582.34 to 975.3	45.75 U/mL Interval 32.98 to 63.47	460.73 U/mL Interval 328.95 to 645.31	—	37.99 U/mL Interval 27.75 to 52.0	503.25 U/mL Interval 383.05 to 661.17	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks post vaccination 1

Population: The number analyzed may differ between proteins because of insufficient samples.

GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.

Outcome measures

Measure	PATH-wSP (300 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (300 mcg)+Saline: Vaccination 1 n=49 Participants Single injection of 300 mcg PATH-wSP in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh.	PATH-wSP (600 mcg)+Active Control: Vaccination 1 n=48 Participants A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	Active Control Only: Vaccination 2 A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.	PATH-wSP (600 mcg): Vaccination 2 n=47 Participants Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection	PATH-wSP (1000 mcg): Vaccination 2 n=49 Participants Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection	Saline: Vaccination 2 A single injection of saline in one arm, one month after initial injection	PATH-wSP (600 mcg): Vaccination 2 A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage	Saline: Vaccination 2 A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.	PATH-wSP (600 mcg)+Saline: Vaccination 2 A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.	PATH-wSP (600 mcg)+Saline: Vaccination 1 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1	PATH-wSP (600 mcg)+Saline: Vaccination 2 Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2	Active Control Only: Baseline Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination	Active Control Only: Vaccination 1 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1	Active Control Only: Vaccination 2 Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Geometric Mean Concentration (GMC) Ratio of Tetanus Booster Immune Response Among Toddler Subjects	21.83 IU/mL Interval 18.94 to 25.17	1.15 IU/mL Interval 0.93 to 1.43	21.64 IU/mL Interval 19.01 to 24.62	—	1.27 IU/mL Interval 1.03 to 1.55	21.92 IU/mL Interval 18.95 to 25.35	—	—	—	—	—	—	—	—	—

Adverse Events

Adult Cohort: PATH-wSP (600 mcg)

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Adult Cohort: PATH-wSP (1000 mcg)

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Adult Cohort: Saline

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Toddler Cohort: PATH-wSP (300 mcg)+Active Control

Serious events: 6 serious events

Other events: 50 other events

Deaths: 1 deaths

Toddler Cohort: PATH-wSP (300 mcg)+Saline

Serious events: 2 serious events

Other events: 47 other events

Deaths: 0 deaths

Toddler Cohort: PATH-wSP (600 mcg)+Active Control

Serious events: 2 serious events

Other events: 48 other events

Deaths: 0 deaths

Toddler Cohort: PATH-wSP (600 mcg)+Saline

Serious events: 3 serious events

Other events: 48 other events

Deaths: 0 deaths

Toddler Cohort: Active Control Only

Serious events: 2 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adult Cohort: PATH-wSP (600 mcg) n=18 participants at risk A single injection of 600 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 600 mcg PATH-wSP in the alternate arm.	Adult Cohort: PATH-wSP (1000 mcg) n=18 participants at risk A single injection of 1000 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 1000 mcg PATH-wSP in the alternate arm.	Adult Cohort: Saline n=18 participants at risk A single injection of saline in one arm, followed 4 weeks later by a single injection of saline in the alternate arm.	Toddler Cohort: PATH-wSP (300 mcg)+Active Control n=50 participants at risk A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.	Toddler Cohort: PATH-wSP (300 mcg)+Saline n=50 participants at risk A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.	Toddler Cohort: PATH-wSP (600 mcg)+Active Control n=50 participants at risk A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.	Toddler Cohort: PATH-wSP (600 mcg)+Saline n=50 participants at risk A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.	Toddler Cohort: Active Control Only n=50 participants at risk A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines in the right thigh. These 3 injections are followed by a single injection of saline in the left thigh 8 weeks later.
Psychiatric disorders Conversion disorder	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Injury, poisoning and procedural complications Traumatic intracranial hemorrhage	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Pneumonia	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	4.0% 2/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Gastroenteritis	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Malaria	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Metabolism and nutrition disorders Dehydration	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
General disorders Pyrexia	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Nervous system disorders Febrile convulsion	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Gastrointestinal disorders Intussusception	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.

Other adverse events

Measure	Adult Cohort: PATH-wSP (600 mcg) n=18 participants at risk A single injection of 600 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 600 mcg PATH-wSP in the alternate arm.	Adult Cohort: PATH-wSP (1000 mcg) n=18 participants at risk A single injection of 1000 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 1000 mcg PATH-wSP in the alternate arm.	Adult Cohort: Saline n=18 participants at risk A single injection of saline in one arm, followed 4 weeks later by a single injection of saline in the alternate arm.	Toddler Cohort: PATH-wSP (300 mcg)+Active Control n=50 participants at risk A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.	Toddler Cohort: PATH-wSP (300 mcg)+Saline n=50 participants at risk A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later.	Toddler Cohort: PATH-wSP (600 mcg)+Active Control n=50 participants at risk A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.	Toddler Cohort: PATH-wSP (600 mcg)+Saline n=50 participants at risk A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later.	Toddler Cohort: Active Control Only n=50 participants at risk A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines in the right thigh. These 3 injections are followed by a single injection of saline in the left thigh 8 weeks later.
Metabolism and nutrition disorders Hyponatraemia	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Blood and lymphatic system disorders Anemia	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	20.0% 10/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	8.0% 4/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	14.0% 7/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	10.0% 5/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	8.0% 4/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Blood and lymphatic system disorders Leukopenia	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Blood and lymphatic system disorders Neutropenia	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Blood and lymphatic system disorders Thrombocytopenia	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	4.0% 2/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	4.0% 2/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Ear and labyrinth disorders Cerumen impaction	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	4.0% 2/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	4.0% 2/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Ear and labyrinth disorders Ear pain	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Otitis externa	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	8.0% 4/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Otitis media	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	6.0% 3/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	6.0% 3/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	4.0% 2/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Otitis media acute	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Conjunctivitis	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	16.7% 3/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	10.0% 5/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	12.0% 6/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	6.0% 3/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	16.0% 8/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	18.0% 9/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Eye disorders Conjunctivitis allergic	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Gastrointestinal disorders Abdominal pain	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Gastrointestinal disorders Dental caries	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	16.7% 3/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Gastrointestinal disorders Diarrhoea	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	12.0% 6/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	6.0% 3/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Dysentery	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	6.0% 3/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	4.0% 2/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Gastrointestinal disorders Dyspepsia	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Gastrointestinal disorders Enteritis	16.7% 3/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	10.0% 5/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	16.0% 8/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	36.0% 18/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	20.0% 10/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	16.0% 8/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Gastrointestinal disorders Gastritis	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Gastroenteritis	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	30.0% 15/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	26.0% 13/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	12.0% 6/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	16.0% 8/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	32.0% 16/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Gastrointestinal disorders Hyperchlorhydria	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Gastrointestinal disorders Nausea	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Gastrointestinal disorders Peptic ulcer	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Gastrointestinal disorders Stomatitis	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	8.0% 4/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	4.0% 2/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	4.0% 2/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Gastrointestinal disorders Toothache	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Gastrointestinal disorders Vomiting	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
General disorders Hepatobiliary	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	6.0% 3/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	4.0% 2/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Gastrointestinal disorders Pyrexia	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	18.0% 9/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	6.0% 3/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	10.0% 5/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	8.0% 4/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	22.0% 11/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
General disorders Injection site pain	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
General disorders Injection site swelling	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
General disorders Malaise	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Hepatobiliary disorders Hyperbilirubinaemia	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Metabolism and nutrition disorders Hypoproteinaemia	27.8% 5/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	6.0% 3/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	2.0% 1/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	4.0% 2/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Skin and subcutaneous tissue disorders Dermatitis contact	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Abscess	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Cellulitis	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Impetigo	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	24.0% 12/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	12.0% 6/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	20.0% 10/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	12.0% 6/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	20.0% 10/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Malaria	16.7% 3/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	27.8% 5/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	33.3% 6/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	40.0% 20/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	52.0% 26/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	30.0% 15/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	34.0% 17/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	32.0% 16/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Septic rash	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Vulvovaginal candidiasis	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Injury, poisoning and procedural complications Activated partial thromboplastin time prolonged	16.7% 3/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Injury, poisoning and procedural complications Blood fibrinogen increased	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Injury, poisoning and procedural complications Prothrombin time prolonged	27.8% 5/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Injury, poisoning and procedural complications Soft tissue injury	16.7% 3/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	10.0% 5/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Injury, poisoning and procedural complications Laceration	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Wound sepsis	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Metabolism and nutrition disorders Decreased appetite	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	8.0% 4/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	10.0% 5/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	12.0% 6/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	10.0% 5/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Metabolism and nutrition disorders Hypercalcemia	16.7% 3/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	33.3% 6/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Metabolism and nutrition disorders Hyperkalemia	16.7% 3/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Metabolism and nutrition disorders Hypernatraemia	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Metabolism and nutrition disorders Hypocalcaemia	16.7% 3/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	33.3% 6/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Metabolism and nutrition disorders Hypokalaemia	16.7% 3/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	27.8% 5/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Musculoskeletal and connective tissue disorders Neck pain	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Nervous system disorders Burning sensation	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Nervous system disorders Headache	22.2% 4/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	16.7% 3/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Musculoskeletal and connective tissue disorders Torticollis	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Urinary tract infection	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	6.0% 3/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	10.0% 5/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	6.0% 3/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Cervicitis	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Reproductive system and breast disorders Menorrhagia	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Rhinitis	16.7% 3/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	10.0% 5/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	14.0% 7/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	6.0% 3/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Tonsillitis	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	6.0% 3/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Upper respiratory tract infection	61.1% 11/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	16.7% 3/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	44.4% 8/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	82.0% 41/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	78.0% 39/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	88.0% 44/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	86.0% 43/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	86.0% 43/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	6.0% 3/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	6.0% 3/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Respiratory, thoracic and mediastinal disorders Cough	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Pharyngitis	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	16.7% 3/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Pneumonia	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	16.0% 8/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	12.0% 6/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Body tinea	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	6.0% 3/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	12.0% 6/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	8.0% 4/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Skin and subcutaneous tissue disorders Dermatitis	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	20.0% 10/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	6.0% 3/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	6.0% 3/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	12.0% 6/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	14.0% 7/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	14.0% 7/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	6.0% 3/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	6.0% 3/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	10.0% 5/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	10.0% 5/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	22.0% 11/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	6.0% 3/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	6.0% 3/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	10.0% 5/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Tinea capitis	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	6.0% 3/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Tinea cruris	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Tinea versicolour	11.1% 2/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Infections and infestations Respiratory tract infection	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	5.6% 1/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/18 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.	0.00% 0/50 • 4 weeks post-vaccination Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.

Additional Information

Jorge Flores

PATH

Phone: (202) 822-0033

Email: jeflores@path.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place