Trial Outcomes & Findings for A Study of a Vaccine for Pneumonia in Adults and Toddlers in Kenya (NCT NCT02543892)

NCT ID: NCT02543892

Last Updated: 2018-11-28

Results Overview

Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, headache, axillary fever/temperature, fatigue/malaise, and arthralgia/myalgia. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the principal investigator (PI) for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity. Grade 0 is equivalent to no event.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 248 participants
• Primary outcome timeframe: 7 days after the first dose (Day 7)
• Results posted on: 2018-11-28

Participant Flow

Participant milestones

Measure	Adult 0.6mg PATH-wSP Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult 1.0 mg PATH-wSP Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult Placebo Low Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Adult Placebo High Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler 0.6mg PATH-wSP Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler 1.0 mg PATH-wSP Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler Placebo Low Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler Placebo High Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline
Received Vaccination 1 STARTED	12	12	12	12	50	50	50	50
Received Vaccination 1 COMPLETED	12	12	12	12	50	50	50	50
Received Vaccination 1 NOT COMPLETED	0	0	0	0	0	0	0	0
Received Vaccination 2 STARTED	12	12	12	12	50	50	50	50
Received Vaccination 2 COMPLETED	11	11	12	12	50	49	50	49
Received Vaccination 2 NOT COMPLETED	1	1	0	0	0	1	0	1
Had Immunology Data STARTED	11	11	12	12	50	49	50	49
Had Immunology Data COMPLETED	11	11	12	12	50	49	49	49
Had Immunology Data NOT COMPLETED	0	0	0	0	0	0	1	0

Reasons for withdrawal

Measure	Adult 0.6mg PATH-wSP Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult 1.0 mg PATH-wSP Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult Placebo Low Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Adult Placebo High Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler 0.6mg PATH-wSP Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler 1.0 mg PATH-wSP Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler Placebo Low Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler Placebo High Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline
Received Vaccination 2 Withdrawal by Subject	1	0	0	0	0	0	0	1
Received Vaccination 2 Physician Decision	0	0	0	0	0	1	0	0
Received Vaccination 2 Adverse Event	0	1	0	0	0	0	0	0
Had Immunology Data Withdrawal by Subject	0	0	0	0	0	0	1	0

Baseline Characteristics

A Study of a Vaccine for Pneumonia in Adults and Toddlers in Kenya

Baseline characteristics by cohort

Measure	Adult 0.6mg PATH-wSP n=12 Participants Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult 1.0 mg PATH-wSP n=12 Participants Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult Placebo Low Dose n=12 Participants Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Adult Placebo High Dose n=12 Participants Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler 0.6mg PATH-wSP n=50 Participants Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler 1.0 mg PATH-wSP n=50 Participants Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler Placebo Low Dose n=50 Participants Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler Placebo High Dose n=50 Participants Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Total n=248 Participants Total of all reporting groups
Age, Continuous	25.7 years STANDARD_DEVIATION 7.04 • n=5 Participants	30.8 years STANDARD_DEVIATION 5.51 • n=7 Participants	29.5 years STANDARD_DEVIATION 6.74 • n=5 Participants	27.6 years STANDARD_DEVIATION 6.78 • n=4 Participants	1.4 years STANDARD_DEVIATION 0.25 • n=21 Participants	1.4 years STANDARD_DEVIATION 0.19 • n=10 Participants	1.3 years STANDARD_DEVIATION 0.21 • n=115 Participants	1.4 years STANDARD_DEVIATION 0.21 • n=24 Participants	6.6 years STANDARD_DEVIATION 11.1 • n=42 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	23 Participants n=21 Participants	29 Participants n=10 Participants	31 Participants n=115 Participants	24 Participants n=24 Participants	125 Participants n=42 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	27 Participants n=21 Participants	21 Participants n=10 Participants	19 Participants n=115 Participants	26 Participants n=24 Participants	123 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	12 Participants n=4 Participants	50 Participants n=21 Participants	50 Participants n=10 Participants	50 Participants n=115 Participants	50 Participants n=24 Participants	248 Participants n=42 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Ethnic Group Chonyi	11 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	38 Participants n=21 Participants	45 Participants n=10 Participants	40 Participants n=115 Participants	42 Participants n=24 Participants	197 Participants n=42 Participants
Ethnic Group Giriama	1 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants	5 Participants n=10 Participants	9 Participants n=115 Participants	5 Participants n=24 Participants	37 Participants n=42 Participants
Ethnic Group Luo	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Ethnic Group Other	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	3 Participants n=24 Participants	13 Participants n=42 Participants

PRIMARY outcome

Timeframe: 7 days after the first dose (Day 7)

Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, headache, axillary fever/temperature, fatigue/malaise, and arthralgia/myalgia. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the principal investigator (PI) for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity. Grade 0 is equivalent to no event.

Outcome measures

Measure	Adult 0.6mg PATH-wSP n=12 Participants Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult 1.0 mg PATH-wSP n=12 Participants Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult Placebo n=24 Participants Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Adult Placebo High Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler 0.6mg PATH-wSP Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler 1.0 mg PATH-wSP Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler Placebo Low Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler Placebo High Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Cutaneous Rash · Grade 0	11 Participants	12 Participants	22 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Cutaneous Rash · Grade 1	1 Participants	0 Participants	1 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Cutaneous Rash · Grade 2	0 Participants	0 Participants	1 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Cutaneous Rash · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Headache · Grade 0	11 Participants	8 Participants	19 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Headache · Grade 1	1 Participants	3 Participants	5 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Headache · Grade 2	0 Participants	1 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Headache · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Fatigue/Malaise · Grade 0	9 Participants	8 Participants	21 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Fatigue/Malaise · Grade 1	2 Participants	3 Participants	2 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Fatigue/Malaise · Grade 2	1 Participants	1 Participants	1 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Fatigue/Malaise · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Myalgia · Grade 0	10 Participants	8 Participants	23 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Myalgia · Grade 1	1 Participants	4 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Myalgia · Grade 2	1 Participants	0 Participants	1 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Myalgia · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Arthralgia · Grade 0	10 Participants	9 Participants	23 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Arthralgia · Grade 1	1 Participants	2 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Arthralgia · Grade 2	1 Participants	1 Participants	1 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Arthralgia · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Pain at Injection Site · Grade 0	2 Participants	0 Participants	17 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Pain at Injection Site · Grade 1	9 Participants	9 Participants	7 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Pain at Injection Site · Grade 2	1 Participants	2 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Pain at Injection Site · Grade 3	0 Participants	1 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Swelling/Hardness at injection site · Grade 0	12 Participants	10 Participants	24 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Swelling/Hardness at injection site · Grade 1	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Swelling/Hardness at injection site · Grade 2	0 Participants	2 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 Swelling/Hardness at injection site · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after the second dose (Day 35)

Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, headache, axillary fever/temperature, fatigue/malaise, and arthralgia/myalgia. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the principal investigator (PI) for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity.

Outcome measures

Measure	Adult 0.6mg PATH-wSP n=11 Participants Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult 1.0 mg PATH-wSP n=11 Participants Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult Placebo n=24 Participants Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Adult Placebo High Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler 0.6mg PATH-wSP Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler 1.0 mg PATH-wSP Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler Placebo Low Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler Placebo High Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Headache · Grade 0	10 Participants	10 Participants	19 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Headache · Grade 2	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Cutaneous Rash · Grade 0	11 Participants	11 Participants	22 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Cutaneous Rash · Grade 1	0 Participants	0 Participants	2 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Cutaneous Rash · Grade 2	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Cutaneous Rash · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Headache · Grade 1	1 Participants	1 Participants	5 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Headache · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Fatigue/Malaise · Grade 0	9 Participants	9 Participants	22 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Fatigue/Malaise · Grade 1	1 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Fatigue/Malaise · Grade 2	1 Participants	2 Participants	1 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Fatigue/Malaise · Grade 3	0 Participants	0 Participants	1 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Myalgia · Grade 0	10 Participants	10 Participants	24 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Myalgia · Grade 1	1 Participants	1 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Myalgia · Grade 2	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Myalgia · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Arthralgia · Grade 0	7 Participants	9 Participants	22 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Arthralgia · Grade 1	4 Participants	1 Participants	1 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Arthralgia · Grade 2	0 Participants	1 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Arthralgia · Grade 3	0 Participants	0 Participants	1 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Pain at Injection Site · Grade 0	4 Participants	2 Participants	15 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Pain at Injection Site · Grade 1	7 Participants	8 Participants	8 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Pain at Injection Site · Grade 2	0 Participants	1 Participants	1 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Pain at Injection Site · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Swelling/Hardness at injection site · Grade 0	11 Participants	10 Participants	24 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Swelling/Hardness at injection site · Grade 1	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Swelling/Hardness at injection site · Grade 2	0 Participants	1 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Swelling/Hardness at injection site · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Temperature · Grade 0	10 Participants	10 Participants	24 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Temperature · Grade 1	1 Participants	1 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Temperature · Grade 2	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 Temperature · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after the first dose (Day 7)

Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, axillary fever/temperature, drowsiness, irritability, and decreased appetite. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the PI for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity. Grade 0 is equivalent to no event.

Outcome measures

Measure	Adult 0.6mg PATH-wSP n=50 Participants Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult 1.0 mg PATH-wSP n=50 Participants Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult Placebo n=100 Participants Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Adult Placebo High Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler 0.6mg PATH-wSP Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler 1.0 mg PATH-wSP Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler Placebo Low Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler Placebo High Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Temperature · Grade 0	43 Participants	47 Participants	93 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Temperature · Grade 1	5 Participants	2 Participants	6 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Temperature · Grade 2	2 Participants	1 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Temperature · Grade 3	0 Participants	0 Participants	1 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Cutaneous Rash · Grade 0	46 Participants	44 Participants	91 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Cutaneous Rash · Grade 1	0 Participants	4 Participants	7 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Cutaneous Rash · Grade 2	4 Participants	2 Participants	2 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Cutaneous Rash · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Irritability · Grade 0	42 Participants	45 Participants	97 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Irritability · Grade 1	7 Participants	5 Participants	3 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Irritability · Grade 2	1 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Irritability · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Drowsiness · Grade 0	50 Participants	49 Participants	98 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Drowsiness · Grade 1	0 Participants	1 Participants	2 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Drowsiness · Grade 2	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Drowsiness · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Redness at injection site · Grade 1	2 Participants	4 Participants	6 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Loss of appetite · Grade 0	41 Participants	48 Participants	95 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Loss of appetite · Grade 1	9 Participants	2 Participants	5 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Loss of appetite · Grade 2	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Loss of appetite · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Tenderness at injection site · Grade 0	29 Participants	41 Participants	94 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Tenderness at injection site · Grade 1	18 Participants	8 Participants	6 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Tenderness at injection site · Grade 2	3 Participants	1 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Tenderness at injection site · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Redness at injection site · Grade 0	48 Participants	46 Participants	94 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Redness at injection site · Grade 2	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Redness at injection site · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Swelling/hardness at injection site · Grade 0	46 Participants	45 Participants	99 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Swelling/hardness at injection site · Grade 1	4 Participants	5 Participants	1 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Swelling/hardness at injection site · Grade 2	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 Swelling/hardness at injection site · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after the second dose (Day 35)

Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, axillary fever/temperature, drowsiness, irritability, and decreased appetite. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the PI for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity. Grade 0 is equivalent to no event.

Outcome measures

Measure	Adult 0.6mg PATH-wSP n=50 Participants Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult 1.0 mg PATH-wSP n=50 Participants Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult Placebo n=100 Participants Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Adult Placebo High Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler 0.6mg PATH-wSP Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler 1.0 mg PATH-wSP Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler Placebo Low Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler Placebo High Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Temperature · Grade 0	42 Participants	41 Participants	80 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Temperature · Grade 1	5 Participants	6 Participants	11 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Temperature · Grade 2	3 Participants	2 Participants	8 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Temperature · Grade 3	0 Participants	1 Participants	1 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Cutaneous Rash · Grade 0	45 Participants	46 Participants	93 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Cutaneous Rash · Grade 1	4 Participants	4 Participants	6 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Cutaneous Rash · Grade 2	1 Participants	0 Participants	1 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Cutaneous Rash · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Irritability · Grade 0	30 Participants	32 Participants	61 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Irritability · Grade 1	18 Participants	17 Participants	36 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Irritability · Grade 2	2 Participants	1 Participants	3 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Irritability · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Drowsiness · Grade 0	48 Participants	49 Participants	89 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Drowsiness · Grade 1	2 Participants	1 Participants	9 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Drowsiness · Grade 2	0 Participants	0 Participants	2 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Drowsiness · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Loss of appetite · Grade 0	36 Participants	36 Participants	78 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Loss of appetite · Grade 1	10 Participants	14 Participants	20 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Loss of appetite · Grade 2	4 Participants	0 Participants	2 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Loss of appetite · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Tenderness at injection site · Grade 0	30 Participants	36 Participants	75 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Tenderness at injection site · Grade 1	13 Participants	12 Participants	21 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Tenderness at injection site · Grade 2	6 Participants	2 Participants	2 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Tenderness at injection site · Grade 3	1 Participants	0 Participants	2 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Redness at injection site · Grade 0	46 Participants	49 Participants	97 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Redness at injection site · Grade 1	4 Participants	1 Participants	3 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Redness at injection site · Grade 2	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Redness at injection site · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Swelling/hardness at injection site · Grade 0	47 Participants	46 Participants	93 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Swelling/hardness at injection site · Grade 1	0 Participants	4 Participants	4 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Swelling/hardness at injection site · Grade 2	3 Participants	0 Participants	3 Participants	—	—	—	—	—
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 Swelling/hardness at injection site · Grade 3	0 Participants	0 Participants	0 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 112 days

Only treatment-emergent adverse events (TEAEs) were included in the analysis; adverse events (AEs) that were not TEAEs were to have been listed.

Outcome measures

Measure	Adult 0.6mg PATH-wSP n=12 Participants Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult 1.0 mg PATH-wSP n=12 Participants Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult Placebo n=24 Participants Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Adult Placebo High Dose n=50 Participants Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler 0.6mg PATH-wSP n=50 Participants Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler 1.0 mg PATH-wSP n=100 Participants Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler Placebo Low Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler Placebo High Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline
Number of Adverse Events (AE), by Relation to Vaccine and Seriousness Serious : Related	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	2 adverse events	—	—
Number of Adverse Events (AE), by Relation to Vaccine and Seriousness Serious : Not related	0 adverse events	0 adverse events	0 adverse events	3 adverse events	2 adverse events	3 adverse events	—	—
Number of Adverse Events (AE), by Relation to Vaccine and Seriousness Non-serious : Related	0 adverse events	0 adverse events	0 adverse events	0 adverse events	2 adverse events	1 adverse events	—	—
Number of Adverse Events (AE), by Relation to Vaccine and Seriousness Non-serious : Not related	18 adverse events	21 adverse events	39 adverse events	148 adverse events	80 adverse events	253 adverse events	—	—

SECONDARY outcome

Timeframe: Baseline and 12 weeks after vaccination 2 (Day 0 and Day 112)

Proteins were measured on the Meso Scale Discovery (MSD) platform using an an electrochemiluminescence detection assay. Units were arbitrary.

Outcome measures

Measure	Adult 0.6mg PATH-wSP n=11 Participants Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult 1.0 mg PATH-wSP n=11 Participants Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult Placebo n=12 Participants Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Adult Placebo High Dose n=12 Participants Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler 0.6mg PATH-wSP n=50 Participants Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler 1.0 mg PATH-wSP n=49 Participants Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler Placebo Low Dose n=49 Participants Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler Placebo High Dose n=49 Participants Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline
Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins PiuA: Post-vaccination 2	1001.9 arbitrary units Interval 496.4 to 2022.1	1049.7 arbitrary units Interval 655.9 to 1680.0	1540.4 arbitrary units Interval 843.2 to 2813.9	1214.3 arbitrary units Interval 621.0 to 2374.4	1091.9 arbitrary units Interval 857.6 to 1390.3	1343.2 arbitrary units Interval 1044.9 to 1726.6	809 arbitrary units Interval 639.0 to 1024.4	899 arbitrary units Interval 681.2 to 1186.4
Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins PiaA: Baseline	1313.4 arbitrary units Interval 674.9 to 2556.0	1462.5 arbitrary units Interval 788.2 to 2713.8	1620.3 arbitrary units Interval 1061.7 to 2472.9	1611.4 arbitrary units Interval 1027.4 to 2527.5	560.6 arbitrary units Interval 404.0 to 778.0	662.8 arbitrary units Interval 527.2 to 833.1	571.4 arbitrary units Interval 431.4 to 756.8	626.5 arbitrary units Interval 473.7 to 828.4
Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins PiaA: Post-vaccination 2	1768.8 arbitrary units Interval 850.6 to 3678.1	1802.5 arbitrary units Interval 1036.0 to 3136.3	1540 arbitrary units Interval 958.0 to 2475.5	1638.8 arbitrary units Interval 1018.4 to 2636.9	743.6 arbitrary units Interval 537.3 to 1029.1	904.3 arbitrary units Interval 703.5 to 1162.2	647.6 arbitrary units Interval 505.0 to 830.4	640.5 arbitrary units Interval 484.1 to 847.4
Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins L460D: Baseline	642.5 arbitrary units Interval 370.6 to 1113.8	804.6 arbitrary units Interval 462.2 to 1400.7	614.4 arbitrary units Interval 484.5 to 779.2	1022.3 arbitrary units Interval 755.4 to 1383.5	267.7 arbitrary units Interval 199.2 to 359.6	326.8 arbitrary units Interval 258.5 to 413.1	197.4 arbitrary units Interval 158.2 to 246.4	330.6 arbitrary units Interval 253.9 to 430.5
Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins L460D: Post-vaccination 2	1004.1 arbitrary units Interval 608.8 to 1656.1	1294.2 arbitrary units Interval 781.3 to 2143.7	620.3 arbitrary units Interval 455.0 to 845.6	943.0 arbitrary units Interval 658.4 to 1350.6	422.1 arbitrary units Interval 313.0 to 569.1	563.6 arbitrary units Interval 442.0 to 718.7	262.3 arbitrary units Interval 206.6 to 332.9	389.6 arbitrary units Interval 294.7 to 515.2
Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins PspA-Fam1: Baseline	1555.7 arbitrary units Interval 791.5 to 3057.8	1342.1 arbitrary units Interval 689.9 to 2610.7	2145.3 arbitrary units Interval 1476.3 to 3117.4	2837.2 arbitrary units Interval 1792.5 to 4490.7	197 arbitrary units Interval 123.2 to 315.1	358 arbitrary units Interval 264.0 to 485.4	230.3 arbitrary units Interval 164.4 to 322.6	414.4 arbitrary units Interval 278.1 to 617.4
Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins PspA-Fam1: Post-vaccination 2	3344.5 arbitrary units Interval 1868.9 to 5985.2	2684.4 arbitrary units Interval 1475.7 to 4883.1	2071.8 arbitrary units Interval 1345.9 to 3189.3	2588.5 arbitrary units Interval 1558.8 to 4298.5	326.2 arbitrary units Interval 211.7 to 502.6	593.8 arbitrary units Interval 433.9 to 812.6	315.1 arbitrary units Interval 231.5 to 429.0	560.4 arbitrary units Interval 376.9 to 833.3
Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins PhtD: Baseline	736.6 arbitrary units Interval 441.9 to 1227.6	942.3 arbitrary units Interval 506.3 to 1754.0	655.7 arbitrary units Interval 453.0 to 949.1	619.5 arbitrary units Interval 456.2 to 841.4	671.3 arbitrary units Interval 498.1 to 904.6	713.2 arbitrary units Interval 537.6 to 946.3	644.1 arbitrary units Interval 473.1 to 876.7	775.8 arbitrary units Interval 563.6 to 1068.0
Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins PhtD: Post-vaccination 2	842.5 arbitrary units Interval 497.8 to 1426.0	923.3 arbitrary units Interval 530.6 to 1606.6	663.8 arbitrary units Interval 451.4 to 976.2	592 arbitrary units Interval 422.0 to 830.6	870.3 arbitrary units Interval 655.2 to 1156.1	1064.5 arbitrary units Interval 826.7 to 1370.9	776.3 arbitrary units Interval 595.7 to 1011.8	922.7 arbitrary units Interval 695.7 to 1223.6
Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins BCH0785: Baseline	593.8 arbitrary units Interval 349.4 to 1008.9	562.3 arbitrary units Interval 299.5 to 1055.7	1214.5 arbitrary units Interval 729.7 to 2021.3	790.1 arbitrary units Interval 425.3 to 1467.5	287.4 arbitrary units Interval 208.0 to 397.1	389.3 arbitrary units Interval 288.8 to 524.9	237.1 arbitrary units Interval 168.9 to 332.7	346.6 arbitrary units Interval 246.7 to 487.1
Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins BCH0785: Post-vaccination 2	713.5 arbitrary units Interval 410.0 to 1241.6	640.6 arbitrary units Interval 383.3 to 1070.8	1205 arbitrary units Interval 730.8 to 1986.9	747.9 arbitrary units Interval 421.2 to 1328.2	398 arbitrary units Interval 284.8 to 556.1	627.8 arbitrary units Interval 467.7 to 842.7	301.8 arbitrary units Interval 219.1 to 415.8	367.4 arbitrary units Interval 261.9 to 515.2
Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins StkP: Baseline	524.6 arbitrary units Interval 255.5 to 1076.8	917.6 arbitrary units Interval 484.9 to 1736.2	1270.6 arbitrary units Interval 819.5 to 1970.0	973.3 arbitrary units Interval 539.9 to 1754.7	192 arbitrary units Interval 136.8 to 269.5	218.9 arbitrary units Interval 160.4 to 298.8	153.6 arbitrary units Interval 113.1 to 208.6	197 arbitrary units Interval 141.8 to 273.8
Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins StkP: Post-vaccination 2	701.1 arbitrary units Interval 343.2 to 1432.3	1209.4 arbitrary units Interval 729.7 to 2004.3	1329.5 arbitrary units Interval 859.3 to 2056.9	907.7 arbitrary units Interval 512.9 to 1606.2	346 arbitrary units Interval 245.4 to 487.8	409 arbitrary units Interval 309.3 to 540.9	199.1 arbitrary units Interval 147.2 to 269.3	211.6 arbitrary units Interval 152.0 to 294.6
Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins PcpA: Baseline	1099.7 arbitrary units Interval 629.2 to 1922.2	967 arbitrary units Interval 536.3 to 1743.6	1240.7 arbitrary units Interval 874.6 to 1760.1	1053.8 arbitrary units Interval 784.5 to 1415.6	505.8 arbitrary units Interval 324.9 to 787.4	431.9 arbitrary units Interval 286.1 to 652.0	635.4 arbitrary units Interval 398.9 to 1011.9	506.1 arbitrary units Interval 322.7 to 793.8
Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins PcpA: Post-vaccination 2	1094.6 arbitrary units Interval 608.8 to 1968.0	820.8 arbitrary units Interval 499.0 to 1350.0	1259.7 arbitrary units Interval 870.2 to 1823.6	972.3 arbitrary units Interval 741.6 to 1274.9	611.3 arbitrary units Interval 395.0 to 946.0	580.6 arbitrary units Interval 378.2 to 891.5	778.3 arbitrary units Interval 489.2 to 1238.4	737.5 arbitrary units Interval 493.1 to 1102.8
Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins SPWCV: Baseline	938.2 arbitrary units Interval 787.3 to 1118.1	886.3 arbitrary units Interval 618.9 to 1269.3	893.5 arbitrary units Interval 792.2 to 1007.7	742 arbitrary units Interval 587.7 to 936.8	495.2 arbitrary units Interval 433.5 to 565.8	544.9 arbitrary units Interval 463.3 to 640.8	488.3 arbitrary units Interval 429.7 to 554.9	590.8 arbitrary units Interval 516.6 to 675.7
Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins SPWCV: Post-vaccination 2	1042.2 arbitrary units Interval 853.0 to 1273.3	954.9 arbitrary units Interval 714.7 to 1275.9	930.6 arbitrary units Interval 785.9 to 1101.9	698.9 arbitrary units Interval 562.7 to 868.1	636.8 arbitrary units Interval 555.1 to 730.5	688.8 arbitrary units Interval 605.0 to 784.3	562.1 arbitrary units Interval 499.8 to 632.2	654.5 arbitrary units Interval 570.9 to 750.4
Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins PiuA: Baseline	659.7 arbitrary units Interval 372.6 to 1167.9	796.1 arbitrary units Interval 509.9 to 1243.0	1554.8 arbitrary units Interval 848.3 to 2849.5	1223.9 arbitrary units Interval 625.0 to 2396.6	811.6 arbitrary units Interval 638.3 to 1032.0	917.7 arbitrary units Interval 735.1 to 1145.7	665.4 arbitrary units Interval 507.6 to 872.2	888 arbitrary units Interval 677.2 to 1164.5

SECONDARY outcome

Timeframe: Baseline and 12 weeks after vaccination 2 (Day 0 and Day 112)

Between baseline and 28 days after vaccination 2. Proteins were measured on the Meso Scale Discovery (MSD) platform using an an electrochemiluminescence detection assay.

Outcome measures

Measure	Adult 0.6mg PATH-wSP n=11 Participants Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult 1.0 mg PATH-wSP n=11 Participants Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult Placebo n=24 Participants Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Adult Placebo High Dose n=50 Participants Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler 0.6mg PATH-wSP n=49 Participants Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler 1.0 mg PATH-wSP n=98 Participants Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler Placebo Low Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler Placebo High Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline
Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins L460D	1.56 fold change Interval 1.28 to 1.91	1.61 fold change Interval 1.24 to 2.09	0.97 fold change Interval 0.88 to 1.05	1.58 fold change Interval 1.35 to 1.84	1.72 fold change Interval 1.45 to 2.05	1.25 fold change Interval 1.11 to 1.41	—	—
Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins PspA-Fam1	2.15 fold change Interval 1.47 to 3.14	2.00 fold change Interval 1.18 to 3.38	0.94 fold change Interval 0.87 to 1.02	1.66 fold change Interval 1.34 to 2.04	1.66 fold change Interval 1.36 to 2.03	1.36 fold change Interval 1.11 to 1.67	—	—
Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins PhtD	1.14 fold change Interval 0.96 to 1.36	0.98 fold change Interval 0.82 to 1.16	0.98 fold change Interval 0.91 to 1.06	1.30 fold change Interval 1.11 to 1.51	1.49 fold change Interval 1.31 to 1.7	1.20 fold change Interval 1.07 to 1.34	—	—
Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins BCH0785	1.20 fold change Interval 1.02 to 1.42	1.14 fold change Interval 0.77 to 1.68	0.97 fold change Interval 0.9 to 1.04	1.38 fold change Interval 1.15 to 2.15	1.87 fold change Interval 1.53 to 2.28	1.18 fold change Interval 1.06 to 1.32	—	—
Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins StkP	1.34 fold change Interval 1.1 to 1.62	1.32 fold change Interval 0.98 to 1.77	0.99 fold change Interval 0.92 to 1.06	1.80 fold change Interval 1.51 to 2.15	1.87 fold change Interval 1.53 to 2.28	1.18 fold change Interval 1.06 to 1.32	—	—
Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins PcpA	1.00 fold change Interval 0.87 to 1.14	0.85 fold change Interval 0.65 to 1.11	0.97 fold change Interval 0.9 to 1.05	1.21 fold change Interval 0.98 to 1.49	1.34 fold change Interval 1.06 to 1.7	1.34 fold change Interval 1.11 to 1.61	—	—
Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins SPWCV	1.11 fold change Interval 0.93 to 1.33	1.08 fold change Interval 0.88 to 1.32	0.99 fold change Interval 0.91 to 1.07	1.29 fold change Interval 1.13 to 1.47	1.26 fold change Interval 1.12 to 1.43	1.12 fold change Interval 1.05 to 1.2	—	—
Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins PiuA	1.52 fold change Interval 1.17 to 1.97	1.32 fold change Interval 0.84 to 2.08	0.99 fold change Interval 0.93 to 1.06	1.35 fold change Interval 1.12 to 1.62	1.46 fold change Interval 1.22 to 1.76	1.11 fold change Interval 0.98 to 1.25	—	—
Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins PiaA	1.35 fold change Interval 1.1 to 1.65	1.23 fold change Interval 0.99 to 1.54	0.98 fold change Interval 0.9 to 1.08	1.33 fold change Interval 1.14 to 1.55	1.36 fold change Interval 1.15 to 1.62	1.08 fold change Interval 0.94 to 1.24	—	—

SECONDARY outcome

Timeframe: Baseline and 12 weeks after vaccination 2 (Day 0 and Day 112)

Between baseline and 28 days after vaccination 2. Proteins were measured on the Meso Scale Discovery (MSD) platform using an an electrochemiluminescence detection assay.

Outcome measures

Measure	Adult 0.6mg PATH-wSP n=11 Participants Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult 1.0 mg PATH-wSP n=11 Participants Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult Placebo n=24 Participants Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Adult Placebo High Dose n=50 Participants Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler 0.6mg PATH-wSP n=49 Participants Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler 1.0 mg PATH-wSP n=98 Participants Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler Placebo Low Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler Placebo High Dose Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline
Number of Subjects With Immunoglobulin G (IgG) Seroresponse SPWCV · Between 2 and 3 fold rise	0 Participants	0 Participants	0 Participants	6 Participants	2 Participants	3 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse L460D · <2 fold rise	9 Participants	9 Participants	24 Participants	34 Participants	33 Participants	78 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse L460D · Between 2 and 3 fold rise	2 Participants	0 Participants	0 Participants	12 Participants	11 Participants	13 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse L460D · Between 3 and 4 fold rise	0 Participants	2 Participants	0 Participants	2 Participants	1 Participants	6 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse L460D · ≥4 fold rise	0 Participants	0 Participants	0 Participants	2 Participants	4 Participants	1 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse PspA-Fam1 · <2 fold rise	6 Participants	9 Participants	24 Participants	31 Participants	30 Participants	72 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse PspA-Fam1 · Between 2 and 3 fold rise	2 Participants	0 Participants	0 Participants	11 Participants	12 Participants	6 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse PspA-Fam1 · Between 3 and 4 fold rise	0 Participants	0 Participants	0 Participants	5 Participants	3 Participants	2 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse PspA-Fam1 · ≥4 fold rise	3 Participants	2 Participants	0 Participants	3 Participants	4 Participants	18 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse PhtD · <2 fold rise	11 Participants	11 Participants	24 Participants	37 Participants	39 Participants	78 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse PhtD · Between 2 and 3 fold rise	0 Participants	0 Participants	0 Participants	11 Participants	4 Participants	17 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse PhtD · Between 3 and 4 fold rise	0 Participants	0 Participants	0 Participants	2 Participants	6 Participants	2 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse PhtD · ≥4 fold rise	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse BCH0785 · <2 fold rise	11 Participants	10 Participants	24 Participants	36 Participants	33 Participants	81 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse BCH0785 · Between 2 and 3 fold rise	0 Participants	1 Participants	0 Participants	7 Participants	6 Participants	6 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse BCH0785 · Between 3 and 4 fold rise	0 Participants	0 Participants	0 Participants	4 Participants	4 Participants	5 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse BCH0785 · ≥4 fold rise	0 Participants	0 Participants	0 Participants	3 Participants	6 Participants	6 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse StkP · <2 fold rise	9 Participants	10 Participants	24 Participants	25 Participants	27 Participants	78 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse StkP · Between 2 and 3 fold rise	2 Participants	0 Participants	0 Participants	16 Participants	12 Participants	15 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse StkP · Between 3 and 4 fold rise	0 Participants	0 Participants	0 Participants	1 Participants	5 Participants	3 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse StkP · ≥4 fold rise	0 Participants	1 Participants	0 Participants	8 Participants	5 Participants	2 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse PcpA · <2 fold rise	11 Participants	11 Participants	24 Participants	44 Participants	33 Participants	69 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse PcpA · Between 2 and 3 fold rise	0 Participants	0 Participants	0 Participants	1 Participants	7 Participants	13 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse PcpA · Between 3 and 4 fold rise	0 Participants	0 Participants	0 Participants	3 Participants	5 Participants	7 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse PcpA · ≥4 fold rise	0 Participants	0 Participants	0 Participants	2 Participants	4 Participants	9 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse SPWCV · <2 fold rise	11 Participants	11 Participants	24 Participants	43 Participants	45 Participants	95 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse SPWCV · Between 3 and 4 fold rise	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse SPWCV · ≥4 fold rise	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse PiuA · <2 fold rise	9 Participants	9 Participants	24 Participants	40 Participants	37 Participants	82 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse PiuA · Between 2 and 3 fold rise	1 Participants	2 Participants	0 Participants	6 Participants	6 Participants	11 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse PiuA · Between 3 and 4 fold rise	1 Participants	0 Participants	0 Participants	0 Participants	3 Participants	4 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse PiuA · ≥4 fold rise	0 Participants	0 Participants	0 Participants	4 Participants	3 Participants	1 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse PiaA · <2 fold rise	9 Participants	10 Participants	24 Participants	43 Participants	38 Participants	89 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse PiaA · Between 2 and 3 fold rise	2 Participants	1 Participants	0 Participants	3 Participants	5 Participants	3 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse PiaA · Between 3 and 4 fold rise	0 Participants	0 Participants	0 Participants	1 Participants	4 Participants	4 Participants	—	—
Number of Subjects With Immunoglobulin G (IgG) Seroresponse PiaA · ≥4 fold rise	0 Participants	0 Participants	0 Participants	3 Participants	2 Participants	2 Participants	—	—

Adverse Events

Adult 0.6mg PATH-wSP

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Adult 1.0 mg PATH-wSP

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Adult Placebo

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Toddler 0.6mg PATH-wSP

Serious events: 2 serious events

Other events: 45 other events

Deaths: 0 deaths

Toddler 1.0 mg PATH-wSP

Serious events: 1 serious events

Other events: 44 other events

Deaths: 0 deaths

Toddler Placebo

Serious events: 5 serious events

Other events: 87 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adult 0.6mg PATH-wSP n=12 participants at risk Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult 1.0 mg PATH-wSP n=12 participants at risk Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult Placebo n=24 participants at risk Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler 0.6mg PATH-wSP n=50 participants at risk Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler 1.0 mg PATH-wSP n=50 participants at risk Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler Placebo n=100 participants at risk Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline
Infections and infestations Pneumonia	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	2.0% 2/100 • 112 days from receipt of first vaccination
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination
Gastrointestinal disorders Gastroenteritis	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination
Infections and infestations Malaria	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination
Nervous system disorders Febrile convulsion	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	2.0% 2/100 • 112 days from receipt of first vaccination
Infections and infestations Pneumococcal bacteremia	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination

Other adverse events

Measure	Adult 0.6mg PATH-wSP n=12 participants at risk Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult 1.0 mg PATH-wSP n=12 participants at risk Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Adult Placebo n=24 participants at risk Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline	Toddler 0.6mg PATH-wSP n=50 participants at risk Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler 1.0 mg PATH-wSP n=50 participants at risk Two 1 mg doses of PATH-wSP with a 28 day interval between doses PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Toddler Placebo n=100 participants at risk Two injections of normal saline with a 28 day interval between injections Placebo: Normal Saline
Infections and infestations Upper respiratory tract infection	50.0% 6/12 • 112 days from receipt of first vaccination	33.3% 4/12 • 112 days from receipt of first vaccination	37.5% 9/24 • 112 days from receipt of first vaccination	54.0% 27/50 • 112 days from receipt of first vaccination	6.0% 3/50 • 112 days from receipt of first vaccination	23.0% 23/100 • 112 days from receipt of first vaccination
Infections and infestations Gastroenteritis	8.3% 1/12 • 112 days from receipt of first vaccination	16.7% 2/12 • 112 days from receipt of first vaccination	4.2% 1/24 • 112 days from receipt of first vaccination	22.0% 11/50 • 112 days from receipt of first vaccination	4.0% 2/50 • 112 days from receipt of first vaccination	11.0% 11/100 • 112 days from receipt of first vaccination
Infections and infestations Tonsillitis	8.3% 1/12 • 112 days from receipt of first vaccination	8.3% 1/12 • 112 days from receipt of first vaccination	8.3% 2/24 • 112 days from receipt of first vaccination	6.0% 3/50 • 112 days from receipt of first vaccination	8.0% 4/50 • 112 days from receipt of first vaccination	7.0% 7/100 • 112 days from receipt of first vaccination
Infections and infestations Conjunctivitis	0.00% 0/12 • 112 days from receipt of first vaccination	8.3% 1/12 • 112 days from receipt of first vaccination	8.3% 2/24 • 112 days from receipt of first vaccination	6.0% 3/50 • 112 days from receipt of first vaccination	12.0% 6/50 • 112 days from receipt of first vaccination	8.0% 8/100 • 112 days from receipt of first vaccination
Infections and infestations Malaria	8.3% 1/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	8.3% 2/24 • 112 days from receipt of first vaccination	6.0% 3/50 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	6.0% 6/100 • 112 days from receipt of first vaccination
Infections and infestations Rhinitis	0.00% 0/12 • 112 days from receipt of first vaccination	8.3% 1/12 • 112 days from receipt of first vaccination	4.2% 1/24 • 112 days from receipt of first vaccination	40.0% 20/50 • 112 days from receipt of first vaccination	46.0% 23/50 • 112 days from receipt of first vaccination	47.0% 47/100 • 112 days from receipt of first vaccination
Infections and infestations Urinary tract infection	8.3% 1/12 • 112 days from receipt of first vaccination	8.3% 1/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination
Infections and infestations Body tinea	8.3% 1/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	6.0% 3/50 • 112 days from receipt of first vaccination	6.0% 3/50 • 112 days from receipt of first vaccination	11.0% 11/100 • 112 days from receipt of first vaccination
Infections and infestations Cellulitis	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	4.2% 1/24 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	2.0% 2/100 • 112 days from receipt of first vaccination
Infections and infestations Helminthic infection	8.3% 1/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	4.0% 4/100 • 112 days from receipt of first vaccination
Infections and infestations Mastitis	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	4.2% 1/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Infections and infestations Onychomycosis	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	4.2% 1/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Infections and infestations Pelvic inflammatory disease	0.00% 0/12 • 112 days from receipt of first vaccination	8.3% 1/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Infections and infestations Pharyngitis	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	4.2% 1/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Infections and infestations Urethritis	8.3% 1/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Infections and infestations Wound sepsis	0.00% 0/12 • 112 days from receipt of first vaccination	8.3% 1/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Infections and infestations Rash pustular	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	26.0% 13/50 • 112 days from receipt of first vaccination	14.0% 7/50 • 112 days from receipt of first vaccination	11.0% 11/100 • 112 days from receipt of first vaccination
Infections and infestations Tinea capitis	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	6.0% 3/50 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	5.0% 5/100 • 112 days from receipt of first vaccination
Infections and infestations Pneumonia	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	4.0% 2/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Infections and infestations Varicella	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	4.0% 2/50 • 112 days from receipt of first vaccination	3.0% 3/100 • 112 days from receipt of first vaccination
Infections and infestations Otitis media	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	6.0% 3/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	2.0% 2/100 • 112 days from receipt of first vaccination
Infections and infestations Subcutaneous abscess	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	4.0% 2/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	3.0% 3/100 • 112 days from receipt of first vaccination
Infections and infestations Otitis media acute	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	3.0% 3/100 • 112 days from receipt of first vaccination
Infections and infestations Abscess limb	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Infections and infestations Abscess neck	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination
Infections and infestations Abscess of eyelid	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination
Infections and infestations Acarodermatitis	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination
Infections and infestations Bronchiolitis	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Infections and infestations Dermatitis infected	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination
Infections and infestations Dysentery	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination
Infections and infestations Febrile infection	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination
Infections and infestations Furuncle	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Infections and infestations Impetigo	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination
Infections and infestations Oral candidiasis	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination
Infections and infestations Otitis externa	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Infections and infestations Septic rash	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination
Infections and infestations Skin infection	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination
Infections and infestations Tinea infection	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Infections and infestations Dental caries	8.3% 1/12 • 112 days from receipt of first vaccination	8.3% 1/12 • 112 days from receipt of first vaccination	8.3% 2/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Infections and infestations Toothache	0.00% 0/12 • 112 days from receipt of first vaccination	16.7% 2/12 • 112 days from receipt of first vaccination	4.2% 1/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Gastrointestinal disorders Abdominal Pain	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	8.3% 2/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Gastrointestinal disorders Gastritis	0.00% 0/12 • 112 days from receipt of first vaccination	8.3% 1/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Gastrointestinal disorders Diarrhoea	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	26.0% 13/50 • 112 days from receipt of first vaccination	12.0% 6/50 • 112 days from receipt of first vaccination	20.0% 20/100 • 112 days from receipt of first vaccination
Gastrointestinal disorders Stomatitis	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	2.0% 2/100 • 112 days from receipt of first vaccination
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	8.3% 2/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/12 • 112 days from receipt of first vaccination	8.3% 1/12 • 112 days from receipt of first vaccination	4.2% 1/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	4.2% 1/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	4.2% 1/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Nervous system disorders Headache	25.0% 3/12 • 112 days from receipt of first vaccination	16.7% 2/12 • 112 days from receipt of first vaccination	4.2% 1/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Nervous system disorders Febrile convulsion	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/12 • 112 days from receipt of first vaccination	8.3% 1/12 • 112 days from receipt of first vaccination	4.2% 1/24 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	4.0% 2/50 • 112 days from receipt of first vaccination	2.0% 2/100 • 112 days from receipt of first vaccination
Injury, poisoning and procedural complications Thermal burn	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	4.0% 2/50 • 112 days from receipt of first vaccination	4.0% 4/100 • 112 days from receipt of first vaccination
Injury, poisoning and procedural complications Skin wound	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	4.0% 2/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination
Injury, poisoning and procedural complications Limb injury	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	2.0% 2/100 • 112 days from receipt of first vaccination
Injury, poisoning and procedural complications Skin injury	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	2.0% 2/100 • 112 days from receipt of first vaccination
Injury, poisoning and procedural complications Greenstick fracture	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Injury, poisoning and procedural complications Wound	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination
General disorders Fatigue	8.3% 1/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
General disorders Vaccination site pain	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	4.2% 1/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
General disorders Pyrexia	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	4.0% 2/50 • 112 days from receipt of first vaccination	14.0% 7/50 • 112 days from receipt of first vaccination	13.0% 13/100 • 112 days from receipt of first vaccination
General disorders Vaccination site induration	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	4.0% 2/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
General disorders Vaccination site swelling	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	4.2% 1/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Reproductive system and breast disorders Menorrhagia	0.00% 0/12 • 112 days from receipt of first vaccination	8.3% 1/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Reproductive system and breast disorders Balanoposthitis	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	4.2% 1/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	4.2% 1/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination
Skin and subcutaneous tissue disorders Rash vesicular	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	3.0% 3/100 • 112 days from receipt of first vaccination
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Skin and subcutaneous tissue disorders Urticaria papular	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	4.2% 1/24 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination
Hepatobiliary disorders Hepatitis acute	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	1.0% 1/100 • 112 days from receipt of first vaccination
Investigations White blood cell count increased	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/12 • 112 days from receipt of first vaccination	0.00% 0/24 • 112 days from receipt of first vaccination	0.00% 0/50 • 112 days from receipt of first vaccination	2.0% 1/50 • 112 days from receipt of first vaccination	0.00% 0/100 • 112 days from receipt of first vaccination

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