Trial Outcomes & Findings for Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants (NCT NCT04398706)

Last Updated: 2025-09-08

Results Overview

An AE was any untoward medical occurrence in a participant or in a clinical investigation participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. Immediate events were recorded to capture medically relevant unsolicited systemic AEs (including those related to the product administered) that occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination and included both serious adverse events (SAEs) and non-serious unsolicited AEs.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

852 participants

Primary outcome timeframe

Up to 30 minutes after each vaccination

Results posted on

2025-09-08

Participant Flow

The Stage I of study was conducted at 22 active centers in the US between 22 May 2020 and 10 March 2021. The Stage II of study was conducted at 35 active centers in the US, Canada and Honduras between 16 April 2021 and 24 February 2022.

A total of 140 participants were randomized in Stage I and 712 participants were randomized in Stage II of study.

Participant milestones

Participant milestones
Measure	Stage I: Group 1 SP0202-IIb Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.	Stage I: Group 2 SP0202-VI Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age \[that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII (measles, mumps, and rubella) and Varivax at 12 to 15 months of age\].	Stage II: Group 6 SP0202-VI Infants aged 2 months received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII Infants aged 2 months received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 Infants aged 2 months received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Overall Study STARTED	35	35	35	35	179	178	179	176
Overall Study COMPLETED	35	31	32	32	148	147	151	160
Overall Study NOT COMPLETED	0	4	3	3	31	31	28	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Stage I: Group 2 SP0202-VI Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age \[that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII (measles, mumps, and rubella) and Varivax at 12 to 15 months of age\].	Stage II: Group 6 SP0202-VI Infants aged 2 months received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII Infants aged 2 months received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 Infants aged 2 months received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Overall Study Adverse Event	0	0	0	0	1	1	0
Overall Study Lost to Follow-up	1	2	1	6	3	8	2
Overall Study Withdrawal by parent/guardian	2	1	2	19	23	13	11
Overall Study Protocol deviation	1	0	0	6	4	6	3

Baseline Characteristics

Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stage I: Group 1 SP0202-IIb n=35 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.	Stage I: Group 2 SP0202-VI n=35 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII n=35 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 n=35 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb n=179 Participants Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 6 SP0202-VI n=178 Participants Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII n=179 Participants Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 n=176 Participants Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Total n=852 Participants Total of all reporting groups
Age, Continuous	1.1 years STANDARD_DEVIATION 0.11 • n=5 Participants	1.1 years STANDARD_DEVIATION 0.10 • n=7 Participants	1.1 years STANDARD_DEVIATION 0.12 • n=5 Participants	1.2 years STANDARD_DEVIATION 0.11 • n=4 Participants	0.2 years STANDARD_DEVIATION 0.03 • n=21 Participants	0.2 years STANDARD_DEVIATION 0.03 • n=10 Participants	0.2 years STANDARD_DEVIATION 0.03 • n=115 Participants	0.2 years STANDARD_DEVIATION 0.03 • n=24 Participants	0.3 years STANDARD_DEVIATION 0.36 • n=42 Participants
Sex/Gender, Customized Female	17 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants	17 Participants n=4 Participants	93 Participants n=21 Participants	94 Participants n=10 Participants	78 Participants n=115 Participants	90 Participants n=24 Participants	421 Participants n=42 Participants
Sex/Gender, Customized Male	18 Participants n=5 Participants	22 Participants n=7 Participants	15 Participants n=5 Participants	18 Participants n=4 Participants	86 Participants n=21 Participants	84 Participants n=10 Participants	101 Participants n=115 Participants	86 Participants n=24 Participants	430 Participants n=42 Participants
Sex/Gender, Customized Missing	0 Participants n=5 Participants	1 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	1 Participants n=42 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	26 Participants n=21 Participants	26 Participants n=10 Participants	23 Participants n=115 Participants	23 Participants n=24 Participants	103 Participants n=42 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	2 Participants n=24 Participants	8 Participants n=42 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	10 Participants n=21 Participants	17 Participants n=10 Participants	10 Participants n=115 Participants	11 Participants n=24 Participants	64 Participants n=42 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 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	1 Participants n=42 Participants
Race/Ethnicity, Customized White	24 Participants n=5 Participants	28 Participants n=7 Participants	29 Participants n=5 Participants	25 Participants n=4 Participants	75 Participants n=21 Participants	67 Participants n=10 Participants	79 Participants n=115 Participants	80 Participants n=24 Participants	407 Participants n=42 Participants
Race/Ethnicity, Customized Multiple	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	64 Participants n=21 Participants	67 Participants n=10 Participants	67 Participants n=115 Participants	59 Participants n=24 Participants	262 Participants n=42 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants	4 Participants n=42 Participants
Race/Ethnicity, Customized Unknown	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	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants
Race/Ethnicity, Customized Missing	0 Participants n=5 Participants	1 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	1 Participants n=42 Participants

PRIMARY outcome

Timeframe: Up to 30 minutes after each vaccination

Population: Analysis was performed on the Safety analysis set (SafAS) that included all participants who received at least 1 dose of the study vaccines and had any safety data available. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.

Outcome measures

Outcome measures
Measure	Stage I: Group 1 SP0202-IIb n=35 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.	Stage I: Group 2 SP0202-VI n=34 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII n=35 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 n=34 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb n=180 Participants Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 6 SP0202-VI n=178 Participants Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII n=176 Participants Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 n=176 Participants Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Number of Participants With Immediate Adverse Events (AEs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 7 days after each vaccination

Population: Analysis was performed on SafAS. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis. Only participants with data collected for each specified category are reported.

A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted in the protocol and CRB and were considered to be related to the product administered. An injection site reaction was an adverse reaction at and around the injection site which were commonly inflammatory reactions. Solicited injection site reactions included tenderness, erythema and swelling around the injection site and were planned to be collected and reported for SP0202/Prevnar 13 for both toddlers and infants.

Outcome measures

Outcome measures
Measure	Stage I: Group 1 SP0202-IIb n=31 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.	Stage I: Group 2 SP0202-VI n=32 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII n=31 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 n=30 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb n=168 Participants Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 6 SP0202-VI n=170 Participants Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII n=168 Participants Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 n=171 Participants Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Number of Participants With Solicited Injection Site Reactions	21 Participants	18 Participants	21 Participants	13 Participants	119 Participants	128 Participants	126 Participants	124 Participants

PRIMARY outcome

Timeframe: Up to 7 days after each vaccination

A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB and considered as related to the product administered. Solicited systemic reactions included fever, vomiting, abnormal crying, drowsiness, appetite loss, and irritability. Reported AEs for each arm were presented as pre-specified in protocol.

Outcome measures

Outcome measures
Measure	Stage I: Group 1 SP0202-IIb n=33 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.	Stage I: Group 2 SP0202-VI n=33 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII n=33 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 n=30 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb n=168 Participants Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 6 SP0202-VI n=169 Participants Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII n=168 Participants Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 n=171 Participants Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Number of Participants With Solicited Systemic Reactions	25 Participants	23 Participants	27 Participants	24 Participants	139 Participants	143 Participants	137 Participants	138 Participants

PRIMARY outcome

Timeframe: Up to 30 days after each vaccination

An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product, and which did not necessarily have a causal relationship with this treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs included both SAEs and non-serious unsolicited AEs. Reported AEs for each arm were presented as pre-specified in protocol.

Outcome measures

Outcome measures
Measure	Stage I: Group 1 SP0202-IIb n=35 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.	Stage I: Group 2 SP0202-VI n=34 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII n=35 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 n=34 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb n=180 Participants Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 6 SP0202-VI n=178 Participants Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII n=176 Participants Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 n=176 Participants Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Number of Participants With Unsolicited AEs	7 Participants	3 Participants	4 Participants	6 Participants	122 Participants	116 Participants	118 Participants	117 Participants

PRIMARY outcome

Timeframe: From first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days

An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. The following AE were captured as AESI throughout the study: Anaphylaxis defined as per the Brighton collaboration case definition, convulsions including febrile convulsions, hypotonic-hyporesponsive episode and apnea. Reported AEs for each arm were presented as pre-specified in protocol.

Outcome measures

Outcome measures
Measure	Stage I: Group 1 SP0202-IIb n=35 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.	Stage I: Group 2 SP0202-VI n=34 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII n=35 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 n=34 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb n=180 Participants Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 6 SP0202-VI n=178 Participants Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII n=176 Participants Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 n=176 Participants Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Number of Participants With SAEs and Adverse Event of Special Interest (AESIs) Any SAEs	0 Participants	1 Participants	0 Participants	0 Participants	3 Participants	9 Participants	8 Participants	9 Participants
Number of Participants With SAEs and Adverse Event of Special Interest (AESIs) Any AESIs	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 30

Population: Per protocol analysis set 1 (PPAS1) was a subset of Full analysis set (FAS)1. FAS1: All randomized participants to Groups 1 to 4 who received at least 1 dose of study vaccine and had a valid post vaccination blood sample result \[serotype specific IgG concentration or serotype specific opsonophagocytic activity (OPA) titer for at least 1 serotype, or titer/concentration for at least 1 antigen on concomitant vaccines\]. Only participants with data collected for each specified category are reported.

The GMCs for serotype specific pneumococcal IgG antibodies were measured using pneumococcal capsular polysaccharide-electro-chemiluminescent assay (PnPS-ECL), a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.

Outcome measures

Outcome measures
Measure	Stage I: Group 1 SP0202-IIb n=25 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.	Stage I: Group 2 SP0202-VI n=26 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII n=27 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 n=29 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 6 SP0202-VI Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose Serotype 9N	3.46 microgram/millilitre (mcg/mL) Interval 2.21 to 5.43	2.02 microgram/millilitre (mcg/mL) Interval 1.43 to 2.84	2.78 microgram/millilitre (mcg/mL) Interval 2.04 to 3.79	0.668 microgram/millilitre (mcg/mL) Interval 0.437 to 1.02	—	—	—	—
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose Serotype 10A	1.84 microgram/millilitre (mcg/mL) Interval 1.18 to 2.87	1.05 microgram/millilitre (mcg/mL) Interval 0.669 to 1.66	1.48 microgram/millilitre (mcg/mL) Interval 0.988 to 2.21	0.244 microgram/millilitre (mcg/mL) Interval 0.18 to 0.331	—	—	—	—
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose Serotype 1	2.46 microgram/millilitre (mcg/mL) Interval 1.59 to 3.82	2.12 microgram/millilitre (mcg/mL) Interval 1.4 to 3.21	3.29 microgram/millilitre (mcg/mL) Interval 2.55 to 4.24	3.80 microgram/millilitre (mcg/mL) Interval 2.76 to 5.24	—	—	—	—
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose Serotype 3	0.766 microgram/millilitre (mcg/mL) Interval 0.569 to 1.03	0.973 microgram/millilitre (mcg/mL) Interval 0.748 to 1.26	1.16 microgram/millilitre (mcg/mL) Interval 0.963 to 1.4	0.835 microgram/millilitre (mcg/mL) Interval 0.629 to 1.11	—	—	—	—
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose Serotype 4	1.53 microgram/millilitre (mcg/mL) Interval 1.07 to 2.19	1.51 microgram/millilitre (mcg/mL) Interval 1.1 to 2.08	2.27 microgram/millilitre (mcg/mL) Interval 1.58 to 3.27	1.73 microgram/millilitre (mcg/mL) Interval 1.32 to 2.25	—	—	—	—
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose Serotype 5	2.44 microgram/millilitre (mcg/mL) Interval 1.74 to 3.42	2.38 microgram/millilitre (mcg/mL) Interval 1.66 to 3.42	2.80 microgram/millilitre (mcg/mL) Interval 2.0 to 3.93	2.69 microgram/millilitre (mcg/mL) Interval 2.02 to 3.58	—	—	—	—
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose Serotype 6A	7.53 microgram/millilitre (mcg/mL) Interval 5.48 to 10.4	5.87 microgram/millilitre (mcg/mL) Interval 4.2 to 8.2	8.29 microgram/millilitre (mcg/mL) Interval 6.51 to 10.6	8.54 microgram/millilitre (mcg/mL) Interval 6.44 to 11.3	—	—	—	—
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose Serotype 6B	5.21 microgram/millilitre (mcg/mL) Interval 3.67 to 7.4	4.16 microgram/millilitre (mcg/mL) Interval 3.15 to 5.5	7.11 microgram/millilitre (mcg/mL) Interval 5.21 to 9.7	5.77 microgram/millilitre (mcg/mL) Interval 4.33 to 7.7	—	—	—	—
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose Serotype 7F	2.99 microgram/millilitre (mcg/mL) Interval 2.32 to 3.86	3.23 microgram/millilitre (mcg/mL) Interval 2.37 to 4.41	2.91 microgram/millilitre (mcg/mL) Interval 2.23 to 3.8	3.80 microgram/millilitre (mcg/mL) Interval 3.06 to 4.73	—	—	—	—
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose Serotype 9V	3.25 microgram/millilitre (mcg/mL) Interval 2.47 to 4.27	2.99 microgram/millilitre (mcg/mL) Interval 2.22 to 4.01	5.27 microgram/millilitre (mcg/mL) Interval 3.99 to 6.97	3.13 microgram/millilitre (mcg/mL) Interval 2.31 to 4.24	—	—	—	—
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose Serotype 14	7.37 microgram/millilitre (mcg/mL) Interval 5.39 to 10.1	6.54 microgram/millilitre (mcg/mL) Interval 4.62 to 9.27	5.75 microgram/millilitre (mcg/mL) Interval 4.48 to 7.38	9.83 microgram/millilitre (mcg/mL) Interval 7.65 to 12.6	—	—	—	—
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose Serotype 18C	1.80 microgram/millilitre (mcg/mL) Interval 1.25 to 2.59	2.23 microgram/millilitre (mcg/mL) Interval 1.57 to 3.19	2.19 microgram/millilitre (mcg/mL) Interval 1.67 to 2.87	2.53 microgram/millilitre (mcg/mL) Interval 1.99 to 3.21	—	—	—	—
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose Serotype 19A	3.67 microgram/millilitre (mcg/mL) Interval 2.56 to 5.26	5.41 microgram/millilitre (mcg/mL) Interval 3.62 to 8.08	5.45 microgram/millilitre (mcg/mL) Interval 4.17 to 7.11	6.20 microgram/millilitre (mcg/mL) Interval 4.83 to 7.96	—	—	—	—
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose Serotype 19F	3.88 microgram/millilitre (mcg/mL) Interval 2.77 to 5.42	4.12 microgram/millilitre (mcg/mL) Interval 2.99 to 5.7	5.79 microgram/millilitre (mcg/mL) Interval 4.02 to 8.35	6.50 microgram/millilitre (mcg/mL) Interval 4.69 to 9.02	—	—	—	—
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose Serotype 23F	2.42 microgram/millilitre (mcg/mL) Interval 1.71 to 3.43	2.65 microgram/millilitre (mcg/mL) Interval 1.98 to 3.55	3.64 microgram/millilitre (mcg/mL) Interval 2.75 to 4.82	3.02 microgram/millilitre (mcg/mL) Interval 2.11 to 4.32	—	—	—	—
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose Serotype 8	6.86 microgram/millilitre (mcg/mL) Interval 4.96 to 9.5	4.91 microgram/millilitre (mcg/mL) Interval 3.74 to 6.44	7.11 microgram/millilitre (mcg/mL) Interval 5.17 to 9.8	0.235 microgram/millilitre (mcg/mL) Interval 0.158 to 0.35	—	—	—	—
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose Serotype 11A	4.41 microgram/millilitre (mcg/mL) Interval 3.25 to 5.99	3.20 microgram/millilitre (mcg/mL) Interval 2.48 to 4.13	4.61 microgram/millilitre (mcg/mL) Interval 3.34 to 6.35	0.188 microgram/millilitre (mcg/mL) Interval 0.144 to 0.247	—	—	—	—
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose Serotype 12F	0.767 microgram/millilitre (mcg/mL) Interval 0.454 to 1.29	0.778 microgram/millilitre (mcg/mL) Interval 0.541 to 1.12	0.907 microgram/millilitre (mcg/mL) Interval 0.596 to 1.38	0.094 microgram/millilitre (mcg/mL) Interval 0.078 to 0.112	—	—	—	—
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose Serotype 15B	0.680 microgram/millilitre (mcg/mL) Interval 0.447 to 1.03	0.560 microgram/millilitre (mcg/mL) Interval 0.37 to 0.848	0.644 microgram/millilitre (mcg/mL) Interval 0.425 to 0.974	0.172 microgram/millilitre (mcg/mL) Interval 0.122 to 0.241	—	—	—	—
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose Serotype 22F	4.43 microgram/millilitre (mcg/mL) Interval 3.12 to 6.3	4.26 microgram/millilitre (mcg/mL) Interval 2.66 to 6.82	5.20 microgram/millilitre (mcg/mL) Interval 3.51 to 7.69	0.178 microgram/millilitre (mcg/mL) Interval 0.122 to 0.259	—	—	—	—
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose Serotype 33F	1.26 microgram/millilitre (mcg/mL) Interval 0.694 to 2.29	1.13 microgram/millilitre (mcg/mL) Interval 0.771 to 1.65	1.75 microgram/millilitre (mcg/mL) Interval 1.09 to 2.79	0.256 microgram/millilitre (mcg/mL) Interval 0.189 to 0.345	—	—	—	—

PRIMARY outcome

Timeframe: Day 150

Population: Per protocol analysis set 2 (PPAS2) was a subset of FAS2. FAS2: All randomized participants to Groups 5 to 8 who received at least 1 dose of study vaccine in primary series and had a valid post-primary series vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least 1 serotype, or titer/concentration for at least 1 antigen on concomitant vaccines). Only participants with data collected for each specified category are reported.

Percentage of infants with serotype specific IgG concentration \>=0.35 mcg/mL for each pneumococcal serotype included in the SP0202 formulations were measured using ECL, a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.

Outcome measures

Outcome measures
Measure	Stage I: Group 1 SP0202-IIb n=133 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.	Stage I: Group 2 SP0202-VI n=122 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII n=125 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 n=132 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 6 SP0202-VI Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3 Serotype 4	97.0 percentage of participants Interval 92.5 to 99.2	95.9 percentage of participants Interval 90.7 to 98.7	97.6 percentage of participants Interval 93.1 to 99.5	97.7 percentage of participants Interval 93.5 to 99.5	—	—	—	—
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3 Serotype 5	98.5 percentage of participants Interval 94.7 to 99.8	96.7 percentage of participants Interval 91.8 to 99.1	93.6 percentage of participants Interval 87.8 to 97.2	97.0 percentage of participants Interval 92.4 to 99.2	—	—	—	—
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3 Serotype 6A	99.2 percentage of participants Interval 95.9 to 100.0	96.7 percentage of participants Interval 91.8 to 99.1	99.2 percentage of participants Interval 95.6 to 100.0	99.2 percentage of participants Interval 95.9 to 100.0	—	—	—	—
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3 Serotype 6B	85.7 percentage of participants Interval 78.6 to 91.2	81.1 percentage of participants Interval 73.1 to 87.7	84.0 percentage of participants Interval 76.4 to 89.9	97.0 percentage of participants Interval 92.4 to 99.2	—	—	—	—
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3 Serotype 7F	100 percentage of participants Interval 97.3 to 100.0	100 percentage of participants Interval 97.0 to 100.0	99.2 percentage of participants Interval 95.6 to 100.0	100 percentage of participants Interval 97.2 to 100.0	—	—	—	—
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3 Serotype 9V	96.2 percentage of participants Interval 91.4 to 98.8	89.3 percentage of participants Interval 82.5 to 94.2	94.4 percentage of participants Interval 88.8 to 97.7	99.2 percentage of participants Interval 95.9 to 100.0	—	—	—	—
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3 Serotype 14	99.2 percentage of participants Interval 95.9 to 100.0	99.2 percentage of participants Interval 95.5 to 100.0	97.6 percentage of participants Interval 93.1 to 99.5	96.9 percentage of participants Interval 92.4 to 99.2	—	—	—	—
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3 Serotype 18C	97.0 percentage of participants Interval 92.5 to 99.2	97.5 percentage of participants Interval 93.0 to 99.5	97.6 percentage of participants Interval 93.1 to 99.5	96.2 percentage of participants Interval 91.4 to 98.8	—	—	—	—
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3 Serotype 19A	94.0 percentage of participants Interval 88.5 to 97.4	93.4 percentage of participants Interval 87.5 to 97.1	96.0 percentage of participants Interval 90.9 to 98.7	97.0 percentage of participants Interval 92.4 to 99.2	—	—	—	—
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3 Serotype 19F	100 percentage of participants Interval 97.3 to 100.0	99.2 percentage of participants Interval 95.5 to 100.0	96.8 percentage of participants Interval 92.0 to 99.1	99.2 percentage of participants Interval 95.8 to 100.0	—	—	—	—
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3 Serotype 23F	97.7 percentage of participants Interval 93.5 to 99.5	96.7 percentage of participants Interval 91.8 to 99.1	96.0 percentage of participants Interval 90.9 to 98.7	93.9 percentage of participants Interval 88.4 to 97.3	—	—	—	—
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3 Serotype 8	99.2 percentage of participants Interval 95.9 to 100.0	100 percentage of participants Interval 97.0 to 100.0	99.2 percentage of participants Interval 95.6 to 100.0	9.2 percentage of participants Interval 4.8 to 15.5	—	—	—	—
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3 Serotype 9N	99.2 percentage of participants Interval 95.9 to 100.0	98.4 percentage of participants Interval 94.2 to 99.8	98.4 percentage of participants Interval 94.3 to 99.8	65.9 percentage of participants Interval 57.2 to 73.9	—	—	—	—
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3 Serotype 10A	93.2 percentage of participants Interval 87.5 to 96.9	92.6 percentage of participants Interval 86.5 to 96.6	96.0 percentage of participants Interval 90.9 to 98.7	3.8 percentage of participants Interval 1.2 to 8.6	—	—	—	—
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3 Serotype 11A	98.5 percentage of participants Interval 94.7 to 99.8	100 percentage of participants Interval 97.0 to 100.0	97.6 percentage of participants Interval 93.1 to 99.5	7.6 percentage of participants Interval 3.7 to 13.5	—	—	—	—
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3 Serotype 12F	97.7 percentage of participants Interval 93.5 to 99.5	93.4 percentage of participants Interval 87.5 to 97.1	94.4 percentage of participants Interval 88.8 to 97.7	0 percentage of participants Interval 0.0 to 2.8	—	—	—	—
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3 Serotype 15B	98.5 percentage of participants Interval 94.7 to 99.8	95.9 percentage of participants Interval 90.7 to 98.7	97.6 percentage of participants Interval 93.1 to 99.5	6.9 percentage of participants Interval 3.2 to 12.6	—	—	—	—
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3 Serotype 22F	100 percentage of participants Interval 97.3 to 100.0	97.5 percentage of participants Interval 93.0 to 99.5	97.6 percentage of participants Interval 93.1 to 99.5	3.0 percentage of participants Interval 0.8 to 7.6	—	—	—	—
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3 Serotype 33F	91.7 percentage of participants Interval 85.7 to 95.8	89.3 percentage of participants Interval 82.5 to 94.2	92.8 percentage of participants Interval 86.8 to 96.7	3.8 percentage of participants Interval 1.3 to 8.7	—	—	—	—
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3 Serotype 1	97.7 percentage of participants Interval 93.5 to 99.5	96.7 percentage of participants Interval 91.8 to 99.1	95.2 percentage of participants Interval 89.8 to 98.2	97.0 percentage of participants Interval 92.4 to 99.2	—	—	—	—
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3 Serotype 3	94.7 percentage of participants Interval 89.5 to 97.9	95.1 percentage of participants Interval 89.6 to 98.2	97.6 percentage of participants Interval 93.1 to 99.5	81.8 percentage of participants Interval 74.2 to 88.0	—	—	—	—

PRIMARY outcome

Timeframe: Day 150

Population: PPAS2 was a subset of FAS2. FAS2: All randomized participants to Groups 5 to 8 who received at least 1 dose of study vaccine in primary series and had a valid post-primary series vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least 1 serotype, or titer/concentration for at least 1 antigen on concomitant vaccines). Only participants with data collected for each specified category are reported.

The GMCs for serotype-specific pneumococcal IgG antibodies were measured using PnPS-ECL, a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.

Outcome measures

Outcome measures
Measure	Stage I: Group 1 SP0202-IIb n=133 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.	Stage I: Group 2 SP0202-VI n=122 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII n=125 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 n=132 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 6 SP0202-VI Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3 Serotype 1	1.91 mcg/mL Interval 1.66 to 2.19	2.21 mcg/mL Interval 1.88 to 2.61	1.97 mcg/mL Interval 1.66 to 2.34	2.81 mcg/mL Interval 2.39 to 3.3	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3 Serotype 3	0.800 mcg/mL Interval 0.721 to 0.887	1.14 mcg/mL Interval 1.01 to 1.27	1.17 mcg/mL Interval 1.04 to 1.31	0.676 mcg/mL Interval 0.598 to 0.764	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3 Serotype 4	0.900 mcg/mL Interval 0.819 to 0.988	0.880 mcg/mL Interval 0.798 to 0.971	1.06 mcg/mL Interval 0.951 to 1.18	1.63 mcg/mL Interval 1.45 to 1.83	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3 Serotype 5	3.62 mcg/mL Interval 3.02 to 4.35	3.26 mcg/mL Interval 2.7 to 3.95	3.00 mcg/mL Interval 2.42 to 3.71	1.88 mcg/mL Interval 1.63 to 2.17	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3 Serotype 6A	3.41 mcg/mL Interval 2.93 to 3.96	2.77 mcg/mL Interval 2.33 to 3.3	3.26 mcg/mL Interval 2.78 to 3.82	4.53 mcg/mL Interval 3.93 to 5.21	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3 Serotype 6B	1.95 mcg/mL Interval 1.52 to 2.49	1.64 mcg/mL Interval 1.22 to 2.2	1.97 mcg/mL Interval 1.51 to 2.59	2.87 mcg/mL Interval 2.36 to 3.48	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3 Serotype 7F	3.88 mcg/mL Interval 3.47 to 4.34	3.68 mcg/mL Interval 3.27 to 4.14	3.45 mcg/mL Interval 3.05 to 3.9	3.93 mcg/mL Interval 3.53 to 4.36	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3 Serotype 9V	1.35 mcg/mL Interval 1.18 to 1.55	1.16 mcg/mL Interval 0.989 to 1.37	1.49 mcg/mL Interval 1.27 to 1.74	2.41 mcg/mL Interval 2.12 to 2.74	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3 Serotype 14	7.49 mcg/mL Interval 6.36 to 8.81	6.83 mcg/mL Interval 5.85 to 7.98	6.84 mcg/mL Interval 5.73 to 8.17	7.41 mcg/mL Interval 6.2 to 8.86	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3 Serotype 18C	1.67 mcg/mL Interval 1.49 to 1.87	1.56 mcg/mL Interval 1.391 to 1.76	1.46 mcg/mL Interval 1.31 to 1.63	1.92 mcg/mL Interval 1.67 to 2.2	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3 Serotype 19A	1.86 mcg/mL Interval 1.57 to 2.2	1.74 mcg/mL Interval 1.43 to 2.11	1.86 mcg/mL Interval 1.57 to 2.21	2.17 mcg/mL Interval 1.85 to 2.54	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3 Serotype 19F	3.32 mcg/mL Interval 2.98 to 3.7	3.31 mcg/mL Interval 2.93 to 3.75	2.95 mcg/mL Interval 2.51 to 3.46	3.70 mcg/mL Interval 3.23 to 4.24	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3 Serotype 23F	2.69 mcg/mL Interval 2.31 to 3.13	1.96 mcg/mL Interval 1.69 to 2.28	2.05 mcg/mL Interval 1.73 to 2.43	1.71 mcg/mL Interval 1.44 to 2.04	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3 Serotype 8	3.27 mcg/mL Interval 2.92 to 3.66	2.87 mcg/mL Interval 2.55 to 3.22	3.08 mcg/mL Interval 2.7 to 3.51	0.105 mcg/mL Interval 0.093 to 0.119	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3 Serotype 9N	2.53 mcg/mL Interval 2.26 to 2.84	2.39 mcg/mL Interval 2.1 to 2.71	2.42 mcg/mL Interval 2.12 to 2.77	0.510 mcg/mL Interval 0.424 to 0.612	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3 Serotype 10A	2.86 mcg/mL Interval 2.29 to 3.57	2.84 mcg/mL Interval 2.24 to 3.59	3.26 mcg/mL Interval 2.68 to 3.97	0.098 mcg/mL Interval 0.089 to 0.108	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3 Serotype 11A	2.52 mcg/mL Interval 2.21 to 2.88	2.51 mcg/mL Interval 2.21 to 2.85	2.32 mcg/mL Interval 1.99 to 2.71	0.108 mcg/mL Interval 0.095 to 0.123	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3 Serotype 12F	1.93 mcg/mL Interval 1.68 to 2.23	1.56 mcg/mL Interval 1.33 to 1.82	1.54 mcg/mL Interval 1.31 to 1.81	0.076 mcg/mL Interval 0.075 to 0.078	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3 Serotype 15B	7.88 mcg/mL Interval 6.54 to 9.48	7.161 mcg/mL Interval 5.73 to 8.95	6.84 mcg/mL Interval 5.54 to 8.45	0.097 mcg/mL Interval 0.087 to 0.107	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3 Serotype 22F	12.3 mcg/mL Interval 10.8 to 14.1	10.4 mcg/mL Interval 8.59 to 12.6	9.27 mcg/mL Interval 7.58 to 11.3	0.092 mcg/mL Interval 0.083 to 0.103	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3 Serotype 33F	2.67 mcg/mL Interval 2.11 to 3.37	2.61 mcg/mL Interval 2.05 to 3.32	2.57 mcg/mL Interval 2.09 to 3.16	0.093 mcg/mL Interval 0.085 to 0.101	—	—	—	—

PRIMARY outcome

Timeframe: Day 330

Population: Per protocol analysis set 3 (PPAS3) was a subset of Full analysis set 3 (FAS3). FAS3: All randomized participants to Groups 5 to 8 who received at least 1 dose of study vaccine at time of booster and had a valid post-booster vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least 1 serotype or titer/concentration for at least 1 antigen on concomitant vaccines). Only participants with data collected for each specified category are reported.

The GMCs for serotype specific pneumococcal IgG antibodies were measured using PnPS-ECL, a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.

Outcome measures

Outcome measures
Measure	Stage I: Group 1 SP0202-IIb n=122 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.	Stage I: Group 2 SP0202-VI n=108 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII n=101 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 n=128 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 6 SP0202-VI Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4 Serotype 1	3.16 mcg/mL Interval 2.68 to 3.73	3.59 mcg/mL Interval 3.02 to 4.26	3.44 mcg/mL Interval 2.87 to 4.12	3.89 mcg/mL Interval 3.35 to 4.5	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4 Serotype 3	0.755 mcg/mL Interval 0.675 to 0.844	1.07 mcg/mL Interval 0.949 to 1.21	1.03 mcg/mL Interval 0.922 to 1.16	0.961 mcg/mL Interval 0.843 to 1.09	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4 Serotype 4	1.37 mcg/mL Interval 1.18 to 1.59	1.25 mcg/mL Interval 1.08 to 1.45	1.75 mcg/mL Interval 1.49 to 2.05	2.41 mcg/mL Interval 2.09 to 2.77	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4 Serotype 5	7.56 mcg/mL Interval 6.24 to 9.18	6.46 mcg/mL Interval 5.25 to 7.95	6.63 mcg/mL Interval 5.32 to 8.24	3.07 mcg/mL Interval 2.67 to 3.54	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4 Serotype 6A	9.44 mcg/mL Interval 8.01 to 11.1	8.08 mcg/mL Interval 6.93 to 9.43	7.80 mcg/mL Interval 6.5 to 9.36	10.8 mcg/mL Interval 9.36 to 12.4	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4 Serotype 6B	8.77 mcg/mL Interval 7.14 to 10.8	8.36 mcg/mL Interval 6.88 to 10.2	7.96 mcg/mL Interval 6.63 to 9.57	8.54 mcg/mL Interval 7.46 to 9.78	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4 Serotype 7F	4.42 mcg/mL Interval 3.93 to 4.97	4.19 mcg/mL Interval 3.63 to 4.85	3.76 mcg/mL Interval 3.33 to 4.24	5.41 mcg/mL Interval 4.8 to 6.09	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4 Serotype 9V	2.20 mcg/mL Interval 1.89 to 2.57	2.06 mcg/mL Interval 1.78 to 2.38	2.57 mcg/mL Interval 2.2 to 3.01	4.32 mcg/mL Interval 3.77 to 4.95	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4 Serotype 14	6.94 mcg/mL Interval 5.93 to 8.11	6.77 mcg/mL Interval 5.62 to 8.14	7.70 mcg/mL Interval 6.58 to 9.0	8.73 mcg/mL Interval 7.34 to 10.4	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4 Serotype 18C	1.79 mcg/mL Interval 1.58 to 2.02	1.66 mcg/mL Interval 1.46 to 1.9	1.55 mcg/mL Interval 1.37 to 1.77	2.81 mcg/mL Interval 2.46 to 3.21	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4 Serotype 19A	6.92 mcg/mL Interval 5.79 to 8.28	7.36 mcg/mL Interval 6.12 to 8.84	7.72 mcg/mL Interval 6.37 to 9.36	7.38 mcg/mL Interval 6.28 to 8.67	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4 Serotype 19F	6.64 mcg/mL Interval 5.75 to 7.67	7.48 mcg/mL Interval 6.18 to 9.06	6.68 mcg/mL Interval 5.62 to 7.94	7.03 mcg/mL Interval 6.05 to 8.16	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4 Serotype 23F	3.78 mcg/mL Interval 3.19 to 4.49	2.90 mcg/mL Interval 2.46 to 3.42	2.99 mcg/mL Interval 2.5 to 3.57	3.54 mcg/mL Interval 3.02 to 4.16	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4 Serotype 8	4.64 mcg/mL Interval 3.94 to 5.46	4.36 mcg/mL Interval 3.74 to 5.08	4.26 mcg/mL Interval 3.56 to 5.1	0.238 mcg/mL Interval 0.196 to 0.289	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4 Serotype 9N	4.16 mcg/mL Interval 3.6 to 4.79	4.23 mcg/mL Interval 3.72 to 4.8	3.80 mcg/mL Interval 3.18 to 4.54	0.953 mcg/mL Interval 0.773 to 1.18	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4 Serotype 10A	5.67 mcg/mL Interval 4.71 to 6.83	5.70 mcg/mL Interval 4.76 to 6.83	4.78 mcg/mL Interval 3.96 to 5.78	0.160 mcg/mL Interval 0.137 to 0.187	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4 Serotype 11A	3.66 mcg/mL Interval 3.17 to 4.21	3.92 mcg/mL Interval 3.36 to 4.57	3.22 mcg/mL Interval 2.69 to 3.85	0.154 mcg/mL Interval 0.128 to 0.186	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4 Serotype 12F	2.68 mcg/mL Interval 2.3 to 3.13	2.25 mcg/mL Interval 1.94 to 2.61	2.04 mcg/mL Interval 1.73 to 2.41	0.080 mcg/mL Interval 0.076 to 0.085	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4 Serotype 15B	19.6 mcg/mL Interval 16.5 to 23.2	17.3 mcg/mL Interval 14.2 to 21.2	15.7 mcg/mL Interval 12.6 to 19.5	0.114 mcg/mL Interval 0.097 to 0.134	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4 Serotype 22F	24.5 mcg/mL Interval 21.1 to 28.3	21.3 mcg/mL Interval 17.8 to 25.6	20.6 mcg/mL Interval 16.8 to 25.2	0.173 mcg/mL Interval 0.144 to 0.206	—	—	—	—
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4 Serotype 33F	4.74 mcg/mL Interval 4.07 to 5.52	4.83 mcg/mL Interval 4.13 to 5.65	4.62 mcg/mL Interval 3.89 to 5.49	0.158 mcg/mL Interval 0.134 to 0.186	—	—	—	—

SECONDARY outcome

Timeframe: Day 30

Population: Results are based on PPAS1 which is a subset of the FAS1 for toddlers. Only participants with data collected for each specified category are reported.

The GMs for serotype specific OPA titers were measured using multiplex opsonophagocytic assay (MOPA) which is used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination.

Outcome measures

Outcome measures
Measure	Stage I: Group 1 SP0202-IIb n=24 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.	Stage I: Group 2 SP0202-VI n=24 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII n=23 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 n=25 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 6 SP0202-VI Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose Serotype 4	3467 1/dilution (1/dil) Interval 2296.0 to 5234.0	2862 1/dilution (1/dil) Interval 2027.0 to 4041.0	5420 1/dilution (1/dil) Interval 3366.0 to 8725.0	2975 1/dilution (1/dil) Interval 1981.0 to 4466.0	—	—	—	—
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose Serotype 5	1287 1/dilution (1/dil) Interval 736.0 to 2252.0	1333 1/dilution (1/dil) Interval 867.0 to 2050.0	1397 1/dilution (1/dil) Interval 817.0 to 2389.0	1307 1/dilution (1/dil) Interval 820.0 to 2082.0	—	—	—	—
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose Serotype 1	138 1/dilution (1/dil) Interval 62.1 to 306.0	94.2 1/dilution (1/dil) Interval 49.9 to 178.0	177 1/dilution (1/dil) Interval 92.3 to 339.0	247 1/dilution (1/dil) Interval 140.0 to 434.0	—	—	—	—
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose Serotype 3	272 1/dilution (1/dil) Interval 204.0 to 363.0	314 1/dilution (1/dil) Interval 229.0 to 431.0	393 1/dilution (1/dil) Interval 287.0 to 537.0	216 1/dilution (1/dil) Interval 160.0 to 292.0	—	—	—	—
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose Serotype 6A	4623 1/dilution (1/dil) Interval 3110.0 to 6871.0	6083 1/dilution (1/dil) Interval 4341.0 to 8523.0	7232 1/dilution (1/dil) Interval 5071.0 to 10315.0	7553 1/dilution (1/dil) Interval 5386.0 to 10592.0	—	—	—	—
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose Serotype 6B	3027 1/dilution (1/dil) Interval 1935.0 to 4737.0	3542 1/dilution (1/dil) Interval 2348.0 to 5342.0	5171 1/dilution (1/dil) Interval 3369.0 to 7935.0	4679 1/dilution (1/dil) Interval 3132.0 to 6992.0	—	—	—	—
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose Serotype 7F	8449 1/dilution (1/dil) Interval 5127.0 to 13924.0	7640 1/dilution (1/dil) Interval 4974.0 to 11734.0	6284 1/dilution (1/dil) Interval 4099.0 to 9634.0	10443 1/dilution (1/dil) Interval 6580.0 to 16575.0	—	—	—	—
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose Serotype 9V	3612 1/dilution (1/dil) Interval 2492.0 to 5236.0	3254 1/dilution (1/dil) Interval 2121.0 to 4991.0	4720 1/dilution (1/dil) Interval 2911.0 to 7654.0	4057 1/dilution (1/dil) Interval 2778.0 to 5926.0	—	—	—	—
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose Serotype 14	3598 1/dilution (1/dil) Interval 2195.0 to 5898.0	3881 1/dilution (1/dil) Interval 2534.0 to 5943.0	3191 1/dilution (1/dil) Interval 2045.0 to 4979.0	2828 1/dilution (1/dil) Interval 1948.0 to 4107.0	—	—	—	—
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose Serotype 18C	1490 1/dilution (1/dil) Interval 921.0 to 2411.0	1760 1/dilution (1/dil) Interval 1176.0 to 2634.0	1722 1/dilution (1/dil) Interval 1233.0 to 2404.0	2424 1/dilution (1/dil) Interval 1558.0 to 3771.0	—	—	—	—
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose Serotype 19A	3082 1/dilution (1/dil) Interval 2115.0 to 4493.0	3174 1/dilution (1/dil) Interval 2302.0 to 4377.0	3004 1/dilution (1/dil) Interval 2121.0 to 4256.0	5354 1/dilution (1/dil) Interval 3343.0 to 8577.0	—	—	—	—
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose Serotype 19F	1194 1/dilution (1/dil) Interval 838.0 to 1701.0	1806 1/dilution (1/dil) Interval 1207.0 to 2702.0	1569 1/dilution (1/dil) Interval 955.0 to 2576.0	2554 1/dilution (1/dil) Interval 1818.0 to 3588.0	—	—	—	—
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose Serotype 23F	5451 1/dilution (1/dil) Interval 3431.0 to 8662.0	7457 1/dilution (1/dil) Interval 5131.0 to 10838.0	5179 1/dilution (1/dil) Interval 3303.0 to 8121.0	9264 1/dilution (1/dil) Interval 5738.0 to 14957.0	—	—	—	—
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose Serotype 8	4244 1/dilution (1/dil) Interval 2705.0 to 6658.0	7003 1/dilution (1/dil) Interval 5065.0 to 9681.0	7989 1/dilution (1/dil) Interval 5076.0 to 12576.0	222 1/dilution (1/dil) Interval 120.0 to 412.0	—	—	—	—
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose Serotype 9N	11562 1/dilution (1/dil) Interval 9510.0 to 14057.0	8391 1/dilution (1/dil) Interval 6117.0 to 11511.0	12115 1/dilution (1/dil) Interval 8129.0 to 18054.0	2061 1/dilution (1/dil) Interval 1445.0 to 2940.0	—	—	—	—
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose Serotype 10A	3582 1/dilution (1/dil) Interval 2518.0 to 5096.0	3615 1/dilution (1/dil) Interval 2706.0 to 4829.0	4001 1/dilution (1/dil) Interval 2768.0 to 5782.0	10.0 1/dilution (1/dil) Interval 4.07 to 24.7	—	—	—	—
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose Serotype 11A	611 1/dilution (1/dil) Interval 378.0 to 988.0	686 1/dilution (1/dil) Interval 349.0 to 1345.0	661 1/dilution (1/dil) Interval 311.0 to 1408.0	4.14 1/dilution (1/dil) Interval 3.86 to 4.44	—	—	—	—
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose Serotype 12F	6767 1/dilution (1/dil) Interval 4628.0 to 9895.0	7391 1/dilution (1/dil) Interval 4704.0 to 11615.0	7955 1/dilution (1/dil) Interval 4793.0 to 13205.0	5.27 1/dilution (1/dil) Interval 3.28 to 8.46	—	—	—	—
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose Serotype 15B	1087 1/dilution (1/dil) Interval 402.0 to 2941.0	1346 1/dilution (1/dil) Interval 496.0 to 3658.0	1476 1/dilution (1/dil) Interval 467.0 to 4671.0	37.7 1/dilution (1/dil) Interval 20.3 to 69.8	—	—	—	—
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose Serotype 22F	4106 1/dilution (1/dil) Interval 2963.0 to 5690.0	3352 1/dilution (1/dil) Interval 2354.0 to 4773.0	4443 1/dilution (1/dil) Interval 2858.0 to 6906.0	69.0 1/dilution (1/dil) Interval 24.3 to 196.0	—	—	—	—
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose Serotype 33F	39691 1/dilution (1/dil) Interval 27999.0 to 56266.0	30399 1/dilution (1/dil) Interval 18394.0 to 50238.0	35326 1/dilution (1/dil) Interval 24106.0 to 51770.0	2689 1/dilution (1/dil) Interval 1702.0 to 4249.0	—	—	—	—

SECONDARY outcome

Timeframe: Day 150

Population: Results are based on PPPAS2-OPA subset which is a subset of the FAS for infants. Only participants with data collected for each specified category are reported.

The GMs for serotype specific OPA titers were measured using MOPA which is used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination.

Outcome measures

Outcome measures
Measure	Stage I: Group 1 SP0202-IIb n=89 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.	Stage I: Group 2 SP0202-VI n=85 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII n=83 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 n=95 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 6 SP0202-VI Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3 Serotype 5	602 1/dil Interval 469.0 to 771.0	492 1/dil Interval 372.0 to 652.0	495 1/dil Interval 370.0 to 662.0	569 1/dil Interval 450.0 to 719.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3 Serotype 6A	2456 1/dil Interval 2032.0 to 2969.0	2223 1/dil Interval 1743.0 to 2834.0	2664 1/dil Interval 2187.0 to 3245.0	2799 1/dil Interval 2307.0 to 3395.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3 Serotype 14	1959 1/dil Interval 1580.0 to 2429.0	1767 1/dil Interval 1391.0 to 2244.0	2293 1/dil Interval 1858.0 to 2829.0	1920 1/dil Interval 1574.0 to 2344.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3 Serotype 6B	1436 1/dil Interval 1008.0 to 2045.0	1041 1/dil Interval 677.0 to 1602.0	1885 1/dil Interval 1384.0 to 2567.0	2472 1/dil Interval 1934.0 to 3160.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3 Serotype 7F	5964 1/dil Interval 4989.0 to 7130.0	5449 1/dil Interval 4536.0 to 6545.0	5889 1/dil Interval 4980.0 to 6963.0	5252 1/dil Interval 4521.0 to 6102.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3 Serotype 9V	898 1/dil Interval 659.0 to 1224.0	700 1/dil Interval 483.0 to 1014.0	1136 1/dil Interval 866.0 to 1492.0	1319 1/dil Interval 1040.0 to 1672.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3 Serotype 1	73.6 1/dil Interval 53.4 to 101.0	81.7 1/dil Interval 59.1 to 113.0	66.4 1/dil Interval 46.7 to 94.5	114 1/dil Interval 86.4 to 151.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3 Serotype 3	170 1/dil Interval 146.0 to 197.0	218 1/dil Interval 180.0 to 266.0	260 1/dil Interval 226.0 to 300.0	178 1/dil Interval 147.0 to 215.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3 Serotype 4	703 1/dil Interval 586.0 to 843.0	616 1/dil Interval 492.0 to 771.0	1154 1/dil Interval 934.0 to 1425.0	1789 1/dil Interval 1489.0 to 2151.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3 Serotype 18C	866 1/dil Interval 731.0 to 1026.0	819 1/dil Interval 668.0 to 1003.0	804 1/dil Interval 660.0 to 979.0	1000 1/dil Interval 804.0 to 1245.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3 Serotype 19A	640 1/dil Interval 521.0 to 788.0	512 1/dil Interval 384.0 to 684.0	778 1/dil Interval 630.0 to 962.0	1130 1/dil Interval 959.0 to 1332.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3 Serotype 19F	533 1/dil Interval 422.0 to 674.0	591 1/dil Interval 451.0 to 774.0	629 1/dil Interval 461.0 to 860.0	613 1/dil Interval 489.0 to 768.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3 Serotype 23F	2654 1/dil Interval 2157.0 to 3265.0	1967 1/dil Interval 1500.0 to 2580.0	2279 1/dil Interval 1770.0 to 2934.0	4299 1/dil Interval 3536.0 to 5227.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3 Serotype 8	1486 1/dil Interval 1239.0 to 1782.0	1440 1/dil Interval 1237.0 to 1677.0	1612 1/dil Interval 1378.0 to 1886.0	133 1/dil Interval 89.9 to 196.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3 Serotype 9N	4261 1/dil Interval 3534.0 to 5138.0	4994 1/dil Interval 4248.0 to 5870.0	5257 1/dil Interval 4150.0 to 6661.0	811 1/dil Interval 585.0 to 1126.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3 Serotype 10A	2306 1/dil Interval 1539.0 to 3453.0	2722 1/dil Interval 1875.0 to 3951.0	3251 1/dil Interval 2501.0 to 4225.0	9.42 1/dil Interval 6.33 to 14.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3 Serotype 11A	52.6 1/dil Interval 36.7 to 75.3	64.9 1/dil Interval 44.2 to 95.3	76.6 1/dil Interval 52.6 to 112.0	5.91 1/dil Interval 4.62 to 7.54	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3 Serotype 12F	2182 1/dil Interval 1764.0 to 2700.0	2179 1/dil Interval 1798.0 to 2640.0	2334 1/dil Interval 1836.0 to 2967.0	5.31 1/dil Interval 4.15 to 6.8	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3 Serotype 15B	6686 1/dil Interval 5281.0 to 8466.0	5859 1/dil Interval 4218.0 to 8139.0	5220 1/dil Interval 3829.0 to 7116.0	28.1 1/dil Interval 22.8 to 34.7	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3 Serotype 22F	5227 1/dil Interval 4421.0 to 6181.0	4657 1/dil Interval 3802.0 to 5706.0	4617 1/dil Interval 3725.0 to 5723.0	16.1 1/dil Interval 12.5 to 20.7	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3 Serotype 33F	10070 1/dil Interval 7198.0 to 14088.0	11179 1/dil Interval 8604.0 to 14524.0	11900 1/dil Interval 8552.0 to 16559.0	311 1/dil Interval 181.0 to 535.0	—	—	—	—

SECONDARY outcome

Timeframe: Day 330

Population: Results are based on PPAS3-OPA subset which is a subset of the FAS3 for infants. Only participants with data collected for each specified category are reported.

Outcome measures

Outcome measures
Measure	Stage I: Group 1 SP0202-IIb n=82 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.	Stage I: Group 2 SP0202-VI n=73 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII n=70 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 n=92 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 6 SP0202-VI Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4 Serotype 1	407 1/dil Interval 295.0 to 561.0	355 1/dil Interval 255.0 to 495.0	320 1/dil Interval 211.0 to 486.0	318 1/dil Interval 251.0 to 403.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4 Serotype 3	274 1/dil Interval 230.0 to 328.0	308 1/dil Interval 244.0 to 390.0	376 1/dil Interval 314.0 to 450.0	348 1/dil Interval 294.0 to 412.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4 Serotype 4	3754 1/dil Interval 3002.0 to 4694.0	2536 1/dil Interval 1915.0 to 3359.0	5556 1/dil Interval 4318.0 to 7150.0	6028 1/dil Interval 4801.0 to 7570.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4 Serotype 5	2348 1/dil Interval 1884.0 to 2926.0	1787 1/dil Interval 1365.0 to 2339.0	2131 1/dil Interval 1626.0 to 2794.0	1396 1/dil Interval 1119.0 to 1740.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4 Serotype 6A	5153 1/dil Interval 4338.0 to 6119.0	4786 1/dil Interval 3929.0 to 5829.0	4433 1/dil Interval 3434.0 to 5722.0	6862 1/dil Interval 5741.0 to 8202.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4 Serotype 6B	3899 1/dil Interval 3019.0 to 5037.0	3305 1/dil Interval 2614.0 to 4178.0	3638 1/dil Interval 2756.0 to 4802.0	7092 1/dil Interval 5699.0 to 8825.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4 Serotype 7F	10234 1/dil Interval 8469.0 to 12368.0	8643 1/dil Interval 7263.0 to 10285.0	9232 1/dil Interval 7448.0 to 11444.0	13971 1/dil Interval 11575.0 to 16863.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4 Serotype 9V	3044 1/dil Interval 2424.0 to 3823.0	2641 1/dil Interval 2137.0 to 3263.0	2956 1/dil Interval 2363.0 to 3698.0	4364 1/dil Interval 3459.0 to 5505.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4 Serotype 14	3415 1/dil Interval 2785.0 to 4188.0	3098 1/dil Interval 2527.0 to 3798.0	4190 1/dil Interval 3397.0 to 5168.0	3378 1/dil Interval 2559.0 to 4459.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4 Serotype 18C	1891 1/dil Interval 1565.0 to 2285.0	1422 1/dil Interval 1110.0 to 1823.0	1368 1/dil Interval 1092.0 to 1713.0	2821 1/dil Interval 2342.0 to 3399.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4 Serotype 19A	3808 1/dil Interval 3057.0 to 4743.0	3086 1/dil Interval 2422.0 to 3933.0	3580 1/dil Interval 2806.0 to 4566.0	7535 1/dil Interval 6068.0 to 9357.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4 Serotype 9N	9479 1/dil Interval 7967.0 to 11277.0	8565 1/dil Interval 7485.0 to 9800.0	10257 1/dil Interval 8771.0 to 11995.0	3043 1/dil Interval 2370.0 to 3906.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4 Serotype 19F	2071 1/dil Interval 1730.0 to 2481.0	1821 1/dil Interval 1313.0 to 2527.0	1654 1/dil Interval 1173.0 to 2332.0	2249 1/dil Interval 1750.0 to 2889.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4 Serotype 23F	5444 1/dil Interval 4211.0 to 7037.0	4444 1/dil Interval 3644.0 to 5418.0	4047 1/dil Interval 3019.0 to 5424.0	18569 1/dil Interval 14765.0 to 23352.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4 Serotype 8	4559 1/dil Interval 3753.0 to 5537.0	4229 1/dil Interval 3527.0 to 5070.0	4916 1/dil Interval 3751.0 to 6443.0	773 1/dil Interval 616.0 to 970.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4 Serotype 10A	4278 1/dil Interval 3125.0 to 5856.0	4797 1/dil Interval 3722.0 to 6184.0	4768 1/dil Interval 3358.0 to 6770.0	46.6 1/dil Interval 23.9 to 90.9	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4 Serotype 11A	433 1/dil Interval 310.0 to 604.0	390 1/dil Interval 253.0 to 603.0	550 1/dil Interval 372.0 to 812.0	8.11 1/dil Interval 5.45 to 12.1	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4 Serotype 12F	4520 1/dil Interval 3743.0 to 5459.0	4757 1/dil Interval 3800.0 to 5956.0	5030 1/dil Interval 3785.0 to 6685.0	7.92 1/dil Interval 5.26 to 12.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4 Serotype 33F	26134 1/dil Interval 20845.0 to 32766.0	21202 1/dil Interval 17071.0 to 26332.0	32376 1/dil Interval 25782.0 to 40657.0	3224 1/dil Interval 2388.0 to 4353.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4 Serotype 15B	14756 1/dil Interval 11612.0 to 18750.0	13136 1/dil Interval 9623.0 to 17932.0	12799 1/dil Interval 9111.0 to 17981.0	55.2 1/dil Interval 36.7 to 83.0	—	—	—	—
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4 Serotype 22F	20372 1/dil Interval 15640.0 to 26536.0	16063 1/dil Interval 12306.0 to 20967.0	21319 1/dil Interval 15648.0 to 29045.0	65.7 1/dil Interval 37.7 to 114.0	—	—	—	—

SECONDARY outcome

Timeframe: Day 150

Population: Results are based on PPAS2 which is a subset of the FAS2 for infants. Only participants with data collected for this outcome measure are reported.

Anti-rotavirus IgA antibodies in human serum were measured by enzyme linked immunosorbent assay (ELISA). A reference standard assayed on each plate was used to calculate the amount of specific anti-rotavirus IgA antibody in the units assigned by the reference standard.

Outcome measures

Outcome measures
Measure	Stage I: Group 1 SP0202-IIb n=119 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.	Stage I: Group 2 SP0202-VI n=105 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII n=110 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 n=120 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 6 SP0202-VI Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
For Infants: GMC of Anti-Rotavirus Serum Immunoglobulin A (IgA) Antibodies 30 Days Post-Dose 3	407 Units (U)/mL Interval 303.0 to 545.0	390 Units (U)/mL Interval 283.0 to 537.0	494 Units (U)/mL Interval 369.0 to 661.0	393 Units (U)/mL Interval 277.0 to 560.0	—	—	—	—

SECONDARY outcome

Timeframe: Day 150

Population: Results are based on PPAS2 which is a subset of the FAS2 for infants. Only participants with data collected for each specified category are reported.

Percentage of participants with toxoid concentration \>=0.10 mcg/mL for diphtheria and tetanus and \>=0.15 mcg/mL for PRP are presented. Anti-diphtheria and anti-tetanus concentrations were measured using electro-chemiluminescence assay (ECL) and anti-PRP concentrations were measured using a Farr-type radioimmunoassay.

Outcome measures

Outcome measures
Measure	Stage I: Group 1 SP0202-IIb n=130 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.	Stage I: Group 2 SP0202-VI n=118 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII n=123 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 n=130 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 6 SP0202-VI Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
For Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3 Anti-Diphtheria toxoid	94.6 percentage of participants Interval 89.2 to 97.8	97.5 percentage of participants Interval 92.7 to 99.5	95.9 percentage of participants Interval 90.8 to 98.7	96.9 percentage of participants Interval 92.3 to 99.2	—	—	—	—
For Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3 Anti-Tetanus toxoid	100 percentage of participants Interval 97.2 to 100.0	100 percentage of participants Interval 96.9 to 100.0	100 percentage of participants Interval 97.0 to 100.0	100 percentage of participants Interval 97.2 to 100.0	—	—	—	—
For Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3 Anti-PRP	99.2 percentage of participants Interval 95.7 to 100.0	99.1 percentage of participants Interval 95.2 to 100.0	98.2 percentage of participants Interval 93.7 to 99.8	100 percentage of participants Interval 97.2 to 100.0	—	—	—	—

SECONDARY outcome

Timeframe: Day 150

Population: Results are based on PPAS2 which is a subset of the FAS2 for infants. Only participants with data collected for each specified category are reported.

Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. Response was defined as a titer \>=8.

Outcome measures

Outcome measures
Measure	Stage I: Group 1 SP0202-IIb n=125 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.	Stage I: Group 2 SP0202-VI n=109 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII n=114 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 n=127 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 6 SP0202-VI Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
For Infants: Percentage of Participants With Antibody Responses to Poliovirus 1, 2 and 3 30 Days Post-Dose 3 Anti-poliovirus 3	100 percentage of participants Interval 97.1 to 100.0	100 percentage of participants Interval 96.7 to 100.0	99.1 percentage of participants Interval 95.1 to 100.0	100 percentage of participants Interval 97.1 to 100.0	—	—	—	—
For Infants: Percentage of Participants With Antibody Responses to Poliovirus 1, 2 and 3 30 Days Post-Dose 3 Anti-poliovirus 1	99.2 percentage of participants Interval 95.6 to 100.0	100 percentage of participants Interval 96.7 to 100.0	97.4 percentage of participants Interval 92.5 to 99.5	100 percentage of participants Interval 97.1 to 100.0	—	—	—	—
For Infants: Percentage of Participants With Antibody Responses to Poliovirus 1, 2 and 3 30 Days Post-Dose 3 Anti-poliovirus 2	100 percentage of participants Interval 97.0 to 100.0	100 percentage of participants Interval 96.5 to 100.0	99.1 percentage of participants Interval 95.1 to 100.0	100 percentage of participants Interval 97.1 to 100.0	—	—	—	—

SECONDARY outcome

Timeframe: Day 150

Population: Results are based on PPAS2 which is a subset of the FAS2 for infants. Only participants with data collected for this outcome measure are reported.

Serum samples were collected for analysis by ECL to determine the GMC of antibodies to the following Pertussis antigens: Pertussis toxoid/toxin, Filamentous hemagglutinin, Pertactin and Fimbriae types 2 and 3.

Outcome measures

Outcome measures
Measure	Stage I: Group 1 SP0202-IIb n=130 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.	Stage I: Group 2 SP0202-VI n=118 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII n=123 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 n=130 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 6 SP0202-VI Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
For Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3 Pertussis toxoid/toxin	67.9 ELISA units (EU)/mL Interval 60.1 to 76.6	77.2 ELISA units (EU)/mL Interval 67.4 to 88.5	66.3 ELISA units (EU)/mL Interval 57.4 to 76.6	68.3 ELISA units (EU)/mL Interval 59.7 to 78.2	—	—	—	—
For Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3 Filamentous hemagglutinin	109 ELISA units (EU)/mL Interval 94.9 to 124.0	107 ELISA units (EU)/mL Interval 94.4 to 122.0	108 ELISA units (EU)/mL Interval 95.2 to 123.0	104 ELISA units (EU)/mL Interval 93.0 to 116.0	—	—	—	—
For Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3 Pertactin	38.3 ELISA units (EU)/mL Interval 32.3 to 45.4	36.1 ELISA units (EU)/mL Interval 29.4 to 44.3	39.8 ELISA units (EU)/mL Interval 32.8 to 48.3	45.2 ELISA units (EU)/mL Interval 37.7 to 54.1	—	—	—	—
For Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3 Fimbriae types 2 and 3	347 ELISA units (EU)/mL Interval 295.0 to 408.0	341 ELISA units (EU)/mL Interval 286.0 to 407.0	315 ELISA units (EU)/mL Interval 262.0 to 380.0	343 ELISA units (EU)/mL Interval 282.0 to 418.0	—	—	—	—

SECONDARY outcome

Timeframe: Day 150

Population: Results are based on PPAS2 which is a subset of the FAS2 for infants. Only participants with data collected for this outcome measure are reported.

Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ immunodiagnostic system using chemiluminescence detection technology. The VITROS ECi immunodiagnostic system uses an antibody mediated antigen sandwich formation to detect the presence of anti-hepatitis B surface antigen total immunoglobulin in human serum. The threshold presented is \>=10 milli international units (mIU).

Outcome measures

Outcome measures
Measure	Stage I: Group 1 SP0202-IIb n=121 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.	Stage I: Group 2 SP0202-VI n=106 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII n=108 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 n=123 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 6 SP0202-VI Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
For Infants: Percentage of Participants With Antibody Responses to Hepatitis-B Antigens 30 Days Post-Dose 3	98.3 percentage of participants Interval 94.2 to 99.8	99.1 percentage of participants Interval 94.9 to 100.0	98.1 percentage of participants Interval 93.5 to 99.8	99.2 percentage of participants Interval 95.6 to 100.0	—	—	—	—

SECONDARY outcome

Timeframe: Day 330

Population: Results are based on PPAS3 which is a subset of the FAS3 for infants. Only participants with data collected for this outcome measure are reported.

Anti-measles antibodies were determined by bulk measles IgG enzyme immunoassay (EIA); anti-mumps antibodies by ELISA, anti-rubella antibodies by bulk rubella IgG EIA and anti-varicella antibodies were determined by glycoprotein ELISA to detect total IgG antibody to respective virus before and after vaccination with a virus-containing vaccine. Percentage of participants with anti-measles antibody concentrations \>=255 mIU/mL, anti-mumps antibody concentrations: \>=10 antibody units/mL, anti-rubella antibody concentrations \>=10 IU/mL and anti-varicella concentrations \>=5 units/mL is reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Stage I: Group 1 SP0202-IIb n=118 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.	Stage I: Group 2 SP0202-VI n=104 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII n=98 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 n=124 Participants Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 6 SP0202-VI Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
For Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4 Anti-Measles	97.5 percentage of participants Interval 92.7 to 99.5	97.1 percentage of participants Interval 91.8 to 99.4	96.9 percentage of participants Interval 91.3 to 99.4	98.4 percentage of participants Interval 94.3 to 99.8	—	—	—	—
For Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4 Anti-Mumps	99.2 percentage of participants Interval 95.4 to 100.0	97.1 percentage of participants Interval 91.8 to 99.4	96.9 percentage of participants Interval 91.3 to 99.4	98.4 percentage of participants Interval 94.3 to 99.8	—	—	—	—
For Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4 Anti-Rubella	98.3 percentage of participants Interval 94.0 to 99.8	98.1 percentage of participants Interval 93.2 to 99.8	99.0 percentage of participants Interval 94.4 to 100.0	98.4 percentage of participants Interval 94.3 to 99.8	—	—	—	—
For Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4 Anti-Varicella	100 percentage of participants Interval 96.9 to 100.0	99.0 percentage of participants Interval 94.8 to 100.0	95.9 percentage of participants Interval 89.9 to 98.9	98.4 percentage of participants Interval 94.3 to 99.8	—	—	—	—

Adverse Events

Stage I: Group 1 SP0202-IIb

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Stage I: Group 2 SP0202-VI

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

Stage I: Group 3 SP0202-VII

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Stage I: Group 4 Prevnar 13

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Stage II: Group 5 SP0202-IIb

Serious events: 3 serious events

Other events: 160 other events

Deaths: 0 deaths

Stage II: Group 6 SP0202-VI

Serious events: 9 serious events

Other events: 164 other events

Deaths: 1 deaths

Stage II: Group 7 SP0202-VII

Serious events: 8 serious events

Other events: 159 other events

Deaths: 0 deaths

Stage II: Group 8 Prevnar 13

Serious events: 9 serious events

Other events: 158 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Stage I: Group 1 SP0202-IIb n=35 participants at risk Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.	Stage I: Group 2 SP0202-VI n=34 participants at risk Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII n=35 participants at risk Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 n=34 participants at risk Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb n=180 participants at risk Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 6 SP0202-VI n=178 participants at risk Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII n=176 participants at risk Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 n=176 participants at risk Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Congenital, familial and genetic disorders Heart Disease Congenital	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.56% 1/178 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Eye disorders Eyelid Ptosis	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/178 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.57% 1/176 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Gastrointestinal disorders Diarrhoea	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.56% 1/180 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/178 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Gastrointestinal disorders Haematochezia	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/178 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.57% 1/176 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
General disorders Death	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.56% 1/178 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Infections and infestations Bacterial Diarrhoea	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.56% 1/178 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Infections and infestations Bronchiolitis	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.56% 1/178 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.57% 1/176 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Infections and infestations Covid-19	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/178 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.57% 1/176 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Infections and infestations Gastroenteritis	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.56% 1/178 • Number of events 2 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.57% 1/176 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Infections and infestations Hand-Foot-And-Mouth Disease	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	2.9% 1/34 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/178 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Infections and infestations Nasopharyngitis	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.56% 1/178 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Infections and infestations Pneumonia	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.56% 1/180 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/178 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.57% 1/176 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	1.1% 2/176 • Number of events 2 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Infections and infestations Pneumonia Influenzal	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/178 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.57% 1/176 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Infections and infestations Pyelonephritis	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.56% 1/178 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.57% 1/176 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Infections and infestations Respiratory Syncytial Virus Bronchiolitis	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	1.1% 2/178 • Number of events 2 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.57% 1/176 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Infections and infestations Respiratory Syncytial Virus Infection	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/178 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.57% 1/176 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Infections and infestations Subcutaneous Abscess	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/178 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.57% 1/176 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Infections and infestations Urinary Tract Infection	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.56% 1/180 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.56% 1/178 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Infections and infestations Viral Infection	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/178 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.57% 1/176 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Injury, poisoning and procedural complications Accidental Overdose	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/178 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.57% 1/176 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Injury, poisoning and procedural complications Femur Fracture	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/178 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.57% 1/176 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Metabolism and nutrition disorders Dehydration	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.56% 1/178 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.56% 1/178 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Musculoskeletal and connective tissue disorders Limb Asymmetry	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/178 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.57% 1/176 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Nervous system disorders Febrile Convulsion	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.56% 1/178 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.57% 1/176 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/180 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/178 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/176 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.57% 1/176 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.

Other adverse events

Other adverse events
Measure	Stage I: Group 1 SP0202-IIb n=35 participants at risk Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.	Stage I: Group 2 SP0202-VI n=34 participants at risk Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.	Stage I: Group 3 SP0202-VII n=35 participants at risk Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.	Stage I: Group 4 Prevnar 13 n=34 participants at risk Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.	Stage II: Group 5 SP0202-IIb n=180 participants at risk Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 6 SP0202-VI n=178 participants at risk Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 7 SP0202-VII n=176 participants at risk Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).	Stage II: Group 8 Prevnar 13 n=176 participants at risk Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Gastrointestinal disorders Diarrhoea	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	5.7% 2/35 • Number of events 2 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	10.0% 18/180 • Number of events 22 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	9.0% 16/178 • Number of events 18 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	9.7% 17/176 • Number of events 20 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	14.2% 25/176 • Number of events 26 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Gastrointestinal disorders Teething	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	5.9% 2/34 • Number of events 2 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	1.1% 2/180 • Number of events 2 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	1.7% 3/178 • Number of events 3 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	1.7% 3/176 • Number of events 6 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	2.3% 4/176 • Number of events 4 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Gastrointestinal disorders Vomiting	8.6% 3/35 • Number of events 3 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	5.7% 2/35 • Number of events 2 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	8.8% 3/34 • Number of events 3 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	23.9% 43/180 • Number of events 65 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	20.2% 36/178 • Number of events 58 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	24.4% 43/176 • Number of events 60 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	25.6% 45/176 • Number of events 58 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
General disorders Crying	45.7% 16/35 • Number of events 16 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	17.6% 6/34 • Number of events 6 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	48.6% 17/35 • Number of events 17 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	50.0% 17/34 • Number of events 17 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	62.8% 113/180 • Number of events 230 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	62.9% 112/178 • Number of events 224 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	57.4% 101/176 • Number of events 204 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	60.2% 106/176 • Number of events 231 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
General disorders Injection Site Bruising	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	2.9% 1/34 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	2.9% 1/35 • Number of events 2 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	2.9% 1/34 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	6.1% 11/180 • Number of events 17 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	5.6% 10/178 • Number of events 14 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	8.0% 14/176 • Number of events 29 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	9.7% 17/176 • Number of events 23 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
General disorders Injection Site Erythema	57.1% 20/35 • Number of events 31 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	41.2% 14/34 • Number of events 25 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	37.1% 13/35 • Number of events 21 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	29.4% 10/34 • Number of events 18 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	39.4% 71/180 • Number of events 269 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	32.6% 58/178 • Number of events 213 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	36.9% 65/176 • Number of events 282 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	36.9% 65/176 • Number of events 260 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
General disorders Injection Site Pain	45.7% 16/35 • Number of events 26 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	35.3% 12/34 • Number of events 20 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	54.3% 19/35 • Number of events 34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	38.2% 13/34 • Number of events 23 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	66.7% 120/180 • Number of events 673 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	71.3% 127/178 • Number of events 757 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	71.0% 125/176 • Number of events 736 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	70.5% 124/176 • Number of events 816 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
General disorders Injection Site Swelling	45.7% 16/35 • Number of events 24 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	41.2% 14/34 • Number of events 21 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	40.0% 14/35 • Number of events 22 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	26.5% 9/34 • Number of events 16 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	27.8% 50/180 • Number of events 186 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	27.0% 48/178 • Number of events 171 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	27.8% 49/176 • Number of events 166 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	33.5% 59/176 • Number of events 203 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
General disorders Pyrexia	11.4% 4/35 • Number of events 4 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	20.6% 7/34 • Number of events 7 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	22.9% 8/35 • Number of events 8 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	26.5% 9/34 • Number of events 9 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	37.2% 67/180 • Number of events 108 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	34.3% 61/178 • Number of events 82 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	35.8% 63/176 • Number of events 90 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	38.6% 68/176 • Number of events 97 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Infections and infestations Bronchiolitis	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	3.9% 7/180 • Number of events 8 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	6.2% 11/178 • Number of events 12 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	4.5% 8/176 • Number of events 10 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	4.5% 8/176 • Number of events 8 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Infections and infestations Nasopharyngitis	2.9% 1/35 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	2.9% 1/34 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	33.9% 61/180 • Number of events 92 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	30.9% 55/178 • Number of events 78 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	34.7% 61/176 • Number of events 92 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	27.3% 48/176 • Number of events 73 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Infections and infestations Otitis Media	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	3.9% 7/180 • Number of events 7 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	2.2% 4/178 • Number of events 5 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	2.3% 4/176 • Number of events 4 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	5.7% 10/176 • Number of events 11 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Infections and infestations Otitis Media Acute	2.9% 1/35 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	2.2% 4/180 • Number of events 5 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	1.7% 3/178 • Number of events 3 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	5.7% 10/176 • Number of events 11 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	3.4% 6/176 • Number of events 8 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Infections and infestations Upper Respiratory Tract Infection	2.9% 1/35 • Number of events 1 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/35 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	0.00% 0/34 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	5.0% 9/180 • Number of events 11 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	4.5% 8/178 • Number of events 8 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	2.8% 5/176 • Number of events 5 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	5.7% 10/176 • Number of events 12 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Metabolism and nutrition disorders Decreased Appetite	25.7% 9/35 • Number of events 9 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	20.6% 7/34 • Number of events 7 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	37.1% 13/35 • Number of events 13 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	32.4% 11/34 • Number of events 11 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	38.9% 70/180 • Number of events 118 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	39.3% 70/178 • Number of events 109 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	38.6% 68/176 • Number of events 110 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	38.1% 67/176 • Number of events 118 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Nervous system disorders Somnolence	34.3% 12/35 • Number of events 12 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	32.4% 11/34 • Number of events 11 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	34.3% 12/35 • Number of events 12 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	29.4% 10/34 • Number of events 10 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	52.2% 94/180 • Number of events 209 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	54.5% 97/178 • Number of events 211 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	52.3% 92/176 • Number of events 209 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	59.1% 104/176 • Number of events 220 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Psychiatric disorders Irritability	60.0% 21/35 • Number of events 21 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	47.1% 16/34 • Number of events 16 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	62.9% 22/35 • Number of events 22 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	58.8% 20/34 • Number of events 20 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	61.1% 110/180 • Number of events 270 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	65.2% 116/178 • Number of events 278 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	64.8% 114/176 • Number of events 262 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.	66.5% 117/176 • Number of events 289 • AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months) Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.

Additional Information

Trial Transparency Team

Sanofi Pasteur

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Email: [email protected]

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