Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005) (NCT NCT02531373)

Last Updated: 2019-04-02

Results Overview

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

338 participants

Primary outcome timeframe

Up to 6 weeks after vaccination

Results posted on

2019-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	Adults: V114 Medium Dose Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1	Adults: V114 High Dose Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1	Adults: V114 Medium Dose + ACP Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1	Adults: V114 High Dose + ACP Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1	Infants: V114 Medium Dose Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age	Infants: V114 High Dose Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age	Infants: V114 Medium Dose + ACP Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) at 2, 4, 6, and 12-15 months of age	Infants: V114 High Dose + ACP Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP at 2, 4, 6, and 12-15 months of age	Infants: Prevnar 13™ Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
Overall Study STARTED	20	20	20	20	51	51	52	52	52
Overall Study Vaccination 1	20	20	20	20	50	50	52	52	52
Overall Study Vaccination 2	0	0	0	0	49	48	50	51	51
Overall Study Vaccination 3	0	0	0	0	48	47	49	51	49
Overall Study Vaccination 4	0	0	0	0	44	43	43	43	43
Overall Study COMPLETED	20	20	20	20	43	42	41	43	43
Overall Study NOT COMPLETED	0	0	0	0	8	9	11	9	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Infants: V114 Medium Dose Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age	Infants: V114 High Dose Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age	Infants: V114 Medium Dose + ACP Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) at 2, 4, 6, and 12-15 months of age	Infants: V114 High Dose + ACP Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP at 2, 4, 6, and 12-15 months of age	Infants: Prevnar 13™ Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
Overall Study Lack of Efficacy	3	2	4	8	5
Overall Study Lost to Follow-up	0	2	2	0	0
Overall Study Physician Decision	2	1	0	0	0
Overall Study Protocol Violation	0	1	1	0	1
Overall Study Withdrawal by Parent/Guardian	0	3	4	1	3
Overall Study Withdrawal by Subject	3	0	0	0	0

Baseline Characteristics

A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adults: V114 Medium Dose n=20 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1	Adults: V114 High Dose n=20 Participants Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1	Adults: V114 Medium Dose + ACP n=20 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1	Adults: V114 High Dose + ACP n=20 Participants Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1	Infants: V114 Medium Dose n=50 Participants Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age	Infants: V114 High Dose n=50 Participants Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age	Infants: V114 Medium Dose + ACP n=52 Participants Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) at 2, 4, 6, and 12-15 months of age	Infants: V114 High Dose + ACP n=52 Participants Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP at 2, 4, 6, and 12-15 months of age	Infants: Prevnar 13™ n=52 Participants Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age	Total n=336 Participants Total of all reporting groups
Age, Customized 6 weeks	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	3 Participants n=6 Participants	1 Participants n=6 Participants	9 Participants n=64 Participants
Age, Customized 7 weeks	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=10 Participants	3 Participants n=115 Participants	4 Participants n=6 Participants	2 Participants n=6 Participants	15 Participants n=64 Participants
Age, Customized 8 weeks	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	19 Participants n=21 Participants	15 Participants n=10 Participants	16 Participants n=115 Participants	19 Participants n=6 Participants	26 Participants n=6 Participants	95 Participants n=64 Participants
Age, Customized 9 weeks	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	14 Participants n=21 Participants	22 Participants n=10 Participants	22 Participants n=115 Participants	20 Participants n=6 Participants	16 Participants n=6 Participants	94 Participants n=64 Participants
Age, Customized 10 weeks	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=10 Participants	4 Participants n=115 Participants	4 Participants n=6 Participants	2 Participants n=6 Participants	20 Participants n=64 Participants
Age, Customized 11 weeks	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	6 Participants n=115 Participants	0 Participants n=6 Participants	4 Participants n=6 Participants	16 Participants n=64 Participants
Age, Customized 12 weeks	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=6 Participants	1 Participants n=6 Participants	7 Participants n=64 Participants
Age, Customized 18 to 29 years	6 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	20 Participants n=64 Participants
Age, Customized 30 to 39 years	10 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	6 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	35 Participants n=64 Participants
Age, Customized 40 to 49 years	4 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	25 Participants n=64 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	14 Participants n=7 Participants	11 Participants n=5 Participants	13 Participants n=4 Participants	23 Participants n=21 Participants	23 Participants n=10 Participants	29 Participants n=115 Participants	32 Participants n=6 Participants	25 Participants n=6 Participants	182 Participants n=64 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants	7 Participants n=4 Participants	27 Participants n=21 Participants	27 Participants n=10 Participants	23 Participants n=115 Participants	20 Participants n=6 Participants	27 Participants n=6 Participants	154 Participants n=64 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=64 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=64 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	7 Participants n=21 Participants	6 Participants n=10 Participants	5 Participants n=115 Participants	8 Participants n=6 Participants	7 Participants n=6 Participants	45 Participants n=64 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	16 Participants n=7 Participants	18 Participants n=5 Participants	16 Participants n=4 Participants	38 Participants n=21 Participants	40 Participants n=10 Participants	41 Participants n=115 Participants	41 Participants n=6 Participants	40 Participants n=6 Participants	264 Participants n=64 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=10 Participants	5 Participants n=115 Participants	3 Participants n=6 Participants	5 Participants n=6 Participants	24 Participants n=64 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants

PRIMARY outcome

Timeframe: Up to 6 weeks after vaccination

Population: The analysis population included all randomized adult participants who received study vaccination.

Outcome measures

Outcome measures
Measure	Adults: V114 Medium Dose n=20 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1	Adults: V114 High Dose n=20 Participants Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1	Adults: V114 Medium Dose + ACP n=20 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1	Adults: V114 High Dose + ACP n=20 Participants Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1	Infants: Prevnar 13™ Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
Adults: Percentage of Participants With an Adverse Event	90.0 Percentage of participants Interval 68.3 to 98.8	95.0 Percentage of participants Interval 75.1 to 99.9	95.0 Percentage of participants Interval 75.1 to 99.9	95.0 Percentage of participants Interval 75.1 to 99.9	—

PRIMARY outcome

Timeframe: Up to 1 month after Vaccination 4 (Month 11-15)

Population: The analysis population included all randomized infant participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.

An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

Outcome measures

Outcome measures
Measure	Adults: V114 Medium Dose n=50 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1	Adults: V114 High Dose n=50 Participants Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1	Adults: V114 Medium Dose + ACP n=51 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1	Adults: V114 High Dose + ACP n=52 Participants Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1	Infants: Prevnar 13™ n=52 Participants Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
Infants: Percentage of Participants With an Adverse Event	96.0 Percentage of participants	94.0 Percentage of participants	96.1 Percentage of participants	98.1 Percentage of participants	100.0 Percentage of participants

PRIMARY outcome

Timeframe: Up to time of Vaccination 4 (Month 10-13)

Outcome measures

Outcome measures
Measure	Adults: V114 Medium Dose n=50 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1	Adults: V114 High Dose n=50 Participants Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1	Adults: V114 Medium Dose + ACP n=51 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1	Adults: V114 High Dose + ACP n=52 Participants Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1	Infants: Prevnar 13™ n=52 Participants Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants

PRIMARY outcome

Timeframe: Up to 14 days after any vaccination

Solicited injection-site AEs were injection-site erythema, injection-site induration, injection-site pain, and injection-site swelling.

Outcome measures

Outcome measures
Measure	Adults: V114 Medium Dose n=50 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1	Adults: V114 High Dose n=50 Participants Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1	Adults: V114 Medium Dose + ACP n=51 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1	Adults: V114 High Dose + ACP n=52 Participants Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1	Infants: Prevnar 13™ n=52 Participants Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
Infants: Percentage of Participants With a Solicited Injection-site Adverse Event	78.0 Percentage of participants	80.0 Percentage of participants	58.8 Percentage of participants	80.8 Percentage of participants	57.7 Percentage of participants

PRIMARY outcome

Timeframe: Up to 14 days after any vaccination

Population: The analysis population included all randomized infant participants who received at least one dose of study vaccination and had follow-up for the outcome measure. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.

Solicited systemic AEs were irritability, decreased appetite, somnolence, and urticaria.

Outcome measures

Outcome measures
Measure	Adults: V114 Medium Dose n=44 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1	Adults: V114 High Dose n=43 Participants Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1	Adults: V114 Medium Dose + ACP n=47 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1	Adults: V114 High Dose + ACP n=49 Participants Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1	Infants: Prevnar 13™ n=46 Participants Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
Infants: Percentage of Participants With a Solicited Systemic Adverse Event	88.0 Percentage of participants	86.0 Percentage of participants	92.2 Percentage of participants	94.2 Percentage of participants	88.5 Percentage of participants

PRIMARY outcome

Timeframe: 1 month after Vaccination 3 (Month 5)

Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.

Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.

Outcome measures

Outcome measures
Measure	Adults: V114 Medium Dose n=50 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1	Adults: V114 High Dose n=50 Participants Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1	Adults: V114 Medium Dose + ACP n=52 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1	Adults: V114 High Dose + ACP Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1	Infants: Prevnar 13™ Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 19F	1.81 µg/mL Interval 1.44 to 2.28	2.37 µg/mL Interval 1.99 to 2.83	2.19 µg/mL Interval 1.8 to 2.66	—	—
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 1	1.33 µg/mL Interval 1.07 to 1.67	1.49 µg/mL Interval 1.19 to 1.87	1.63 µg/mL Interval 1.28 to 2.07	—	—
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 3	0.94 µg/mL Interval 0.78 to 1.13	1.12 µg/mL Interval 0.89 to 1.41	0.53 µg/mL Interval 0.42 to 0.67	—	—
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 4	1.46 µg/mL Interval 1.2 to 1.77	1.31 µg/mL Interval 1.05 to 1.64	1.14 µg/mL Interval 0.89 to 1.45	—	—
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 5	1.29 µg/mL Interval 0.96 to 1.74	1.13 µg/mL Interval 0.83 to 1.55	1.36 µg/mL Interval 0.94 to 1.98	—	—
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 6A	1.41 µg/mL Interval 0.95 to 2.1	1.52 µg/mL Interval 1.07 to 2.16	2.82 µg/mL Interval 1.93 to 4.12	—	—
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 6B	1.80 µg/mL Interval 1.15 to 2.82	1.30 µg/mL Interval 0.83 to 2.02	1.62 µg/mL Interval 1.01 to 2.61	—	—
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 7F	2.23 µg/mL Interval 1.77 to 2.81	2.87 µg/mL Interval 2.44 to 3.37	2.97 µg/mL Interval 2.24 to 3.93	—	—
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 9V	1.68 µg/mL Interval 1.24 to 2.29	1.44 µg/mL Interval 1.05 to 1.97	1.48 µg/mL Interval 1.1 to 1.97	—	—
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 14	4.24 µg/mL Interval 3.31 to 5.42	4.58 µg/mL Interval 3.7 to 5.67	4.94 µg/mL Interval 3.51 to 6.95	—	—
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 18C	0.96 µg/mL Interval 0.71 to 1.31	1.22 µg/mL Interval 0.99 to 1.51	1.54 µg/mL Interval 1.14 to 2.07	—	—
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 19A	1.47 µg/mL Interval 1.18 to 1.82	1.43 µg/mL Interval 1.19 to 1.72	1.63 µg/mL Interval 1.2 to 2.21	—	—
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 22F (non-Prevnar serotype)	4.34 µg/mL Interval 3.4 to 5.55	4.79 µg/mL Interval 3.88 to 5.91	0.05 µg/mL Interval 0.05 to 0.06	—	—
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 23F	1.08 µg/mL Interval 0.72 to 1.62	1.16 µg/mL Interval 0.83 to 1.61	1.19 µg/mL Interval 0.82 to 1.71	—	—
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 33F (non-Prevnar serotype)	1.32 µg/mL Interval 0.79 to 2.21	1.09 µg/mL Interval 0.64 to 1.85	0.06 µg/mL Interval 0.05 to 0.07	—	—

SECONDARY outcome

Timeframe: 1 month after vaccination

Population: The analysis population included all adult participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.

Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.

Outcome measures

Outcome measures
Measure	Adults: V114 Medium Dose n=20 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1	Adults: V114 High Dose n=20 Participants Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1	Adults: V114 Medium Dose + ACP Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1	Adults: V114 High Dose + ACP Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1	Infants: Prevnar 13™ Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 23F	11.55 µg/mL Interval 5.78 to 23.08	8.91 µg/mL Interval 4.14 to 19.2	—	—	—
Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 1	3.47 µg/mL Interval 1.83 to 6.61	4.99 µg/mL Interval 2.51 to 9.93	—	—	—
Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 3	0.50 µg/mL Interval 0.31 to 0.82	0.71 µg/mL Interval 0.44 to 1.15	—	—	—
Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 4	0.96 µg/mL Interval 0.56 to 1.65	1.47 µg/mL Interval 0.76 to 2.86	—	—	—
Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 5	3.08 µg/mL Interval 1.41 to 6.74	2.20 µg/mL Interval 1.02 to 4.77	—	—	—
Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 6A	8.42 µg/mL Interval 3.55 to 19.98	4.78 µg/mL Interval 1.99 to 11.47	—	—	—
Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 6B	7.25 µg/mL Interval 3.03 to 17.35	3.71 µg/mL Interval 1.36 to 10.14	—	—	—
Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 7F	5.12 µg/mL Interval 2.35 to 11.17	6.12 µg/mL Interval 3.3 to 11.34	—	—	—
Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 9V	2.76 µg/mL Interval 1.18 to 6.46	2.27 µg/mL Interval 1.28 to 4.04	—	—	—
Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 14	14.97 µg/mL Interval 6.62 to 33.84	9.96 µg/mL Interval 4.24 to 23.41	—	—	—
Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 18C	9.48 µg/mL Interval 4.51 to 19.91	8.91 µg/mL Interval 4.4 to 18.04	—	—	—
Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 19A	15.19 µg/mL Interval 9.85 to 23.41	4.62 µg/mL Interval 2.61 to 8.16	—	—	—
Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 19F	8.67 µg/mL Interval 4.15 to 18.15	7.96 µg/mL Interval 4.33 to 14.61	—	—	—
Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 22F	2.93 µg/mL Interval 1.8 to 4.78	4.04 µg/mL Interval 2.38 to 6.86	—	—	—
Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies Serotype 33F	4.06 µg/mL Interval 1.66 to 9.93	6.16 µg/mL Interval 3.18 to 11.94	—	—	—

SECONDARY outcome

Timeframe: Baseline and 1 month after vaccination

Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay. GMFR is defined as the geometric mean of the ratio of concentration at 1 month after vaccination divided by concentration at baseline.

Outcome measures

Outcome measures
Measure	Adults: V114 Medium Dose n=20 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1	Adults: V114 High Dose n=20 Participants Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1	Adults: V114 Medium Dose + ACP Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1	Adults: V114 High Dose + ACP Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1	Infants: Prevnar 13™ Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies Serotype 1	14.94 Ratio Interval 7.73 to 28.9	14.41 Ratio Interval 7.93 to 26.17	—	—	—
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies Serotype 3	3.12 Ratio Interval 2.08 to 4.67	4.73 Ratio Interval 2.82 to 7.92	—	—	—
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies Serotype 4	7.24 Ratio Interval 4.21 to 12.45	12.66 Ratio Interval 6.2 to 25.86	—	—	—
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies Serotype 5	6.59 Ratio Interval 3.31 to 13.12	5.79 Ratio Interval 2.91 to 11.52	—	—	—
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies Serotype 6A	47.27 Ratio Interval 23.68 to 94.36	23.26 Ratio Interval 11.98 to 45.14	—	—	—
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies Serotype 6B	35.70 Ratio Interval 17.46 to 73.0	18.23 Ratio Interval 8.84 to 37.62	—	—	—
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies Serotype 7F	12.84 Ratio Interval 6.71 to 24.56	17.51 Ratio Interval 9.58 to 32.02	—	—	—
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies Serotype 9V	12.28 Ratio Interval 5.37 to 28.1	14.61 Ratio Interval 7.81 to 27.35	—	—	—
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies Serotype 14	14.99 Ratio Interval 5.96 to 37.67	11.96 Ratio Interval 5.8 to 24.64	—	—	—
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies Serotype 18C	29.41 Ratio Interval 15.09 to 57.32	38.44 Ratio Interval 18.66 to 79.2	—	—	—
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies Serotype 19A	8.04 Ratio Interval 4.26 to 15.18	8.80 Ratio Interval 5.12 to 15.14	—	—	—
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies Serotype 19F	20.63 Ratio Interval 9.35 to 45.55	13.52 Ratio Interval 6.49 to 28.19	—	—	—
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies Serotype 22F	12.87 Ratio Interval 6.86 to 24.16	20.85 Ratio Interval 11.81 to 36.82	—	—	—
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies Serotype 23F	45.59 Ratio Interval 25.61 to 81.18	28.44 Ratio Interval 16.04 to 50.44	—	—	—
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies Serotype 33F	9.69 Ratio Interval 4.25 to 22.1	13.25 Ratio Interval 6.07 to 28.92	—	—	—

SECONDARY outcome

Timeframe: 1 month after Vaccination 3 (Month 5)

Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.

Outcome measures

Outcome measures
Measure	Adults: V114 Medium Dose n=50 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1	Adults: V114 High Dose n=50 Participants Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1	Adults: V114 Medium Dose + ACP n=52 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1	Adults: V114 High Dose + ACP Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1	Infants: Prevnar 13™ Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 Serotype 1	97.3 Percentage of participants Interval 85.84 to 99.93	100.0 Percentage of participants Interval 90.97 to 100.0	100.0 Percentage of participants Interval 91.19 to 100.0	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 Serotype 3	94.6 Percentage of participants Interval 81.81 to 99.34	97.4 Percentage of participants Interval 86.52 to 99.94	70.0 Percentage of participants Interval 53.47 to 83.44	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 Serotype 4	100.0 Percentage of participants Interval 90.51 to 100.0	97.4 Percentage of participants Interval 86.52 to 99.94	95.0 Percentage of participants Interval 83.08 to 99.39	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 Serotype 5	94.6 Percentage of participants Interval 81.81 to 99.34	84.6 Percentage of participants Interval 69.47 to 94.14	85.0 Percentage of participants Interval 70.16 to 94.29	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 Serotype 6A	91.9 Percentage of participants Interval 78.09 to 98.3	89.7 Percentage of participants Interval 75.78 to 97.13	95.0 Percentage of participants Interval 83.08 to 99.39	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 Serotype 6B	89.2 Percentage of participants Interval 74.58 to 96.97	82.1 Percentage of participants Interval 66.47 to 92.46	85.0 Percentage of participants Interval 70.16 to 94.29	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 Serotype 7F	100.0 Percentage of participants Interval 90.51 to 100.0	100.0 Percentage of participants Interval 90.97 to 100.0	100.0 Percentage of participants Interval 91.19 to 100.0	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 Serotype 9V	94.6 Percentage of participants Interval 81.81 to 99.34	92.3 Percentage of participants Interval 79.13 to 98.38	95.0 Percentage of participants Interval 83.08 to 99.39	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 Serotype 14	100.0 Percentage of participants Interval 90.51 to 100.0	100.0 Percentage of participants Interval 90.97 to 100.0	97.5 Percentage of participants Interval 86.84 to 99.94	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 Serotype 18C	86.5 Percentage of participants Interval 71.23 to 95.46	97.4 Percentage of participants Interval 86.52 to 99.94	97.5 Percentage of participants Interval 86.84 to 99.94	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 Serotype 19A	94.6 Percentage of participants Interval 81.81 to 99.34	100.0 Percentage of participants Interval 90.97 to 100.0	95.0 Percentage of participants Interval 83.08 to 99.39	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 Serotype 19F	97.3 Percentage of participants Interval 85.84 to 99.93	100.0 Percentage of participants Interval 90.97 to 100.0	100.0 Percentage of participants Interval 91.19 to 100.0	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 Serotype 22F (non-Prevnar serotype)	100.0 Percentage of participants Interval 90.51 to 100.0	100.0 Percentage of participants Interval 90.97 to 100.0	0.0 Percentage of participants Interval 0.0 to 8.81	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 Serotype 23F	86.5 Percentage of participants Interval 71.23 to 95.46	86.8 Percentage of participants Interval 71.91 to 95.59	85.0 Percentage of participants Interval 70.16 to 94.29	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 Serotype 33F (non-Prevnar serotype)	81.1 Percentage of participants Interval 64.84 to 92.04	71.8 Percentage of participants Interval 55.13 to 85.0	0.0 Percentage of participants Interval 0.0 to 8.81	—	—

SECONDARY outcome

Timeframe: Before Vaccination 4 (Month 10-13)

Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.

Outcome measures

Outcome measures
Measure	Adults: V114 Medium Dose n=50 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1	Adults: V114 High Dose n=50 Participants Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1	Adults: V114 Medium Dose + ACP n=52 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1	Adults: V114 High Dose + ACP Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1	Infants: Prevnar 13™ Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 Serotype 1	30.8 Percentage of participants Interval 17.02 to 47.57	43.6 Percentage of participants Interval 27.81 to 60.38	57.5 Percentage of participants Interval 40.89 to 72.96	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 Serotype 3	10.3 Percentage of participants Interval 2.87 to 24.22	15.4 Percentage of participants Interval 5.86 to 30.53	7.5 Percentage of participants Interval 1.57 to 20.39	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 Serotype 4	17.9 Percentage of participants Interval 7.54 to 33.53	33.3 Percentage of participants Interval 19.09 to 50.22	27.5 Percentage of participants Interval 14.6 to 43.89	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 Serotype 5	61.5 Percentage of participants Interval 44.62 to 76.64	56.4 Percentage of participants Interval 39.62 to 72.19	72.5 Percentage of participants Interval 56.11 to 85.4	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 Serotype 6A	48.7 Percentage of participants Interval 32.42 to 65.22	56.4 Percentage of participants Interval 39.62 to 72.19	82.5 Percentage of participants Interval 67.22 to 92.66	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 Serotype 6B	71.8 Percentage of participants Interval 55.13 to 85.0	71.8 Percentage of participants Interval 55.13 to 85.0	62.5 Percentage of participants Interval 45.8 to 77.27	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 Serotype 7F	82.1 Percentage of participants Interval 66.47 to 92.46	92.3 Percentage of participants Interval 79.13 to 98.38	97.5 Percentage of participants Interval 86.84 to 99.94	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 Serotype 9V	53.8 Percentage of participants Interval 37.18 to 69.91	64.1 Percentage of participants Interval 47.18 to 78.8	45.0 Percentage of participants Interval 29.26 to 61.51	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 Serotype 14	87.2 Percentage of participants Interval 72.57 to 95.7	87.2 Percentage of participants Interval 72.57 to 95.7	87.5 Percentage of participants Interval 73.2 to 95.81	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 Serotype 18C	12.8 Percentage of participants Interval 4.3 to 27.43	23.1 Percentage of participants Interval 11.13 to 39.33	35.0 Percentage of participants Interval 20.63 to 51.68	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 Serotype 19A	33.3 Percentage of participants Interval 19.09 to 50.22	28.2 Percentage of participants Interval 15.0 to 44.87	55.0 Percentage of participants Interval 38.49 to 70.74	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 Serotype 19F	35.9 Percentage of participants Interval 21.2 to 52.82	46.2 Percentage of participants Interval 30.09 to 62.82	62.5 Percentage of participants Interval 45.8 to 77.27	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 Serotype 22F (non-Prevnar serotype)	97.4 Percentage of participants Interval 86.52 to 99.94	97.4 Percentage of participants Interval 86.52 to 99.94	2.5 Percentage of participants Interval 0.06 to 13.16	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 Serotype 23F	33.3 Percentage of participants Interval 19.09 to 50.22	43.6 Percentage of participants Interval 27.81 to 60.38	32.5 Percentage of participants Interval 18.57 to 49.13	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 Serotype 33F (non-Prevnar serotype)	92.3 Percentage of participants Interval 79.13 to 98.38	87.2 Percentage of participants Interval 72.57 to 95.7	0.0 Percentage of participants Interval 0.0 to 8.81	—	—

SECONDARY outcome

Timeframe: 1 month after Vaccination 4 (Month 11-15)

Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.

Outcome measures

Outcome measures
Measure	Adults: V114 Medium Dose n=50 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1	Adults: V114 High Dose n=50 Participants Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1	Adults: V114 Medium Dose + ACP n=52 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1	Adults: V114 High Dose + ACP Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1	Infants: Prevnar 13™ Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 Serotype 1	100.0 Percentage of participants Interval 89.11 to 100.0	100.0 Percentage of participants Interval 90.0 to 100.0	100.0 Percentage of participants Interval 90.26 to 100.0	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 Serotype 3	96.9 Percentage of participants Interval 83.78 to 99.92	97.1 Percentage of participants Interval 85.08 to 99.93	83.3 Percentage of participants Interval 67.19 to 93.63	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 Serotype 4	90.6 Percentage of participants Interval 74.98 to 98.02	97.1 Percentage of participants Interval 85.08 to 99.93	97.2 Percentage of participants Interval 85.47 to 99.93	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 Serotype 5	100.0 Percentage of participants Interval 89.11 to 100.0	100.0 Percentage of participants Interval 90.0 to 100.0	100.0 Percentage of participants Interval 90.26 to 100.0	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 Serotype 6A	100.0 Percentage of participants Interval 89.11 to 100.0	100.0 Percentage of participants Interval 90.0 to 100.0	100.0 Percentage of participants Interval 90.26 to 100.0	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 Serotype 6B	100.0 Percentage of participants Interval 89.11 to 100.0	97.1 Percentage of participants Interval 85.08 to 99.93	100.0 Percentage of participants Interval 90.26 to 100.0	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 Serotype 7F	100.0 Percentage of participants Interval 89.11 to 100.0	100.0 Percentage of participants Interval 90.0 to 100.0	100.0 Percentage of participants Interval 90.26 to 100.0	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 Serotype 9V	100.0 Percentage of participants Interval 89.11 to 100.0	100.0 Percentage of participants Interval 90.0 to 100.0	100.0 Percentage of participants Interval 90.26 to 100.0	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 Serotype 14	100.0 Percentage of participants Interval 89.11 to 100.0	100.0 Percentage of participants Interval 90.0 to 100.0	97.2 Percentage of participants Interval 85.47 to 99.93	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 Serotype 18C	100.0 Percentage of participants Interval 89.11 to 100.0	97.1 Percentage of participants Interval 85.08 to 99.93	100.0 Percentage of participants Interval 90.26 to 100.0	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 Serotype 19A	100.0 Percentage of participants Interval 89.11 to 100.0	100.0 Percentage of participants Interval 90.0 to 100.0	100.0 Percentage of participants Interval 90.26 to 100.0	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 Serotype 19F	100.0 Percentage of participants Interval 89.11 to 100.0	97.1 Percentage of participants Interval 85.08 to 99.93	100.0 Percentage of participants Interval 90.26 to 100.0	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 Serotype 22F (non-Prevnar serotype)	100.0 Percentage of participants Interval 89.11 to 100.0	100.0 Percentage of participants Interval 90.0 to 100.0	5.6 Percentage of participants Interval 0.68 to 18.66	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 Serotype 23F	100.0 Percentage of participants Interval 89.11 to 100.0	100.0 Percentage of participants Interval 90.0 to 100.0	100.0 Percentage of participants Interval 90.26 to 100.0	—	—
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 Serotype 33F (non-Prevnar serotype)	100.0 Percentage of participants Interval 89.11 to 100.0	100.0 Percentage of participants Interval 90.0 to 100.0	0.0 Percentage of participants Interval 0.0 to 9.74	—	—

SECONDARY outcome

Timeframe: Before Vaccination 4 (Month 10-13)

Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.

Outcome measures

Outcome measures
Measure	Adults: V114 Medium Dose n=50 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1	Adults: V114 High Dose n=50 Participants Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1	Adults: V114 Medium Dose + ACP n=52 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1	Adults: V114 High Dose + ACP Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1	Infants: Prevnar 13™ Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 1	0.27 µg/mL Interval 0.22 to 0.33	0.30 µg/mL Interval 0.24 to 0.37	0.40 µg/mL Interval 0.31 to 0.51	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 3	0.14 µg/mL Interval 0.11 to 0.18	0.21 µg/mL Interval 0.17 to 0.26	0.09 µg/mL Interval 0.07 to 0.12	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 4	0.21 µg/mL Interval 0.17 to 0.25	0.26 µg/mL Interval 0.22 to 0.3	0.23 µg/mL Interval 0.18 to 0.3	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 5	0.42 µg/mL Interval 0.35 to 0.49	0.40 µg/mL Interval 0.33 to 0.49	0.59 µg/mL Interval 0.44 to 0.79	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 6A	0.35 µg/mL Interval 0.26 to 0.45	0.33 µg/mL Interval 0.26 to 0.42	0.63 µg/mL Interval 0.46 to 0.87	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 6B	0.52 µg/mL Interval 0.41 to 0.66	0.50 µg/mL Interval 0.38 to 0.65	0.43 µg/mL Interval 0.3 to 0.62	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 7F	0.56 µg/mL Interval 0.46 to 0.67	0.79 µg/mL Interval 0.66 to 0.94	0.89 µg/mL Interval 0.68 to 1.18	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 9V	0.34 µg/mL Interval 0.29 to 0.4	0.42 µg/mL Interval 0.33 to 0.53	0.35 µg/mL Interval 0.27 to 0.47	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 14	0.83 µg/mL Interval 0.62 to 1.11	0.92 µg/mL Interval 0.72 to 1.18	1.53 µg/mL Interval 1.13 to 2.07	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 18C	0.16 µg/mL Interval 0.13 to 0.19	0.20 µg/mL Interval 0.16 to 0.25	0.28 µg/mL Interval 0.21 to 0.37	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 19A	0.27 µg/mL Interval 0.21 to 0.35	0.32 µg/mL Interval 0.24 to 0.44	0.39 µg/mL Interval 0.31 to 0.5	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 19F	0.28 µg/mL Interval 0.23 to 0.35	0.35 µg/mL Interval 0.29 to 0.43	0.48 µg/mL Interval 0.36 to 0.63	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 22F (non-Prevnar serotype)	0.97 µg/mL Interval 0.82 to 1.16	1.14 µg/mL Interval 0.93 to 1.4	0.06 µg/mL Interval 0.05 to 0.07	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 23F	0.23 µg/mL Interval 0.18 to 0.3	0.26 µg/mL Interval 0.19 to 0.35	0.26 µg/mL Interval 0.19 to 0.35	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 33F (non-Prevnar serotype)	0.91 µg/mL Interval 0.75 to 1.1	0.96 µg/mL Interval 0.7 to 1.33	0.05 µg/mL Interval 0.05 to 0.05	—	—

SECONDARY outcome

Timeframe: 1 month after Vaccination 4 (Month 11-15)

Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.

Outcome measures

Outcome measures
Measure	Adults: V114 Medium Dose n=50 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1	Adults: V114 High Dose n=50 Participants Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1	Adults: V114 Medium Dose + ACP n=52 Participants Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1	Adults: V114 High Dose + ACP Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1	Infants: Prevnar 13™ Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 33F (non-Prevnar serotype)	5.22 µg/mL Interval 3.87 to 7.04	4.84 µg/mL Interval 3.81 to 6.15	0.05 µg/mL Interval 0.05 to 0.06	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 22F (non-Prevnar serotype)	6.57 µg/mL Interval 5.09 to 8.47	8.20 µg/mL Interval 6.61 to 10.17	0.07 µg/mL Interval 0.05 to 0.09	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 23F	2.76 µg/mL Interval 2.11 to 3.61	2.99 µg/mL Interval 2.18 to 4.1	3.81 µg/mL Interval 2.89 to 5.01	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 1	1.74 µg/mL Interval 1.33 to 2.29	2.32 µg/mL Interval 1.76 to 3.05	2.05 µg/mL Interval 1.58 to 2.66	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 3	1.02 µg/mL Interval 0.84 to 1.24	1.26 µg/mL Interval 0.96 to 1.65	0.87 µg/mL Interval 0.65 to 1.17	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 4	1.35 µg/mL Interval 0.99 to 1.84	1.84 µg/mL Interval 1.33 to 2.56	1.68 µg/mL Interval 1.25 to 2.25	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 5	2.33 µg/mL Interval 1.8 to 3.0	2.53 µg/mL Interval 1.95 to 3.27	3.80 µg/mL Interval 2.8 to 5.17	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 6A	5.59 µg/mL Interval 4.15 to 7.52	5.24 µg/mL Interval 3.81 to 7.19	9.13 µg/mL Interval 7.31 to 11.41	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 6B	6.46 µg/mL Interval 5.2 to 8.01	5.12 µg/mL Interval 3.55 to 7.39	6.80 µg/mL Interval 5.38 to 8.6	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 7F	2.94 µg/mL Interval 2.28 to 3.79	4.34 µg/mL Interval 3.49 to 5.4	5.26 µg/mL Interval 4.01 to 6.9	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 9V	2.53 µg/mL Interval 1.85 to 3.47	2.36 µg/mL Interval 1.91 to 2.92	3.09 µg/mL Interval 2.39 to 4.0	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 14	5.87 µg/mL Interval 4.05 to 8.52	4.42 µg/mL Interval 3.41 to 5.73	5.68 µg/mL Interval 4.08 to 7.92	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 18C	1.68 µg/mL Interval 1.3 to 2.16	2.49 µg/mL Interval 1.9 to 3.27	2.62 µg/mL Interval 2.06 to 3.34	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 19A	4.85 µg/mL Interval 3.62 to 6.5	4.92 µg/mL Interval 3.66 to 6.61	6.60 µg/mL Interval 5.23 to 8.34	—	—
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies Serotype 19F	4.24 µg/mL Interval 3.22 to 5.58	4.30 µg/mL Interval 3.15 to 5.87	4.28 µg/mL Interval 3.34 to 5.49	—	—

Adverse Events

V114 Medium Adults

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

V114 High Adults

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

V114 Medium + ACP Adults

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

V114 High + ACP Adults

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

V114 Medium Infants

Serious events: 5 serious events

Other events: 47 other events

Deaths: 0 deaths

V114 High Infants

Serious events: 4 serious events

Other events: 46 other events

Deaths: 0 deaths

V114 Medium + ACP Infants

Serious events: 1 serious events

Other events: 49 other events

Deaths: 0 deaths

V114 High + ACP Infants

Serious events: 3 serious events

Other events: 51 other events

Deaths: 0 deaths

Prevnar 13 Infants

Serious events: 4 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	V114 Medium Adults n=20 participants at risk Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1	V114 High Adults n=20 participants at risk Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1	V114 Medium + ACP Adults n=20 participants at risk Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1	V114 High + ACP Adults n=20 participants at risk Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1	V114 Medium Infants n=50 participants at risk Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age	V114 High Infants n=50 participants at risk Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age	V114 Medium + ACP Infants n=51 participants at risk Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with ACP at 2, 4, 6, and 12-15 months of age	V114 High + ACP Infants n=52 participants at risk Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP at 2, 4, 6, and 12-15 months of age	Prevnar 13 Infants n=52 participants at risk Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
Gastrointestinal disorders Abdominal pain	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/51 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	1.9% 1/52 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Infections and infestations Bronchiolitis	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	2.0% 1/50 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/51 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	3.8% 2/52 • Number of events 2 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	1.9% 1/52 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Infections and infestations Cellulitis	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	2.0% 1/50 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/51 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Infections and infestations Gastroenteritis viral	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/51 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	1.9% 1/52 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Infections and infestations Influenza	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/51 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	1.9% 1/52 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	2.0% 1/50 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	2.0% 1/50 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/51 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	2.0% 1/50 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	2.0% 1/51 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	1.9% 1/52 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Infections and infestations Viral infection	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	2.0% 1/50 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/51 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Injury, poisoning and procedural complications Burns third degree	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	2.0% 1/50 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/51 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Injury, poisoning and procedural complications Child maltreatment syndrome	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	2.0% 1/50 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/51 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Injury, poisoning and procedural complications Concussion	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	2.0% 1/50 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/51 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	2.0% 1/50 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/51 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Metabolism and nutrition disorders Neonatal insufficient breast milk syndrome	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	2.0% 1/50 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/51 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Nervous system disorders Seizure	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	2.0% 1/50 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/51 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.

Other adverse events

Other adverse events
Measure	V114 Medium Adults n=20 participants at risk Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1	V114 High Adults n=20 participants at risk Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1	V114 Medium + ACP Adults n=20 participants at risk Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1	V114 High + ACP Adults n=20 participants at risk Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1	V114 Medium Infants n=50 participants at risk Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age	V114 High Infants n=50 participants at risk Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age	V114 Medium + ACP Infants n=51 participants at risk Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with ACP at 2, 4, 6, and 12-15 months of age	V114 High + ACP Infants n=52 participants at risk Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP at 2, 4, 6, and 12-15 months of age	Prevnar 13 Infants n=52 participants at risk Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age
General disorders Fatigue	35.0% 7/20 • Number of events 8 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	45.0% 9/20 • Number of events 9 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	45.0% 9/20 • Number of events 9 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	40.0% 8/20 • Number of events 8 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/51 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Gastrointestinal disorders Diarrhoea	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	5.0% 1/20 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	10.0% 5/50 • Number of events 5 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	6.0% 3/50 • Number of events 4 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	7.8% 4/51 • Number of events 4 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	1.9% 1/52 • Number of events 2 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	11.5% 6/52 • Number of events 6 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Gastrointestinal disorders Flatulence	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	6.0% 3/50 • Number of events 3 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	4.0% 2/50 • Number of events 2 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	3.9% 2/51 • Number of events 4 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	1.9% 1/52 • Number of events 2 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/51 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	5.8% 3/52 • Number of events 3 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	3.8% 2/52 • Number of events 2 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Gastrointestinal disorders Vomiting	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	10.0% 5/50 • Number of events 5 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	12.0% 6/50 • Number of events 8 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	7.8% 4/51 • Number of events 4 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	3.8% 2/52 • Number of events 2 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	9.6% 5/52 • Number of events 5 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
General disorders Injection site bruising	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	4.0% 2/50 • Number of events 2 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	4.0% 2/50 • Number of events 2 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	5.9% 3/51 • Number of events 3 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
General disorders Injection site erythema	15.0% 3/20 • Number of events 3 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	25.0% 5/20 • Number of events 5 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	10.0% 2/20 • Number of events 2 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	10.0% 2/20 • Number of events 2 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	38.0% 19/50 • Number of events 27 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	42.0% 21/50 • Number of events 34 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	31.4% 16/51 • Number of events 27 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	32.7% 17/52 • Number of events 31 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	28.8% 15/52 • Number of events 26 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
General disorders Injection site induration	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	5.0% 1/20 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	38.0% 19/50 • Number of events 26 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	36.0% 18/50 • Number of events 31 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	29.4% 15/51 • Number of events 18 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	36.5% 19/52 • Number of events 38 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	25.0% 13/52 • Number of events 28 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
General disorders Injection site pain	85.0% 17/20 • Number of events 20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	95.0% 19/20 • Number of events 23 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	90.0% 18/20 • Number of events 24 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	85.0% 17/20 • Number of events 21 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	64.0% 32/50 • Number of events 69 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	62.0% 31/50 • Number of events 67 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	43.1% 22/51 • Number of events 39 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	73.1% 38/52 • Number of events 82 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	40.4% 21/52 • Number of events 46 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
General disorders Injection site swelling	25.0% 5/20 • Number of events 5 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	30.0% 6/20 • Number of events 6 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	20.0% 4/20 • Number of events 4 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	25.0% 5/20 • Number of events 5 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	20.0% 10/50 • Number of events 13 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	32.0% 16/50 • Number of events 23 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	19.6% 10/51 • Number of events 18 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	36.5% 19/52 • Number of events 30 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	25.0% 13/52 • Number of events 19 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
General disorders Injection site warmth	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	10.0% 2/20 • Number of events 2 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/51 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	1.9% 1/52 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
General disorders Pyrexia	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	5.0% 1/20 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	34.0% 17/50 • Number of events 28 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	28.0% 14/50 • Number of events 26 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	31.4% 16/51 • Number of events 23 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	30.8% 16/52 • Number of events 25 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	40.4% 21/52 • Number of events 37 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Infections and infestations Bronchiolitis	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	2.0% 1/50 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	6.0% 3/50 • Number of events 3 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/51 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	1.9% 1/52 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	3.8% 2/52 • Number of events 3 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Infections and infestations Conjunctivitis	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	6.0% 3/50 • Number of events 4 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	4.0% 2/50 • Number of events 2 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	3.9% 2/51 • Number of events 2 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	1.9% 1/52 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	7.7% 4/52 • Number of events 4 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	6.0% 3/50 • Number of events 3 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	2.0% 1/51 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	1.9% 1/52 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Infections and infestations Otitis media	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	8.0% 4/50 • Number of events 4 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	6.0% 3/50 • Number of events 3 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	5.9% 3/51 • Number of events 3 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	5.8% 3/52 • Number of events 3 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	9.6% 5/52 • Number of events 6 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Infections and infestations Otitis media acute	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	4.0% 2/50 • Number of events 2 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	12.0% 6/50 • Number of events 7 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/51 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	1.9% 1/52 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	5.8% 3/52 • Number of events 3 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Infections and infestations Upper respiratory tract infection	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	10.0% 2/20 • Number of events 2 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	14.0% 7/50 • Number of events 7 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	8.0% 4/50 • Number of events 4 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	13.7% 7/51 • Number of events 8 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	5.8% 3/52 • Number of events 3 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	11.5% 6/52 • Number of events 6 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	2.0% 1/50 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	2.0% 1/50 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	3.9% 2/51 • Number of events 2 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	3.8% 2/52 • Number of events 2 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	5.8% 3/52 • Number of events 3 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Metabolism and nutrition disorders Decreased appetite	10.0% 2/20 • Number of events 2 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	5.0% 1/20 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	32.0% 16/50 • Number of events 34 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	48.0% 24/50 • Number of events 40 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	31.4% 16/51 • Number of events 28 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	51.9% 27/52 • Number of events 55 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	46.2% 24/52 • Number of events 38 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Musculoskeletal and connective tissue disorders Arthralgia	15.0% 3/20 • Number of events 3 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	5.0% 1/20 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	10.0% 2/20 • Number of events 2 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	20.0% 4/20 • Number of events 4 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/51 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Musculoskeletal and connective tissue disorders Myalgia	40.0% 8/20 • Number of events 8 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	50.0% 10/20 • Number of events 10 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	35.0% 7/20 • Number of events 7 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	50.0% 10/20 • Number of events 11 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	4.0% 2/50 • Number of events 4 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	6.0% 3/50 • Number of events 3 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/51 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	1.9% 1/52 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Nervous system disorders Headache	20.0% 4/20 • Number of events 4 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	20.0% 4/20 • Number of events 4 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	25.0% 5/20 • Number of events 5 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	25.0% 5/20 • Number of events 5 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/51 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/52 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Nervous system disorders Somnolence	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	60.0% 30/50 • Number of events 69 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	68.0% 34/50 • Number of events 76 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	60.8% 31/51 • Number of events 91 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	73.1% 38/52 • Number of events 97 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	75.0% 39/52 • Number of events 95 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Psychiatric disorders Irritability	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	82.0% 41/50 • Number of events 143 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	82.0% 41/50 • Number of events 167 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	90.2% 46/51 • Number of events 195 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	90.4% 47/52 • Number of events 200 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	84.6% 44/52 • Number of events 171 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	8.0% 4/50 • Number of events 4 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	6.0% 3/50 • Number of events 4 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	9.8% 5/51 • Number of events 6 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	1.9% 1/52 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	9.6% 5/52 • Number of events 5 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	5.0% 1/20 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	6.0% 3/50 • Number of events 3 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	2.0% 1/50 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	3.9% 2/51 • Number of events 2 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	5.8% 3/52 • Number of events 4 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	5.8% 3/52 • Number of events 3 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	5.0% 1/20 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	8.0% 4/50 • Number of events 4 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	7.8% 4/51 • Number of events 5 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	1.9% 1/52 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	7.7% 4/52 • Number of events 4 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/50 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	6.0% 3/50 • Number of events 3 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	2.0% 1/51 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	3.8% 2/52 • Number of events 2 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	1.9% 1/52 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Skin and subcutaneous tissue disorders Rash	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	0.00% 0/20 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	8.0% 4/50 • Number of events 4 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	2.0% 1/50 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	2.0% 1/51 • Number of events 1 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	3.8% 2/52 • Number of events 2 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.	5.8% 3/52 • Number of events 3 • Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4. The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Publication restrictions are in place

Restriction type: OTHER