Trial Outcomes & Findings for Safety and Tolerability Study for the Pneumococcal Conjugate Vaccine V114 Versus Prevnar™ (V114-001) (NCT NCT01215175)

Last Updated: 2019-03-18

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

Target enrollment

150 participants

Primary outcome timeframe

Up to Day 14 after vaccination

Results posted on

2019-03-18

Participant Flow

The study was conducted in 15 sites in the US and Finland. Of the 60 randomized adult participants only one participant discontinued from the study. Of the 90 randomized toddler participants only one participant discontinued from the study. A total of 150 participants were screened and all were enrolled.

Participant milestones

Participant milestones
Measure	V114 Adjuvanted - Adult Cohort Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	Prevnar™ - Adult Cohort Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.	V114 Adjuvanted - Toddler Cohort Healthy toddlers (12-15 months of age) participants who completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum non-adjuvanted V114 on Day 1.	V114 Nonadjuvanted-Toddler Cohort Healthy toddlers (12-15 months of age) participants who completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum non-adjuvanted V114 on Day 1.	Prevnar™ - Toddler Cohort Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
Overall Study STARTED	30	30	33	29	28
Overall Study Treated	30	30	33	29	28
Overall Study COMPLETED	30	29	33	28	28
Overall Study NOT COMPLETED	0	1	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	V114 Adjuvanted - Adult Cohort Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	Prevnar™ - Adult Cohort Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.	V114 Adjuvanted - Toddler Cohort Healthy toddlers (12-15 months of age) participants who completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum non-adjuvanted V114 on Day 1.	V114 Nonadjuvanted-Toddler Cohort Healthy toddlers (12-15 months of age) participants who completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum non-adjuvanted V114 on Day 1.	Prevnar™ - Toddler Cohort Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
Overall Study Lost to Follow-up	0	1	0	1	0

Baseline Characteristics

Safety and Tolerability Study for the Pneumococcal Conjugate Vaccine V114 Versus Prevnar™ (V114-001)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V114 Adjuvanted - Adult Cohort n=30 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	Prevnar™ - Adult Cohort n=30 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.	V114 Adjuvanted - Toddler Cohort n=33 Participants Healthy toddlers (12-15 months of age) participants who completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum non-adjuvanted V114 on Day 1.	V114 Nonadjuvanted-Toddler Cohort n=29 Participants Healthy toddlers (12-15 months of age) participants who completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum non-adjuvanted V114 on Day 1.	Prevnar™ - Toddler Cohort n=28 Participants Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.	Total n=150 Participants Total of all reporting groups
Age, Customized < 12 months (enrolled in error)	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	1 Participants n=10 Participants
Age, Customized 12 Months	0 Participants n=93 Participants	0 Participants n=4 Participants	16 Participants n=27 Participants	14 Participants n=483 Participants	11 Participants n=36 Participants	41 Participants n=10 Participants
Age, Customized 13 Months	0 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants	4 Participants n=483 Participants	1 Participants n=36 Participants	8 Participants n=10 Participants
Age, Customized 14 Months	0 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants	4 Participants n=483 Participants	6 Participants n=36 Participants	13 Participants n=10 Participants
Age, Customized 15 Months	0 Participants n=93 Participants	0 Participants n=4 Participants	10 Participants n=27 Participants	7 Participants n=483 Participants	10 Participants n=36 Participants	27 Participants n=10 Participants
Age, Customized 18 to 29 Years	8 Participants n=93 Participants	8 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	16 Participants n=10 Participants
Age, Customized 30 to 39 Years	14 Participants n=93 Participants	15 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	29 Participants n=10 Participants
Age, Customized 40 to 45 Years	8 Participants n=93 Participants	7 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	15 Participants n=10 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	16 Participants n=4 Participants	21 Participants n=27 Participants	15 Participants n=483 Participants	17 Participants n=36 Participants	82 Participants n=10 Participants
Sex: Female, Male Male	17 Participants n=93 Participants	14 Participants n=4 Participants	12 Participants n=27 Participants	14 Participants n=483 Participants	11 Participants n=36 Participants	68 Participants n=10 Participants

PRIMARY outcome

Timeframe: Up to Day 14 after vaccination

Population: The analysis population included all randomized participants who received study vaccination and who had available post-treatment safety data.

Outcome measures

Outcome measures
Measure	V114 Adjuvanted - Adult Cohort n=30 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	Prevnar™ - Adult Cohort n=30 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.	Prevnar™ - Toddler Cohort Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
Adult: Percentage of Participants With Any Adverse Event	93.3 Percentage of Participants	83.3 Percentage of Participants	—

PRIMARY outcome

Timeframe: Up to Day 14 after vaccination

Population: The analysis population included all randomized participants who received study vaccination and who had available post-treatment safety data.

Outcome measures

Outcome measures
Measure	V114 Adjuvanted - Adult Cohort n=33 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	Prevnar™ - Adult Cohort n=28 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.	Prevnar™ - Toddler Cohort n=28 Participants Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
Toddler: Percentage of Participants With Any Adverse Event	93.9 Percentage of Participants	89.3 Percentage of Participants	85.7 Percentage of Participants

PRIMARY outcome

Timeframe: Up to Day 14 after vaccination

Population: The analysis population included all randomized participants who received study vaccination and who had available post-treatment safety data.

A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.

Outcome measures

Outcome measures
Measure	V114 Adjuvanted - Adult Cohort n=30 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	Prevnar™ - Adult Cohort n=30 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.	Prevnar™ - Toddler Cohort Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
Adult: Percentage of Participants With Any Serious Adverse Event	0.0 Percentage of Participants	0.0 Percentage of Participants	—

PRIMARY outcome

Timeframe: Up to Day 14 after vaccination

Population: The analysis population included all randomized participants who received study vaccination and who had available post-treatment safety data.

Outcome measures

Outcome measures
Measure	V114 Adjuvanted - Adult Cohort n=33 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	Prevnar™ - Adult Cohort n=28 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.	Prevnar™ - Toddler Cohort n=28 Participants Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
Toddler: Percentage of Participants With Any Serious Adverse Event	0.0 Percentage of Participants	0.0 Percentage of Participants	0.0 Percentage of Participants

PRIMARY outcome

Timeframe: Up to Day 14 after vaccination

Population: The analysis population included all randomized participants who received study vaccination and who had available post-treatment safety data.

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. Relatedness of the AE to study vaccine was determined by the investigator.

Outcome measures

Outcome measures
Measure	V114 Adjuvanted - Adult Cohort n=30 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	Prevnar™ - Adult Cohort n=30 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.	Prevnar™ - Toddler Cohort Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
Adult: Percentage of Participants With Any Vaccine-related Adverse Event	93.3 Percentage of Participants	83.3 Percentage of Participants	—

PRIMARY outcome

Timeframe: Up to Day 14 after vaccination

Population: The analysis population included all randomized toddler participants who received study vaccination and who had available post-treatment safety data.

Outcome measures

Outcome measures
Measure	V114 Adjuvanted - Adult Cohort n=33 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	Prevnar™ - Adult Cohort n=28 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.	Prevnar™ - Toddler Cohort n=28 Participants Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
Toddler: Percentage of Participants With Any Vaccine-related Adverse Event	84.8 Percentage of Participants	78.6 Percentage of Participants	75.0 Percentage of Participants

SECONDARY outcome

Timeframe: Day 30 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.

Immunoglobulin G (IgG) for the serotypes contained in V114 was determined using an electrochemiluminescence assay.

Outcome measures

Outcome measures
Measure	V114 Adjuvanted - Adult Cohort n=30 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	Prevnar™ - Adult Cohort n=30 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.	Prevnar™ - Toddler Cohort Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 1 (non-Prevnar serotype)	96.2 Percentage of Participants Interval 80.4 to 99.9	41.7 Percentage of Participants Interval 22.1 to 63.4	—
Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 3 (non-Prevnar serotype)	100.0 Percentage of Participants Interval 86.8 to 100.0	83.3 Percentage of Participants Interval 62.6 to 95.3	—
Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 4	100.0 Percentage of Participants Interval 86.8 to 100.0	100.0 Percentage of Participants Interval 85.2 to 100.0	—
Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 5 (non-Prevnar serotype)	100.0 Percentage of Participants Interval 86.8 to 100.0	95.8 Percentage of Participants Interval 78.9 to 99.9	—
Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 6A (non-Prevnar serotype)	96.2 Percentage of Participants Interval 80.4 to 99.9	87.0 Percentage of Participants Interval 66.4 to 97.2	—
Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 6B	96.2 Percentage of Participants Interval 80.4 to 99.9	87.0 Percentage of Participants Interval 66.4 to 97.2	—
Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 7F(non-Prevnar serotype)	96.2 Percentage of Participants Interval 80.4 to 99.9	50.0 Percentage of Participants Interval 29.1 to 70.9	—
Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 9V	100.0 Percentage of Participants Interval 86.8 to 100.0	95.7 Percentage of Participants Interval 78.1 to 99.9	—
Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 14	100.0 Percentage of Participants Interval 86.8 to 100.0	95.7 Percentage of Participants Interval 78.1 to 99.9	—
Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 18C	100.0 Percentage of Participants Interval 86.8 to 100.0	95.7 Percentage of Participants Interval 78.1 to 99.9	—
Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 19A (non-Prevnar serotype)	100.0 Percentage of Participants Interval 86.8 to 100.0	100.0 Percentage of Participants Interval 85.8 to 100.0	—
Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 19F	100.0 Percentage of Participants Interval 86.8 to 100.0	100.0 Percentage of Participants Interval 85.2 to 100.0	—
Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 22F (non-Prevnar serotype)	96.2 Percentage of Participants Interval 80.4 to 99.9	45.8 Percentage of Participants Interval 25.6 to 67.2	—
Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 23F	96.2 Percentage of Participants Interval 80.4 to 99.9	100.0 Percentage of Participants Interval 85.2 to 100.0	—
Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 33F (non-Prevnar serotype)	96.2 Percentage of Participants Interval 80.4 to 99.9	62.5 Percentage of Participants Interval 40.6 to 81.2	—

SECONDARY outcome

Timeframe: Day 30 after vaccination

Population: The analysis population included all toddler participants who did not have a protocol violation that could have impacted the validity of the antibody responses.

Immunoglobulin G (IgG) for the serotypes contained in V114 was determined using an electrochemiluminescence assay.

Outcome measures

Outcome measures
Measure	V114 Adjuvanted - Adult Cohort n=33 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	Prevnar™ - Adult Cohort n=28 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.	Prevnar™ - Toddler Cohort n=28 Participants Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 1 (non-Prevnar serotype)	100.0 Percentage of Participants Interval 88.4 to 100.0	95.7 Percentage of Participants Interval 78.1 to 99.9	0.0 Percentage of Participants Interval 0.0 to 15.4
Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 3 (non-Prevnar serotype)	93.3 Percentage of Participants Interval 77.9 to 99.2	95.7 Percentage of Participants Interval 78.1 to 99.9	18.2 Percentage of Participants Interval 5.2 to 40.3
Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 4	93.3 Percentage of Participants Interval 77.9 to 99.2	100.0 Percentage of Participants Interval 85.2 to 100.0	100.0 Percentage of Participants Interval 84.6 to 100.0
Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 5 (non-Prevnar serotype)	90.0 Percentage of Participants Interval 73.5 to 97.9	95.7 Percentage of Participants Interval 78.1 to 99.9	68.2 Percentage of Participants Interval 45.1 to 86.1
Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 6A (non-Prevnar serotype)	96.7 Percentage of Participants Interval 82.8 to 99.9	87.0 Percentage of Participants Interval 66.4 to 97.2	86.4 Percentage of Participants Interval 65.1 to 97.1
Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 6B	100.0 Percentage of Participants Interval 88.4 to 100.0	95.7 Percentage of Participants Interval 78.1 to 99.9	95.5 Percentage of Participants Interval 77.2 to 99.9
Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 7F(non-Prevnar serotype)	90.0 Percentage of Participants Interval 73.5 to 97.9	100.0 Percentage of Participants Interval 85.2 to 100.0	9.1 Percentage of Participants Interval 1.1 to 29.2
Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 9V	100.0 Percentage of Participants Interval 88.4 to 100.0	100.0 Percentage of Participants Interval 85.2 to 100.0	100.0 Percentage of Participants Interval 84.6 to 100.0
Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 14	100.0 Percentage of Participants Interval 88.4 to 100.0	100.0 Percentage of Participants Interval 85.2 to 100.0	100.0 Percentage of Participants Interval 84.6 to 100.0
Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 18C	86.7 Percentage of Participants Interval 69.3 to 96.2	95.7 Percentage of Participants Interval 78.1 to 99.9	100.0 Percentage of Participants Interval 84.6 to 100.0
Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 19A (non-Prevnar serotype)	83.3 Percentage of Participants Interval 65.3 to 94.4	95.7 Percentage of Participants Interval 78.1 to 99.9	72.7 Percentage of Participants Interval 49.8 to 89.3
Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 19F	96.7 Percentage of Participants Interval 82.8 to 99.9	100.0 Percentage of Participants Interval 85.2 to 100.0	100.0 Percentage of Participants Interval 84.6 to 100.0
Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 22F non-Prevnar serotype)	100.0 Percentage of Participants Interval 89.4 to 100.0	100.0 Percentage of Participants Interval 87.7 to 100.0	3.8 Percentage of Participants Interval 0.1 to 19.6
Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 23F	100.0 Percentage of Participants Interval 88.4 to 100.0	95.7 Percentage of Participants Interval 78.1 to 99.9	100.0 Percentage of Participants Interval 84.6 to 100.0
Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Serotype 33F (non-Prevnar serotype)	63.3 Percentage of Participants Interval 43.9 to 80.1	69.6 Percentage of Participants Interval 47.1 to 86.8	0.0 Percentage of Participants Interval 0.0 to 15.4

SECONDARY outcome

Timeframe: Day 30 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.

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

Outcome measures

Outcome measures
Measure	V114 Adjuvanted - Adult Cohort n=30 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	Prevnar™ - Adult Cohort n=30 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.	Prevnar™ - Toddler Cohort Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 1 (non-Prevnar serotype)	7.9 µg/mL Interval 4.5 to 13.8	0.7 µg/mL Interval 0.5 to 1.0	—
Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 3 (non-Prevnar serotype)	2.9 µg/mL Interval 2.0 to 4.3	1.1 µg/mL Interval 0.8 to 1.5	—
Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 4	4.2 µg/mL Interval 2.6 to 6.9	3.4 µg/mL Interval 2.3 to 5.0	—
Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 5 (non-Prevnar serotype)	15.1 µg/mL Interval 8.3 to 27.5	1.8 µg/mL Interval 1.4 to 2.4	—
Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 6A (non-Prevnar serotype)	12.4 µg/mL Interval 6.3 to 24.6	4.0 µg/mL Interval 1.9 to 8.6	—
Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 6B	20.1 µg/mL Interval 10.9 to 37.2	5.9 µg/mL Interval 2.5 to 13.8	—
Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 7F (non-Prevnar serotype)	6.8 µg/mL Interval 3.9 to 12.0	0.7 µg/mL Interval 0.5 to 1.0	—
Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 9V	7.9 µg/mL Interval 4.8 to 13.2	7.4 µg/mL Interval 4.4 to 12.4	—
Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 14	25.8 µg/mL Interval 15.8 to 42.0	12.5 µg/mL Interval 6.7 to 23.4	—
Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 18C	14.7 µg/mL Interval 8.7 to 24.8	8.6 µg/mL Interval 4.5 to 16.7	—
Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 19A (non-Prevnar serotype)	19.1 µg/mL Interval 12.7 to 28.8	5.8 µg/mL Interval 3.5 to 9.5	—
Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 19F	12.1 µg/mL Interval 7.1 to 20.6	7.5 µg/mL Interval 4.5 to 12.7	—
Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 22F (non-Prevnar serotype)	5.9 µg/mL Interval 3.8 to 8.9	0.7 µg/mL Interval 0.5 to 1.0	—
Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 23F	11.2 µg/mL Interval 5.8 to 21.7	14.2 µg/mL Interval 7.8 to 25.9	—
Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 33F (non-Prevnar serotype)	8.2 µg/mL Interval 4.8 to 14.1	1.1 µg/mL Interval 0.6 to 2.1	—

SECONDARY outcome

Timeframe: Day 30 after vaccination

Population: The analysis population included all toddler participants who did not have a protocol violation that could have impacted the validity of the antibody responses.

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

Outcome measures

Outcome measures
Measure	V114 Adjuvanted - Adult Cohort n=33 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	Prevnar™ - Adult Cohort n=28 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.	Prevnar™ - Toddler Cohort n=28 Participants Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 1 (non-Prevnar serotype)	3.0 µg/mL Interval 2.3 to 4.1	4.3 µg/mL Interval 2.8 to 6.6	0.1 µg/mL Interval 0.0 to 0.1
Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 3 (non-Prevnar serotype)	2.2 µg/mL Interval 1.6 to 3.0	2.5 µg/mL Interval 1.7 to 3.6	0.4 µg/mL Interval 0.3 to 0.5
Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 4	1.5 µg/mL Interval 1.0 to 2.2	2.5 µg/mL Interval 1.7 to 3.9	2.8 µg/mL Interval 1.9 to 4.0
Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 5 (non-Prevnar serotype)	1.8 µg/mL Interval 1.3 to 2.5	2.5 µg/mL Interval 1.8 to 3.5	0.7 µg/mL Interval 0.4 to 1.0
Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 6A (non-Prevnar serotype)	3.5 µg/mL Interval 2.1 to 6.0	2.8 µg/mL Interval 1.6 to 4.9	2.2 µg/mL Interval 1.1 to 4.6
Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 6B	7.1 µg/mL Interval 4.8 to 10.6	8.2 µg/mL Interval 5.2 to 12.9	7.0 µg/mL Interval 4.5 to 10.9
Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 7F (non-Prevnar serotype)	2.0 µg/mL Interval 1.4 to 3.0	3.2 µg/mL Interval 2.2 to 4.6	0.1 µg/mL Interval 0.1 to 0.2
Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 9V	3.3 µg/mL Interval 2.4 to 4.6	4.7 µg/mL Interval 3.3 to 6.8	5.9 µg/mL Interval 3.6 to 9.9
Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 14	9.4 µg/mL Interval 6.0 to 14.7	10.0 µg/mL Interval 7.1 to 14.1	10.8 µg/mL Interval 6.1 to 18.8
Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 18C	2.1 µg/mL Interval 1.4 to 3.1	2.7 µg/mL Interval 1.8 to 4.0	3.9 µg/mL Interval 2.7 to 5.8
Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 19A (non-Prevnar serotype)	1.6 µg/mL Interval 1.1 to 2.4	2.3 µg/mL Interval 1.6 to 3.4	1.7 µg/mL Interval 1.0 to 2.7
Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 19F	1.9 µg/mL Interval 1.4 to 2.7	2.7 µg/mL Interval 1.9 to 3.7	4.2 µg/mL Interval 2.8 to 6.1
Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 22F (non-Prevnar serotype)	12.5 µg/mL Interval 8.7 to 17.8	8.8 µg/mL Interval 6.4 to 12.2	0.2 µg/mL Interval 0.1 to 0.3
Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 23F	4.3 µg/mL Interval 3.1 to 6.0	4.3 µg/mL Interval 3.0 to 6.2	7.1 µg/mL Interval 4.6 to 10.9
Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Serotype 33F (non-Prevnar serotype)	0.9 µg/mL Interval 0.6 to 1.5	1.1 µg/mL Interval 0.6 to 1.9	0.1 µg/mL Interval 0.1 to 0.2

SECONDARY outcome

Timeframe: Day 30 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.

OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay.

Outcome measures

Outcome measures
Measure	V114 Adjuvanted - Adult Cohort n=30 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	Prevnar™ - Adult Cohort n=30 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.	Prevnar™ - Toddler Cohort Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 1 (non-Prevnar serotype)	92.3 Percentage of Participants Interval 74.9 to 99.1	16.7 Percentage of Participants Interval 4.7 to 37.4	—
Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 3 (non-Prevnar serotype)	96.2 Percentage of Participants Interval 80.4 to 99.9	69.6 Percentage of Participants Interval 47.1 to 86.8	—
Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 4	100.0 Percentage of Participants Interval 86.8 to 100.0	100.0 Percentage of Participants Interval 85.8 to 100.0	—
Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 5 (non-Prevnar serotype)	92.3 Percentage of Participants Interval 74.9 to 99.1	29.2 Percentage of Participants Interval 12.6 to 51.1	—
Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 6A (non-Prevnar serotype)	100.0 Percentage of Participants Interval 86.8 to 100.0	91.7 Percentage of Participants Interval 73.0 to 99.0	—
Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 6B	100.0 Percentage of Participants Interval 86.8 to 100.0	100.0 Percentage of Participants Interval 85.8 to 100.0	—
Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 6C (non-Prevnar serotype)	100.0 Percentage of Participants Interval 86.8 to 100.0	79.2 Percentage of Participants Interval 57.8 to 92.9	—
Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 7F (non-Prevnar serotype)	96.2 Percentage of Participants Interval 80.4 to 99.9	68.2 Percentage of Participants Interval 45.1 to 86.1	—
Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 9V	100.0 Percentage of Participants Interval 86.8 to 100.0	100.0 Percentage of Participants Interval 85.8 to 100.0	—
Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 14	100.0 Percentage of Participants Interval 86.8 to 100.0	100.0 Percentage of Participants Interval 85.8 to 100.0	—
Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 18C	100.0 Percentage of Participants Interval 86.8 to 100.0	100.0 Percentage of Participants Interval 85.8 to 100.0	—
Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 19A (non-Prevnar serotype)	100.0 Percentage of Participants Interval 86.8 to 100.0	100.0 Percentage of Participants Interval 85.8 to 100.0	—
Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 19F	100.0 Percentage of Participants Interval 86.8 to 100.0	100.0 Percentage of Participants Interval 85.8 to 100.0	—
Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 22F (non-Prevnar serotype)	92.3 Percentage of Participants Interval 74.9 to 99.1	45.8 Percentage of Participants Interval 25.6 to 67.2	—
Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 23F	100.0 Percentage of Participants Interval 86.8 to 100.0	95.8 Percentage of Participants Interval 78.9 to 99.9	—
Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 33F (non-Prevnar serotype)	100.0 Percentage of Participants Interval 86.8 to 100.0	100.0 Percentage of Participants Interval 85.8 to 100.0	—

SECONDARY outcome

Timeframe: Day 30 after vaccination

Population: The analysis population included all toddler participants who did not have a protocol violation that could have impacted the validity of the antibody responses.

OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay.

Outcome measures

SECONDARY outcome

Timeframe: Day 30 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.

OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay

Outcome measures

Outcome measures
Measure	V114 Adjuvanted - Adult Cohort n=30 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	Prevnar™ - Adult Cohort n=30 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.	Prevnar™ - Toddler Cohort Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 1 (non-Prevnar serotype)	471.9 Titer Interval 211.0 to 1055.2	3.7 Titer Interval 2.0 to 6.9	—
Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 3 (non-Prevnar serotype)	357.9 Titer Interval 200.8 to 637.8	26.1 Titer Interval 11.3 to 60.4	—
Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 4	9684.2 Titer Interval 7150.8 to 13115.2	8928.4 Titer Interval 6237.2 to 12780.7	—
Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 5 (non-Prevnar serotype)	2405.5 Titer Interval 881.8 to 6562.0	8.1 Titer Interval 3.3 to 19.9	—
Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 6A (non-Prevnar serotype)	21117.8 Titer Interval 13491.5 to 33055.2	3475.2 Titer Interval 933.3 to 12939.6	—
Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 6B	21795.1 Titer Interval 12869.3 to 36911.7	9073.3 Titer Interval 3475.8 to 23685.6	—
Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 6C (non-Prevnar serotype)	10940.7 Titer Interval 5931.6 to 20179.8	462.6 Titer Interval 99.1 to 2159.4	—
Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 7F (non-Prevnar serotype)	11685.4 Titer Interval 4940.8 to 27637.0	261.4 Titer Interval 55.4 to 1232.4	—
Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 9V	29321.9 Titer Interval 16598.3 to 51798.8	18343.5 Titer Interval 11891.7 to 28295.5	—
Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 14	17469.5 Titer Interval 10512.8 to 29029.7	13145.2 Titer Interval 8055.9 to 21449.6	—
Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 18C	12180.6 Titer Interval 7864.0 to 18866.5	6287.9 Titer Interval 2731.8 to 14473.4	—
Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 19A (non-Prevnar serotype)	8458.3 Titer Interval 6267.9 to 11414.2	2778.0 Titer Interval 1642.0 to 4700.1	—
Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 19F	4597.9 Titer Interval 3251.1 to 6502.8	2665.8 Titer Interval 1243.5 to 5714.9	—
Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 22F (non-Prevnar serotype)	11404.1 Titer Interval 3689.3 to 35251.2	41.2 Titer Interval 9.4 to 180.6	—
Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 23F	8616.0 Titer Interval 4380.2 to 16947.8	8664.4 Titer Interval 3134.6 to 23949.3	—
Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 33F (non-Prevnar serotype)	169577.5 Titer Interval 85502.9 to 336322.5	8430.4 Titer Interval 4998.6 to 14218.4	—

SECONDARY outcome

Timeframe: Day 30 after vaccination

Population: The analysis population included all toddler participants who did not have a protocol violation that could have impacted the validity of the antibody responses.

OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay

Outcome measures

Outcome measures
Measure	V114 Adjuvanted - Adult Cohort n=33 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	Prevnar™ - Adult Cohort n=28 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.	Prevnar™ - Toddler Cohort n=28 Participants Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 19F	1136.4 Titer Interval 734.7 to 1757.5	1117.8 Titer Interval 601.5 to 2077.4	2493.4 Titer Interval 1567.5 to 3966.2
Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 1 (non-Prevnar serotype)	94.0 Titer Interval 56.1 to 157.4	164.3 Titer Interval 68.0 to 397.1	2.0 Titer Interval 2.0 to 2.0
Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 3 (non-Prevnar serotype)	438.8 Titer Interval 319.0 to 603.6	566.2 Titer Interval 400.5 to 800.5	33.8 Titer Interval 16.1 to 71.0
Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 4	2933.4 Titer Interval 1939.9 to 4435.5	4360.9 Titer Interval 2893.4 to 6572.6	5163.6 Titer Interval 3701.1 to 7203.9
Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 5 (non-Prevnar serotype)	477.6 Titer Interval 257.8 to 884.8	1060.2 Titer Interval 736.4 to 1526.4	2.0 Titer Interval 2.0 to 2.0
Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 6A (non-Prevnar serotype)	2894.0 Titer Interval 1439.5 to 5818.1	3880.4 Titer Interval 2365.6 to 6365.1	2435.8 Titer Interval 981.1 to 6047.2
Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 6B	6884.6 Titer Interval 4192.9 to 11304.3	6673.5 Titer Interval 3871.5 to 11503.5	8309.3 Titer Interval 5015.1 to 13767.3
Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 6C (non-Prevnar serotype)	534.8 Titer Interval 164.9 to 1734.3	459.5 Titer Interval 104.7 to 2016.1	171.7 Titer Interval 30.7 to 959.0
Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 7F (non-Prevnar serotype)	12555.7 Titer Interval 8244.6 to 19120.9	22607.1 Titer Interval 13359.1 to 38257.1	56.0 Titer Interval 12.1 to 258.9
Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 9V	5154.5 Titer Interval 3657.2 to 7264.9	5933.3 Titer Interval 4529.8 to 7771.6	7435.1 Titer Interval 4567.4 to 12103.1
Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 14	5868.1 Titer Interval 3383.3 to 10177.7	4408.6 Titer Interval 3248.8 to 5982.5	7954.7 Titer Interval 4394.2 to 14399.9
Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 18C	2119.0 Titer Interval 1378.0 to 3258.5	3435.2 Titer Interval 2276.4 to 5183.8	3862.0 Titer Interval 2520.1 to 5918.3
Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 19A (non-Prevnar serotype)	1275.2 Titer Interval 718.3 to 2263.9	1223.8 Titer Interval 381.9 to 3922.0	378.7 Titer Interval 143.3 to 1000.3
Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 22F (non-Prevnar serotype)	6736.5 Titer Interval 4594.7 to 9876.8	9382.9 Titer Interval 5336.8 to 16496.5	4.1 Titer Interval 1.4 to 12.0
Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 23F	7058.5 Titer Interval 4441.1 to 11218.5	6150.7 Titer Interval 3615.1 to 10464.9	18352.1 Titer Interval 10464.0 to 32186.3
Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Serotype 33F (non-Prevnar serotype)	48824.6 Titer Interval 30727.9 to 77579.0	50461.3 Titer Interval 22905.7 to 111166.1	2697.9 Titer Interval 1093.7 to 6655.1

Adverse Events

V114 Adjuvanted -Adult Cohort

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

PREVNAR™-Adult Cohort

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

V114 Adjuvanted- Toddler Cohort

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

V114 Nonadjuvanted-toddler Cohort

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

PREVNAR™- Toddler Cohort

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	V114 Adjuvanted -Adult Cohort n=30 participants at risk Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	PREVNAR™-Adult Cohort n=30 participants at risk Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.	V114 Adjuvanted- Toddler Cohort n=33 participants at risk Healthy toddlers (12-15 months of age) participants who completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum nonadjuvanted V114 on Day 1.	V114 Nonadjuvanted-toddler Cohort n=28 participants at risk Healthy toddlers (12-15 months of age) participants who completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum nonadjuvanted V114 on Day 1.	PREVNAR™- Toddler Cohort n=28 participants at risk Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
Injury, poisoning and procedural complications Muscle strain	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	6.1% 2/33 • Number of events 2 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 6/30 • Number of events 6 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	10.0% 3/30 • Number of events 5 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	14.3% 4/28 • Number of events 4 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	7.1% 2/28 • Number of events 2 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Musculoskeletal and connective tissue disorders Back pain	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Ear and labyrinth disorders Ear pain	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Eye disorders Conjunctivitis	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	6.1% 2/33 • Number of events 2 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Gastrointestinal disorders Constipation	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	7.1% 2/28 • Number of events 2 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Gastrointestinal disorders Crohn's disease	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Gastrointestinal disorders Diarrhoea	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	9.1% 3/33 • Number of events 3 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	7.1% 2/28 • Number of events 2 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	14.3% 4/28 • Number of events 4 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Gastrointestinal disorders Flatulence	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Gastrointestinal disorders Nausea	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	6.7% 2/30 • Number of events 2 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Gastrointestinal disorders Teething	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	7.1% 2/28 • Number of events 2 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Gastrointestinal disorders Vomiting	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	6.1% 2/33 • Number of events 2 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	7.1% 2/28 • Number of events 2 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
General disorders Chills	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
General disorders Fatigue	46.7% 14/30 • Number of events 14 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	33.3% 10/30 • Number of events 10 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	63.6% 21/33 • Number of events 26 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	64.3% 18/28 • Number of events 20 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	60.7% 17/28 • Number of events 18 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
General disorders Injection site erosion	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
General disorders Injection site erythema	33.3% 10/30 • Number of events 10 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	13.3% 4/30 • Number of events 4 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	45.5% 15/33 • Number of events 15 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	21.4% 6/28 • Number of events 6 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	25.0% 7/28 • Number of events 7 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
General disorders Injection site haematoma	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	7.1% 2/28 • Number of events 2 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
General disorders Injection site haemorrhage	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
General disorders Injection site nodule	26.7% 8/30 • Number of events 8 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	16.7% 5/30 • Number of events 5 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	30.3% 10/33 • Number of events 10 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	10.7% 3/28 • Number of events 3 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	25.0% 7/28 • Number of events 7 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
General disorders Injection site pain	90.0% 27/30 • Number of events 27 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	80.0% 24/30 • Number of events 24 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	57.6% 19/33 • Number of events 19 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	57.1% 16/28 • Number of events 16 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	35.7% 10/28 • Number of events 10 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
General disorders Injection site pruritus	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	6.7% 2/30 • Number of events 2 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
General disorders Injection site swelling	50.0% 15/30 • Number of events 15 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	23.3% 7/30 • Number of events 7 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	33.3% 11/33 • Number of events 11 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	28.6% 8/28 • Number of events 8 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	21.4% 6/28 • Number of events 6 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
General disorders Injection site warmth	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
General disorders Irritability	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	18.2% 6/33 • Number of events 6 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	7.1% 2/28 • Number of events 2 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	10.7% 3/28 • Number of events 3 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
General disorders Pyrexia	16.7% 5/30 • Number of events 5 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.3% 1/30 • Number of events 3 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	27.3% 9/33 • Number of events 12 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	7.1% 2/28 • Number of events 3 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	7.1% 2/28 • Number of events 2 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
General disorders Vaccination site erythema	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
General disorders Vaccination site pain	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
General disorders Vaccination site swelling	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Infections and infestations Cellulitis	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Infections and infestations Croup infectious	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Infections and infestations Ear infection	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Infections and infestations Gastroenteritis	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	6.1% 2/33 • Number of events 2 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Infections and infestations Gastroenteritis viral	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Infections and infestations Laryngitis	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Infections and infestations Nasopharyngitis	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	7.1% 2/28 • Number of events 2 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Infections and infestations Otitis media	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	9.1% 3/33 • Number of events 3 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	7.1% 2/28 • Number of events 2 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Infections and infestations Pneumonia	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Infections and infestations Rhinitis	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Infections and infestations Roseola	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Infections and infestations Upper respiratory tract infection	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	6.7% 2/30 • Number of events 2 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	10.7% 3/28 • Number of events 3 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Infections and infestations Viral infection	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Injury, poisoning and procedural complications Head injury	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Musculoskeletal and connective tissue disorders Myalgia	63.3% 19/30 • Number of events 20 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	36.7% 11/30 • Number of events 12 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	30.3% 10/33 • Number of events 10 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	28.6% 8/28 • Number of events 8 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Nervous system disorders Dizziness	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Nervous system disorders Febrile convulsion	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Nervous system disorders Headache	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Nervous system disorders Hypoaesthesia	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	6.7% 2/30 • Number of events 3 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Nervous system disorders Lethargy	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Respiratory, thoracic and mediastinal disorders Cough	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	10.7% 3/28 • Number of events 3 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	6.1% 2/33 • Number of events 2 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	14.3% 4/28 • Number of events 4 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	10.7% 3/28 • Number of events 3 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Skin and subcutaneous tissue disorders Rash	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Skin and subcutaneous tissue disorders Rash morbilliform	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Infections and infestations Bronchitis	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.0% 1/33 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Infections and infestations Subcutaneous abscess	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.3% 1/30 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/30 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/33 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	3.6% 1/28 • Number of events 1 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.	0.00% 0/28 • Up to 1 month after vaccination The safety population consisted of all randomized participants who received study vaccination and who had available post-treatment safety data.

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 study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
Publication restrictions are in place

Restriction type: OTHER

Measure	V114 Adjuvanted - Adult Cohort n=33 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	Prevnar™ - Adult Cohort n=28 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.	Prevnar™ - Toddler Cohort n=28 Participants Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 1 (non-Prevnar serotype)	96.6 Percentage of Participants Interval 82.2 to 99.9	94.7 Percentage of Participants Interval 74.0 to 99.9	0.0 Percentage of Participants Interval 0.0 to 15.4
Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 3 (non-Prevnar serotype)	100.0 Percentage of Participants Interval 88.1 to 100.0	100 Percentage of Participants Interval 82.4 to 100.0	81.0 Percentage of Participants Interval 58.1 to 94.6
Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 4	100.0 Percentage of Participants Interval 88.1 to 100.0	100.0 Percentage of Participants Interval 82.4 to 100.0	100.0 Percentage of Participants Interval 84.6 to 100.0
Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 5 (non-Prevnar serotype)	96.6 Percentage of Participants Interval 82.2 to 99.9	100.0 Percentage of Participants Interval 82.4 to 100.0	0.0 Percentage of Participants Interval 0.0 to 15.4
Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 6A (non-Prevnar serotype)	96.6 Percentage of Participants Interval 82.2 to 99.9	100.0 Percentage of Participants Interval 82.4 to 100.0	95.5 Percentage of Participants Interval 77.2 to 99.9
Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 6B	100.0 Percentage of Participants Interval 88.1 to 100.0	100.0 Percentage of Participants Interval 82.4 to 100.0	100.0 Percentage of Participants Interval 83.9 to 100.0
Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 6C (non-Prevnar serotype)	79.3 Percentage of Participants Interval 60.3 to 92.0	77.8 Percentage of Participants Interval 52.4 to 93.6	61.9 Percentage of Participants Interval 38.4 to 81.9
Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 7F (non-Prevnar serotype)	100.0 Percentage of Participants Interval 88.1 to 100.0	100.0 Percentage of Participants Interval 82.4 to 100.0	50.0 Percentage of Participants Interval 28.2 to 71.8
Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 9V	100.0 Percentage of Participants Interval 88.1 to 100.0	100.0 Percentage of Participants Interval 82.4 to 100.0	100.0 Percentage of Participants Interval 84.6 to 100.0
Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 14	100.0 Percentage of Participants Interval 88.1 to 100.0	100.0 Percentage of Participants Interval 82.4 to 100.0	100.0 Percentage of Participants Interval 84.6 to 100.0
Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 18C	100.0 Percentage of Participants Interval 88.1 to 100.0	100.0 Percentage of Participants Interval 82.4 to 100.0	100.0 Percentage of Participants Interval 84.6 to 100.0
Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 19A (non-Prevnar serotype)	96.6 Percentage of Participants Interval 82.2 to 99.9	89.5 Percentage of Participants Interval 66.9 to 98.7	90.9 Percentage of Participants Interval 70.8 to 98.9
Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 19F	100.0 Percentage of Participants Interval 88.1 to 100.0	100.0 Percentage of Participants Interval 82.4 to 100.0	100.0 Percentage of Participants Interval 84.6 to 100.0
Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 22F (non-Prevnar serotype)	100.0 Percentage of Participants Interval 88.1 to 100.0	100.0 Percentage of Participants Interval 82.4 to 100.0	9.1 Percentage of Participants Interval 1.1 to 29.2
Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 23F	100.0 Percentage of Participants Interval 88.1 to 100.0	100.0 Percentage of Participants Interval 82.4 to 100.0	100.0 Percentage of Participants Interval 84.6 to 100.0
Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Serotype 33F (non-Prevnar serotype)	100.0 Percentage of Participants Interval 88.1 to 100.0	100.0 Percentage of Participants Interval 82.4 to 100.0	95.5 Percentage of Participants Interval 77.2 to 99.9