Trial Outcomes & Findings for Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico (NCT NCT00708682)

Last Updated: 2011-10-25

Results Overview

Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95 percent confidence interval (95% CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

225 participants

Primary outcome timeframe

1 month after the infant series (7 months of age)

Results posted on

2011-10-25

Participant Flow

Participant milestones

Participant milestones
Measure	13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
Infant Series STARTED	225
Infant Series Vaccinated Dose 1	223
Infant Series Vaccinated Dose 2	214
Infant Series Vaccinated Dose 3	194
Infant Series COMPLETED	192
Infant Series NOT COMPLETED	33
After Infant Series STARTED	192
After Infant Series COMPLETED	191
After Infant Series NOT COMPLETED	1
Toddler Dose STARTED	191
Toddler Dose COMPLETED	183
Toddler Dose NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
Infant Series Adverse Event	1
Infant Series Lost to Follow-up	4
Infant Series Protocol Violation	1
Infant Series Parent/legal guardian request	6
Infant Series Failed to return	2
Infant Series Other	19
After Infant Series Parent/Legal Guardian Request	1
Toddler Dose Parent/Legal Guardian Request	1
Toddler Dose Lost to Follow-up	3
Toddler Dose Failed to Return	4

Baseline Characteristics

Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	13vPnC n=225 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
Age Continuous	2.1 months STANDARD_DEVIATION 0.5 • n=5 Participants
Sex: Female, Male Female	109 Participants n=5 Participants
Sex: Female, Male Male	116 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month after the infant series (7 months of age)

Population: Evaluable 3-Dose Infant Immunogenicity population: eligible participants who received treatments as assigned at all 3 doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.

Outcome measures

Outcome measures
Measure	13vPnC n=171 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series Common serotypes - serotype 4	100.0 Percentage of participants Interval 97.9 to 100.0
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series Common serotypes - serotype 6B	97.7 Percentage of participants Interval 94.1 to 99.4
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series Common serotypes - serotype 9V	98.2 Percentage of participants Interval 94.9 to 99.6
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series Common serotypes - serotype 14	98.8 Percentage of participants Interval 95.8 to 99.9
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series Common serotypes - serotype 18C	98.8 Percentage of participants Interval 95.8 to 99.9
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series Common serotypes - serotype 19F	98.2 Percentage of participants Interval 95.0 to 99.6
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series Common serotypes - serotype 23F	92.9 Percentage of participants Interval 87.9 to 96.3
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series Additional serotypes - serotype 1	99.4 Percentage of participants Interval 96.8 to 100.0
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series Additional serotypes - serotype 5	98.2 Percentage of participants Interval 95.0 to 99.6
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series Additional serotypes - serotype 6A	98.8 Percentage of participants Interval 95.8 to 99.9
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series Additional serotypes - serotype 3	94.1 Percentage of participants Interval 89.4 to 97.1
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series Additional serotypes - serotype 7F	98.8 Percentage of participants Interval 95.8 to 99.9
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series Additional serotypes - serotype 19A	99.4 Percentage of participants Interval 96.8 to 100.0

SECONDARY outcome

Timeframe: 1 month after dose 2 of the infant series (5 months of age)

Population: Evaluable 2-Dose Infant Immunogenicity population: eligible participants who received treatments as assigned at dose 1 and dose 2, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.

Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.

Outcome measures

Outcome measures
Measure	13vPnC n=195 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series Common serotypes - serotype 9V	95.9 Percentage of participants Interval 92.1 to 98.2
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series Common serotypes - serotype 14	99.0 Percentage of participants Interval 96.3 to 99.9
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series Common serotypes - serotype 18C	93.3 Percentage of participants Interval 88.9 to 96.4
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series Common serotypes - serotype 19F	98.5 Percentage of participants Interval 95.5 to 99.7
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series Common serotypes - serotype 23F	77.9 Percentage of participants Interval 71.5 to 83.6
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series Additional serotypes - serotype 1	98.5 Percentage of participants Interval 95.6 to 99.7
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series Additional serotypes - serotype 3	96.4 Percentage of participants Interval 92.7 to 98.5
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series Common serotypes - serotype 4	100.0 Percentage of participants Interval 98.1 to 100.0
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series Common serotypes - serotype 6B	80.9 Percentage of participants Interval 74.7 to 86.2
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series Additional serotypes - serotype 5	97.4 Percentage of participants Interval 94.1 to 99.2
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series Additional serotypes - serotype 6A	94.9 Percentage of participants Interval 90.8 to 97.5
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series Additional serotypes - serotype 7F	99.0 Percentage of participants Interval 96.3 to 99.9
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series Additional serotypes - serotype 19A	99.5 Percentage of participants Interval 97.2 to 100.0

SECONDARY outcome

Timeframe: 1 month after the toddler dose (13 months of age)

Population: Evaluable Toddler Immunogenicity population: eligible participants who received treatments as assigned at all 3 doses of the infant series and at the toddler dose, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.

Outcome measures

Outcome measures
Measure	13vPnC n=155 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose Common serotypes - serotype 6B	99.4 Percentage of participants Interval 96.5 to 100.0
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose Common serotypes - serotype 19F	100.0 Percentage of participants Interval 97.6 to 100.0
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose Common serotypes - serotype 23F	99.4 Percentage of participants Interval 96.5 to 100.0
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose Additional serotypes - serotype 1	100.0 Percentage of participants Interval 97.6 to 100.0
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose Additional serotypes - serotype 3	96.7 Percentage of participants Interval 92.5 to 98.9
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose Additional serotypes - serotype 5	100.0 Percentage of participants Interval 97.6 to 100.0
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose Additional serotypes - serotype 6A	100.0 Percentage of participants Interval 97.6 to 100.0
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose Additional serotypes - serotype 7F	100.0 Percentage of participants Interval 97.6 to 100.0
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose Additional serotypes - serotype 19A	100.0 Percentage of participants Interval 97.6 to 100.0
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose Common serotypes - serotype 4	100.0 Percentage of participants Interval 97.6 to 100.0
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose Common serotypes - serotype 9V	100.0 Percentage of participants Interval 97.6 to 100.0
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose Common serotypes - serotype 14	100.0 Percentage of participants Interval 97.6 to 100.0
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose Common serotypes - serotype 18C	100.0 Percentage of participants Interval 97.6 to 100.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Dose 2 of infant series (4 months of age)

Population: Evaluable 2-Dose Infant Immunogenicity population

Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.

Outcome measures

Outcome measures
Measure	13vPnC n=195 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series Common serotypes - serotype 6B	0.84 mcg/mL Interval 0.71 to 0.98
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series Common serotypes - serotype 9V	1.82 mcg/mL Interval 1.6 to 2.08
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series Common serotypes - serotype 14	5.54 mcg/mL Interval 4.72 to 6.5
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series Common serotypes - serotype 18C	1.80 mcg/mL Interval 1.56 to 2.07
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series Common serotypes - serotype 19F	4.14 mcg/mL Interval 3.59 to 4.78
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series Common serotypes - serotype 23F	0.84 mcg/mL Interval 0.71 to 0.99
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series Additional serotypes - serotype 1	3.41 mcg/mL Interval 3.0 to 3.89
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series Common serotypes - serotype 4	3.54 mcg/mL Interval 3.16 to 3.97
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series Additional serotypes - serotype 3	1.11 mcg/mL Interval 1.01 to 1.23
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series Additional serotypes - serotype 5	1.89 mcg/mL Interval 1.67 to 2.13
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series Additional serotypes - serotype 6A	1.86 mcg/mL Interval 1.6 to 2.16
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series Additional serotypes - serotype 7F	2.98 mcg/mL Interval 2.7 to 3.29
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series Additional serotypes - serotype 19A	3.52 mcg/mL Interval 3.07 to 4.03

OTHER_PRE_SPECIFIED outcome

Timeframe: Dose 3 of infant series (6 months of age)

Population: Evaluable 3-Dose Infant Immunogenicity population

Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.

Outcome measures

Outcome measures
Measure	13vPnC n=171 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series Common serotypes - serotype 4	3.48 mcg/mL Interval 3.12 to 3.88
GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series Common serotypes - serotype 6B	5.02 mcg/mL Interval 4.27 to 5.9
GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series Common serotypes - serotype 9V	2.34 mcg/mL Interval 2.11 to 2.6
GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series Common serotypes - serotype 14	9.35 mcg/mL Interval 8.07 to 10.82
GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series Common serotypes - serotype 18C	2.50 mcg/mL Interval 2.23 to 2.81
GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series Common serotypes - serotype 19F	3.75 mcg/mL Interval 3.28 to 4.29
GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series Common serotypes - serotype 23F	1.83 mcg/mL Interval 1.55 to 2.17
GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series Additional serotypes - serotype 1	4.23 mcg/mL Interval 3.73 to 4.79
GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series Additional serotypes - serotype 3	1.17 mcg/mL Interval 1.03 to 1.33
GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series Additional serotypes - serotype 5	3.11 mcg/mL Interval 2.75 to 3.52
GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series Additional serotypes - serotype 6A	4.08 mcg/mL Interval 3.56 to 4.68
GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series Additional serotypes - serotype 7F	3.71 mcg/mL Interval 3.34 to 4.12
GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series Additional serotypes - serotype 19A	4.19 mcg/mL Interval 3.71 to 4.74

OTHER_PRE_SPECIFIED outcome

Timeframe: Toddler Dose (12 months of age)

Population: Evaluable Toddler Immunogenicity population subset where the number of participants analyzed (N) equals (=) those who had a valid and determinate assay result for antibody GMC at both the infant dose 3 and toddler dose.

Outcome measures

Outcome measures
Measure	13vPnC n=137 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose Common serotypes - serotype 14	10.62 mcg/mL Interval 9.16 to 12.32
GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose Common serotypes - serotype 18C	3.93 mcg/mL Interval 3.45 to 4.48
GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose Common serotypes - serotype 19F	11.33 mcg/mL Interval 9.68 to 13.26
GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose Additional serotypes - serotype 5	4.75 mcg/mL Interval 4.18 to 5.4
GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose Additional serotypes - serotype 6A	11.64 mcg/mL Interval 9.93 to 13.64
GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose Additional serotypes - serotype 7F	5.81 mcg/mL Interval 5.18 to 6.51
GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose Additional serotypes - serotype 19A	8.95 mcg/mL Interval 7.84 to 10.23
GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose Common serotypes - serotype 4	5.10 mcg/mL Interval 4.41 to 5.89
GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose Common serotypes - serotype 6B	15.41 mcg/mL Interval 12.92 to 18.38
GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose Common serotypes - serotype 9V	3.76 mcg/mL Interval 3.29 to 4.29
GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose Common serotypes - serotype 23F	5.70 mcg/mL Interval 4.81 to 6.77
GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose Additional serotypes - serotype 1	5.86 mcg/mL Interval 5.08 to 6.75
GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose Additional serotypes - serotype 3	1.62 mcg/mL Interval 1.42 to 1.84

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 4 days after dose 1 of Infant Series (2 months of age)

Population: Safety population: All participants who received at least 1 dose of the study vaccine; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.

Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters \[cm\] to 2.0cm); Moderate (2.5 to 7.0cm); Severe (greater than \[\>\] 7.0cm). Participants may be represented in more than 1 category.

Outcome measures

Outcome measures
Measure	13vPnC n=214 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) Swelling: Mild	25.1 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) Swelling: Moderate	11.9 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) Swelling: Severe	0 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) Redness: Any	33.8 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) Redness: Mild	27.9 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) Tenderness: Any	63.5 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) Tenderness: Significant	12.4 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) Swelling: Any	31.2 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) Redness: Moderate	10.6 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) Redness: Severe	0 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 4 days after dose 2 of Infant Series (4 months of age)

Population: Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.

Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (\>7.0cm). Participants may be represented in more than 1 category.

Outcome measures

Outcome measures
Measure	13vPnC n=196 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) Tenderness: Any	69.4 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) Tenderness: Significant	12.6 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) Swelling: Any	29.9 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) Swelling: Mild	20.0 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) Redness: Any	28.9 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) Redness: Mild	19.5 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) Swelling: Moderate	13.3 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) Swelling: Severe	0 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) Redness: Moderate	12.3 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) Redness: Severe	0 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 4 days after dose 3 (6 months of age)

Population: Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.

Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (\>7.0cm). Participants may be represented in more than 1 category.

Outcome measures

Outcome measures
Measure	13vPnC n=168 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) Tenderness: Significant	15.4 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) Swelling: Any	29.4 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) Tenderness: Any	61.3 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) Swelling: Mild	19.0 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) Swelling: Moderate	14.6 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) Swelling: Severe	0 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) Redness: Any	31.8 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) Redness: Mild	20.9 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) Redness: Moderate	13.9 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) Redness: Severe	0 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 4 days after toddler dose (12 months of age)

Population: Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.

Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (\>7.0cm). Participants may be represented in more than 1 category.

Outcome measures

Outcome measures
Measure	13vPnC n=154 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) Tenderness: Any	43.7 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) Tenderness: Significant	3.8 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) Swelling: Any	21.3 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) Swelling: Mild	8.1 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) Swelling: Moderate	15.8 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) Swelling: Severe	0 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) Redness: Any	22.0 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) Redness: Mild	8.8 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) Redness: Moderate	15.7 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) Redness: Severe	0 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 4 days after dose 1 of Infant Series (2 months of age)

Population: Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.

Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.

Outcome measures

Outcome measures
Measure	13vPnC n=217 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age) Fever ≥38 degrees C but ≤39 degrees C	7.0 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age) Fever >39 degrees C but ≤40 degrees C	0 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age) Fever >40 degrees C	0 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age) Decreased appetite	31.0 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age) Irritability	69.8 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age) Increased sleep	37.2 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age) Decreased sleep	32.8 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 4 days after dose 2 of Infant Series (4 months of age)

Population: Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.

Outcome measures

Outcome measures
Measure	13vPnC n=198 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age) Fever ≥38 degrees C but ≤39 degrees C	18.5 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age) Fever >39 degrees C but ≤40 degrees C	0.6 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age) Fever >40 degrees C	0 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age) Decreased appetite	29.3 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age) Irritability	62.2 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age) Increased sleep	24.5 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age) Decreased sleep	35.1 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 4 days after dose 3 of Infant Series (6 months of age)

Population: Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.

Outcome measures

Outcome measures
Measure	13vPnC n=172 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age) Fever >40 degrees C	0 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age) Decreased appetite	25.7 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age) Irritability	63.2 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age) Increased sleep	22.9 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age) Fever ≥38 degrees C but ≤39 degrees C	18.3 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age) Fever >39 degrees C but ≤40 degrees C	2.2 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age) Decreased sleep	37.3 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 4 days after toddler dose (12 months of age)

Population: Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.

Outcome measures

Outcome measures
Measure	13vPnC n=162 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age) Fever ≥38 degrees C but ≤39 degrees C	23.0 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age) Fever >39 degrees C but ≤40 degrees C	0 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age) Fever >40 degrees C	0 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age) Decreased appetite	33.8 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age) Irritability	46.7 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age) Increased sleep	17.9 Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age) Decreased sleep	22.0 Percentage of participants

Adverse Events

Infant Series 13vPnC

Serious events: 3 serious events

Other events: 182 other events

Deaths: 0 deaths

After the Infant Series 13vPnC

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Toddler Dose 13vPnC

Serious events: 2 serious events

Other events: 96 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Infant Series 13vPnC n=223 participants at risk 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5mL dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series). Other Adverse Events (AEs) (non-serious events): the number affected (n) for non-systematic (non-solicited) Other Adverse Events n=79; systematic (solicited) Any Local Reaction n=154, 139, and 112 for Dose 1, 2,and 3 of infant series, respectively; systematic (solicited) Any Systemic Event n=182, 144, and 126 for Dose 1, 2,and 3 of infant series, respectively.	After the Infant Series 13vPnC n=223 participants at risk 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).	Toddler Dose 13vPnC n=191 participants at risk 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose). Other AEs (non-serious events): the number affected (n) for non-systematic (non-solicited) Other AEs n=50; systematic (solicited) Any Local Reaction n=73; systematic (solicited) Any Systemic Event n=96.
Cardiac disorders Myocarditis	0.45% 1/223 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/223 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/191 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	0.45% 1/223 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/223 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/191 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	0.45% 1/223 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.45% 1/223 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/191 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Bronchiolitis	0.45% 1/223 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/223 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/191 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Angioedema	0.45% 1/223 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/223 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/191 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Kawasaki's disease	0.45% 1/223 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/223 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/191 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	0.00% 0/223 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.45% 1/223 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/191 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Breath holding	0.00% 0/223 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.45% 1/223 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/191 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Acute sinusitis	0.00% 0/223 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/223 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.52% 1/191 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Seizure anoxic	0.00% 0/223 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/223 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.52% 1/191 • Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

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Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER