Safety and Immunogenicity Study of 20vPnC in Healthy Chil... | NCT04642079

Obsolete or Duplicate NCT IDs

Not provided

ID	Type	Description	Link
2019-003308-11	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1: =>15 through 23 months of age	Experimental	20vPnC	Biological: 20vPnC
Cohort 2: 2 through 4 years of age	Experimental	20vPnC	Biological: 20vPnC
Cohort 3: 5 through 9 years of age	Experimental	20vPnC	Biological: 20vPnC
Cohort 4: 10 through 17 years of age	Experimental	20vPnC	Biological: 20vPnC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
20vPnC	Biological	20-valent pneumococcal conjugate vaccine	Cohort 1: =>15 through 23 months of age Cohort 2: 2 through 4 years of age Cohort 3: 5 through 9 years of age

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination	Local reactions included redness, swelling and, pain at the injection site, recorded by parent's/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. One measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: > 0.0 to 2.0 cm, moderate: >2.0 to 7.0 cm and severe: >7.0 cm. Pain at the injection site was graded as mild: hurt if gently touched (cohort 1) and did not interfere with activity (cohort 2-4); moderate: hurt if gently touched with crying (cohort 1) and interfered with daily activity (cohort 2-4) and; severe: limited limb movement (cohort 1) and prevented daily activity (cohort 2-4). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method.	Within 7 days after vaccination on Day 1
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1	Systemic events for Cohort 1 included fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. Fever was defined as temperature >=38.0 degrees Celsius (C) and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0-degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.	Within 7 days after vaccination on Day 1
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4	Systemic events for Cohort 2-4 included fever, fatigue, headache, muscle pain and joint pain, recorded by parents/legal guardians of participant's using an e-diary. Fever was defined as temperature >=38.0 degrees C and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevents daily routine activity). 95% CI was based on Clopper and Pearson method.

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Predefined Levels of Pneumococcal Serotype-Specific IgG Concentrations for the 7 Additional Serotypes at 1 Month After Vaccination in Cohort 1 Only	Pneumococcal serotype-specific IgG concentrations were measured from serum samples for the 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. Percentage of participants with predefined level (>=0.35 micrograms per milliliter) of IgG concentration for the 7 additional 20vPnC serotypes was presented. 2-sided 95% CI was based on Clopper and Pearson method.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Northwest Arkansas Pediatrics		Fayetteville	Arkansas	72703	United States
The Children's Clinic of Jonesboro, P.A.

References Module

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort 1: 20vPnC: >=15 to <24 Months	Participants aged greater than or equal to (>=) 15 months to less than (<) 24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 milliliter (mL) 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered greater than (>) 2 months before enrollment into the study.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 18, 2021	Apr 4, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Cohort 4: 10 through 17 years of age

Enrolled population included all participants who signed informed consent form (ICF).

Arm/Group Information

ID	Title	Description
BG000	Cohort 1: 20vPnC: >=15 to <24 Months	Participants aged greater than >=15 months to <24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered >2 months before enrollment into the study.
BG001	Cohort 2: 20vPnC: >=2 to <5 Years	Participants aged >=2 to <5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered >2 months before enrollment into the study.
BG002	Cohort 3: 20vPnC: >=5 to <10 Years	Participants aged >=5 to <10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
BG003	Cohort 4: 20vPnC: >=10 to <18 Years	Participants aged >=10 to <18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

28 Days to 23 Months

Title	Measurements
	BG000210 BG0010 BG0020 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00093 BG001111 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00035 BG00146 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination

Local reactions included redness, swelling and, pain at the injection site, recorded by parent's/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. One measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: > 0.0 to 2.0 cm, moderate: >2.0 to 7.0 cm and severe: >7.0 cm. Pain at the injection site was graded as mild: hurt if gently touched (cohort 1) and did not interfere with activity (cohort 2-4); moderate: hurt if gently touched with crying (cohort 1) and interfered with daily activity (cohort 2-4) and; severe: limited limb movement (cohort 1) and prevented daily activity (cohort 2-4). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method.

Safety population included all participants who received 20vPnC and had safety follow-up after vaccination. Here, "Number of Participants Analyzed" signifies the number of participants with any electronic diary data after vaccination.

Posted

Number

95% Confidence Interval

Percentage of participants

Within 7 days after vaccination on Day 1

ID	Title	Description
OG000	Cohort 1: 20vPnC: >=15 to <24 Months	Participants aged greater than >=15 months to <24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered >2 months before enrollment into the study.
OG001	Cohort 2: 20vPnC: >=2 to <5 Years	Participants aged >=2 to <5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered >2 months before enrollment into the study.
OG002	Cohort 3: 20vPnC: >=5 to <10 Years	Participants aged >=5 to <10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
OG003	Cohort 4: 20vPnC: >=10 to <18 Years	Participants aged >=10 to <18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.

Units	Counts
Participants	OG000204 OG001215 OG002199 OG003

Title

Denominators

Categories

Redness: Any

Title	Measurements
	OG00037.7(31.1 to 44.8) OG00139.1(32.5 to 45.9) OG00237.2(30.5 to 44.3) OG003

Primary

Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1

Systemic events for Cohort 1 included fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. Fever was defined as temperature >=38.0 degrees Celsius (C) and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0-degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.

Posted

Number

95% Confidence Interval

Percentage of participants

Within 7 days after vaccination on Day 1

ID	Title	Description
OG000	Cohort 1: 20vPnC: >=15 to <24 Months	Participants aged greater than >=15 months to <24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered >2 months before enrollment into the study.

Primary

Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4

Systemic events for Cohort 2-4 included fever, fatigue, headache, muscle pain and joint pain, recorded by parents/legal guardians of participant's using an e-diary. Fever was defined as temperature >=38.0 degrees C and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevents daily routine activity). 95% CI was based on Clopper and Pearson method.

Posted

Number

95% Confidence Interval

Percentage of participants

Within 7 days after vaccination on Day 1

ID	Title	Description
OG000	Cohort 2: 20vPnC: >=2 to <5 Years	Participants aged >=2 to <5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered >2 months before enrollment into the study.
OG001	Cohort 3: 20vPnC: >=5 to <10 Years	Participants aged >=5 to <10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.

Primary

Percentage of Participants Reporting Adverse Events (AEs) up to 1 Month After Vaccination

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.

Posted

Number

95% Confidence Interval

Percentage of participants

From vaccination (on Day 1) up to 1 month after vaccination

ID	Title	Description
OG000	Cohort 1: 20vPnC: >=15 to <24 Months	Participants aged greater than >=15 months to <24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered >2 months before enrollment into the study.
OG001	Cohort 2: 20vPnC: >=2 to <5 Years	Participants aged >=2 to <5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered >2 months before enrollment into the study.

Primary

Percentage of Participants Reporting Serious Adverse Events (SAEs) up to 6 Months After Vaccination

An SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.

Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.

Posted

Number

95% Confidence Interval

Percentage of participants

From vaccination (on Day 1) up to 6 months after vaccination

ID	Title	Description
OG000	Cohort 1: 20vPnC: >=15 to <24 Months	Participants aged greater than >=15 months to <24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered >2 months before enrollment into the study.
OG001	Cohort 2: 20vPnC: >=2 to <5 Years	Participants aged >=2 to <5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered >2 months before enrollment into the study.

Primary

Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 Months After Vaccination

An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method.

Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.

Posted

Number

95% Confidence Interval

Percentage of participants

From vaccination (on Day 1) up to 6 months after vaccination

ID	Title	Description
OG000	Cohort 1: 20vPnC: >=15 to <24 Months	Participants aged greater than >=15 months to <24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered >2 months before enrollment into the study.
OG001	Cohort 2: 20vPnC: >=2 to <5 Years	Participants aged >=2 to <5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered >2 months before enrollment into the study.
OG002	Cohort 3: 20vPnC: >=5 to <10 Years

Primary

Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2

Pneumococcal serotype-specific IgG concentrations were measured from serum samples for the 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding 2-sided 95% CIs (based on Student's t distribution). Superiority of IgG concentration 1 month after 20vPnC to before vaccination for each serotype was demonstrated if the 95% lower CI of GMFR was >1.

Evaluable immunogenicity population (EIP) included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days after vaccination for Cohorts 1-2; no other major protocol deviations. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants with valid assay results at both timepoints for the specified serotype.

Posted

Geometric Mean

95% Confidence Interval

Fold rise

Before vaccination on Day 1 to 1 month after vaccination

ID	Title	Description
OG000	Cohort 1: 20vPnC: >=15 to <24 Months	Participants aged greater than >=15 months to <24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered >2 months before enrollment into the study.

Primary

GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4

Pneumococcal serotype-specific OPA titers were measured from serum samples for 7 the additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution). Superiority of OPA titers 1 month after 20vPnC to before vaccination for each serotype was demonstrated if the 95% lower CI of the GMFR was >1.

EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 49 days after vaccination for Cohorts 3-4; no other major protocol deviations. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants with valid assay results at both timepoints for the specified serotype.

Posted

Geometric Mean

95% Confidence Interval

Fold rise

Before vaccination on Day 1 to 1 month after vaccination

ID	Title	Description
OG000	Cohort 3: 20vPnC: >=5 to <10 Years	Participants aged >=5 to <10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
OG001	Cohort 4: 20vPnC: >=10 to <18 Years

Secondary

Percentage of Participants With Predefined Levels of Pneumococcal Serotype-Specific IgG Concentrations for the 7 Additional Serotypes at 1 Month After Vaccination in Cohort 1 Only

Pneumococcal serotype-specific IgG concentrations were measured from serum samples for the 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. Percentage of participants with predefined level (>=0.35 micrograms per milliliter) of IgG concentration for the 7 additional 20vPnC serotypes was presented. 2-sided 95% CI was based on Clopper and Pearson method.

Posted

Number

95% Confidence Interval

Percentage of participants

At 1 Month after vaccination on Day 1

ID	Title	Description
OG000	Cohort 1: 20vPnC: >=15 to <24 Months	Participants aged greater than >=15 months to <24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered >2 months before enrollment into the study.

Units	Counts
Participants

Secondary

Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only

Pneumococcal serotype-specific OPA titers were measured from serum samples for 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. Percentage of participants with >=4-fold rise in serotype-specific OPA titers from before vaccination to 1 month after vaccination with 20vPnC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. OPA titers were measured in a randomized subset of samples in Cohort 2 for this outcome measure.

EIP included all participants who were eligible; received 20vPnC;at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days or 27 to 49 days after vaccination for Cohort 2 or Cohorts 3-4, respectively; no other major protocol deviations. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants with valid assay results at both timepoints for the specified serotype.

Posted

Number

95% Confidence Interval

Percentage of participants

Before vaccination on Day 1 to 1 month after vaccination

ID	Title	Description
OG000	Cohort 2: 20vPnC: >=2 to <5 Years	Participants aged >=2 to <5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered >2 months before enrollment into the study.

Secondary

Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination

Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMCs the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding 2-sided 95% CIs (based on the Student's t distribution).

EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days or within 27 to 49 days after vaccination for Cohorts 1-2 or Cohorts 3-4, respectively; no other major protocol deviations. Here, "Number of Participants Analyzed" signifies participants included in the EIP and "Number Analyzed" signifies participants with valid IgG concentrations at the specified timepoint for specified serotype.

Posted

Geometric Mean

95% Confidence Interval

Micrograms per milliliter

Before vaccination and 1 month after vaccination

ID	Title	Description
OG000	Cohort 1: 20vPnC: >=15 to <24 Months	Participants aged greater than >=15 months to <24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered >2 months before enrollment into the study.
OG001	Cohort 2: 20vPnC: >=2 to <5 Years

Secondary

GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2

Pneumococcal serotype-specific IgG concentrations were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution).

EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days after vaccination for Cohorts 1-2; no other major protocol deviations. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants with valid assay results at both timepoints for the specified serotype.

Posted

Geometric Mean

95% Confidence Interval

Fold rise

Before vaccination on Day 1 to 1 month after vaccination

ID	Title	Description
OG000	Cohort 1: 20vPnC: >=15 to <24 Months	Participants aged greater than >=15 months to <24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered >2 months before enrollment into the study.
OG001	Cohort 2: 20vPnC: >=2 to <5 Years

Secondary

GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4

Pneumococcal serotype-specific IgG concentrations were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution).

EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 49 days after vaccination for Cohorts 3-4; no other major protocol deviations. Here, "Number of Participants Analyzed" signifies participants included in the EIP and "Number Analyzed" signifies participants with valid assay results at both timepoints for the specified serotype.

Posted

Geometric Mean

95% Confidence Interval

Fold rise

Before vaccination on Day 1 to 1 month after vaccination

ID	Title	Description
OG000	Cohort 3: 20vPnC: >=5 to <10 Years	Participants aged >=5 to <10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
OG001	Cohort 4: 20vPnC: >=10 to <18 Years

Secondary

Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination

Pneumococcal serotype-specific OPA titers were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding 2-sided 95% CIs (based on the Student's t distribution). OPA titers were measured in a randomized subset of serum samples in Cohorts 1 and 2. OPA titers for the 13vPnC serotypes were measured in a randomized subset of serum samples in Cohorts 3 and 4.

EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days or 27 to 49 days after vaccination for Cohorts 1-2 or Cohorts 3-4, respectively; no other major protocol deviations. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants with valid OPA titers at the specified timepoint for specified serotype.

Posted

Geometric Mean

95% Confidence Interval

Titer

Before vaccination on Day 1 and 1 month after vaccination

ID	Title	Description
OG000	Cohort 1: 20vPnC: >=15 to <24 Months	Participants aged greater than >=15 months to <24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered >2 months before enrollment into the study.

Secondary

GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2

Pneumococcal serotype-specific OPA titers were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution). OPA titers measured in a randomized subset of serum samples in Cohorts 1 and 2 for this outcome measure.

EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days after vaccination for Cohorts 1-2; no other major protocol deviations. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants with valid assay results at both timepoints for the specified serotype.

Posted

Geometric Mean

95% Confidence Interval

Fold rise

Before vaccination on Day 1 to 1 month after vaccination

ID	Title	Description
OG000	Cohort 1: 20vPnC: >=15 to <24 Months	Participants aged greater than >=15 months to <24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered >2 months before enrollment into the study.

Secondary

GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4

Pneumococcal serotype-specific OPA titers were measured for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution). OPA titers for the 13vPnC serotypes were measured in a randomized subset of serum samples in Cohorts 3 and 4.

EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 49 days after vaccination for Cohorts 3-4; no other major protocol deviations. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and " Number Analyzed" signifies participants with valid assay results at both timepoints for the specified serotype.

Posted

Geometric Mean

95% Confidence Interval

Fold rise

Before vaccination on Day 1 to 1 month after vaccination

ID	Title	Description
OG000	Cohort 3: 20vPnC: >=5 to <10 Years	Participants aged >=5 to <10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
OG001	Cohort 4: 20vPnC: >=10 to <18 Years

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1: 20vPnC: >=15 to <24 Months	Participants aged greater than >=15 months to <24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered >2 months before enrollment into the study.	209	2	209	173	209
EG001	Cohort 2: 20vPnC: >=2 to <5 Years	Participants aged >=2 to <5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered >2 months before enrollment into the study.	216	0	216	163	216
EG002	Cohort 3: 20vPnC: >=5 to <10 Years	Participants aged >=5 to <10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.	201	0	201	178	201
EG003	Cohort 4: 20vPnC: >=10 to <18 Years	Participants aged >=10 to <18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.	205	3	205	186	205

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Appendicitis	Infections and infestations	MedDRA 24.1	Non-systematic Assessment	EG0000 events0 affected209 at risk EG0010 events0 affected216 at risk EG0020 events0 affected201 at risk EG0031 events1 affected205 at risk
Near drowning	Injury, poisoning and procedural complications	MedDRA 24.1	Non-systematic Assessment	EG0001 events1 affected209 at risk EG0010 events0 affected216 at risk EG0020 events0 affected201 at risk EG003
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Non-systematic Assessment	EG0000 events0 affected209 at risk EG0010 events0 affected216 at risk EG0020 events0 affected201 at risk EG003
Headache	Nervous system disorders	MedDRA 24.1	Non-systematic Assessment	EG0000 events0 affected209 at risk EG0010 events0 affected216 at risk EG0020 events0 affected201 at risk EG003
Febrile convulsion	Nervous system disorders	MedDRA 24.1	Non-systematic Assessment	EG0001 events1 affected209 at risk EG0010 events0 affected216 at risk EG0020 events0 affected201 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site erythema (REDNESS)	General disorders	MedDRA 24.1	Systematic Assessment	EG00084 events77 affected209 at risk EG00186 events84 affected216 at risk EG00279 events74 affected201 at risk EG00332 events31 affected205 at risk
Injection site pain (PAIN)	General disorders	MedDRA 24.1	Systematic Assessment	EG000115 events107 affected209 at risk EG001157 events142 affected216 at risk EG002178 events165 affected201 at risk EG003
Injection site swelling (SWELLING)	General disorders	MedDRA 24.1	Systematic Assessment	EG00051 events45 affected209 at risk EG00154 events50 affected216 at risk EG00257 events54 affected201 at risk EG003
Pyrexia (FEVER)	General disorders	MedDRA 24.1	Systematic Assessment	EG00025 events24 affected209 at risk EG0019 events7 affected216 at risk EG0021 events1 affected201 at risk EG003
Decreased appetite (DECREASED APPETITE)	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG00072 events51 affected209 at risk EG0010 events0 affected216 at risk EG0020 events0 affected201 at risk EG003
Arthralgia (JOINT PAIN)	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected209 at risk EG0019 events8 affected216 at risk EG00214 events13 affected201 at risk EG003
Myalgia (MUSCLE PAIN)	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected209 at risk EG00163 events57 affected216 at risk EG00286 events78 affected201 at risk EG003
Headache (HEADACHE)	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected209 at risk EG00113 events12 affected216 at risk EG00245 events37 affected201 at risk EG003
Hypersomnia (INCREASED SLEEP)	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG000104 events85 affected209 at risk EG0010 events0 affected216 at risk EG0020 events0 affected201 at risk EG003
Irritability (IRRITABILITY)	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG000170 events126 affected209 at risk EG0010 events0 affected216 at risk EG0020 events0 affected201 at risk EG003
Fatigue (FATIGUE)	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected209 at risk EG00198 events80 affected216 at risk EG00276 events56 affected201 at risk EG003

ID	Term
D011008	Pneumococcal Infections

Participants aged >=10 to <18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.

OG00180.6(72.9 to 86.9)

OG00281.7(74.3 to 87.7)

OG00166.2(57.6 to 74.1)

OG00262.6(54.5 to 70.2)

OG00196.8(92.6 to 98.9)

OG00294.5(89.8 to 97.5)

OG00189.4(83.2 to 94.0)

OG00293.9(89.1 to 97.0)

OG00187.6(80.9 to 92.6)

OG00281.0(74.2 to 86.6)

OG00179.9(72.4 to 86.1)

OG00275.3(67.8 to 81.8)

ID	Term
D013290	Streptococcal Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections