Trial to Evaluate the Safety and Immunogenicity of a 20-v... | NCT03760146

ID	Type	Description	Link
2018-004279-11	EudraCT Number

Trial to Evaluate the Safety and Immunogenicity of a 20-v... | NCT03760146 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
60 years and above 20vPnC/Saline	Experimental	20vPnC and saline	Biological: 20vPnC Other: Saline
60 years and above 13vPnC/PPSV23	Active Comparator	13vPnC and PPSV23	Biological: 13vPnC Biological: PPSV23
50 through 59 years of age 20vPnC	Experimental	20vPnC	Biological: 20vPnC
18 through 49 years of age 20vPnC	Experimental	20vPnC	Biological: 20vPnC
50 through 59 years of age 13vPnC	Active Comparator	13vPnC	Biological: 13vPnC
18 through 49 years of age 13vPnC	Active Comparator	13vPnC	Biological: 13vPnC

Name	Type	Description	Arm Group Labels	Other Names
20vPnC	Biological	20vPnC	18 through 49 years of age 20vPnC 50 through 59 years of age 20vPnC 60 years and above 20vPnC/Saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts	Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm) and severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).	Within 10 days after 20vPnC or 13vPnC
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts	Systemic events fever, fatigue, headache, muscle pain and joint pain were recorded by using an electronic diary. Fever was defined as greater than or equal to (>=) 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity).	Within 7 days after 20vPnC or 13vPnC
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination in All Cohorts	An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.	Within 1 month after 20vPnC or 13vPnC
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination in All Cohorts	An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event.

Secondary Outcomes

Measure	Description	Time Frame
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population	OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Accel Research Sites		Birmingham	Alabama	35216	United States
Coastal Clinical Research, Inc.

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36368038	Derived	Sabharwal C, Sundaraiyer V, Peng Y, Moyer L, Belanger TJ, Gessner BD, Jodar L, Jansen KU, Gruber WC, Scott DA, Watson W. Immunogenicity of a 20-valent pneumococcal conjugate vaccine in adults 18 to 64 years old with medical conditions and other factors that increase risk of pneumococcal disease. Hum Vaccin Immunother. 2022 Nov 30;18(6):2126253. doi: 10.1080/21645515.2022.2126253. Epub 2022 Nov 11.
34940806

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

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort 1: 20vPnC/Saline	Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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	Feb 11, 2019	Dec 2, 2020

Type	Comment	Reasons
Adverse Event		FG00011 subjects FG0018 subjects FG0020 subjects FG0030 subjects FG0040 subjects FG0050 subjects
Death		FG0001 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
Lost to Follow-up		FG00041 subjects FG00128 subjects FG0029 subjects FG0032 subjects FG004
No longer met eligibility criteria		FG0003 subjects FG0019 subjects FG0020 subjects FG0030 subjects FG004
Protocol Violation		FG00021 subjects FG00113 subjects FG0021 subjects FG0030 subjects FG004
Withdrawal by Subject		FG00019 subjects FG00120 subjects FG0021 subjects FG0030 subjects FG004

Arm/Group Information

ID	Title	Description
BG000	Cohort 1: 20vPnC/Saline	Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
BG001	Cohort 1: 13vPnC/PPSV23	Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
BG002	Cohort 2: 20vPnC	Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
BG003	Cohort 2: 13vPnC	Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
BG004	Cohort 3: 20vPnC	Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
BG005	Cohort 3: 13vPnC	Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
BG006	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, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00064.6± 4.82 BG00164.6± 4.81 BG00254.9± 2.77 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000897 BG001879 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG000167 BG001169 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0006 BG0019 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 With Local Reactions Within 10 Days After Vaccination in All Cohorts

Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm) and severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).

Safety population included all participants who received 1 dose of any of the following: 20vPnC, 13vPnC, PPSV23 or saline and had safety follow-up after any vaccination. Here, "Overall Number of Participants Analyzed" =number of participants with any electronic diary data after 20vPnC or 13vPnC.

Posted

Number

95% Confidence Interval

percentage of participants

Within 10 days after 20vPnC or 13vPnC

ID	Title	Description
OG000	Cohort 1: 20vPnC/Saline	Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
OG001	Cohort 1: 13vPnC/PPSV23	Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
OG002	Cohort 2: 20vPnC	Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
OG003	Cohort 2: 13vPnC	Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
OG004	Cohort 3: 20vPnC	Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
OG005	Cohort 3: 13vPnC	Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).

Units	Counts
Participants	OG0001505 OG0011483 OG002331 OG003

Title

Denominators

Categories

Redness: Any

Title	Measurements
	OG0007.3(6.0 to 8.7) OG0016.2(5.0 to 7.6) OG0028.2(5.4 to 11.6) OG003

Primary

Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts

Systemic events fever, fatigue, headache, muscle pain and joint pain were recorded by using an electronic diary. Fever was defined as greater than or equal to (>=) 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity).

Posted

Number

95% Confidence Interval

percentage of participants

Within 7 days after 20vPnC or 13vPnC

ID	Title	Description
OG000	Cohort 1: 20vPnC/Saline	Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
OG001	Cohort 1: 13vPnC/PPSV23	Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).

Primary

Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination in All Cohorts

An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.

Safety population included all participants who received 1 dose of any of the following: 20vPnC, 13vPnC, PPSV23 or saline and had safety follow-up after any vaccination.

Posted

Number

95% Confidence Interval

percentage of participants

Within 1 month after 20vPnC or 13vPnC

ID	Title	Description
OG000	Cohort 1: 20vPnC/Saline	Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
OG001	Cohort 1: 13vPnC/PPSV23	Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
OG002	Cohort 2: 20vPnC

Primary

Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination in All Cohorts

An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event.

Safety population included all participants who received 1 dose of any of the following: 20vPnC, 13vPnC, PPSV23 or saline and had safety follow-up after any vaccination.

Posted

Number

95% Confidence Interval

percentage of participants

Within 6 months after 20vPnC or 13vPnC

ID	Title	Description
OG000	Cohort 1: 20vPnC/Saline	Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
OG001	Cohort 1: 13vPnC/PPSV23	Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).

Primary

Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination in All Cohorts

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.

Safety population included all participants who received 1 dose of any of the following: 20vPnC, 13vPnC, PPSV23 or saline and had safety follow-up after any vaccination.

Posted

Number

95% Confidence Interval

percentage of participants

Within 6 months after 20vPnC or 13vPnC

ID	Title	Description
OG000	Cohort 1: 20vPnC/Saline	Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
OG001	Cohort 1: 13vPnC/PPSV23	Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
OG002

Primary

Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population

OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.

Evaluable 13-matched immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received Vaccination 1 as randomized, had at least 1 valid OPA titer for any of the 13 matched serotypes from the blood collection 27 to 49 days after Vaccination 1, had no other major protocol deviations. Number analyzed=participants evaluable for this outcome measure at specified rows.

Posted

Geometric Mean

95% Confidence Interval

titer

1 month after Vaccination 1

ID	Title	Description
OG000	Cohort 1: 20vPnC/Saline	Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
OG001	Cohort 1: 13vPnC/PPSV23	Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).

Primary

Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP)

OPA GMTs were determined for serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.

Evaluable 7-additional immunogenicity population: participants who were enrolled in the appropriate cohort based on age, received 20vPnC if randomized to 20vPnC/saline group or received both vaccinations if randomized to 13vPnC/PPSV23 group, had at least 1 valid OPA titers for any of the 7 additional serotypes from the blood collection 27 to 49 days after Vaccination 1 or Vaccination 2 respectively, had no other major protocol deviations. Number analyzed=participants evaluable at specified rows.

Posted

Geometric Mean

95% Confidence Interval

titer

1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline"; 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23"

ID	Title	Description
OG000	Cohort 1: 20vPnC/Saline	Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
OG001	Cohort 1: 13vPnC/PPSV23

Secondary

Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population

OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.

Evaluable-20 immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received the vaccination as randomized, had at least 1 valid OPA titer from the blood collection 27 to 49 days after 20vPnC, had no other major protocol deviations. Number analyzed=participants evaluable at specified rows.

Posted

Geometric Mean

95% Confidence Interval

titer

1 month after vaccination

ID	Title	Description
OG000	Cohort 2: 20vPnC	Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
OG001	Cohort 1: 20vPnC/Saline (60-64 Years of Age)	Participants were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).

Secondary

Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population

Posted

Geometric Mean

95% Confidence Interval

titer

1 month after vaccination

ID	Title	Description
OG000	Cohort 3: 20vPnC	Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
OG001	Cohort 1: 20vPnC/Saline (60-64 Years of Age)	Participants were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).

Secondary

Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population

OPA GMFR is the ratio of OPA GMT, 1 month after vaccination to before vaccination OPA GMT. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

Posted

Geometric Mean

95% Confidence Interval

fold rise

Before Vaccination 1 to 1 month after Vaccination 1

ID	Title	Description
OG000	Cohort 1: 20vPnC/Saline	Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
OG001	Cohort 1: 13vPnC/PPSV23	Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).

Secondary

Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population

E7-AIP included participants who were enrolled in appropriate cohort based on age, received 20vPnC if randomized to 20vPnC/saline group or received both vaccinations if randomized to 13vPnC/PPSV23 group, had at least 1 valid OPA titers for any of 7 additional serotypes from blood collection 27 to 49 days after Vaccination 1 or Vaccination 2 respectively, had no other major protocol deviations. Number analyzed=participants evaluable with OPA titers available at both timepoints at specified row.

Posted

Geometric Mean

95% Confidence Interval

fold rise

From before Vaccination 1 to 1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline" or From before Vaccination 1 to 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23"

ID	Title	Description
OG000	Cohort 1: 20vPnC/Saline	Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
OG001

Secondary

Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population

Posted

Geometric Mean

95% Confidence Interval

fold rise

Before vaccination to 1 month after vaccination

ID	Title	Description
OG000	Cohort 2: 20vPnC	Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
OG001	Cohort 3: 20vPnC	Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).

Secondary

Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population

Percentage of participants with a >=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

Posted

Number

95% Confidence Interval

percentage of participants

Before Vaccination 1 to 1 month after Vaccination 1

ID	Title	Description
OG000	Cohort 1: 20vPnC/Saline	Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
OG001	Cohort 1: 13vPnC/PPSV23

Secondary

Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP

Posted

Number

95% Confidence Interval

percentage of participants

Before Vaccination 1 to 1 month after Vaccination 1 for "Cohort 1: 20vPnC/Saline"; Before Vaccination 1 to 1 month after Vaccination 2 for "Cohort 1: 13vPnC/PPSV23"

ID	Title	Description
OG000	Cohort 1: 20vPnC/Saline	Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
OG001

Secondary

Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population

Posted

Number

95% Confidence Interval

percentage of participants

Before vaccination to 1 month after vaccination

ID	Title	Description
OG000	Cohort 2: 20vPnC	Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
OG001	Cohort 3: 20vPnC	Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).

Secondary

Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population

Evaluable 13-matched immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received Vaccination 1 as randomized, had at least 1 valid OPA titer for any of the 13 matched serotypes from the blood collection 27 to 49 days after Vaccination 1, had no other major protocol deviations. Number analyzed =participants evaluable for this outcome measure at specified rows.

Posted

Number

95% Confidence Interval

percentage of participants

1 month after Vaccination 1

ID	Title	Description
OG000	Cohort 1: 20vPnC/Saline	Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
OG001	Cohort 1: 13vPnC/PPSV23	Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).

Secondary

Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population

The percentage of participants with OPA titers >=LLOQ along with corresponding 2-sided 95% CIs were calculated 1 month after vaccination for pneumococcal serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F.

Posted

Number

95% Confidence Interval

percentage of participants

1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline" or 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23"

ID	Title	Description
OG000	Cohort 1: 20vPnC/Saline	Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
OG001	Cohort 1: 13vPnC/PPSV23

Secondary

Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population

The percentage of participants with OPA titers >=LLOQ along with corresponding 2-sided 95% CIs were calculated 1 month after vaccination for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure were planned to be analyzed for the 20vPnC groups of Cohorts 2 and 3 only.

Posted

Number

95% Confidence Interval

percentage of participants

1 month after vaccination

ID	Title	Description
OG000	Cohort 2: 20vPnC	Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
OG001	Cohort 3: 20vPnC	Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1: 20vPnC/Saline	Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after vaccination 1).	1	1,507	36	1,507	1,074	1,507
EG001	Cohort 1: 13vPnC/PPSV23	Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).	0	1,490	29	1,490	1,063	1,490
EG002	Cohort 2: 20vPnC	Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).	0	334	1	334	281	334
EG003	Cohort 2: 13vPnC	Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).	0	111	1	111	91	111
EG004	Cohort 3: 20vPnC	Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).	0	335	2	335	302	335
EG005	Cohort 3: 13vPnC	Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).	0	112	1	112	107	112

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG0030 affected111 at risk EG004
Acute myocardial infarction	Cardiac disorders	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0012 affected1,490 at risk EG0020 affected334 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA v22.1	Non-systematic Assessment	EG0003 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Silent myocardial infarction	Cardiac disorders	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Chest pain	General disorders	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Hernia	General disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Biloma	Hepatobiliary disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Appendicitis	Infections and infestations	MedDRA v22.1	Non-systematic Assessment	EG0002 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Arthritis infective	Infections and infestations	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Cellulitis	Infections and infestations	MedDRA v22.1	Non-systematic Assessment	EG0002 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Erysipelas	Infections and infestations	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Diverticulitis	Infections and infestations	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Kidney infection	Infections and infestations	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Gun shot wound	Injury, poisoning and procedural complications	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Heat exhaustion	Injury, poisoning and procedural complications	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Muscle rupture	Injury, poisoning and procedural complications	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Stress fracture	Injury, poisoning and procedural complications	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Blood pressure increased	Investigations	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Neck mass	Musculoskeletal and connective tissue disorders	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA v22.1	Non-systematic Assessment	EG0002 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v22.1	Non-systematic Assessment	EG0002 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Hepatic encephalopathy	Nervous system disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Syncope	Nervous system disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Device malfunction	Product Issues	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Completed suicide	Psychiatric disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA v22.1	Non-systematic Assessment	EG0002 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
End stage renal disease	Renal and urinary disorders	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v22.1	Non-systematic Assessment	EG0002 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0011 affected1,490 at risk EG0020 affected334 at risk EG003
Skin bacterial infection	Infections and infestations	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0010 affected1,490 at risk EG0021 affected334 at risk EG003
Ureteric obstruction	Renal and urinary disorders	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0010 affected1,490 at risk EG0021 affected334 at risk EG003
Herpes simplex meningitis	Infections and infestations	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fatigue (FATIGUE)	General disorders	MedDRA v22.1	Systematic Assessment	EG000454 affected1,507 at risk EG001455 affected1,490 at risk EG002130 affected334 at risk EG00340 affected111 at risk EG004143 affected335 at risk EG00549 affected112 at risk
Injection site erythema (REDNESS)	General disorders	MedDRA v22.1	Systematic Assessment	EG000110 affected1,507 at risk EG00192 affected1,490 at risk EG00227 affected334 at risk EG003
Injection site pain (PAIN)	General disorders	MedDRA v22.1	Systematic Assessment	EG000834 affected1,507 at risk EG001803 affected1,490 at risk EG002240 affected334 at risk EG003
Injection site swelling (SWELLING)	General disorders	MedDRA v22.1	Systematic Assessment	EG000113 affected1,507 at risk EG001118 affected1,490 at risk EG00229 affected334 at risk EG003
Arthralgia (JOINT PAIN)	Musculoskeletal and connective tissue disorders	MedDRA v22.1	Systematic Assessment	EG000190 affected1,507 at risk EG001203 affected1,490 at risk EG00251 affected334 at risk EG003
Myalgia (MUSCLE PAIN)	Musculoskeletal and connective tissue disorders	MedDRA v22.1	Systematic Assessment	EG000588 affected1,507 at risk EG001553 affected1,490 at risk EG002165 affected334 at risk EG003
Headache (HEADACHE)	Nervous system disorders	MedDRA v22.1	Systematic Assessment	EG000324 affected1,507 at risk EG001345 affected1,490 at risk EG002107 affected334 at risk EG003
Pyrexia (FEVER)	General disorders	MedDRA v22.1	Systematic Assessment	EG0000 affected1,507 at risk EG0010 affected1,490 at risk EG0025 affected334 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0010 affected1,490 at risk EG0024 affected334 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0010 affected1,490 at risk EG0024 affected334 at risk EG003
Influenza	Infections and infestations	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA v22.1	Non-systematic Assessment	EG0000 affected1,507 at risk EG0010 affected1,490 at risk EG0020 affected334 at risk EG003

Title

Denominators

Categories

Fever: >=38.0 degree C

Title	Measurements
	OG0000.9(0.5 to 1.6) OG0010.8(0.4 to 1.4) OG0021.5(0.5 to 3.5) OG0030.9(0.0 to 4.9) OG0041.2(0.3 to 3.0) OG0051.8(0.2 to 6.3)

Fever: >=38.0 degree C to 38.4 degree C

Title	Measurements
	OG0000.3(0.1 to 0.7) OG0010.4(0.1 to 0.9) OG0020.6(0.1 to 2.2) OG003

Fever: >38.4 degree C to 38.9 degree C

Title	Measurements
	OG0000.3(0.1 to 0.7) OG0010.2(0.0 to 0.6) OG0020.3(0.0 to 1.7) OG003

Fever: >38.9 degree C to 40.0 degree C

Title	Measurements
	OG0000.0(0.0 to 0.4) OG0010(0.0 to 0.2) OG0020.3(0.0 to 1.7) OG003

Fever: >40.0 degree C

Title	Measurements
	OG0000.3(0.1 to 0.8) OG0010.2(0.0 to 0.6) OG0020.3(0.0 to 1.7) OG003

Fatigue: Any

Title	Measurements
	OG00030.2(27.9 to 32.6) OG00130.7(28.3 to 33.1) OG00239.3(34.0 to 44.8) OG003

Fatigue: Mild

Title	Measurements
	OG00016.1(14.3 to 18.1) OG00117.5(15.6 to 19.6) OG00221.1(16.9 to 25.9) OG003

Fatigue: Moderate

Title	Measurements
	OG00012.8(11.2 to 14.6) OG00111.9(10.3 to 13.7) OG00217.2(13.3 to 21.7) OG003

Fatigue: Severe

Title	Measurements
	OG0001.2(0.7 to 1.9) OG0011.2(0.7 to 1.9) OG0020.9(0.2 to 2.6) OG003

Headache: Any

Title	Measurements
	OG00021.5(19.5 to 23.7) OG00123.3(21.1 to 25.5) OG00232.3(27.3 to 37.7) OG003

Headache: Mild

Title	Measurements
	OG00015.5(13.7 to 17.4) OG00117.0(15.1 to 19.0) OG00220.5(16.3 to 25.3) OG003

Headache: Moderate

Title	Measurements
	OG0005.4(4.3 to 6.6) OG0015.9(4.8 to 7.3) OG00210.9(7.7 to 14.7) OG003

Headache: Severe

Title	Measurements
	OG0000.7(0.3 to 1.2) OG0010.3(0.1 to 0.8) OG0020.9(0.2 to 2.6) OG003

Muscle pain: Any

Title	Measurements
	OG00039.1(36.6 to 41.6) OG00137.3(34.8 to 39.8) OG00249.8(44.3 to 55.4) OG003

Muscle pain: Mild

Title	Measurements
	OG00028.9(26.6 to 31.3) OG00126.8(24.6 to 29.2) OG00233.8(28.8 to 39.2) OG003

Muscle pain: Moderate

Title	Measurements
	OG0009.8(8.3 to 11.4) OG00110.0(8.5 to 11.6) OG00215.4(11.7 to 19.8) OG003

Muscle pain: Severe

Title	Measurements
	OG0000.4(0.1 to 0.9) OG0010.5(0.2 to 1.0) OG0020.6(0.1 to 2.2) OG003

Joint pain: Any

Title	Measurements
	OG00012.6(11.0 to 14.4) OG00113.7(12.0 to 15.5) OG00215.4(11.7 to 19.8) OG003

Joint pain: Mild

Title	Measurements
	OG0006.9(5.7 to 8.3) OG0017.1(5.9 to 8.6) OG00210.6(7.5 to 14.4) OG003

Joint pain: Moderate

Title	Measurements
	OG0005.4(4.3 to 6.6) OG0016.3(5.2 to 7.7) OG0024.8(2.8 to 7.7) OG003

Joint pain: Severe

Title	Measurements
	OG0000.3(0.1 to 0.8) OG0010.2(0.0 to 0.6) OG0020(0.0 to 1.1) OG003

Title

Denominators

Categories

Serotype 1

- ParticipantsOG0001430
- ParticipantsOG0011419

Title	Measurements
	OG000123.4(112.3 to 135.5) OG001153.8(140.2 to 168.8)

Serotype 3

- ParticipantsOG0001415
- ParticipantsOG0011411

Title	Measurements
	OG00040.7(38.0 to 43.6) OG001

Serotype 4

- ParticipantsOG0001415
- ParticipantsOG0011409

Title	Measurements
	OG000508.7(456.5 to 566.9) OG001

Serotype 5

- ParticipantsOG0001418
- ParticipantsOG0011395

Title	Measurements
	OG00091.6(83.4 to 100.5) OG001

Serotype 6A

- ParticipantsOG0001403
- ParticipantsOG0011390

Title	Measurements
	OG000889.0(795.0 to 994.1) OG001

Serotype 6B

- ParticipantsOG0001413
- ParticipantsOG0011401

Title	Measurements
	OG0001115.2(1003.1 to 1239.8) OG001

Serotype 7F

- ParticipantsOG0001409
- ParticipantsOG0011391

Title	Measurements
	OG000968.8(887.0 to 1058.3) OG001

Serotype 9V

- ParticipantsOG0001399
- ParticipantsOG0011391

Title	Measurements
	OG0001455.5(1317.5 to 1608.0) OG001

Serotype 14

- ParticipantsOG0001418
- ParticipantsOG0011408

Title	Measurements
	OG000746.7(679.0 to 821.2) OG001

Serotype 18C

- ParticipantsOG0001420
- ParticipantsOG0011403

Title	Measurements
	OG0001252.6(1123.1 to 1397.0) OG001

Serotype 19A

- ParticipantsOG0001420
- ParticipantsOG0011398

Title	Measurements
	OG000517.9(472.2 to 568.0) OG001

Serotype 19F

- ParticipantsOG0001421
- ParticipantsOG0011403

Title	Measurements
	OG000265.8(240.2 to 294.1) OG001

Serotype 23F

- ParticipantsOG0001424
- ParticipantsOG0011409

Title	Measurements
	OG000276.5(242.5 to 315.2) OG001

Group IDs	Group Description	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	Serotype 1: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI	Ratio of GMTs	0.80	2-Sided	95	0.71	0.90	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the geometric mean ratio (GMR) for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 3: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI	Ratio of GMTs	0.85	2-Sided	95	0.78	0.93	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 4: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI	Ratio of GMTs	0.81	2-Sided	95	0.71	0.93	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 5: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI	Ratio of GMTs	0.83	2-Sided	95	0.74	0.94	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 6A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI	Ratio of GMTs	0.76	2-Sided	95	0.66	0.88	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 6B: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI	Ratio of GMTs	0.83	2-Sided	95	0.73	0.95	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 7F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI	Ratio of GMTs	0.86	2-Sided	95	0.77	0.96	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 9V: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI	Ratio of GMTs	0.93	2-Sided	95	0.82	1.05	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 14: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI	Ratio of GMTs	1.00	2-Sided	95	0.89	1.13	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 18C: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI	Ratio of GMTs	0.85	2-Sided	95	0.74	0.97	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 19A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI	Ratio of GMTs	0.80	2-Sided	95	0.71	0.90	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 19F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI	Ratio of GMTs	0.80	2-Sided	95	0.70	0.91	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 23F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI	Ratio of GMTs	0.83	2-Sided	95	0.70	0.97	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).

Title

Denominators

Categories

Serotype 8

- ParticipantsOG0001374
- ParticipantsOG0011319

Title	Measurements
	OG000465.6(422.5 to 513.1) OG001848.1(769.1 to 935.2)

Serotype 10A

- ParticipantsOG0001310
- ParticipantsOG0011263

Title	Measurements
	OG0002007.6(1808.0 to 2229.1) OG001

Serotype 11A

- ParticipantsOG0001198
- ParticipantsOG0011209

Title	Measurements
	OG0004426.8(3965.5 to 4941.8) OG001

Serotype 12F

- ParticipantsOG0001294
- ParticipantsOG0011222

Title	Measurements
	OG0002538.7(2255.3 to 2857.7) OG001

Serotype 15B

- ParticipantsOG0001283
- ParticipantsOG0011249

Title	Measurements
	OG0002398.2(2090.6 to 2751.2) OG001

Serotype 22F

- ParticipantsOG0001274
- ParticipantsOG0011227

Title	Measurements
	OG0003666.2(3244.4 to 4143.0) OG001

Serotype 33F

- ParticipantsOG0001157
- ParticipantsOG0011201

Title	Measurements
	OG0005125.9(4611.3 to 5698.0) OG001

Group IDs	Group Description	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	Serotype 8: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI	Ratio of GMTs	0.55	2-Sided	95	0.49	0.62	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 10A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI	Ratio of GMTs	1.86	2-Sided	95	1.63	2.12	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 11A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI	Ratio of GMTs	1.75	2-Sided	95	1.52	2.01	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 12F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI	Ratio of GMTs	1.48	2-Sided	95	1.27	1.72	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 15B: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI	Ratio of GMTs	3.12	2-Sided	95	2.62	3.71	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 22F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI	Ratio of GMTs	1.99	2-Sided	95	1.70	2.32	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 33F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI	Ratio of GMTs	1.38	2-Sided	95	1.21	1.57	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).

Title

Denominators

Categories

Serotype 1

- ParticipantsOG000320
- ParticipantsOG001941

Title	Measurements
	OG000135.9(113.1 to 163.4) OG001131.8(117.2 to 148.3)

Serotype 3

- ParticipantsOG000318
- ParticipantsOG001935

Title	Measurements
	OG00043.3(38.0 to 49.4) OG001

Serotype 4

- ParticipantsOG000318
- ParticipantsOG001931

Title	Measurements
	OG000633.3(513.9 to 780.4) OG001

Serotype 5

- ParticipantsOG000313
- ParticipantsOG001935

Title	Measurements
	OG00084.6(70.3 to 101.8) OG001

Serotype 6A

- ParticipantsOG000318
- ParticipantsOG001921

Title	Measurements
	OG0001203.9(968.1 to 1497.1) OG001

Serotype 6B

- ParticipantsOG000318
- ParticipantsOG001933

Title	Measurements
	OG0001502.7(1228.2 to 1838.5) OG001

Serotype 7F

- ParticipantsOG000313
- ParticipantsOG001924

Title	Measurements
	OG0001047.0(884.0 to 1240.2) OG001

Serotype 9V

- ParticipantsOG000312
- ParticipantsOG001922

Title	Measurements
	OG0001725.7(1424.4 to 2090.6) OG001

Serotype 14

- ParticipantsOG000313
- ParticipantsOG001933

Title	Measurements
	OG000926.2(761.8 to 1126.0) OG001

Serotype 18C

- ParticipantsOG000315
- ParticipantsOG001937

Title	Measurements
	OG0001805.0(1459.6 to 2232.2) OG001

Serotype 19A

- ParticipantsOG000318
- ParticipantsOG001932

Title	Measurements
	OG000618.4(519.9 to 735.5) OG001

Serotype 19F

- ParticipantsOG000320
- ParticipantsOG001937

Title	Measurements
	OG000286.7(236.0 to 348.2) OG001

Serotype 23F

- ParticipantsOG000319
- ParticipantsOG001937

Title	Measurements
	OG000549.1(425.4 to 708.9) OG001

Serotype 8

- ParticipantsOG000314
- ParticipantsOG001901

Title	Measurements
	OG000486.9(400.6 to 591.9) OG001

Serotype 10A

- ParticipantsOG000296
- ParticipantsOG001857

Title	Measurements
	OG0002520.4(2076.0 to 3060.0) OG001

Serotype 11A

- ParticipantsOG000271
- ParticipantsOG001796

Title	Measurements
	OG0006416.9(5131.9 to 8023.6) OG001

Serotype 12F

- ParticipantsOG000292
- ParticipantsOG001855

Title	Measurements
	OG0003445.1(2807.8 to 4227.1) OG001

Serotype 15B

- ParticipantsOG000284
- ParticipantsOG001830

Title	Measurements
	OG0003355.9(2582.0 to 4361.8) OG001

Serotype 22F

- ParticipantsOG000284
- ParticipantsOG001835

Title	Measurements
	OG0003808.1(2998.2 to 4836.8) OG001

Serotype 33F

- ParticipantsOG000266
- ParticipantsOG001765

Title	Measurements
	OG0005571.3(4495.7 to 6904.2) OG001

Group IDs	Group Description	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	Serotype 1: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.03	2-Sided	95	0.84	1.26	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 3: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.06	2-Sided	95	0.92	1.22	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 4: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.10	2-Sided	95	0.87	1.38	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 5: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	0.88	2-Sided	95	0.72	1.07	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 6A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.21	2-Sided	95	0.95	1.53	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 6B: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.25	2-Sided	95	1.00	1.56	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 7F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	0.89	2-Sided	95	0.74	1.07	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 9V: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.02	2-Sided	95	0.83	1.26	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 14: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.25	2-Sided	95	1.01	1.54	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 18C: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.33	2-Sided	95	1.06	1.68	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 19A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.03	2-Sided	95	0.85	1.25	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 19F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	0.99	2-Sided	95	0.80	1.22	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 23F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.68	2-Sided	95	1.27	2.22	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 8: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	0.97	2-Sided	95	0.78	1.20	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 10A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.03	2-Sided	95	0.84	1.28	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 11A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.22	2-Sided	95	0.96	1.56	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 12F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.11	2-Sided	95	0.88	1.39	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 15B: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.17	2-Sided	95	0.88	1.56	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 22F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	0.90	2-Sided	95	0.69	1.17	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 33F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.02	2-Sided	95	0.81	1.30	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).

Title

Denominators

Categories

Serotype 1

- ParticipantsOG000316
- ParticipantsOG001941

Title	Measurements
	OG000162.6(135.1 to 195.6) OG001132.0(117.7 to 148.1)

Serotype 3

- ParticipantsOG000316
- ParticipantsOG001935

Title	Measurements
	OG00042.1(36.9 to 48.1) OG001

Serotype 4

- ParticipantsOG000315
- ParticipantsOG001931

Title	Measurements
	OG0001966.7(1599.5 to 2418.3) OG001

Serotype 5

- ParticipantsOG000317
- ParticipantsOG001935

Title	Measurements
	OG000107.9(89.4 to 130.1) OG001

Serotype 6A

- ParticipantsOG000315
- ParticipantsOG001921

Title	Measurements
	OG0003930.5(3176.0 to 4864.4) OG001

Serotype 6B

- ParticipantsOG000314
- ParticipantsOG001933

Title	Measurements
	OG0004260.0(3461.3 to 5243.1) OG001

Serotype 7F

- ParticipantsOG000311
- ParticipantsOG001924

Title	Measurements
	OG0001872.8(1564.2 to 2242.4) OG001

Serotype 9V

- ParticipantsOG000315
- ParticipantsOG001922

Title	Measurements
	OG0006041.4(4962.5 to 7354.9) OG001

Serotype 14

- ParticipantsOG000316
- ParticipantsOG001933

Title	Measurements
	OG0001848.4(1514.7 to 2255.7) OG001

Serotype 18C

- ParticipantsOG000312
- ParticipantsOG001937

Title	Measurements
	OG0004460.5(3584.6 to 5550.4) OG001

Serotype 19A

- ParticipantsOG000312
- ParticipantsOG001932

Title	Measurements
	OG0001415.0(1181.8 to 1694.2) OG001

Serotype 19F

- ParticipantsOG000315
- ParticipantsOG001937

Title	Measurements
	OG000654.8(538.2 to 796.8) OG001

Serotype 23F

- ParticipantsOG000315
- ParticipantsOG001937

Title	Measurements
	OG0001559.2(1208.1 to 2012.2) OG001

Serotype 8

- ParticipantsOG000306
- ParticipantsOG001901

Title	Measurements
	OG000867.0(709.7 to 1059.2) OG001

Serotype 10A

- ParticipantsOG000292
- ParticipantsOG001857

Title	Measurements
	OG0004157.3(3410.9 to 5067.0) OG001

Serotype 11A

- ParticipantsOG000263
- ParticipantsOG001796

Title	Measurements
	OG0007169.3(5735.7 to 8961.1) OG001

Serotype 12F

- ParticipantsOG000273
- ParticipantsOG001855

Title	Measurements
	OG0005875.4(4719.8 to 7314.1) OG001

Serotype 15B

- ParticipantsOG000279
- ParticipantsOG001830

Title	Measurements
	OG0004601.0(3487.9 to 6069.4) OG001

Serotype 22F

- ParticipantsOG000273
- ParticipantsOG001835

Title	Measurements
	OG0007568.2(5927.4 to 9663.2) OG001

Serotype 33F

- ParticipantsOG000251
- ParticipantsOG001765

Title	Measurements
	OG0007976.9(6341.7 to 10033.7) OG001

Group IDs	Group Description	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	Serotype 1: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.23	2-Sided	95	1.01	1.50	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 3: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.00	2-Sided	95	0.87	1.16	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 4: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	3.31	2-Sided	95	2.65	4.13	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 5: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.11	2-Sided	95	0.91	1.36	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 6A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	3.84	2-Sided	95	3.06	4.83	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 6B: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	3.41	2-Sided	95	2.73	4.26	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 7F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.58	2-Sided	95	1.30	1.91	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 9V: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	3.50	2-Sided	95	2.83	4.33	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 14: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	2.39	2-Sided	95	1.93	2.96	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 18C: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	3.20	2-Sided	95	2.53	4.04	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 19A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	2.31	2-Sided	95	1.91	2.81	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 19F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	2.17	2-Sided	95	1.76	2.68	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 23F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	4.80	2-Sided	95	3.65	6.32	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 8: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.71	2-Sided	95	1.38	2.12	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 10A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.62	2-Sided	95	1.31	2.00	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 11A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.32	2-Sided	95	1.04	1.68	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 12F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.91	2-Sided	95	1.51	2.41	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 15B: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.52	2-Sided	95	1.13	2.05	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 22F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.69	2-Sided	95	1.30	2.20	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
OG000 OG001	Serotype 33F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI	Ratio of GMTs	1.40	2-Sided	95	1.10	1.79	Non-Inferiority	Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).

Title

Denominators

Categories

Serotype 1

- ParticipantsOG0001425
- ParticipantsOG0011418

Title	Measurements
	OG00012.6(11.5 to 13.8) OG00115.4(14.1 to 16.8)

Serotype 3

- ParticipantsOG0001404
- ParticipantsOG0011401

Title	Measurements
	OG0004.8(4.5 to 5.2) OG001

Serotype 4

- ParticipantsOG0001370
- ParticipantsOG0011374

Title	Measurements
	OG00031.2(27.8 to 34.9) OG001

Serotype 5

- ParticipantsOG0001411
- ParticipantsOG0011394

Title	Measurements
	OG0006.1(5.6 to 6.6) OG001

Serotype 6A

- ParticipantsOG0001382
- ParticipantsOG0011371

Title	Measurements
	OG00034.3(30.7 to 38.3) OG001

Serotype 6B

- ParticipantsOG0001360
- ParticipantsOG0011360

Title	Measurements
	OG00023.8(21.3 to 26.6) OG001

Serotype 7F

- ParticipantsOG0001367
- ParticipantsOG0011355

Title	Measurements
	OG00012.2(11.1 to 13.3) OG001

Serotype 9V

- ParticipantsOG0001317
- ParticipantsOG0011294

Title	Measurements
	OG00011.0(9.9 to 12.2) OG001

Serotype 14

- ParticipantsOG0001370
- ParticipantsOG0011366

Title	Measurements
	OG0009.3(8.3 to 10.3) OG001

Serotype 18C

- ParticipantsOG0001407
- ParticipantsOG0011396

Title	Measurements
	OG00033.8(30.0 to 38.1) OG001

Serotype 19A

- ParticipantsOG0001400
- ParticipantsOG0011379

Title	Measurements
	OG00021.0(19.0 to 23.3) OG001

Serotype 19F

- ParticipantsOG0001405
- ParticipantsOG0011397

Title	Measurements
	OG0008.6(7.9 to 9.5) OG001

Serotype 23F

- ParticipantsOG0001409
- ParticipantsOG0011402

Title	Measurements
	OG00024.9(22.0 to 28.1) OG001

Title

Denominators

Categories

Serotype 8

- ParticipantsOG0001353
- ParticipantsOG0011293

Title	Measurements
	OG00022.1(20.0 to 24.5) OG00140.4(36.6 to 44.7)

Serotype 10A

- ParticipantsOG0001208
- ParticipantsOG0011164

Title	Measurements
	OG00018.5(16.5 to 20.6) OG001

Serotype 11A

- ParticipantsOG000973
- ParticipantsOG001993

Title	Measurements
	OG0009.3(8.1 to 10.7) OG001

Serotype 12F

- ParticipantsOG0001226
- ParticipantsOG0011147

Title	Measurements
	OG00072.4(64.2 to 81.6) OG001

Serotype 15B

- ParticipantsOG0001228
- ParticipantsOG0011178

Title	Measurements
	OG00055.4(47.7 to 64.4) OG001

Serotype 22F

- ParticipantsOG0001178
- ParticipantsOG0011156

Title	Measurements
	OG00078.5(67.3 to 91.5) OG001

Serotype 33F

- ParticipantsOG0001020
- ParticipantsOG0011080

Title	Measurements
	OG0007.5(6.7 to 8.5) OG001

Title

Denominators

Categories

Serotype 1

- ParticipantsOG000319
- ParticipantsOG001315

Title	Measurements
	OG00014.4(12.0 to 17.3) OG00118.6(16.0 to 21.8)

Serotype 3

- ParticipantsOG000317
- ParticipantsOG001312

Title	Measurements
	OG0005.1(4.4 to 5.9) OG001

Serotype 4

- ParticipantsOG000304
- ParticipantsOG001302

Title	Measurements
	OG00043.4(34.4 to 54.9) OG001

Serotype 5

- ParticipantsOG000312
- ParticipantsOG001315

Title	Measurements
	OG0005.9(5.0 to 7.0) OG001

Serotype 6A

- ParticipantsOG000312
- ParticipantsOG001305

Title	Measurements
	OG00050.3(40.2 to 63.0) OG001

Serotype 6B

- ParticipantsOG000299
- ParticipantsOG001286

Title	Measurements
	OG00031.7(25.3 to 39.7) OG001

Serotype 7F

- ParticipantsOG000300
- ParticipantsOG001284

Title	Measurements
	OG00012.8(10.7 to 15.4) OG001

Serotype 9V

- ParticipantsOG000288
- ParticipantsOG001281

Title	Measurements
	OG00012.1(9.9 to 14.7) OG001

Serotype 14

- ParticipantsOG000300
- ParticipantsOG001291

Title	Measurements
	OG00010.4(8.3 to 13.0) OG001

Serotype 18C

- ParticipantsOG000308
- ParticipantsOG001299

Title	Measurements
	OG00048.3(37.9 to 61.5) OG001

Serotype 19A

- ParticipantsOG000310
- ParticipantsOG001299

Title	Measurements
	OG00023.6(19.2 to 29.1) OG001

Serotype 19F

- ParticipantsOG000316
- ParticipantsOG001310

Title	Measurements
	OG0009.2(7.6 to 11.3) OG001

Serotype 23F

- ParticipantsOG000313
- ParticipantsOG001309

Title	Measurements
	OG00047.8(37.2 to 61.3) OG001

Serotype 8

- ParticipantsOG000310
- ParticipantsOG001300

Title	Measurements
	OG00023.9(19.3 to 29.6) OG001

Serotype 10A

- ParticipantsOG000273
- ParticipantsOG001260

Title	Measurements
	OG00017.9(14.2 to 22.6) OG001

Serotype 11A

- ParticipantsOG000213
- ParticipantsOG001220

Title	Measurements
	OG00010.4(7.7 to 14.2) OG001

Serotype 12F

- ParticipantsOG000279
- ParticipantsOG001252

Title	Measurements
	OG000107.3(85.8 to 134.1) OG001

Serotype 15B

- ParticipantsOG000263
- ParticipantsOG001248

Title	Measurements
	OG00072.1(51.9 to 100.1) OG001

Serotype 22F

- ParticipantsOG000256
- ParticipantsOG001241

Title	Measurements
	OG00063.5(44.8 to 90.1) OG001

Serotype 33F

- ParticipantsOG000233
- ParticipantsOG001213

Title	Measurements
	OG0009.1(7.1 to 11.7) OG001

Title

Denominators

Categories

Serotype 1

- ParticipantsOG0001425
- ParticipantsOG0011418

Title	Measurements
	OG00072.1(69.7 to 74.4) OG00174.8(72.4 to 77.0)

Serotype 3

- ParticipantsOG0001404
- ParticipantsOG0011401

Title	Measurements
	OG00056.1(53.4 to 58.7) OG001

Serotype 4

- ParticipantsOG0001370
- ParticipantsOG0011374

Title	Measurements
	OG00075.5(73.2 to 77.8) OG001

Serotype 5

- ParticipantsOG0001411
- ParticipantsOG0011394

Title	Measurements
	OG00055.6(52.9 to 58.2) OG001

Serotype 6A

- ParticipantsOG0001382
- ParticipantsOG0011371

Title	Measurements
	OG00080.5(78.3 to 82.5) OG001

Serotype 6B

- ParticipantsOG0001360
- ParticipantsOG0011360

Title	Measurements
	OG00075.7(73.3 to 77.9) OG001

Serotype 7F

- ParticipantsOG0001367
- ParticipantsOG0011355

Title	Measurements
	OG00071.8(69.3 to 74.1) OG001

Serotype 9V

- ParticipantsOG0001317
- ParticipantsOG0011294

Title	Measurements
	OG00067.7(65.1 to 70.3) OG001

Serotype 14

- ParticipantsOG0001370
- ParticipantsOG0011366

Title	Measurements
	OG00058.2(55.5 to 60.8) OG001

Serotype 18C

- ParticipantsOG0001407
- ParticipantsOG0011396

Title	Measurements
	OG00077.7(75.4 to 79.8) OG001

Serotype 19A

- ParticipantsOG0001400
- ParticipantsOG0011379

Title	Measurements
	OG00073.6(71.3 to 75.9) OG001

Serotype 19F

- ParticipantsOG0001405
- ParticipantsOG0011397

Title	Measurements
	OG00063.6(61.1 to 66.2) OG001

Serotype 23F

- ParticipantsOG0001409
- ParticipantsOG0011402

Title	Measurements
	OG00070.6(68.2 to 73.0) OG001

Title

Denominators

Categories

Serotype 8

- ParticipantsOG0001353
- ParticipantsOG0011293

Title	Measurements
	OG00077.8(75.5 to 80.0) OG00186.8(84.8 to 88.6)

Serotype 10A

- ParticipantsOG0001208
- ParticipantsOG0011164

Title	Measurements
	OG00075.5(73.0 to 77.9) OG001

Serotype 11A

- ParticipantsOG000973
- ParticipantsOG001993

Title	Measurements
	OG00059.2(56.0 to 62.3) OG001

Serotype 12F

- ParticipantsOG0001226
- ParticipantsOG0011147

Title	Measurements
	OG00087.4(85.5 to 89.2) OG001

Serotype 15B

- ParticipantsOG0001228
- ParticipantsOG0011178

Title	Measurements
	OG00077.8(75.3 to 80.1) OG001

Serotype 22F

- ParticipantsOG0001178
- ParticipantsOG0011156

Title	Measurements
	OG00082.7(80.4 to 84.8) OG001

Serotype 33F

- ParticipantsOG0001020
- ParticipantsOG0011080

Title	Measurements
	OG00060.1(57.0 to 63.1) OG001

Title

Denominators

Categories

Serotype 1

- ParticipantsOG000319
- ParticipantsOG001315

Title	Measurements
	OG00074.9(69.8 to 79.6) OG00186.0(81.7 to 89.7)

Serotype 3

- ParticipantsOG000317
- ParticipantsOG001312

Title	Measurements
	OG00059.0(53.4 to 64.5) OG001

Serotype 4

- ParticipantsOG000304
- ParticipantsOG001302

Title	Measurements
	OG00084.2(79.6 to 88.1) OG001

Serotype 5

- ParticipantsOG000312
- ParticipantsOG001315

Title	Measurements
	OG00054.8(49.1 to 60.4) OG001

Serotype 6A

- ParticipantsOG000312
- ParticipantsOG001305

Title	Measurements
	OG00085.9(81.5 to 89.6) OG001

Serotype 6B

- ParticipantsOG000299
- ParticipantsOG001286

Title	Measurements
	OG00078.9(73.9 to 83.4) OG001

Serotype 7F

- ParticipantsOG000300
- ParticipantsOG001284

Title	Measurements
	OG00073.0(67.6 to 77.9) OG001

Serotype 9V

- ParticipantsOG000288
- ParticipantsOG001281

Title	Measurements
	OG00073.6(68.1 to 78.6) OG001

Serotype 14

- ParticipantsOG000300
- ParticipantsOG001291

Title	Measurements
	OG00062.3(56.6 to 67.8) OG001

Serotype 18C

- ParticipantsOG000308
- ParticipantsOG001299

Title	Measurements
	OG00082.5(77.8 to 86.5) OG001

Serotype 19A

- ParticipantsOG000310
- ParticipantsOG001299

Title	Measurements
	OG00080.0(75.1 to 84.3) OG001

Serotype 19F

- ParticipantsOG000316
- ParticipantsOG001310

Title	Measurements
	OG00064.2(58.7 to 69.5) OG001

Serotype 23F

- ParticipantsOG000313
- ParticipantsOG001309

Title	Measurements
	OG00081.2(76.4 to 85.3) OG001

Serotype 8

- ParticipantsOG000310
- ParticipantsOG001300

Title	Measurements
	OG00079.4(74.4 to 83.7) OG001

Serotype 10A

- ParticipantsOG000273
- ParticipantsOG001260

Title	Measurements
	OG00078.8(73.4 to 83.5) OG001

Serotype 11A

- ParticipantsOG000213
- ParticipantsOG001220

Title	Measurements
	OG00061.0(54.1 to 67.6) OG001

Serotype 12F

- ParticipantsOG000279
- ParticipantsOG001252

Title	Measurements
	OG00093.2(89.6 to 95.9) OG001

Serotype 15B

- ParticipantsOG000263
- ParticipantsOG001248

Title	Measurements
	OG00082.5(77.4 to 86.9) OG001

Serotype 22 F

- ParticipantsOG000256
- ParticipantsOG001241

Title	Measurements
	OG00080.5(75.1 to 85.1) OG001

Serotype 33F

- ParticipantsOG000233
- ParticipantsOG001213

Title	Measurements
	OG00063.9(57.4 to 70.1) OG001

Title

Denominators

Categories

Serotype 1

- ParticipantsOG0001430
- ParticipantsOG0011419

Title	Measurements
	OG00085.0(83.0 to 86.8) OG00187.9(86.1 to 89.5)

Serotype 3

- ParticipantsOG0001415
- ParticipantsOG0011411

Title	Measurements
	OG00084.2(82.2 to 86.0) OG001

Serotype 4

- ParticipantsOG0001415
- ParticipantsOG0011409

Title	Measurements
	OG00091.1(89.5 to 92.5) OG001

Serotype 5

- ParticipantsOG0001418
- ParticipantsOG0011395

Title	Measurements
	OG00071.9(69.5 to 74.3) OG001

Serotype 6A

- ParticipantsOG0001403
- ParticipantsOG0011390

Title	Measurements
	OG00088.9(87.1 to 90.5) OG001

Serotype 6B

- ParticipantsOG0001413
- ParticipantsOG0011401

Title	Measurements
	OG00090.5(88.9 to 92.0) OG001

Serotype 7F

- ParticipantsOG0001409
- ParticipantsOG0011391

Title	Measurements
	OG00089.1(87.3 to 90.7) OG001

Serotype 9V

- ParticipantsOG0001399
- ParticipantsOG0011391

Title	Measurements
	OG00089.1(87.4 to 90.7) OG001

Serotype 14

- ParticipantsOG0001418
- ParticipantsOG0011408

Title	Measurements
	OG00091.6(90.0 to 93.0) OG001

Serotype 18C

- ParticipantsOG0001420
- ParticipantsOG0011403

Title	Measurements
	OG00093.8(92.4 to 95.0) OG001

Serotype 19A

- ParticipantsOG0001420
- ParticipantsOG0011398

Title	Measurements
	OG00096.3(95.2 to 97.3) OG001

Serotype 19F

- ParticipantsOG0001421
- ParticipantsOG0011403

Title	Measurements
	OG00080.3(78.1 to 82.3) OG001

Serotype 23F

- ParticipantsOG0001424
- ParticipantsOG0011409

Title	Measurements
	OG00082.1(80.0 to 84.1) OG001

Title

Denominators

Categories

Serotype 8

- ParticipantsOG0001374
- ParticipantsOG0011319

Title	Measurements
	OG00092.9(91.5 to 94.2) OG00196.6(95.5 to 97.5)

Serotype 10A

- ParticipantsOG0001310
- ParticipantsOG0011263

Title	Measurements
	OG00095.6(94.3 to 96.6) OG001

Serotype 11A

- ParticipantsOG0001198
- ParticipantsOG0011209

Title	Measurements
	OG00097.7(96.6 to 98.4) OG001

Serotype 12F

- ParticipantsOG0001294
- ParticipantsOG0011222

Title	Measurements
	OG00095.7(94.4 to 96.7) OG001

Serotype 15B

- ParticipantsOG0001283
- ParticipantsOG0011249

Title	Measurements
	OG00094.1(92.6 to 95.3) OG001

Serotype 22F

- ParticipantsOG0001274
- ParticipantsOG0011227

Title	Measurements
	OG00098.6(97.8 to 99.2) OG001

Serotype 33F

- ParticipantsOG0001157
- ParticipantsOG0011201

Title	Measurements
	OG00096.4(95.1 to 97.4) OG001

Title

Denominators

Categories

Serotype 1

- ParticipantsOG000320
- ParticipantsOG001316

Title	Measurements
	OG00087.2(83.0 to 90.6) OG00192.1(88.5 to 94.8)

Serotype 3

- ParticipantsOG000318
- ParticipantsOG001316

Title	Measurements
	OG00087.4(83.3 to 90.9) OG001

Serotype 4

- ParticipantsOG000318
- ParticipantsOG001315

Title	Measurements
	OG00094.0(90.8 to 96.4) OG001

Serotype 5

- ParticipantsOG000313
- ParticipantsOG001317

Title	Measurements
	OG00072.8(67.6 to 77.7) OG001

Serotype 6A

- ParticipantsOG000318
- ParticipantsOG001315

Title	Measurements
	OG00091.8(88.2 to 94.6) OG001

Serotype 6B

- ParticipantsOG000318
- ParticipantsOG001314

Title	Measurements
	OG00095.3(92.3 to 97.3) OG001

Serotype 7F

- ParticipantsOG000313
- ParticipantsOG001311

Title	Measurements
	OG00092.7(89.2 to 95.3) OG001

Serotype 9V

- ParticipantsOG000312
- ParticipantsOG001315

Title	Measurements
	OG00092.6(89.1 to 95.3) OG001

Serotype 14

- ParticipantsOG000313
- ParticipantsOG001316

Title	Measurements
	OG00094.9(91.8 to 97.1) OG001

Serotype 18C

- ParticipantsOG000315
- ParticipantsOG001312

Title	Measurements
	OG00097.5(95.1 to 98.9) OG001

Serotype 19A

- ParticipantsOG000318
- ParticipantsOG001312

Title	Measurements
	OG00098.7(96.8 to 99.7) OG001

Serotype 19F

- ParticipantsOG000320
- ParticipantsOG001315

Title	Measurements
	OG00081.9(77.2 to 85.9) OG001

Serotype 23F

- ParticipantsOG000319
- ParticipantsOG001315

Title	Measurements
	OG00089.3(85.4 to 92.5) OG001

Serotype 8

- ParticipantsOG000314
- ParticipantsOG001306

Title	Measurements
	OG00092.4(88.8 to 95.0) OG001

Serotype 10A

- ParticipantsOG000296
- ParticipantsOG001292

Title	Measurements
	OG00098.3(96.1 to 99.4) OG001

Serotype 11A

- ParticipantsOG000271
- ParticipantsOG001263

Title	Measurements
	OG00097.0(94.3 to 98.7) OG001

Serotype 12F

- ParticipantsOG000292
- ParticipantsOG001273

Title	Measurements
	OG00097.9(95.6 to 99.2) OG001

Serotype 15B

- ParticipantsOG000284
- ParticipantsOG001279

Title	Measurements
	OG00095.8(92.7 to 97.8) OG001

Serotype 22F

- ParticipantsOG000284
- ParticipantsOG001273

Title	Measurements
	OG00098.2(95.9 to 99.4) OG001

Serotype 33F

- ParticipantsOG000266
- ParticipantsOG001251

Title	Measurements
	OG00095.9(92.7 to 97.9) OG001

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

ID	Term
C414006	23-valent pneumococcal capsular polysaccharide vaccine
D012965	Sodium Chloride

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017670	Sodium Compounds