Trial to Evaluate the Safety and Immunogenicity of 3 Lots... | NCT03828617

Trial to Evaluate the Safety and Immunogenicity of 3 Lots... | NCT03828617 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
20vPnC Lot 1	Experimental	20vPnC Lot 1	Biological: 20vPnC
20vPnC Lot 2	Experimental	20vPnC Lot 2	Biological: 20vPnC
20vPnC Lot 3	Experimental	20vPnC Lot 3	Biological: 20vPnC
13vPnC	Active Comparator	13vPnC	Biological: 13vPnC

Name	Type	Description	Arm Group Labels	Other Names
20vPnC	Biological	20vPnC	20vPnC Lot 1
20vPnC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Local Reactions Within 10 Days After Vaccination	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). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.	Within 10 days after vaccination
Percentage of Participants With Systemic Events Within 7 Days After Vaccination	Systemic events fever, fatigue, headache, muscle pain, 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). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.	Within 7 days after vaccination
Percentage of Participants With Any Adverse Events (AEs) Within 1 Month After Vaccination	An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.	Within 1 month after vaccination
Percentage of Participants With Any Serious Adverse Events (SAEs) Within 6 Months After Vaccination

Secondary Outcomes

Measure	Description	Time Frame
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination	Fold rises are the ratios of the 1 month after vaccination to before vaccination OPA titers. 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, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Anaheim Clinical Trials, LLC		Anaheim	California	92801	United States
Kaiser Permanente Sacramento

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.
34315611

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	20vPnC Lot 1	Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination.
FG001	20vPnC Lot 2

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	Oct 22, 2018	Nov 3, 2020

Type	Comment	Reasons
Lost to Follow-up		FG00022 subjects FG00112 subjects FG00223 subjects FG0037 subjects
No longer met eligibility criteria		FG0000 subjects FG0011 subjects FG0021 subjects FG0033 subjects
Protocol Violation		FG0000 subjects FG0012 subjects FG0020 subjects FG0030 subjects
Withdrawal by Subject		FG0002 subjects FG0010 subjects FG0022 subjects FG0030 subjects

Arm/Group Information

ID	Title	Description
BG000	20vPnC Lot 1	Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination.
BG001	20vPnC Lot 2	Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination.
BG002	20vPnC Lot 3	Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.
BG003	13vPnC	Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00035.6± 9.17 BG00135.7± 9.03 BG00234.9± 9.05 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000331 BG001316 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00048 BG00158 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0005 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

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). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.

Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.

Posted

Number

95% Confidence Interval

percentage of participants

Within 10 days after vaccination

ID	Title	Description
OG000	Pooled 20vPnC	Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.
OG001	13vPnC	Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.

Units	Counts
Participants	OG0001456 OG001243

Title

Denominators

Categories

Redness: Any

Title	Measurements
	OG0007.0(5.7 to 8.4) OG0016.2(3.5 to 10.0)

Redness: Mild

Title	Measurements
	OG000

Primary

Percentage of Participants With Systemic Events Within 7 Days After Vaccination

Systemic events fever, fatigue, headache, muscle pain, 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). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.

Posted

Number

95% Confidence Interval

percentage of participants

Within 7 days after vaccination

ID	Title	Description
OG000	Pooled 20vPnC	Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.
OG001	13vPnC	Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.

Primary

Percentage of Participants With Any Adverse Events (AEs) Within 1 Month After Vaccination

An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.

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

Posted

Number

95% Confidence Interval

percentage of participants

Within 1 month after vaccination

ID	Title	Description
OG000	Pooled 20vPnC	Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.
OG001	13vPnC	Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.

Units	Counts
Participants

Primary

Percentage of Participants With Any Serious Adverse Events (SAEs) Within 6 Months After Vaccination

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. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.

Safety population includes all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination.

Posted

Number

95% Confidence Interval

percentage of participants

Within 6 month after vaccination

ID	Title	Description
OG000	Pooled 20vPnC	Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.
OG001	13vPnC	Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.

Primary

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

An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.

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

Posted

Number

95% Confidence Interval

percentage of participants

Within 6 months after vaccination

ID	Title	Description
OG000	Pooled 20vPnC	Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.
OG001	13vPnC	Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.

Units	Counts

Primary

Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination

OPA titers 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 GMTs and 2-sided 95% CIs were calculated. Data for this outcome measure were planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.

EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, "Number analyzed" = participants evaluable for this outcome measure at specified rows.

Posted

Geometric Mean

95% Confidence Interval

titer

1 month after vaccination

ID	Title	Description
OG000	20vPnC Lot 1	Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination.
OG001	20vPnC Lot 2	Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination.
OG002

Secondary

Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination

Fold rises are the ratios of the 1 month after vaccination to before vaccination OPA titers. 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, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.

Posted

Geometric Mean

95% Confidence Interval

fold rise

Before vaccination to 1 month after vaccination

ID	Title	Description
OG000	20vPnC Lot 1	Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination.
OG001	20vPnC Lot 2	Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination.

Secondary

Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination

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, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.

Posted

Number

95% Confidence Interval

percentage of participants

Before vaccination to 1 month after vaccination

ID	Title	Description
OG000	20vPnC Lot 1	Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination.
OG001	20vPnC Lot 2	Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination.

Secondary

Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination

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

Posted

Number

95% Confidence Interval

percentage of participants

1 month after vaccination

ID	Title	Description
OG000	20vPnC Lot 1	Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination.
OG001	20vPnC Lot 2	Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination.

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	Pooled 20vPnC	Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.	0	1,463	10	1,463	1,275	1,463
EG001	13vPnC	Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.	0	245	0	245	206	245

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Splenic cyst	Blood and lymphatic system disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,463 at risk EG0010 affected245 at risk
Gastritis	Gastrointestinal disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,463 at risk EG0010 affected245 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,463 at risk EG0010 affected245 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,463 at risk EG0010 affected245 at risk
Abdominal abscess	Infections and infestations	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,463 at risk EG0010 affected245 at risk
Osteomyelitis	Infections and infestations	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,463 at risk EG0010 affected245 at risk
Pneumonia mycoplasmal	Infections and infestations	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,463 at risk EG0010 affected245 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,463 at risk EG0010 affected245 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,463 at risk EG0010 affected245 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,463 at risk EG0010 affected245 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,463 at risk EG0010 affected245 at risk
Suicidal ideation	Psychiatric disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,463 at risk EG0010 affected245 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,463 at risk EG0010 affected245 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA v22.1	Non-systematic Assessment	EG0001 affected1,463 at risk EG0010 affected245 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fatigue	General disorders	MedDRA v22.1	Systematic Assessment	EG000693 affected1,463 at risk EG001106 affected245 at risk
Injection site erythema (REDNESS)	General disorders	MedDRA v22.1	Systematic Assessment	EG000102 affected1,463 at risk EG00115 affected245 at risk
Injection site pain (PAIN)	General disorders	MedDRA v22.1	Systematic Assessment	EG0001,146 affected1,463 at risk EG001184 affected245 at risk
Injection site swelling (SWELLING)	General disorders	MedDRA v22.1	Systematic Assessment	EG000124 affected1,463 at risk EG00121 affected245 at risk
Pyrexia (FEVER)	General disorders	MedDRA v22.1	Systematic Assessment	EG00018 affected1,463 at risk EG0012 affected245 at risk
Arthralgia (JOINT PAIN)	Musculoskeletal and connective tissue disorders	MedDRA v22.1	Systematic Assessment	EG000245 affected1,463 at risk EG00134 affected245 at risk
Myalgia (MUSCLE PAIN)	Musculoskeletal and connective tissue disorders	MedDRA v22.1	Systematic Assessment	EG000904 affected1,463 at risk EG001147 affected245 at risk
Headache	Nervous system disorders	MedDRA v22.1	Systematic Assessment	EG000527 affected1,463 at risk EG00192 affected245 at risk

Title

Denominators

Categories

Fever: >=38.0 degree C (Any)

Title	Measurements
	OG0001.2(0.7 to 1.9) OG0010.8(0.1 to 2.9)

Fever: >=38.0 degree C to 38.4 degree C

Title	Measurements
	OG0000.8(0.4 to 1.3) OG0010.4(0.0 to 2.3)

Fever: >38.4 degree C to 38.9 degree C

Title	Measurements
	OG0000.3(0.1 to 0.7) OG0010.4(0.0 to 2.3)

Fever: >38.9 degree C to 40.0 degree C

Title	Measurements
	OG0000.2(0.0 to 0.6) OG0010(0.0 to 1.5)

Fever: >40.0 degree C

Title	Measurements
	OG0000(0.0 to 0.3) OG0010(0.0 to 1.5)

Fatigue: Any

Title	Measurements
	OG00047.6(45.0 to 50.2) OG00143.6(37.3 to 50.1)

Fatigue: Mild

Title	Measurements
	OG00024.7(22.5 to 27.0) OG00124.3(19.0 to 30.2)

Fatigue: Moderate

Title	Measurements
	OG00021.2(19.1 to 23.4) OG00117.7(13.1 to 23.1)

Fatigue: Severe

Title	Measurements
	OG0001.7(1.1 to 2.5) OG0011.6(0.5 to 4.2)

Headache: Any

Title	Measurements
	OG00036.2(33.7 to 38.7) OG00137.9(31.7 to 44.3)

Headache: Mild

Title	Measurements
	OG00022.6(20.5 to 24.8) OG00127.2(21.7 to 33.2)

Headache: Moderate

Title	Measurements
	OG00012.0(10.4 to 13.8) OG0019.9(6.4 to 14.3)

Headache: Severe

Title	Measurements
	OG0001.6(1.0 to 2.4) OG0010.8(0.1 to 2.9)

Muscle pain: Any

Title	Measurements
	OG00062.1(59.5 to 64.6) OG00160.5(54.0 to 66.7)

Muscle pain: Mild

Title	Measurements
	OG00038.5(36.0 to 41.0) OG00138.7(32.5 to 45.1)

Muscle pain: Moderate

Title	Measurements
	OG00022.5(20.4 to 24.8) OG00119.8(14.9 to 25.3)

Muscle pain: Severe

Title	Measurements
	OG0001.1(0.6 to 1.8) OG0012.1(0.7 to 4.7)

Joint pain: Any

Title	Measurements
	OG00016.8(14.9 to 18.8) OG00114.0(9.9 to 19.0)

Joint pain: Mild

Title	Measurements
	OG00010.0(8.5 to 11.6) OG0017.8(4.8 to 11.9)

Joint pain: Moderate

Title	Measurements
	OG0006.5(5.2 to 7.8) OG0015.3(2.9 to 9.0)

Joint pain: Severe

Title	Measurements
	OG0000.4(0.2 to 0.9) OG0010.8(0.1 to 2.9)

Title

Denominators

Categories

Serotype 1

- ParticipantsOG000462
- ParticipantsOG001470
- ParticipantsOG002454

Title	Measurements
	OG000199.5(173.5 to 229.6) OG001175.1(152.5 to 201.0) OG002164.6(143.1 to 189.3)

Serotype 3

- ParticipantsOG000458
- ParticipantsOG001469
- ParticipantsOG002451

Title	Measurements
	OG000

Serotype 4

- ParticipantsOG000455
- ParticipantsOG001468
- ParticipantsOG002451

Title	Measurements
	OG000

Serotype 5

- ParticipantsOG000457
- ParticipantsOG001466
- ParticipantsOG002450

Title	Measurements
	OG000

Serotype 6A

- ParticipantsOG000454
- ParticipantsOG001468
- ParticipantsOG002446

Title	Measurements
	OG000

Serotype 6B

- ParticipantsOG000458
- ParticipantsOG001469
- ParticipantsOG002453

Title	Measurements
	OG000

Serotype 7F

- ParticipantsOG000452
- ParticipantsOG001464
- ParticipantsOG002441

Title	Measurements
	OG000

Serotype 9V

- ParticipantsOG000454
- ParticipantsOG001467
- ParticipantsOG002446

Title	Measurements
	OG000

Serotype 14

- ParticipantsOG000455
- ParticipantsOG001467
- ParticipantsOG002450

Title	Measurements
	OG000

Serotype 18C

- ParticipantsOG000455
- ParticipantsOG001465
- ParticipantsOG002449

Title	Measurements
	OG000

Serotype 19A

- ParticipantsOG000451
- ParticipantsOG001465
- ParticipantsOG002450

Title	Measurements
	OG000

Serotype 19F

- ParticipantsOG000455
- ParticipantsOG001466
- ParticipantsOG002452

Title	Measurements
	OG000

Serotype 23F

- ParticipantsOG000459
- ParticipantsOG001471
- ParticipantsOG002454

Title	Measurements
	OG000

Serotype 8

- ParticipantsOG000435
- ParticipantsOG001448
- ParticipantsOG002436

Title	Measurements
	OG000

Serotype 10A

- ParticipantsOG000399
- ParticipantsOG001418
- ParticipantsOG002410

Title	Measurements
	OG000

Serotype 11A

- ParticipantsOG000394
- ParticipantsOG001399
- ParticipantsOG002399

Title	Measurements
	OG000

Serotype 12F

- ParticipantsOG000418
- ParticipantsOG001418
- ParticipantsOG002411

Title	Measurements
	OG000

Serotype 15B

- ParticipantsOG000392
- ParticipantsOG001426
- ParticipantsOG002402

Title	Measurements
	OG000

Serotype 22F

- ParticipantsOG000367
- ParticipantsOG001392
- ParticipantsOG002384

Title	Measurements
	OG000

Serotype 33F

- ParticipantsOG000391
- ParticipantsOG001401
- ParticipantsOG002409

Title	Measurements
	OG000

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 ratios (GMRs) (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% confidence intervals (CIs).	Geometric Mean Ratio (GMR)	1.14	2-Sided	95	0.95	1.37	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG001	Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.	Geometric Mean Ratio (GMR)	1.01	2-Sided	95	0.88	1.16	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG001	Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.	Geometric Mean Ratio	0.96	2-Sided	95	0.78	1.17	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG001	Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.	Geometric Mean Ratio	0.93	2-Sided	95	0.77	1.12	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG001	Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.	Geometric Mean Ratio	1.24	2-Sided	95	1.03	1.50	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG001	Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.	Geometric Mean Ratio	1.01	2-Sided	95	0.85	1.21	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG001	Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.	Geometric Mean Ratio	0.98	2-Sided	95	0.82	1.17	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG001	Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.	Geometric Mean Ratio	1.11	2-Sided	95	0.93	1.33	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG001	Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.	Geometric Mean Ratio	1.07	2-Sided	95	0.90	1.27	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG001	Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.	Geometric Mean Ratio	0.88	2-Sided	95	0.72	1.07	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG001	Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.	Geometric Mean Ratio	0.95	2-Sided	95	0.81	1.12	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG001	Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.	Geometric Mean Ratio	0.99	2-Sided	95	0.81	1.21	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG001	Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.	Geometric Mean Ratio	0.92	2-Sided	95	0.72	1.16	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG001	Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.	Geometric Mean Ratio	1.19	2-Sided	95	1.00	1.40	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG001	Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.	Geometric Mean Ratio	1.11	2-Sided	95	0.91	1.36	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG001	Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.	Geometric Mean Ratio	1.29	2-Sided	95	1.03	1.60	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG001	Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.	Geometric Mean Ratio	1.08	2-Sided	95	0.88	1.33	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG001	Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.	Geometric Mean Ratio	1.16	2-Sided	95	0.91	1.46	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG001	Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.	Geometric Mean Ratio	1.12	2-Sided	95	0.87	1.43	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG001	Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.	Geometric Mean Ratio	1.04	2-Sided	95	0.83	1.30	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG002	Serotype 1: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.21	2-Sided	95	1.01	1.46	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG002	Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.10	2-Sided	95	0.96	1.26	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG002	Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.00	2-Sided	95	0.82	1.22	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG002	Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.08	2-Sided	95	0.89	1.31	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG002	Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.40	2-Sided	95	1.16	1.69	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG002	Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.13	2-Sided	95	0.94	1.35	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG002	Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	0.97	2-Sided	95	0.81	1.16	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG002	Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.04	2-Sided	95	0.87	1.25	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG002	Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.12	2-Sided	95	0.94	1.33	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG002	Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	0.92	2-Sided	95	0.75	1.13	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG002	Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.02	2-Sided	95	0.86	1.20	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG002	Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	0.96	2-Sided	95	0.78	1.17	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG002	Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	0.99	2-Sided	95	0.78	1.25	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG002	Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	0.98	2-Sided	95	0.83	1.16	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG002	Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.06	2-Sided	95	0.87	1.30	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG002	Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	0.99	2-Sided	95	0.80	1.24	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG002	Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.16	2-Sided	95	0.94	1.42	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG002	Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.05	2-Sided	95	0.82	1.33	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG002	Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	0.98	2-Sided	95	0.77	1.26	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG000 OG002	Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.03	2-Sided	95	0.82	1.29	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG001 OG002	Serotype 1: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.06	2-Sided	95	0.89	1.28	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG001 OG002	Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.09	2-Sided	95	0.95	1.24	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG001 OG002	Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.04	2-Sided	95	0.85	1.27	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG001 OG002	Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.16	2-Sided	95	0.96	1.41	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG001 OG002	Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.13	2-Sided	95	0.93	1.36	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG001 OG002	Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.11	2-Sided	95	0.93	1.33	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG001 OG002	Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	0.99	2-Sided	95	0.83	1.19	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG001 OG002	Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	0.94	2-Sided	95	0.78	1.12	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG001 OG002	Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.04	2-Sided	95	0.88	1.24	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG001 OG002	Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.05	2-Sided	95	0.86	1.29	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG001 OG002	Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.07	2-Sided	95	0.91	1.25	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG001 OG002	Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	0.96	2-Sided	95	0.79	1.17	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG001 OG002	Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.08	2-Sided	95	0.85	1.37	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG001 OG002	Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	0.83	2-Sided	95	0.70	0.98	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG001 OG002	Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	0.95	2-Sided	95	0.78	1.17	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG001 OG002	Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	0.77	2-Sided	95	0.62	0.96	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG001 OG002	Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	1.07	2-Sided	95	0.87	1.31	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG001 OG002	Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	0.91	2-Sided	95	0.71	1.15	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG001 OG002	Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	0.88	2-Sided	95	0.69	1.12	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
OG001 OG002	Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.	Geometric Mean Ratio	0.99	2-Sided	95	0.79	1.24	Equivalence	Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).

Title

Denominators

Categories

Serotype 1

- ParticipantsOG000460
- ParticipantsOG001468
- ParticipantsOG002454

Title	Measurements
	OG00020.2(17.6 to 23.1) OG00117.8(15.6 to 20.3) OG00217.3(15.0 to 19.8)

Serotype 3

- ParticipantsOG000456
- ParticipantsOG001462
- ParticipantsOG002449

Title	Measurements
	OG000

Serotype 4

- ParticipantsOG000441
- ParticipantsOG001450
- ParticipantsOG002435

Title	Measurements
	OG000

Serotype 5

- ParticipantsOG000455
- ParticipantsOG001463
- ParticipantsOG002450

Title	Measurements
	OG000

Serotype 6A

- ParticipantsOG000436
- ParticipantsOG001451
- ParticipantsOG002429

Title	Measurements
	OG000

Serotype 6B

- ParticipantsOG000423
- ParticipantsOG001442
- ParticipantsOG002424

Title	Measurements
	OG000

Serotype 7F

- ParticipantsOG000422
- ParticipantsOG001424
- ParticipantsOG002401

Title	Measurements
	OG000

Serotype 9V

- ParticipantsOG000398
- ParticipantsOG001409
- ParticipantsOG002387

Title	Measurements
	OG000

Serotype 14

- ParticipantsOG000426
- ParticipantsOG001436
- ParticipantsOG002434

Title	Measurements
	OG000

Serotype 18C

- ParticipantsOG000435
- ParticipantsOG001448
- ParticipantsOG002439

Title	Measurements
	OG000

Serotype 19A

- ParticipantsOG000443
- ParticipantsOG001456
- ParticipantsOG002440

Title	Measurements
	OG000

Serotype 19F

- ParticipantsOG000450
- ParticipantsOG001458
- ParticipantsOG002448

Title	Measurements
	OG000

Serotype 23F

- ParticipantsOG000452
- ParticipantsOG001458
- ParticipantsOG002445

Title	Measurements
	OG000

Serotype 8

- ParticipantsOG000416
- ParticipantsOG001429
- ParticipantsOG002418

Title	Measurements
	OG000

Serotype 10A

- ParticipantsOG000350
- ParticipantsOG001368
- ParticipantsOG002370

Title	Measurements
	OG000

Serotype 11A

- ParticipantsOG000319
- ParticipantsOG001321
- ParticipantsOG002332

Title	Measurements
	OG000

Serotype 12F

- ParticipantsOG000390
- ParticipantsOG001389
- ParticipantsOG002376

Title	Measurements
	OG000

Serotype 15B

- ParticipantsOG000364
- ParticipantsOG001395
- ParticipantsOG002369

Title	Measurements
	OG000

Serotype 22F

- ParticipantsOG000322
- ParticipantsOG001357
- ParticipantsOG002338

Title	Measurements
	OG000

Serotype 33F

- ParticipantsOG000338
- ParticipantsOG001357
- ParticipantsOG002362

Title	Measurements
	OG000

Title

Denominators

Categories

Serotype 1

- ParticipantsOG000460
- ParticipantsOG001468
- ParticipantsOG002454

Title	Measurements
	OG00083.7(80.0 to 87.0) OG00182.9(79.2 to 86.2) OG00282.4(78.6 to 85.8)

Serotype 3

- ParticipantsOG000456
- ParticipantsOG001462
- ParticipantsOG002449

Title	Measurements
	OG000

Serotype 4

- ParticipantsOG000441
- ParticipantsOG001450
- ParticipantsOG002435

Title	Measurements
	OG000

Serotype 5

- ParticipantsOG000455
- ParticipantsOG001463
- ParticipantsOG002450

Title	Measurements
	OG000

Serotype 6A

- ParticipantsOG000436
- ParticipantsOG001451
- ParticipantsOG002429

Title	Measurements
	OG000

Serotype 6B

- ParticipantsOG000423
- ParticipantsOG001442
- ParticipantsOG002424

Title	Measurements
	OG000

Serotype 7F

- ParticipantsOG000422
- ParticipantsOG001424
- ParticipantsOG002401

Title	Measurements
	OG000

Serotype 9V

- ParticipantsOG000398
- ParticipantsOG001409
- ParticipantsOG002387

Title	Measurements
	OG000

Serotype 14

- ParticipantsOG000426
- ParticipantsOG001436
- ParticipantsOG002434

Title	Measurements
	OG000

Serotype 18C

- ParticipantsOG000435
- ParticipantsOG001448
- ParticipantsOG002439

Title	Measurements
	OG000

Serotype 19A

- ParticipantsOG000443
- ParticipantsOG001456
- ParticipantsOG002440

Title	Measurements
	OG000

Serotype 19F

- ParticipantsOG000450
- ParticipantsOG001458
- ParticipantsOG002448

Title	Measurements
	OG000

Serotype 23F

- ParticipantsOG000452
- ParticipantsOG001458
- ParticipantsOG002445

Title	Measurements
	OG000

Serotype 8

- ParticipantsOG000416
- ParticipantsOG001429
- ParticipantsOG002418

Title	Measurements
	OG000

Serotype 10A

- ParticipantsOG000350
- ParticipantsOG001368
- ParticipantsOG002370

Title	Measurements
	OG000

Serotype 11A

- ParticipantsOG000319
- ParticipantsOG001321
- ParticipantsOG002332

Title	Measurements
	OG000

Serotype 12F

- ParticipantsOG000390
- ParticipantsOG001389
- ParticipantsOG002376

Title	Measurements
	OG000

Serotype 15B

- ParticipantsOG000364
- ParticipantsOG001395
- ParticipantsOG002369

Title	Measurements
	OG000

Serotype 22F

- ParticipantsOG000322
- ParticipantsOG001357
- ParticipantsOG002338

Title	Measurements
	OG000

Serotype 33F

- ParticipantsOG000338
- ParticipantsOG001357
- ParticipantsOG002362

Title	Measurements
	OG000

Title

Denominators

Categories

Serotype 1

- ParticipantsOG000462
- ParticipantsOG001470
- ParticipantsOG002454

Title	Measurements
	OG00091.8(88.9 to 94.1) OG00192.8(90.0 to 94.9) OG00291.0(87.9 to 93.4)

Serotype 3

- ParticipantsOG000458
- ParticipantsOG001469
- ParticipantsOG002451

Title	Measurements
	OG000

Serotype 4

- ParticipantsOG000455
- ParticipantsOG001468
- ParticipantsOG002451

Title	Measurements
	OG000

Serotype 5

- ParticipantsOG000457
- ParticipantsOG001466
- ParticipantsOG002450

Title	Measurements
	OG000

Serotype 6A

- ParticipantsOG000454
- ParticipantsOG001468
- ParticipantsOG002446

Title	Measurements
	OG000

Serotype 6B

- ParticipantsOG000458
- ParticipantsOG001469
- ParticipantsOG002453

Title	Measurements
	OG000

Serotype 7F

- ParticipantsOG000452
- ParticipantsOG001464
- ParticipantsOG002441

Title	Measurements
	OG000

Serotype 9V

- ParticipantsOG000454
- ParticipantsOG001467
- ParticipantsOG002446

Title	Measurements
	OG000

Serotype 14

- ParticipantsOG000455
- ParticipantsOG001467
- ParticipantsOG002450

Title	Measurements
	OG000

Serotype 18C

- ParticipantsOG000455
- ParticipantsOG001465
- ParticipantsOG002449

Title	Measurements
	OG000

Serotype 19A

- ParticipantsOG000451
- ParticipantsOG001465
- ParticipantsOG002450

Title	Measurements
	OG000

Serotype 19F

- ParticipantsOG000455
- ParticipantsOG001466
- ParticipantsOG002452

Title	Measurements
	OG000

Serotype 23F

- ParticipantsOG000459
- ParticipantsOG001471
- ParticipantsOG002454

Title	Measurements
	OG000

Serotype 8

- ParticipantsOG000435
- ParticipantsOG001448
- ParticipantsOG002436

Title	Measurements
	OG000

Serotype 10A

- ParticipantsOG000399
- ParticipantsOG001418
- ParticipantsOG002410

Title	Measurements
	OG000

Serotype 11A

- ParticipantsOG000394
- ParticipantsOG001399
- ParticipantsOG002399

Title	Measurements
	OG000

Serotype 12F

- ParticipantsOG000418
- ParticipantsOG001418
- ParticipantsOG002411

Title	Measurements
	OG000

Serotype 15B

- ParticipantsOG000392
- ParticipantsOG001426
- ParticipantsOG002402

Title	Measurements
	OG000

Serotype 22F

- ParticipantsOG000367
- ParticipantsOG001392
- ParticipantsOG002384

Title	Measurements
	OG000

Serotype 33F

- ParticipantsOG000391
- ParticipantsOG001401
- ParticipantsOG002409

Title	Measurements
	OG000

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