PNEU-TRUE: Lot-to-Lot Consistency of V114 in Healthy Adults (V114-020)

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03950856
• Collaborator: (none)
• Enrollment: 2,340
• Locations: 55
• Arms: 4
• Actual Duration (Months): 9.7
• Patients Per Site: 42.5
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief Summary

The primary objectives are to evaluate the safety and tolerability of V114 and to compare the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) across 3 different lots of V114. The primary hypothesis is that all 3 lots of V114 are equivalent as measured by the serotype-specific OPA GMTs for 15 serotypes in V114 at 30 days postvaccination.

Condition or Disease	Intervention/Treatment	Phase
Pneumococcal Infections; Pneumonia, Pneumococcal	Drug: V114; Drug: Prevnar 13™	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 2340 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults 50 Years of Age or Older (PNEU-TRUE)
• Actual Study Start Date: Jun 12, 2019
• Actual Primary Completion Date: Apr 3, 2020
• Actual Study Completion Date: Apr 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: V114 Lot 1 Single intramuscular (IM) dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Drug: V114; 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in each 0.5 mL dose.
Experimental: V114 Lot 2 Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Drug: V114; 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in each 0.5 mL dose.
Experimental: V114 Lot 3 Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Drug: V114; 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in each 0.5 mL dose.
Active Comparator: Prevnar 13™ Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)	Drug: Prevnar 13™; 13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F in each 0.5. mL dose.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots [Up to Day 5]

   An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of redness/erythema, swelling, and tenderness/pain. The 95% confidence interval (CI) were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with solicited injection-site AEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.

2. Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™ [Up to Day 5]

   An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of redness/erythema, swelling, and tenderness/pain. Per the statistical analysis plan, within-group CIs were not calculated.

3. Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots [Up to Day 14]

   An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with solicited systemic AEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.

4. Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™ [Up to Day 14]

   An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Per the statistical analysis plan, within-group CIs were not calculated.

5. Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With Separate V114 Lots [Up to Month 6]

   A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. Relatedness of an SAE to the study vaccine is determined by the investigator. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with SAEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.

6. Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™ [Up to Month 6]

   A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. Relatedness of an SAE to the study vaccine is determined by the investigator. Per the statistical analysis plan, within-group CIs were not calculated.

7. Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots [Day 30]

   Opsonization of pneumococci for phagocytosis is an important mechanism by which antibodies to polysaccharides protect against disease in vivo. Sera from participants was used to measure geometric mean titer (GMT) of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the Multiplexed Opsonophagocytic Assay (MOPA). Per the statistical analysis plan, within-group CIs were not calculated. 95% CIs were calculated for the GMT ratios between pairs of V114 lots by a constrained longitudinal data analysis (cLDA) model; and the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.

Secondary Outcome Measures

1. Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots [Day 30]

   The geometric mean concentration (GMC) of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex electrochemiluminescence (ECL) using the pneumococcal electrochemiluminescence (PnECL) v2.0 assay. Per the statistical analysis plan, within-group CIs were not calculated; and the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.

2. Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ [Day 30]

   The GMC of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. Per the statistical analysis plan, within-group CIs were not calculated,

3. Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots [Day 1 (Baseline) and Day 30]

   Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the MOPA which reads the reciprocal of the highest dilution that gives ≥50% bacterial killing. The Geometric Mean Fold Rise (GMFR) is the geometric mean of the ratio Day 30/Day 1 OPA responses. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.

4. GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots [Day 1 (Baseline) and Day 30]

   The geometric mean concentration (GMC) of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. The GMFR is the geometric mean of the ratio Day 30/Day 1 IgG concentration. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.

5. Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots [Day 1 (Baseline) and Day 30]

   Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, with the MOPA which reads the reciprocal of the highest dilution (1/dil) that gives ≥50% bacterial killing. Percentage of participants with a ≥ 4-fold change from Day 1 (baseline) to Day 30 (Day 30/Day 1) are presented. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.

6. Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots [Day 1 (Baseline) and Day 30]

   The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. Percentage of participants with a ≥ 4-fold change from Day 1 (baseline) to Day 30 (Day 30/ Day 1) are presented. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Participant has good health in the opinion of the investigator. Any underlying chronic condition must be documented to be in stable condition according to the investigator's judgment.

• Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

• Female participant is eligible to participate if she is not pregnant, not breastfeeding, and is not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees to use agreed upon contraception during the treatment period and for at least 6 weeks after the last dose of study intervention.

Exclusion Criteria:

• History of invasive pneumococcal disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site) or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1).

• Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine.

• Known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease.

• Coagulation disorder contraindicating intramuscular vaccinations.

• Recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring within 72 hours before receipt of study vaccine.

• History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.

• A WOCBP who has a positive urine or serum pregnancy test before the first vaccination at Visit 1 (Day 1).

• Has received any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside of the protocol.

• Has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention at least 30 days before study entry.

• Has received systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination. (Note: Topical, ophthalmic, intra-articular or soft-tissue [e.g., bursa, tendon steroid injections], and inhaled/nebulized steroids are permitted).

• Is receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease.

• Has received any non-live vaccine within the 14 days before receipt of any study vaccine or is scheduled to receive any non-live vaccine within 30 days following receipt of any study vaccine. (Exception: Inactivated influenza vaccine may be administered but must be given at least 7 days before receipt of any study vaccine or at least 15 days after receipt of any study vaccine.)

• Has received any live vaccine within 30 days before receipt of any study vaccine or is scheduled to receive any live vaccine within 30 days following receipt of any study vaccine. If this exclusion criterion is met, then Day 1 Visit may be rescheduled for a time when criterion is not met.

• Has received a blood transfusion or blood products, including immunoglobulin, within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion.

• Currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study.

• In the opinion of the investigator, has a history of clinically relevant drug or alcohol use that would interfere with participation in protocol-specified activities.

• History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study, or interfere with the participant's participation for the full duration of the study.

• Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Synexus Clinical Research US, Inc. ( Site 1031)	Chandler	Arizona	United States	85224
2	Synexus ( Site 1043)	Mesa	Arizona	United States	85206
3	Southland Clinical Research Center ( Site 1027)	Fountain Valley	California	United States	92708
4	Valley Clinical Trials Inc. ( Site 1003)	Northridge	California	United States	91325
5	Center for Clinical Trials, LLC ( Site 1019)	Paramount	California	United States	90723
6	California Research Foundation ( Site 1006)	San Diego	California	United States	92123
7	Artemis Institute for Clinical Research ( Site 1041)	San Marcos	California	United States	92078
8	Alta California Medical Group ( Site 1020)	Simi Valley	California	United States	93065
9	Alliance for Multispecialty Research, LLC ( Site 1029)	Coral Gables	Florida	United States	33134
10	Accel Research Sites-DeLand Clinical Research Unit ( Site 1026)	DeLand	Florida	United States	32720
11	Jacksonville Center for Clinical Research ( Site 1014)	Jacksonville	Florida	United States	32216
12	L&C Professional Medical Research Institute ( Site 1012)	Miami	Florida	United States	33144
13	Alpha Science Research ( Site 1015)	Miami	Florida	United States	33186
14	QPS Miami Research Associates ( Site 1035)	South Miami	Florida	United States	33143
15	Benchmark Research ( Site 1040)	Metairie	Louisiana	United States	70006
16	Centennial Medical Group ( Site 1010)	Elkridge	Maryland	United States	21075
17	Community Clinical Research Network (Marlboro, MA) ( Site 1025)	Marlborough	Massachusetts	United States	01752
18	Wake Research Clinical Research Center of Nevada, LLC ( Site 1044)	Las Vegas	Nevada	United States	89104
19	Southwest CARE Center ( Site 1011)	Santa Fe	New Mexico	United States	87505
20	Corning Center For Clinical Research ( Site 1033)	Corning	New York	United States	14830
21	Regional Clinical Research, Inc. ( Site 1024)	Endwell	New York	United States	13760
22	Rochester Clinical Research, Inc. ( Site 1039)	Rochester	New York	United States	14609
23	PMG Research of Winston Salem ( Site 1037)	Winston-Salem	North Carolina	United States	27103
24	Unity Clinical Research ( Site 1036)	Lindsay	Oklahoma	United States	73052
25	Coastal Carolina Research Center ( Site 1034)	Mount Pleasant	South Carolina	United States	29464
26	Wellness Clinical Research Associates ( Site 1038)	Allen	Texas	United States	75013
27	Diagnostics Research Group ( Site 1042)	San Antonio	Texas	United States	78229
28	Synexus ( Site 1000)	Murray	Utah	United States	84123
29	Advanced Clinical Research ( Site 1028)	West Jordan	Utah	United States	84088
30	Allegiance Research Specialists ( Site 1013)	Wauwatosa	Wisconsin	United States	53226
31	Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 6006)	Blacktown	New South Wales	Australia	2148
32	Australian Clinical Research Network ( Site 6000)	Maroubra	New South Wales	Australia	2035
33	Box Hill Hospital ( Site 6001)	Box Hill	Victoria	Australia	3128
34	Trialswest ( Site 6004)	Murdoch	Western Australia	Australia	6150
35	Clinica Alemana de Santiago Adolescencia ( Site 2000)	Santiago	Región Metropolitana	Chile	7650568
36	CESFAM Colina ( Site 2002)	Santiago	RM	Chile	9350079
37	Instituto Nacional del Torax ( Site 2004)	Santiago		Chile	7500691
38	Centro de Investigacion Clinica UC CICUC ( Site 2001)	Santiago		Chile	8330034
39	Hospital Dr. Hernan Henriquez Aravena ( Site 2003)	Temuco		Chile	4781151
40	Aalborg University Hospital ( Site 3003)	Aalborg		Denmark	9000
41	Aarhus Universitets hospital ( Site 3004)	Aarhus N		Denmark	8200
42	CCBR. Center for Clinical and Basic Research ( Site 3000)	Ballerup		Denmark	2750
43	Rigshospitalet ( Site 3005)	Copenhagen		Denmark	2100
44	Hvidovre Hospital ( Site 3002)	Hvidovre		Denmark	2650
45	Odense Universitetshospital ( Site 3001)	Odense		Denmark	5000
46	Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 4006)	Helsinki		Finland	00100
47	Jarvenpaan rokotetutkimuskeskus ( Site 4005)	Jarvenpaa		Finland	04400
48	Kokkolan rokotetutkimusklinikka ( Site 4002)	Kokkola		Finland	67100
49	Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 4001)	Oulu		Finland	90220
50	Tampereen yliopisto Porin rokotetutkimusklinikka ( Site 4004)	Pori		Finland	28100
51	Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 4000)	Tampere		Finland	33100
52	Turun rokotetutkimuskeskus ( Site 4003)	Turku		Finland	20520
53	Medinova Lakeside Dedicated Research Centre ( Site 5004)	Corby	Northamptonshire	United Kingdom	NN17 2UR
54	GP Direct ( Site 5000)	Harrow		United Kingdom	HA2 0RQ
55	Vauxhall Primary Health Care ( Site 5002)	Liverpool		United Kingdom	L5 8XR

Sponsors and Collaborators

• Merck Sharp & Dohme LLC

Investigators

• Study Director: Medical Director, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 9, 2019

More Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT03950856
• Other Study ID Numbers: V114-020; V114-020; 2018-004266-33
• First Posted: May 15, 2019
• Last Update Posted: Apr 12, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pneumococcal Infections; Pneumonia, Pneumococcal; Heptavalent Pneumococcal Conjugate Vaccine

Study Results

Participant Flow

Recruitment Details	Healthy males or females ≥50 years of age without a history of invasive pneumococcal disease or prior administration of any pneumococcal vaccine were enrolled in this study.

Arm/Group Title	V114 Lot 1	V114 Lot 2	V114 Lot 3	Prevnar13™
Arm/Group Description	Single intramuscular (IM) dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
Period Title: Overall Study
STARTED	702	704	701	233
Vaccinated	698	704	700	231
COMPLETED	683	689	683	227
NOT COMPLETED	19	15	18	6

Baseline Characteristics

Arm/Group Title	V114 Lot 1	V114 Lot 2	V114 Lot 3	Prevnar13™	Total
Arm/Group Description	Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)	Total of all reporting groups
Overall Participants	702	704	701	233	2340
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	64.4 (7.5)	64.4 (7.8)	64.3 (7.4)	64.2 (8.0)	64.4 (7.6)
Sex: Female, Male (Count of Participants)
Female	387 55.1%	422 59.9%	404 57.6%	133 57.1%	1346 57.5%
Male	315 44.9%	282 40.1%	297 42.4%	100 42.9%	994 42.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	131 18.7%	154 21.9%	138 19.7%	41 17.6%	464 19.8%
Not Hispanic or Latino	560 79.8%	540 76.7%	558 79.6%	190 81.5%	1848 79%
Unknown or Not Reported	11 1.6%	10 1.4%	5 0.7%	2 0.9%	28 1.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.1%	4 0.6%	0 0%	0 0%	5 0.2%
Asian	18 2.6%	34 4.8%	36 5.1%	10 4.3%	98 4.2%
Native Hawaiian or Other Pacific Islander	1 0.1%	0 0%	0 0%	0 0%	1 0%
Black or African American	35 5%	41 5.8%	34 4.9%	20 8.6%	130 5.6%
White	644 91.7%	621 88.2%	628 89.6%	203 87.1%	2096 89.6%
More than one race	3 0.4%	4 0.6%	3 0.4%	0 0%	10 0.4%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots
Description	An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of redness/erythema, swelling, and tenderness/pain. The 95% confidence interval (CI) were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with solicited injection-site AEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.
Time Frame	Up to Day 5

Outcome Measure Data

Analysis Population Description

Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.

Arm/Group Title	V114 Lot 1	V114 Lot 2	V114 Lot 3	Prevnar13™
Arm/Group Description	Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
Measure Participants	699	704	700	0
Injection site erythema	10.2 1.5%	11.5 1.6%	11.0 1.6%
Injection site pain	66.1 9.4%	67.0 9.5%	67.3 9.6%
Injection site swelling	15.6 2.2%	15.8 2.2%	14.7 2.1%

2. Primary Outcome

Title	Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
Description	An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of redness/erythema, swelling, and tenderness/pain. Per the statistical analysis plan, within-group CIs were not calculated.
Time Frame	Up to Day 5

Outcome Measure Data

Analysis Population Description

Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.

Arm/Group Title	V114 Combined Lots 1,2 and 3	Prevnar13™
Arm/Group Description	Single IM dose at 0.5 mL of either V114 Lots 1,2 or 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
Measure Participants	2103	230
Injection site erythema	10.9 1.6%	9.6 1.4%
Injection site pain	66.8 9.5%	52.2 7.4%
Injection site swelling	15.4 2.2%	14.3 2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Injection site erythema: V114 Combined Lots - Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.538
	Comments
	Method	Miettinen & Nurminen
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; -3.3 to 4.8
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots minus Prevnar 13™

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Injection site pain: V114 Combined Lots - Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Miettinen & Nurminen
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	14.6
	Confidence Interval	(2-Sided) 95%; 7.9 to 21.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots minus Prevnar 13™

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Injection site swelling: V114 Combined Lots - Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.686
	Comments
	Method	Miettinen & Nurminen
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; -4.3 to 5.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots minus Prevnar 13™

3. Primary Outcome

Title	Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots
Description	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with solicited systemic AEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.
Time Frame	Up to Day 14

Outcome Measure Data

Analysis Population Description

Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.

Arm/Group Title	V114 Lot 1	V114 Lot 2	V114 Lot 3	Prevnar13™
Arm/Group Description	Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
Measure Participants	699	704	700	0
Arthralgia	7.6 1.1%	7.0 1%	8.4 1.2%
Fatigue	22.0 3.1%	20.9 3%	21.6 3.1%
Headache	18.2 2.6%	19.9 2.8%	18.6 2.7%
Myalgia	28.0 4%	24.3 3.5%	28.4 4.1%

4. Primary Outcome

Title	Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
Description	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Per the statistical analysis plan, within-group CIs were not calculated.
Time Frame	Up to Day 14

Outcome Measure Data

Analysis Population Description

Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.

Arm/Group Title	V114 Combined Lots 1,2 and 3	Prevnar13™
Arm/Group Description	Single IM dose at 0.5 mL of either V114 Lots 1,2 or 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
Measure Participants	2103	230
Arthralgia	7.7 1.1%	5.7 0.8%
Fatigue	21.5 3.1%	22.2 3.2%
Headache	18.9 2.7%	18.7 2.7%
Myalgia	26.9 3.8%	21.7 3.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Arthralgia: V114 Combined Lots - Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.272
	Comments
	Method	Miettinen & Nurminen
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	2.0
	Confidence Interval	(2-Sided) 95%; -1.9 to 4.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots minus Prevnar 13™

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Fatigue: V114 Combined Lots - Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.812
	Comments
	Method	Miettinen & Nurminen
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	-0.7
	Confidence Interval	(2-Sided) 95%; -6.7 to 4.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots minus Prevnar 13™

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Headache: V114 Combined Lots - Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.947
	Comments
	Method	Miettinen & Nurminen
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; -5.6 to 5.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots minus Prevnar 13™

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Myalgia: V114 Combined Lots - Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.091
	Comments
	Method	Miettinen & Nurminen
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	5.2
	Confidence Interval	(2-Sided) 95%; -0.9 to 10.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots minus Prevnar 13™

5. Primary Outcome

Title	Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With Separate V114 Lots
Description	A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. Relatedness of an SAE to the study vaccine is determined by the investigator. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with SAEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.
Time Frame	Up to Month 6

Outcome Measure Data

Analysis Population Description

Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.

Arm/Group Title	V114 Lot 1	V114 Lot 2	V114 Lot 3	Prevnar13™
Arm/Group Description	Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
Measure Participants	699	704	700	0
Number (95% Confidence Interval) [Percentage of participants]	0.0 0%	0.0 0%	0.0 0%

6. Primary Outcome

Title	Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
Description	A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. Relatedness of an SAE to the study vaccine is determined by the investigator. Per the statistical analysis plan, within-group CIs were not calculated.
Time Frame	Up to Month 6

Outcome Measure Data

Analysis Population Description

Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.

Arm/Group Title	V114 Combined Lots 1,2 and 3	Prevnar13™
Arm/Group Description	Single IM dose at 0.5 mL of either V114 Lots 1,2 or 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
Measure Participants	2103	230
Number [Percentage of participants]	0.0 0%	0.0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	V114 Combined Lots - Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Miettinen & Nurminen
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -1.6 to 0.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots minus Prevnar 13™

7. Primary Outcome

Title	Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots
Description	Opsonization of pneumococci for phagocytosis is an important mechanism by which antibodies to polysaccharides protect against disease in vivo. Sera from participants was used to measure geometric mean titer (GMT) of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the Multiplexed Opsonophagocytic Assay (MOPA). Per the statistical analysis plan, within-group CIs were not calculated. 95% CIs were calculated for the GMT ratios between pairs of V114 lots by a constrained longitudinal data analysis (cLDA) model; and the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.

Arm/Group Title	V114 Lot 1	V114 Lot 2	V114 Lot 3	Prevnar13™
Arm/Group Description	Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
Measure Participants	698	704	700	0
Serotype 1	248.5	251.6	239.4
Serotype 3	198.3	232.2	214.4
Serotype 4	1073.1	1303.7	1074.4
Serotype 5	389.8	461.6	391.3
Serotype 6A	5845.0	6077.6	6123.8
Serotype 6B	5160.6	5362.7	5109.5
Serotype 7F	3757.7	4590.5	4202.0
Serotype 9V	1708.4	1690.6	1749.9
Serotype 14	2364.8	2509.6	2050.6
Serotype 18C	3880.8	3522.4	3381.0
Serotype 19A	3384.7	3774.8	3498.5
Serotype 19F	1866.4	2017.8	1993.2
Serotype 23F	2222.9	2417.8	2133.0
Serotype 22F	2617.4	2761.6	2676.0
Serotype 33F	7758.1	7736.9	7365.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 1: GMT Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.83 to 1.18
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 1: GMT Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.24
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 1: GMT Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.25
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 3: GMT Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.75 to 0.97
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 3: GMT Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 3: GMT Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 4: GMT Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.70 to 0.97
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 4: GMT Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.18
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 4: GMT Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.21
	Confidence Interval	(2-Sided) 95%; 1.03 to 1.43
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 5: GMT Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 95%; 0.70 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 5: GMT Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.83 to 1.20
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 5: GMT Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.18
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.42
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 6A: GMT Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 6A: GMT Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 6A: GMT Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 6B: GMT Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 6B: GMT Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.18
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 6B: GMT Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 7F: GMT Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.72 to 0.93
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 7F: GMT Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 7F: GMT Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.09
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.24
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 9V: GMT Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 9V: GMT Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 9V: GMT Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 14: GMT Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 14: GMT Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.15
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.34
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 14: GMT Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.22
	Confidence Interval	(2-Sided) 95%; 1.05 to 1.43
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 18C: GMT Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.10
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.26
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 18C: GMT Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.15
	Confidence Interval	(2-Sided) 95%; 1.00 to 1.31
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 18C: GMT Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 19A: GMT Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 19A: GMT Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 19A: GMT Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 19F: GMT Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 19F: GMT Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 19F: GMT Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 23F: GMT Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.77 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 23F: GMT Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.24
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 23F: GMT Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.35
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 22F: GMT Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 41

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 22F: GMT Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 42

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 22F: GMT Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 43

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 33F: GMT Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 44

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 33F: GMT Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 45

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 33F: GMT Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Equivalence
	Comments	Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Identical p-values for the lower and upper bounds.
	Method	cLDA model
	Comments	P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMT ratio and 95% CI were estimated from a cLDA model.

8. Secondary Outcome

Title	Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots
Description	The geometric mean concentration (GMC) of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex electrochemiluminescence (ECL) using the pneumococcal electrochemiluminescence (PnECL) v2.0 assay. Per the statistical analysis plan, within-group CIs were not calculated; and the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.

Arm/Group Title	V114 Lot 1	V114 Lot 2	V114 Lot 3	Prevnar13™
Arm/Group Description	Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
Measure Participants	698	704	700	0
Serotype 1	3.91	4.05	3.83
Serotype 3	0.74	0.86	0.73
Serotype 4	1.79	2.18	1.67
Serotype 5	3.81	4.63	3.96
Serotype 6A	8.09	8.84	8.16
Serotype 6B	10.92	11.46	10.44
Serotype 7F	5.71	7.11	5.94
Serotype 9V	4.20	4.44	4.26
Serotype 14	9.82	11.38	8.66
Serotype 18C	14.07	11.81	10.66
Serotype 19A	15.45	17.34	15.81
Serotype 19F	9.78	11.22	10.65
Serotype 23F	7.38	7.97	7.44
Serotype 22F	4.12	4.41	3.80
Serotype 33F	9.92	10.88	9.45

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 1: GMC Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 1: GMC Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.17
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 1: GMC Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 0.92 to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 3: GMC Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.77 to 0.95
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 3: GMC Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 3: GMC Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.18
	Confidence Interval	(2-Sided) 95%; 1.06 to 1.32
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 4: GMC Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.72 to 0.94
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 4: GMC Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.94 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 4: GMC Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.31
	Confidence Interval	(2-Sided) 95%; 1.14 to 1.50
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 5: GMC Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.72 to 0.95
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 5: GMC Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 5: GMC Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.17
	Confidence Interval	(2-Sided) 95%; 1.02 to 1.35
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 6A: GMC Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 6A: GMC Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 6A: GMC Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95%; 0.93 to 1.27
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 6B: GMC Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 6B: GMC Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 6B: GMC Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.10
	Confidence Interval	(2-Sided) 95%; 0.94 to 1.28
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 7F: GMC Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.80
	Confidence Interval	(2-Sided) 95%; 0.70 to 0.92
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 7F: GMC Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 7F: GMC Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.20
	Confidence Interval	(2-Sided) 95%; 1.04 to 1.37
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 9V: GMC Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.83 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 9V: GMC Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 9V: GMC Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 14: GMC Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 95%; 0.75 to 1.00
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 14: GMC Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.31
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 14: GMC Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.31
	Confidence Interval	(2-Sided) 95%; 1.14 to 1.52
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 18C: GMC Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.19
	Confidence Interval	(2-Sided) 95%; 1.04 to 1.36
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 18C: GMC Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.32
	Confidence Interval	(2-Sided) 95%; 1.15 to 1.51
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 18C: GMC Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.11
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.27
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 19A: GMC Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 19A: GMC Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 19A: GMC Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.10
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.25
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 19F: GMC Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95%; 0.76 to 1.00
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 19F: GMC Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.80 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 19F: GMC Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.92 to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 23F: GMC Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.80 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 23F: GMC Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 23F: GMC Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.93 to 1.24
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 22F: GMC Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 41

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 22F: GMC Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95%; 0.93 to 1.26
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 42

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 22F: GMC Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.16
	Confidence Interval	(2-Sided) 95%; 1.00 to 1.35
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 43

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 33F: GMC Ratio V114 Lot 1 / V114 Lot 2
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 2
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 44

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 3
	Comments	Serotype 33F: GMC Ratio V114 Lot 1 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 1 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 45

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 2, V114 Lot 3
	Comments	Serotype 33F: GMC Ratio V114 Lot 2 / V114 Lot 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.15
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.34
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lot 2 divided by Lot 3
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

9. Secondary Outcome

Title	Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™
Description	The GMC of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. Per the statistical analysis plan, within-group CIs were not calculated,
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.

Arm/Group Title	V114 Combined Lots 1,2 and 3	Prevnar13™
Arm/Group Description	Single IM dose at 0.5 mL of either V114 Lots 1,2 or 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
Measure Participants	2102	231
Serotype 1	3.91	5.22
Serotype 3	0.77	0.55
Serotype 4	1.87	2.38
Serotype 5	4.14	4.66
Serotype 6A	8.38	7.20
Serotype 6B	10.92	7.28
Serotype 7F	6.19	7.12
Serotype 9V	4.30	4.97
Serotype 14	9.89	9.97
Serotype 18C	12.08	9.58
Serotype 19A	16.18	16.66
Serotype 19F	10.52	10.25
Serotype 23F	7.58	6.03
Serotype 22F	4.10	0.34
Serotype 33F	10.03	1.07

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 1: GMC Ratio V114 Combined Lots / Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.75
	Confidence Interval	(2-Sided) 95%; 0.62 to 0.91
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots divided by Prevnar 13™
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 3: GMC Ratio V114 Combined Lots / Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.39
	Confidence Interval	(2-Sided) 95%; 1.20 to 1.61
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots divided by Prevnar 13™
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 4: GMC Ratio V114 Combined Lots / Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 95%; 0.66 to 0.94
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots divided by Prevnar 13™
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 5: GMC Ratio V114 Combined Lots / Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.74 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots divided by Prevnar 13™
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 6A: GMC Ratio V114 Combined Lots / Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.16
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.43
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots divided by Prevnar 13™
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 6B: GMC Ratio V114 Combined Lots / Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.50
	Confidence Interval	(2-Sided) 95%; 1.21 to 1.86
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots divided by Prevnar 13™
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 7F: GMC Ratio V114 Combined Lots / Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95%; 0.73 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots divided by Prevnar 13™
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 9V: GMC Ratio V114 Combined Lots / Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95%; 0.72 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots divided by Prevnar 13™
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 14: GMC Ratio V114 Combined Lots / Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.20
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots divided by Prevnar 13™
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 18C: GMC Ratio V114 Combined Lots / Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.26
	Confidence Interval	(2-Sided) 95%; 1.05 to 1.51
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots divided by Prevnar 13™
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 19A: GMC Ratio V114 Combined Lots / Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots divided by Prevnar 13™
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 19F: GMC Ratio V114 Combined Lots / Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots divided by Prevnar 13™
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 23F: GMC Ratio V114 Combined Lots / Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.26
	Confidence Interval	(2-Sided) 95%; 1.03 to 1.54
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots divided by Prevnar 13™
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 22F: GMC Ratio V114 Combined Lots / Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	12.21
	Confidence Interval	(2-Sided) 95%; 10.11 to 14.74
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots divided by Prevnar 13™
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	V114 Lot 1, V114 Lot 2
	Comments	Serotype 33F: GMC Ratio V114 Combined Lots / Prevnar 13™
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	9.42
	Confidence Interval	(2-Sided) 95%; 7.96 to 11.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	V114 Combined Lots divided by Prevnar 13™
Other Statistical Analysis		GMC ratio and 95% CI were estimated from a cLDA model.

10. Secondary Outcome

Title	Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Description	Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the MOPA which reads the reciprocal of the highest dilution that gives ≥50% bacterial killing. The Geometric Mean Fold Rise (GMFR) is the geometric mean of the ratio Day 30/Day 1 OPA responses. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.
Time Frame	Day 1 (Baseline) and Day 30

Outcome Measure Data

Analysis Population Description

All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.

Arm/Group Title	V114 Lot 1	V114 Lot 2	V114 Lot 3	Prevnar13™
Arm/Group Description	Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
Measure Participants	698	704	700	0
Serotype 1	15.9	16.5	15.4
Serotype 3	6.5	7.6	6.9
Serotype 4	17.4	20.7	16.5
Serotype 5	11.2	13.3	11.1
Serotype 6A	13.7	14.1	14.6
Serotype 6B	33.4	31.2	34.9
Serotype 7F	11.9	14.3	12.9
Serotype 9V	4.8	4.8	5.0
Serotype 14	7.6	7.6	6.2
Serotype 18C	16.7	15.0	14.1
Serotype 19A	10.4	11.0	11.7
Serotype 19F	6.5	6.8	7.3
Serotype 23F	16.8	17.4	17.0
Serotype 22F	27.2	31.1	28.3
Serotype 33F	8.4	7.7	7.5

11. Secondary Outcome

Title	GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Description	The geometric mean concentration (GMC) of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. The GMFR is the geometric mean of the ratio Day 30/Day 1 IgG concentration. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.
Time Frame	Day 1 (Baseline) and Day 30

Outcome Measure Data

Analysis Population Description

All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.

Arm/Group Title	V114 Lot 1	V114 Lot 2	V114 Lot 3	Prevnar13™
Arm/Group Description	Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
Measure Participants	698	704	700	0
Serotype 1	10.9	11.2	10.3
Serotype 3	5.4	6.3	5.2
Serotype 4	8.6	10.5	7.9
Serotype 5	4.5	5.5	4.7
Serotype 6A	22.6	24.1	22.9
Serotype 6B	23.5	24.1	22.1
Serotype 7F	11.7	14.8	12.0
Serotype 9V	9.5	9.8	9.6
Serotype 14	6.5	6.8	5.2
Serotype 18C	20.6	17.0	15.9
Serotype 19A	9.1	10.6	9.5
Serotype 19F	12.3	13.8	13.1
Serotype 23F	14.3	16.2	14.8
Serotype 22F	12.8	13.4	11.1
Serotype 33F	9.2	9.5	7.9

12. Secondary Outcome

Title	Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Description	Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, with the MOPA which reads the reciprocal of the highest dilution (1/dil) that gives ≥50% bacterial killing. Percentage of participants with a ≥ 4-fold change from Day 1 (baseline) to Day 30 (Day 30/Day 1) are presented. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.
Time Frame	Day 1 (Baseline) and Day 30

Outcome Measure Data

Analysis Population Description

All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.

Arm/Group Title	V114 Lot 1	V114 Lot 2	V114 Lot 3	Prevnar13™
Arm/Group Description	Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
Measure Participants	698	704	700	0
Serotype 1	74.4 10.6%	76.8 10.9%	77.2 11%
Serotype 3	64.7 9.2%	68.9 9.8%	64.8 9.2%
Serotype 4	79.4 11.3%	83.6 11.9%	79.5 11.3%
Serotype 5	71.3 10.2%	76.1 10.8%	69.5 9.9%
Serotype 6A	78.5 11.2%	77.8 11.1%	76.9 11%
Serotype 6B	83.3 11.9%	83.6 11.9%	84.5 12.1%
Serotype 7F	69.4 9.9%	71.6 10.2%	70.4 10%
Serotype 9V	53.4 7.6%	51.2 7.3%	53.2 7.6%
Serotype 14	56.8 8.1%	57.6 8.2%	52.3 7.5%
Serotype 18C	80.1 11.4%	79.0 11.2%	78.3 11.2%
Serotype 19A	67.8 9.7%	69.8 9.9%	71.2 10.2%
Serotype 19F	60.8 8.7%	61.9 8.8%	63.0 9%
Serotype 23F	75.4 10.7%	78.3 11.1%	78.2 11.2%
Serotype 22F	71.1 10.1%	73.4 10.4%	72.8 10.4%
Serotype 33F	59.5 8.5%	58.3 8.3%	56.8 8.1%

13. Secondary Outcome

Title	Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Description	The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. Percentage of participants with a ≥ 4-fold change from Day 1 (baseline) to Day 30 (Day 30/ Day 1) are presented. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.
Time Frame	Day 1 (Baseline) and Day 30

Outcome Measure Data

Analysis Population Description

All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.

Arm/Group Title	V114 Lot 1	V114 Lot 2	V114 Lot 3	Prevnar13™
Arm/Group Description	Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
Measure Participants	698	704	700	0
Serotype 1	73.9 10.5%	75.2 10.7%	73.0 10.4%
Serotype 3	58.6 8.3%	61.9 8.8%	54.7 7.8%
Serotype 4	68.8 9.8%	73.8 10.5%	65.7 9.4%
Serotype 5	45.6 6.5%	52.5 7.5%	45.9 6.5%
Serotype 6A	86.6 12.3%	87.2 12.4%	83.8 12%
Serotype 6B	87.0 12.4%	85.6 12.2%	84.2 12%
Serotype 7F	75.3 10.7%	78.8 11.2%	74.8 10.7%
Serotype 9V	72.6 10.3%	73.0 10.4%	71.6 10.2%
Serotype 14	54.4 7.7%	57.9 8.2%	48.3 6.9%
Serotype 18C	84.6 12.1%	78.6 11.2%	76.7 10.9%
Serotype 19A	70.6 10.1%	74.2 10.5%	71.0 10.1%
Serotype 19F	77.8 11.1%	79.0 11.2%	78.6 11.2%
Serotype 23F	76.1 10.8%	80.7 11.5%	76.7 10.9%
Serotype 22F	75.3 10.7%	75.4 10.7%	72.1 10.3%
Serotype 33F	69.4 9.9%	70.9 10.1%	66.1 9.4%

Adverse Events

Time Frame	Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
Adverse Event Reporting Description	For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
Arm/Group Title	V114 Lot 1		V114 Lot 2		V114 Lot 3		Prevnar 13™
Arm/Group Description	Single intramuscular (IM) dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)		Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)		Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)		Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
All Cause Mortality
	V114 Lot 1		V114 Lot 2		V114 Lot 3		Prevnar 13™
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/702 (0.1%)		2/704 (0.3%)		0/701 (0%)		0/233 (0%)
Serious Adverse Events
	V114 Lot 1		V114 Lot 2		V114 Lot 3		Prevnar 13™
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/699 (1.7%)		19/704 (2.7%)		7/700 (1%)		5/230 (2.2%)
Cardiac disorders
Acute myocardial infarction	1/699 (0.1%)	1	0/704 (0%)	0	0/700 (0%)	0	1/230 (0.4%)	1
Angina unstable	0/699 (0%)	0	1/704 (0.1%)	1	0/700 (0%)	0	0/230 (0%)	0
Cardiac failure congestive	0/699 (0%)	0	1/704 (0.1%)	1	0/700 (0%)	0	0/230 (0%)	0
Coronary artery disease	0/699 (0%)	0	1/704 (0.1%)	1	1/700 (0.1%)	1	0/230 (0%)	0
Coronary artery occlusion	1/699 (0.1%)	1	0/704 (0%)	0	0/700 (0%)	0	0/230 (0%)	0
Eye disorders
Blindness	0/699 (0%)	0	1/704 (0.1%)	1	0/700 (0%)	0	0/230 (0%)	0
General disorders
Chest pain	0/699 (0%)	0	1/704 (0.1%)	1	0/700 (0%)	0	0/230 (0%)	0
Death	0/699 (0%)	0	1/704 (0.1%)	1	0/700 (0%)	0	0/230 (0%)	0
Hepatobiliary disorders
Cholecystitis	0/699 (0%)	0	0/704 (0%)	0	0/700 (0%)	0	1/230 (0.4%)	1
Cholelithiasis	0/699 (0%)	0	2/704 (0.3%)	2	0/700 (0%)	0	0/230 (0%)	0
Infections and infestations
Appendicitis	0/699 (0%)	0	0/704 (0%)	0	1/700 (0.1%)	1	0/230 (0%)	0
Bronchitis	1/699 (0.1%)	1	0/704 (0%)	0	0/700 (0%)	0	0/230 (0%)	0
Cellulitis	0/699 (0%)	0	1/704 (0.1%)	1	0/700 (0%)	0	0/230 (0%)	0
Cystitis	0/699 (0%)	0	0/704 (0%)	0	0/700 (0%)	0	1/230 (0.4%)	1
Diverticulitis	1/699 (0.1%)	1	0/704 (0%)	0	0/700 (0%)	0	0/230 (0%)	0
Peritonitis	0/699 (0%)	0	1/704 (0.1%)	1	0/700 (0%)	0	0/230 (0%)	0
Pneumonia	1/699 (0.1%)	1	1/704 (0.1%)	1	0/700 (0%)	0	0/230 (0%)	0
Sepsis	0/699 (0%)	0	1/704 (0.1%)	1	0/700 (0%)	0	0/230 (0%)	0
Injury, poisoning and procedural complications
Pelvic fracture	0/699 (0%)	0	0/704 (0%)	0	1/700 (0.1%)	1	0/230 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	0/699 (0%)	0	1/704 (0.1%)	1	0/700 (0%)	0	0/230 (0%)	0
Breast cancer	1/699 (0.1%)	1	0/704 (0%)	0	0/700 (0%)	0	0/230 (0%)	0
Breast cancer female	1/699 (0.1%)	1	0/704 (0%)	0	0/700 (0%)	0	0/230 (0%)	0
Gastric cancer	0/699 (0%)	0	1/704 (0.1%)	1	0/700 (0%)	0	0/230 (0%)	0
Intraductal proliferative breast lesion	0/699 (0%)	0	0/704 (0%)	0	0/700 (0%)	0	1/230 (0.4%)	1
Invasive breast carcinoma	0/699 (0%)	0	0/704 (0%)	0	1/700 (0.1%)	1	0/230 (0%)	0
Invasive ductal breast carcinoma	0/699 (0%)	0	0/704 (0%)	0	0/700 (0%)	0	1/230 (0.4%)	1
Metastases to peritoneum	0/699 (0%)	0	1/704 (0.1%)	1	0/700 (0%)	0	0/230 (0%)	0
Pancreatic carcinoma	1/699 (0.1%)	1	0/704 (0%)	0	0/700 (0%)	0	0/230 (0%)	0
Prostate cancer	0/699 (0%)	0	0/704 (0%)	0	1/700 (0.1%)	1	0/230 (0%)	0
Rectal cancer	0/699 (0%)	0	0/704 (0%)	0	1/700 (0.1%)	1	0/230 (0%)	0
Nervous system disorders
Cerebral haemorrhage	1/699 (0.1%)	1	0/704 (0%)	0	0/700 (0%)	0	0/230 (0%)	0
Cerebrovascular accident	0/699 (0%)	0	1/704 (0.1%)	1	0/700 (0%)	0	0/230 (0%)	0
Migraine	0/699 (0%)	0	1/704 (0.1%)	1	0/700 (0%)	0	0/230 (0%)	0
Seizure	0/699 (0%)	0	1/704 (0.1%)	1	0/700 (0%)	0	0/230 (0%)	0
Transient ischaemic attack	1/699 (0.1%)	1	1/704 (0.1%)	1	0/700 (0%)	0	0/230 (0%)	0
Psychiatric disorders
Depression	1/699 (0.1%)	1	0/704 (0%)	0	0/700 (0%)	0	0/230 (0%)	0
Renal and urinary disorders
Acute kidney injury	0/699 (0%)	0	1/704 (0.1%)	1	0/700 (0%)	0	0/230 (0%)	0
Reproductive system and breast disorders
Prostatitis	0/699 (0%)	0	0/704 (0%)	0	1/700 (0.1%)	1	0/230 (0%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/699 (0.1%)	1	2/704 (0.3%)	2	0/700 (0%)	0	0/230 (0%)	0
Chronic obstructive pulmonary disease	0/699 (0%)	0	1/704 (0.1%)	1	0/700 (0%)	0	0/230 (0%)	0
Pulmonary embolism	0/699 (0%)	0	0/704 (0%)	0	1/700 (0.1%)	1	0/230 (0%)	0
Respiratory failure	0/699 (0%)	0	1/704 (0.1%)	1	0/700 (0%)	0	0/230 (0%)	0
Other (Not Including Serious) Adverse Events
	V114 Lot 1		V114 Lot 2		V114 Lot 3		Prevnar 13™
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	548/699 (78.4%)		534/704 (75.9%)		535/700 (76.4%)		151/230 (65.7%)
General disorders
Fatigue	154/699 (22%)	202	147/704 (20.9%)	182	151/700 (21.6%)	189	51/230 (22.2%)	74
Injection site erythema	77/699 (11%)	82	86/704 (12.2%)	91	89/700 (12.7%)	91	22/230 (9.6%)	24
Injection site pain	464/699 (66.4%)	518	475/704 (67.5%)	520	471/700 (67.3%)	514	122/230 (53%)	134
Injection site swelling	111/699 (15.9%)	115	115/704 (16.3%)	117	106/700 (15.1%)	109	34/230 (14.8%)	34
Musculoskeletal and connective tissue disorders
Arthralgia	53/699 (7.6%)	68	49/704 (7%)	54	59/700 (8.4%)	75	13/230 (5.7%)	14
Myalgia	196/699 (28%)	226	171/704 (24.3%)	196	199/700 (28.4%)	226	50/230 (21.7%)	54
Nervous system disorders
Headache	127/699 (18.2%)	166	140/704 (19.9%)	170	130/700 (18.6%)	171	43/230 (18.7%)	53

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.