Clincosm LogoSign in Get a demo

Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT03760146
Collaborator
(none)
3,902
Enrollment
68
Locations
6
Arms
12.1
Actual Duration (Months)
57.4
Patients Per Site
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults

Condition or Disease Intervention/Treatment Phase
  • Biological: 20vPnC
  • Biological: 13vPnC
  • Biological: PPSV23
  • Other: Saline
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
3902 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS 18 YEARS OF AGE AND OLDER
Actual Study Start Date :
Dec 12, 2018
Actual Primary Completion Date :
Dec 16, 2019
Actual Study Completion Date :
Dec 16, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 60 years and above 20vPnC/Saline

20vPnC and saline

Biological: 20vPnC
20vPnC

Other: Saline
Placebo
Active Comparator: 60 years and above 13vPnC/PPSV23

13vPnC and PPSV23

Biological: 13vPnC
Pneumococcal conjugate vaccine

Biological: PPSV23
Pneumococcal polysaccharide vaccine
Other Names:
  • Pneumovax 23

    		•
    Experimental: 50 through 59 years of age 20vPnC

    20vPnC

    Biological: 20vPnC
    20vPnC
    Experimental: 18 through 49 years of age 20vPnC

    20vPnC

    Biological: 20vPnC
    20vPnC
    Active Comparator: 50 through 59 years of age 13vPnC

    13vPnC

    Biological: 13vPnC
    Pneumococcal conjugate vaccine
    Active Comparator: 18 through 49 years of age 13vPnC

    13vPnC

    Biological: 13vPnC
    Pneumococcal conjugate vaccine

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts [Within 10 days after 20vPnC or 13vPnC]

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

    2. Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts [Within 7 days after 20vPnC or 13vPnC]

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

    3. Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination in All Cohorts [Within 1 month after 20vPnC or 13vPnC]

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

    4. Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination in All Cohorts [Within 6 months after 20vPnC or 13vPnC]

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

    5. Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination in All Cohorts [Within 6 months after 20vPnC or 13vPnC]

      An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects.

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

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

    7. Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP) [1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline"; 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23"]

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

    Secondary Outcome Measures

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

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

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

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

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

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

    4. Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population [From before Vaccination 1 to 1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline" or From before Vaccination 1 to 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23"]

      OPA GMFR is the ratio of OPA GMT, 1 month after vaccination to before vaccination OPA GMT. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F.

    5. Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population [Before vaccination to 1 month after vaccination]

      OPA GMFR is the ratio of OPA GMT, 1 month after vaccination to before vaccination OPA GMT. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.

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

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

    7. Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP [Before Vaccination 1 to 1 month after Vaccination 1 for "Cohort 1: 20vPnC/Saline"; Before Vaccination 1 to 1 month after Vaccination 2 for "Cohort 1: 13vPnC/PPSV23"]

      Percentage of participants with a >=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F.

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

      Percentage of participants with a >=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.

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

      The percentage of participants with OPA titers >=LLOQ along with corresponding 2-sided 95% CIs were calculated 1 month after vaccination for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

    10. Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population [1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline" or 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23"]

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

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Male or female adults >/= 18 years of age (from the 18th birthday) at enrollment and older.

    2. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product.

    3. Negative urine pregnancy test at Visit1 for all subjects who are of childbearing potential.

    Exclusion Criteria:

    1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.

    2. History of microbiologically proven invasive disease caused by S pneumoniae.

    3. Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study.

    4. Pregnant female subjects or breastfeeding female subjects.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Accel Research Sites Birmingham Alabama United States 35216
    2 Coastal Clinical Research, Inc. Mobile Alabama United States 36608
    3 East Valley Gastroenterology and Hepatology Associates Chandler Arizona United States 85224
    4 The Pain Center of Arizona Peoria Arizona United States 85381
    5 MedPharmics, LLC Phoenix Arizona United States 85015
    6 HOPE Research Institute Phoenix Arizona United States 85018
    7 The Pain Center of Arizona Phoenix Arizona United States 85018
    8 Anaheim Clinical Trials, LLC Anaheim California United States 92801
    9 Diablo Clinical Research, Inc. Walnut Creek California United States 94598
    10 Clinical Research Consulting, LLC Milford Connecticut United States 06460
    11 Nature Coast Clinical Research Crystal River Florida United States 34429
    12 Accel Research Sites - Clinical Research Unit DeLand Florida United States 32720
    13 Research Centers of America, LLC Hollywood Florida United States 33024
    14 Jacksonville Center for Clinical Research Jacksonville Florida United States 32216
    15 Suncoast Research Group, LLC Miami Florida United States 33135
    16 Acevedo Clinical Research Associates Miami Florida United States 33142
    17 Qps-Mra, Llc South Miami Florida United States 33143
    18 Atlanta Center for Medical Research Atlanta Georgia United States 30331
    19 Meridian Clinical Research LLC Savannah Georgia United States 31406
    20 Clinical Research Atlanta Stockbridge Georgia United States 30281
    21 East-West Medical Research Institute Honolulu Hawaii United States 96814
    22 Axtell Clinic, P.A. Newton Kansas United States 67114
    23 Heartland Research Associates, LLC Newton Kansas United States 67114
    24 Heartland Research Associates, LLC Wichita Kansas United States 67205
    25 Northwest Family Physicians Wichita Kansas United States 67205
    26 Heartland Research Associates, LLC Wichita Kansas United States 67207
    27 Meridian Clinical Research, LLC Rockville Maryland United States 20854
    28 Sundance Clinical Research Saint Louis Missouri United States 63141
    29 Meridian Clinical Research, LLC Norfolk Nebraska United States 68701
    30 Meridian Clinical Research LLC Omaha Nebraska United States 68134
    31 ActivMed Practices & Research, Inc. Portsmouth New Hampshire United States 03801
    32 United Medical Associates Binghamton New York United States 13901
    33 Regional Clinical Research, Inc. Endwell New York United States 13760
    34 Rochester Clinical Research, Inc. Rochester New York United States 14609
    35 PharmQuest Greensboro North Carolina United States 27408
    36 M3 Wake Research, Inc. Raleigh North Carolina United States 27612
    37 PMG Research of Wilmington, LLC Wilmington North Carolina United States 28401
    38 Lillestol Research LLC Fargo North Dakota United States 58104
    39 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45206
    40 Sterling Research Group, Ltd. Cincinnati Ohio United States 45219
    41 Cincinnati Children's Hospital Medical Center (CCHMC) Cincinnati Ohio United States 45229
    42 Sterling Research Group, Ltd. Cincinnati Ohio United States 45246
    43 Rapid Medical Research, Inc. Cleveland Ohio United States 44122
    44 Lynn Health Science Institute Oklahoma City Oklahoma United States 73112
    45 Omega Medical Research Warwick Rhode Island United States 02886
    46 Meridian Clinical Research, LLC Dakota Dunes South Dakota United States 57049
    47 Tekton Research, Inc. Austin Texas United States 78745
    48 Bellaire Doctor's Clinic Bellaire Texas United States 77401
    49 Ventavia Research Group, LLC Fort Worth Texas United States 76104
    50 Benchmark Research Fort Worth Texas United States 76135
    51 HealthFirst Medical Group Fort Worth Texas United States 76135
    52 Ventavia Research Group, LLC Keller Texas United States 76248
    53 Clinical Trials of Texas, Inc. San Antonio Texas United States 78229
    54 Ventavia Research Group, LLC Spring Texas United States 77389
    55 DM Clinical Research Tomball Texas United States 77375
    56 Martin Diagnostic Clinic Tomball Texas United States 77375
    57 J. Lewis Research Inc. / Foothill Family Clinic Draper Draper Utah United States 84020
    58 J. Lewis Research, Inc. / Foothill Family Clinic Salt Lake City Utah United States 84109
    59 J. Lewis Research, Inc. / Foothill Family Clinic South Salt Lake City Utah United States 84121
    60 J. Lewis Research, Inc. - Jordan River Family Medicine South Jordan Utah United States 84095
    61 Kaiser Permanente Washington Health Research Institute Seattle Washington United States 98101
    62 Ladulaas Kliniska Studier Boras Sweden 50630
    63 Infektionskliniken Malarsjukhuset Eskilstuna Sweden 63188
    64 ProbarE i Lund Lund Sweden 222 22
    65 Karolinska Trial Alliance, KTA Prim Stockholm Sweden 113 61
    66 Akardo Med Site Stockholm Sweden 114 46
    67 Akademiska Sjukhuset Uppsala Sweden 75185
    68 Avdelningen för kliniska prövningar Örebro Sweden 70362

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT03760146
    Other Study ID Numbers:
    • B7471007
    • 2018-004279-11
    First Posted:
    Nov 30, 2018
    Last Update Posted:
    Dec 2, 2021
    Last Verified:
    Nov 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
    Heptavalent Pneumococcal Conjugate Vaccine

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Cohort 1: 20vPnC/Saline Cohort 1: 13vPnC/PPSV23 Cohort 2: 20vPnC Cohort 2: 13vPnC Cohort 3: 20vPnC Cohort 3: 13vPnC
    Arm/Group Description Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1). Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1). Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1). Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
    Period Title: Overall Study
    STARTED 1514 1495 334 111 336 112
    Evaluable 13-Matched Immunogenicity Population 1435 1420 0 0 0 0
    Evaluable 7-Additional Immunogenicity Population 1433 1383 0 0 0 0
    Vaccination 1 1507 1490 334 111 335 112
    Vaccination 2 1461 1446 0 0 0 0
    Safety Population 1507 1490 334 111 335 112
    Evaluable-20 Immunogenicity Population 946 0 321 0 317 0
    COMPLETED 1418 1417 323 109 319 104
    NOT COMPLETED 96 78 11 2 17 8

    Baseline Characteristics

    Arm/Group Title Cohort 1: 20vPnC/Saline Cohort 1: 13vPnC/PPSV23 Cohort 2: 20vPnC Cohort 2: 13vPnC Cohort 3: 20vPnC Cohort 3: 13vPnC Total
    Arm/Group Description Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1). Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1). Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1). Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1). Total of all reporting groups
    Overall Participants 1507 1490 334 111 335 112 3889
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    64.6
    (4.82)
    64.6
    (4.81)
    54.9
    (2.77)
    55.0
    (3.11)
    34.0
    (8.77)
    33.9
    (8.03)
    60.0
    (11.15)
    Sex: Female, Male (Count of Participants)
    Female
    897
    59.5%
    879
    59%
    195
    58.4%
    69
    62.2%
    214
    63.9%
    77
    68.8%
    2331
    59.9%
    Male
    610
    40.5%
    611
    41%
    139
    41.6%
    42
    37.8%
    121
    36.1%
    35
    31.3%
    1558
    40.1%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    167
    11.1%
    169
    11.3%
    12
    3.6%
    8
    7.2%
    24
    7.2%
    7
    6.3%
    387
    10%
    Not Hispanic or Latino
    1324
    87.9%
    1308
    87.8%
    319
    95.5%
    101
    91%
    300
    89.6%
    102
    91.1%
    3454
    88.8%
    Unknown or Not Reported
    16
    1.1%
    13
    0.9%
    3
    0.9%
    2
    1.8%
    11
    3.3%
    3
    2.7%
    48
    1.2%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    6
    0.4%
    9
    0.6%
    0
    0%
    3
    2.7%
    1
    0.3%
    1
    0.9%
    20
    0.5%
    Asian
    19
    1.3%
    15
    1%
    10
    3%
    2
    1.8%
    11
    3.3%
    1
    0.9%
    58
    1.5%
    Native Hawaiian or Other Pacific Islander
    1
    0.1%
    1
    0.1%
    0
    0%
    0
    0%
    3
    0.9%
    1
    0.9%
    6
    0.2%
    Black or African American
    177
    11.7%
    212
    14.2%
    35
    10.5%
    15
    13.5%
    34
    10.1%
    7
    6.3%
    480
    12.3%
    White
    1295
    85.9%
    1237
    83%
    278
    83.2%
    90
    81.1%
    274
    81.8%
    101
    90.2%
    3275
    84.2%
    More than one race
    7
    0.5%
    9
    0.6%
    6
    1.8%
    1
    0.9%
    8
    2.4%
    1
    0.9%
    32
    0.8%
    Unknown or Not Reported
    2
    0.1%
    7
    0.5%
    5
    1.5%
    0
    0%
    4
    1.2%
    0
    0%
    18
    0.5%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts
    Description Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm) and severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
    Time Frame Within 10 days after 20vPnC or 13vPnC

    Outcome Measure Data

    Analysis Population Description
    Safety population included all participants who received 1 dose of any of the following: 20vPnC, 13vPnC, PPSV23 or saline and had safety follow-up after any vaccination. Here, "Overall Number of Participants Analyzed" =number of participants with any electronic diary data after 20vPnC or 13vPnC.
    Arm/Group Title Cohort 1: 20vPnC/Saline Cohort 1: 13vPnC/PPSV23 Cohort 2: 20vPnC Cohort 2: 13vPnC Cohort 3: 20vPnC Cohort 3: 13vPnC
    Arm/Group Description Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1). Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1). Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1). Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
    Measure Participants 1505 1483 331 111 335 112
    Redness: Any
    7.3
    0.5%
    6.2
    0.4%
    8.2
    2.5%
    5.4
    4.9%
    9.0
    2.7%
    9.8
    8.8%
    Redness: Mild
    3.7
    0.2%
    3.8
    0.3%
    5.1
    1.5%
    2.7
    2.4%
    3.0
    0.9%
    5.4
    4.8%
    Redness: Moderate
    2.8
    0.2%
    2.2
    0.1%
    2.7
    0.8%
    2.7
    2.4%
    5.4
    1.6%
    4.5
    4%
    Redness: Severe
    0.8
    0.1%
    0.2
    0%
    0.3
    0.1%
    0
    0%
    0.6
    0.2%
    0
    0%
    Swelling: Any
    7.5
    0.5%
    8.0
    0.5%
    8.8
    2.6%
    10.8
    9.7%
    11.6
    3.5%
    12.5
    11.2%
    Swelling: Mild
    4.8
    0.3%
    4.9
    0.3%
    5.7
    1.7%
    7.2
    6.5%
    7.2
    2.1%
    8.9
    7.9%
    Swelling: Moderate
    2.4
    0.2%
    2.8
    0.2%
    3.0
    0.9%
    3.6
    3.2%
    4.5
    1.3%
    3.6
    3.2%
    Swelling: Severe
    0.3
    0%
    0.3
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Pain at the injection site: Any
    55.4
    3.7%
    54.1
    3.6%
    72.5
    21.7%
    69.4
    62.5%
    81.2
    24.2%
    82.1
    73.3%
    Pain at the injection site: Mild
    45.3
    3%
    44.6
    3%
    53.5
    16%
    52.3
    47.1%
    42.7
    12.7%
    52.7
    47.1%
    Pain at the injection site: Moderate
    9.9
    0.7%
    9.2
    0.6%
    17.8
    5.3%
    16.2
    14.6%
    38.2
    11.4%
    28.6
    25.5%
    Pain at the injection site: Severe
    0.2
    0%
    0.3
    0%
    1.2
    0.4%
    0.9
    0.8%
    0.3
    0.1%
    0.9
    0.8%
    2. Primary Outcome
    Title Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
    Description Systemic events fever, fatigue, headache, muscle pain and joint pain were recorded by using an electronic diary. Fever was defined as greater than or equal to (>=) 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity).
    Time Frame Within 7 days after 20vPnC or 13vPnC

    Outcome Measure Data

    Analysis Population Description
    Safety population included all participants who received 1 dose of any of the following: 20vPnC, 13vPnC, PPSV23 or saline and had safety follow-up after any vaccination. Here, "Overall Number of Participants Analyzed" =number of participants with any electronic diary data after 20vPnC or 13vPnC.
    Arm/Group Title Cohort 1: 20vPnC/Saline Cohort 1: 13vPnC/PPSV23 Cohort 2: 20vPnC Cohort 2: 13vPnC Cohort 3: 20vPnC Cohort 3: 13vPnC
    Arm/Group Description Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1). Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1). Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1). Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
    Measure Participants 1505 1483 331 111 335 112
    Fever: >=38.0 degree C
    0.9
    0.1%
    0.8
    0.1%
    1.5
    0.4%
    0.9
    0.8%
    1.2
    0.4%
    1.8
    1.6%
    Fever: >=38.0 degree C to 38.4 degree C
    0.3
    0%
    0.4
    0%
    0.6
    0.2%
    0.9
    0.8%
    0.6
    0.2%
    0
    0%
    Fever: >38.4 degree C to 38.9 degree C
    0.3
    0%
    0.2
    0%
    0.3
    0.1%
    0
    0%
    0.3
    0.1%
    0
    0%
    Fever: >38.9 degree C to 40.0 degree C
    0.0
    0%
    0
    0%
    0.3
    0.1%
    0
    0%
    0.3
    0.1%
    1.8
    1.6%
    Fever: >40.0 degree C
    0.3
    0%
    0.2
    0%
    0.3
    0.1%
    0
    0%
    0
    0%
    0
    0%
    Fatigue: Any
    30.2
    2%
    30.7
    2.1%
    39.3
    11.8%
    36.0
    32.4%
    42.7
    12.7%
    43.8
    39.1%
    Fatigue: Mild
    16.1
    1.1%
    17.5
    1.2%
    21.1
    6.3%
    18.0
    16.2%
    18.8
    5.6%
    20.5
    18.3%
    Fatigue: Moderate
    12.8
    0.8%
    11.9
    0.8%
    17.2
    5.1%
    15.3
    13.8%
    22.1
    6.6%
    19.6
    17.5%
    Fatigue: Severe
    1.2
    0.1%
    1.2
    0.1%
    0.9
    0.3%
    2.7
    2.4%
    1.8
    0.5%
    3.6
    3.2%
    Headache: Any
    21.5
    1.4%
    23.3
    1.6%
    32.3
    9.7%
    36.0
    32.4%
    38.8
    11.6%
    33.9
    30.3%
    Headache: Mild
    15.5
    1%
    17.0
    1.1%
    20.5
    6.1%
    21.6
    19.5%
    21.5
    6.4%
    16.1
    14.4%
    Headache: Moderate
    5.4
    0.4%
    5.9
    0.4%
    10.9
    3.3%
    13.5
    12.2%
    14.6
    4.4%
    17.0
    15.2%
    Headache: Severe
    0.7
    0%
    0.3
    0%
    0.9
    0.3%
    0.9
    0.8%
    2.7
    0.8%
    0.9
    0.8%
    Muscle pain: Any
    39.1
    2.6%
    37.3
    2.5%
    49.8
    14.9%
    49.5
    44.6%
    66.6
    19.9%
    74.1
    66.2%
    Muscle pain: Mild
    28.9
    1.9%
    26.8
    1.8%
    33.8
    10.1%
    31.5
    28.4%
    36.4
    10.9%
    42.0
    37.5%
    Muscle pain: Moderate
    9.8
    0.7%
    10.0
    0.7%
    15.4
    4.6%
    17.1
    15.4%
    29.0
    8.7%
    31.3
    27.9%
    Muscle pain: Severe
    0.4
    0%
    0.5
    0%
    0.6
    0.2%
    0.9
    0.8%
    1.2
    0.4%
    0.9
    0.8%
    Joint pain: Any
    12.6
    0.8%
    13.7
    0.9%
    15.4
    4.6%
    20.7
    18.6%
    13.4
    4%
    17.9
    16%
    Joint pain: Mild
    6.9
    0.5%
    7.1
    0.5%
    10.6
    3.2%
    12.6
    11.4%
    6.3
    1.9%
    8.9
    7.9%
    Joint pain: Moderate
    5.4
    0.4%
    6.3
    0.4%
    4.8
    1.4%
    7.2
    6.5%
    7.2
    2.1%
    8.0
    7.1%
    Joint pain: Severe
    0.3
    0%
    0.2
    0%
    0
    0%
    0.9
    0.8%
    0
    0%
    0.9
    0.8%
    3. Primary Outcome
    Title Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination in All Cohorts
    Description An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
    Time Frame Within 1 month after 20vPnC or 13vPnC

    Outcome Measure Data

    Analysis Population Description
    Safety population included all participants who received 1 dose of any of the following: 20vPnC, 13vPnC, PPSV23 or saline and had safety follow-up after any vaccination.
    Arm/Group Title Cohort 1: 20vPnC/Saline Cohort 1: 13vPnC/PPSV23 Cohort 2: 20vPnC Cohort 2: 13vPnC Cohort 3: 20vPnC Cohort 3: 13vPnC
    Arm/Group Description Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1). Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1). Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1). Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
    Measure Participants 1507 1490 334 111 335 112
    Number (95% Confidence Interval) [percentage of participants]
    9.8
    0.7%
    11.1
    0.7%
    10.2
    3.1%
    8.1
    7.3%
    15.2
    4.5%
    11.6
    10.4%
    4. Primary Outcome
    Title Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination in All Cohorts
    Description An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event.
    Time Frame Within 6 months after 20vPnC or 13vPnC

    Outcome Measure Data

    Analysis Population Description
    Safety population included all participants who received 1 dose of any of the following: 20vPnC, 13vPnC, PPSV23 or saline and had safety follow-up after any vaccination.
    Arm/Group Title Cohort 1: 20vPnC/Saline Cohort 1: 13vPnC/PPSV23 Cohort 2: 20vPnC Cohort 2: 13vPnC Cohort 3: 20vPnC Cohort 3: 13vPnC
    Arm/Group Description Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1). Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1). Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1). Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
    Measure Participants 1507 1490 334 111 335 112
    Number (95% Confidence Interval) [percentage of participants]
    2.4
    0.2%
    1.9
    0.1%
    0.3
    0.1%
    0.9
    0.8%
    0.6
    0.2%
    0.9
    0.8%
    5. Primary Outcome
    Title Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination in All Cohorts
    Description An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects.
    Time Frame Within 6 months after 20vPnC or 13vPnC

    Outcome Measure Data

    Analysis Population Description
    Safety population included all participants who received 1 dose of any of the following: 20vPnC, 13vPnC, PPSV23 or saline and had safety follow-up after any vaccination.
    Arm/Group Title Cohort 1: 20vPnC/Saline Cohort 1: 13vPnC/PPSV23 Cohort 2: 20vPnC Cohort 2: 13vPnC Cohort 3: 20vPnC Cohort 3: 13vPnC
    Arm/Group Description Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1). Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1). Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1). Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
    Measure Participants 1507 1490 334 111 335 112
    Number (95% Confidence Interval) [percentage of participants]
    2.3
    0.2%
    2.3
    0.2%
    1.5
    0.4%
    0.9
    0.8%
    1.5
    0.4%
    1.8
    1.6%
    6. Primary Outcome
    Title Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
    Description OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.
    Time Frame 1 month after Vaccination 1

    Outcome Measure Data

    Analysis Population Description
    Evaluable 13-matched immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received Vaccination 1 as randomized, had at least 1 valid OPA titer for any of the 13 matched serotypes from the blood collection 27 to 49 days after Vaccination 1, had no other major protocol deviations. Number analyzed=participants evaluable for this outcome measure at specified rows.
    Arm/Group Title Cohort 1: 20vPnC/Saline Cohort 1: 13vPnC/PPSV23
    Arm/Group Description Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1). Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
    Measure Participants 1435 1420
    Serotype 1
    123.4
    153.8
    Serotype 3
    40.7
    47.8
    Serotype 4
    508.7
    626.9
    Serotype 5
    91.6
    109.7
    Serotype 6A
    889.0
    1165.1
    Serotype 6B
    1115.2
    1341.3
    Serotype 7F
    968.8
    1129.2
    Serotype 9V
    1455.5
    1567.8
    Serotype 14
    746.7
    746.7
    Serotype 18C
    1252.6
    1482.3
    Serotype 19A
    517.9
    645.3
    Serotype 19F
    265.8
    333.3
    Serotype 23F
    276.5
    335.1
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 1: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the geometric mean ratio (GMR) for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 0.80
    Confidence Interval (2-Sided) 95%
    0.71 to 0.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 3: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 0.85
    Confidence Interval (2-Sided) 95%
    0.78 to 0.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 4: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 0.81
    Confidence Interval (2-Sided) 95%
    0.71 to 0.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 5: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 0.83
    Confidence Interval (2-Sided) 95%
    0.74 to 0.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 6A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 0.76
    Confidence Interval (2-Sided) 95%
    0.66 to 0.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 6B: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 0.83
    Confidence Interval (2-Sided) 95%
    0.73 to 0.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 7F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 0.86
    Confidence Interval (2-Sided) 95%
    0.77 to 0.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 9V: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 0.93
    Confidence Interval (2-Sided) 95%
    0.82 to 1.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 14: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.00
    Confidence Interval (2-Sided) 95%
    0.89 to 1.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 18C: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 0.85
    Confidence Interval (2-Sided) 95%
    0.74 to 0.97
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 19A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 0.80
    Confidence Interval (2-Sided) 95%
    0.71 to 0.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 19F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 0.80
    Confidence Interval (2-Sided) 95%
    0.70 to 0.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 23F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 0.83
    Confidence Interval (2-Sided) 95%
    0.70 to 0.97
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Primary Outcome
    Title Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP)
    Description OPA GMTs were determined for serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.
    Time Frame 1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline"; 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23"

    Outcome Measure Data

    Analysis Population Description
    Evaluable 7-additional immunogenicity population: participants who were enrolled in the appropriate cohort based on age, received 20vPnC if randomized to 20vPnC/saline group or received both vaccinations if randomized to 13vPnC/PPSV23 group, had at least 1 valid OPA titers for any of the 7 additional serotypes from the blood collection 27 to 49 days after Vaccination 1 or Vaccination 2 respectively, had no other major protocol deviations. Number analyzed=participants evaluable at specified rows.
    Arm/Group Title Cohort 1: 20vPnC/Saline Cohort 1: 13vPnC/PPSV23
    Arm/Group Description Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1). Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
    Measure Participants 1433 1383
    Serotype 8
    465.6
    848.1
    Serotype 10A
    2007.6
    1079.9
    Serotype 11A
    4426.8
    2534.9
    Serotype 12F
    2538.7
    1716.6
    Serotype 15B
    2398.2
    768.5
    Serotype 22F
    3666.2
    1846.2
    Serotype 33F
    5125.9
    3720.6
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 8: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 0.55
    Confidence Interval (2-Sided) 95%
    0.49 to 0.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 10A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.86
    Confidence Interval (2-Sided) 95%
    1.63 to 2.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 11A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.75
    Confidence Interval (2-Sided) 95%
    1.52 to 2.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 12F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.48
    Confidence Interval (2-Sided) 95%
    1.27 to 1.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 15B: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 3.12
    Confidence Interval (2-Sided) 95%
    2.62 to 3.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 22F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.99
    Confidence Interval (2-Sided) 95%
    1.70 to 2.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 33F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.38
    Confidence Interval (2-Sided) 95%
    1.21 to 1.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    8. Secondary Outcome
    Title Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
    Description OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.
    Time Frame 1 month after vaccination

    Outcome Measure Data

    Analysis Population Description
    Evaluable-20 immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received the vaccination as randomized, had at least 1 valid OPA titer from the blood collection 27 to 49 days after 20vPnC, had no other major protocol deviations. Number analyzed=participants evaluable at specified rows.
    Arm/Group Title Cohort 2: 20vPnC Cohort 1: 20vPnC/Saline (60-64 Years of Age)
    Arm/Group Description Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). Participants were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
    Measure Participants 321 946
    Serotype 1
    135.9
    131.8
    Serotype 3
    43.3
    40.9
    Serotype 4
    633.3
    577.9
    Serotype 5
    84.6
    96.5
    Serotype 6A
    1203.9
    997.1
    Serotype 6B
    1502.7
    1199.0
    Serotype 7F
    1047.0
    1173.0
    Serotype 9V
    1725.7
    1687.9
    Serotype 14
    926.2
    742.3
    Serotype 18C
    1805.0
    1355.2
    Serotype 19A
    618.4
    600.3
    Serotype 19F
    286.7
    290.4
    Serotype 23F
    549.1
    327.5
    Serotype 8
    486.9
    502.3
    Serotype 10A
    2520.4
    2437.0
    Serotype 11A
    6416.9
    5248.9
    Serotype 12F
    3445.1
    3105.2
    Serotype 15B
    3355.9
    2873.7
    Serotype 22F
    3808.1
    4228.4
    Serotype 33F
    5571.3
    5445.2
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 1: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.03
    Confidence Interval (2-Sided) 95%
    0.84 to 1.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 3: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.06
    Confidence Interval (2-Sided) 95%
    0.92 to 1.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 4: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.10
    Confidence Interval (2-Sided) 95%
    0.87 to 1.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 5: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 0.88
    Confidence Interval (2-Sided) 95%
    0.72 to 1.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 6A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.21
    Confidence Interval (2-Sided) 95%
    0.95 to 1.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 6B: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.25
    Confidence Interval (2-Sided) 95%
    1.00 to 1.56
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 7F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 0.89
    Confidence Interval (2-Sided) 95%
    0.74 to 1.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 9V: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.02
    Confidence Interval (2-Sided) 95%
    0.83 to 1.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 14: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.25
    Confidence Interval (2-Sided) 95%
    1.01 to 1.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 18C: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.33
    Confidence Interval (2-Sided) 95%
    1.06 to 1.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 19A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.03
    Confidence Interval (2-Sided) 95%
    0.85 to 1.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 19F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 0.99
    Confidence Interval (2-Sided) 95%
    0.80 to 1.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 23F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.68
    Confidence Interval (2-Sided) 95%
    1.27 to 2.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 8: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 0.97
    Confidence Interval (2-Sided) 95%
    0.78 to 1.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 10A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.03
    Confidence Interval (2-Sided) 95%
    0.84 to 1.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 11A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.22
    Confidence Interval (2-Sided) 95%
    0.96 to 1.56
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 12F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.11
    Confidence Interval (2-Sided) 95%
    0.88 to 1.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 15B: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.17
    Confidence Interval (2-Sided) 95%
    0.88 to 1.56
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 22F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 0.90
    Confidence Interval (2-Sided) 95%
    0.69 to 1.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 33F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.02
    Confidence Interval (2-Sided) 95%
    0.81 to 1.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Secondary Outcome
    Title Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
    Description OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.
    Time Frame 1 month after vaccination

    Outcome Measure Data

    Analysis Population Description
    Evaluable-20 immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received the vaccination as randomized, had at least 1 valid OPA titer from the blood collection 27 to 49 days after 20vPnC, had no other major protocol deviations. Number analyzed=participants evaluable at specified rows.
    Arm/Group Title Cohort 3: 20vPnC Cohort 1: 20vPnC/Saline (60-64 Years of Age)
    Arm/Group Description Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). Participants were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
    Measure Participants 317 946
    Serotype 1
    162.6
    132.0
    Serotype 3
    42.1
    42.0
    Serotype 4
    1966.7
    594.5
    Serotype 5
    107.9
    96.9
    Serotype 6A
    3930.5
    1022.8
    Serotype 6B
    4260.0
    1250.4
    Serotype 7F
    1872.8
    1187.2
    Serotype 9V
    6041.4
    1726.7
    Serotype 14
    1848.4
    772.8
    Serotype 18C
    4460.5
    1395.3
    Serotype 19A
    1415.0
    611.3
    Serotype 19F
    654.8
    301.2
    Serotype 23F
    1559.2
    324.5
    Serotype 8
    867.0
    508.1
    Serotype 10A
    4157.3
    2569.7
    Serotype 11A
    7169.3
    5419.7
    Serotype 12F
    5875.4
    3074.5
    Serotype 15B
    4601.0
    3019.0
    Serotype 22F
    7568.2
    4482.5
    Serotype 33F
    7976.9
    5693.2
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 1: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.23
    Confidence Interval (2-Sided) 95%
    1.01 to 1.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 3: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.00
    Confidence Interval (2-Sided) 95%
    0.87 to 1.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 4: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 3.31
    Confidence Interval (2-Sided) 95%
    2.65 to 4.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 5: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.11
    Confidence Interval (2-Sided) 95%
    0.91 to 1.36
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 6A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 3.84
    Confidence Interval (2-Sided) 95%
    3.06 to 4.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 6B: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 3.41
    Confidence Interval (2-Sided) 95%
    2.73 to 4.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 7F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.58
    Confidence Interval (2-Sided) 95%
    1.30 to 1.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 9V: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 3.50
    Confidence Interval (2-Sided) 95%
    2.83 to 4.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 14: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 2.39
    Confidence Interval (2-Sided) 95%
    1.93 to 2.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 18C: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 3.20
    Confidence Interval (2-Sided) 95%
    2.53 to 4.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 19A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 2.31
    Confidence Interval (2-Sided) 95%
    1.91 to 2.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 19F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 2.17
    Confidence Interval (2-Sided) 95%
    1.76 to 2.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 23F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 4.80
    Confidence Interval (2-Sided) 95%
    3.65 to 6.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 8: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.71
    Confidence Interval (2-Sided) 95%
    1.38 to 2.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 10A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.62
    Confidence Interval (2-Sided) 95%
    1.31 to 2.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 11A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.32
    Confidence Interval (2-Sided) 95%
    1.04 to 1.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 12F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.91
    Confidence Interval (2-Sided) 95%
    1.51 to 2.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 15B: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.52
    Confidence Interval (2-Sided) 95%
    1.13 to 2.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 22F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.69
    Confidence Interval (2-Sided) 95%
    1.30 to 2.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Cohort 1: 20vPnC/Saline, Cohort 1: 13vPnC/PPSV23
    Comments Serotype 33F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of GMTs
    Estimated Value 1.40
    Confidence Interval (2-Sided) 95%
    1.10 to 1.79
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    Title Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
    Description OPA GMFR is the ratio of OPA GMT, 1 month after vaccination to before vaccination OPA GMT. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
    Time Frame Before Vaccination 1 to 1 month after Vaccination 1

    Outcome Measure Data

    Analysis Population Description
    Evaluable 13-matched immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received Vaccination 1 as randomized, had at least 1 valid OPA titer for any of the 13 matched serotypes from the blood collection 27 to 49 days after Vaccination 1, had no other major protocol deviations. Number analyzed=participants evaluable with OPA titers available at both timepoints at the specified row.
    Arm/Group Title Cohort 1: 20vPnC/Saline Cohort 1: 13vPnC/PPSV23
    Arm/Group Description Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1). Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
    Measure Participants 1435 1420
    Serotype 1
    12.6
    15.4
    Serotype 3
    4.8
    5.8
    Serotype 4
    31.2
    39.3
    Serotype 5
    6.1
    7.2
    Serotype 6A
    34.3
    42.6
    Serotype 6B
    23.8
    26.5
    Serotype 7F
    12.2
    13.5
    Serotype 9V
    11.0
    12.5
    Serotype 14
    9.3
    8.3
    Serotype 18C
    33.8
    37.7
    Serotype 19A
    21.0
    25.9
    Serotype 19F
    8.6
    10.8
    Serotype 23F
    24.9
    30.7
    11. Secondary Outcome
    Title Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population
    Description OPA GMFR is the ratio of OPA GMT, 1 month after vaccination to before vaccination OPA GMT. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F.
    Time Frame From before Vaccination 1 to 1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline" or From before Vaccination 1 to 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23"

    Outcome Measure Data

    Analysis Population Description
    E7-AIP included participants who were enrolled in appropriate cohort based on age, received 20vPnC if randomized to 20vPnC/saline group or received both vaccinations if randomized to 13vPnC/PPSV23 group, had at least 1 valid OPA titers for any of 7 additional serotypes from blood collection 27 to 49 days after Vaccination 1 or Vaccination 2 respectively, had no other major protocol deviations. Number analyzed=participants evaluable with OPA titers available at both timepoints at specified row.
    Arm/Group Title Cohort 1: 20vPnC/Saline Cohort 1: 13vPnC/PPSV23
    Arm/Group Description Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1). Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
    Measure Participants 1433 1383
    Serotype 8
    22.1
    40.4
    Serotype 10A
    18.5
    10.1
    Serotype 11A
    9.3
    6.0
    Serotype 12F
    72.4
    47.3
    Serotype 15B
    55.4
    18.2
    Serotype 22F
    78.5
    37.9
    Serotype 33F
    7.5
    5.7
    12. Secondary Outcome
    Title Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
    Description OPA GMFR is the ratio of OPA GMT, 1 month after vaccination to before vaccination OPA GMT. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
    Time Frame Before vaccination to 1 month after vaccination

    Outcome Measure Data

    Analysis Population Description
    Evaluable-20 immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received the vaccination as randomized, had at least 1 valid OPA titer from the blood collection 27 to 49 days after 20vPnC, had no other major protocol deviations. Number analyzed=participants evaluable with OPA titers available at both timepoints at the specified row.
    Arm/Group Title Cohort 2: 20vPnC Cohort 3: 20vPnC
    Arm/Group Description Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
    Measure Participants 321 317
    Serotype 1
    14.4
    18.6
    Serotype 3
    5.1
    4.8
    Serotype 4
    43.4
    131.8
    Serotype 5
    5.9
    7.9
    Serotype 6A
    50.3
    146.5
    Serotype 6B
    31.7
    70.3
    Serotype 7F
    12.8
    19.7
    Serotype 9V
    12.1
    35.1
    Serotype 14
    10.4
    14.6
    Serotype 18C
    48.3
    111.8
    Serotype 19A
    23.6
    39.1
    Serotype 19F
    9.2
    17.8
    Serotype 23F
    47.8
    118.2
    Serotype 8
    23.9
    34.6
    Serotype 10A
    17.9
    22.7
    Serotype 11A
    10.4
    5.2
    Serotype 12F
    107.3
    171.1
    Serotype 15B
    72.1
    65.0
    Serotype 22F
    63.5
    69.3
    Serotype 33F
    9.1
    7.5
    13. Secondary Outcome
    Title Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
    Description Percentage of participants with a >=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
    Time Frame Before Vaccination 1 to 1 month after Vaccination 1

    Outcome Measure Data

    Analysis Population Description
    Evaluable 13-matched immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received Vaccination 1 as randomized, had at least 1 valid OPA titer for any of the 13 matched serotypes from the blood collection 27 to 49 days after Vaccination 1, had no other major protocol deviations. Number analyzed=participants evaluable for this outcome measure at specified rows.
    Arm/Group Title Cohort 1: 20vPnC/Saline Cohort 1: 13vPnC/PPSV23
    Arm/Group Description Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1). Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
    Measure Participants 1435 1420
    Serotype 1
    72.1
    4.8%
    74.8
    5%
    Serotype 3
    56.1
    3.7%
    61.7
    4.1%
    Serotype 4
    75.5
    5%
    79.6
    5.3%
    Serotype 5
    55.6
    3.7%
    60.6
    4.1%
    Serotype 6A
    80.5
    5.3%
    84.0
    5.6%
    Serotype 6B
    75.7
    5%
    77.6
    5.2%
    Serotype 7F
    71.8
    4.8%
    72.3
    4.9%
    Serotype 9V
    67.7
    4.5%
    69.3
    4.7%
    Serotype 14
    58.2
    3.9%
    54.0
    3.6%
    Serotype 18C
    77.7
    5.2%
    79.6
    5.3%
    Serotype 19A
    73.6
    4.9%
    77.5
    5.2%
    Serotype 19F
    63.6
    4.2%
    66.9
    4.5%
    Serotype 23F
    70.6
    4.7%
    74.4
    5%
    14. Secondary Outcome
    Title Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP
    Description Percentage of participants with a >=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F.
    Time Frame Before Vaccination 1 to 1 month after Vaccination 1 for "Cohort 1: 20vPnC/Saline"; Before Vaccination 1 to 1 month after Vaccination 2 for "Cohort 1: 13vPnC/PPSV23"

    Outcome Measure Data

    Analysis Population Description
    E7-AIP included participants who were enrolled in appropriate cohort based on age, received 20vPnC if randomized to 20vPnC/saline group or received both vaccinations if randomized to 13vPnC/PPSV23 group, had at least 1 valid OPA titers for any of 7 additional serotypes from blood collection 27 to 49 days after Vaccination 1 or Vaccination 2 respectively, had no other major protocol deviations. Number analyzed= participants evaluable at specified rows.
    Arm/Group Title Cohort 1: 20vPnC/Saline Cohort 1: 13vPnC/PPSV23
    Arm/Group Description Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1). Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
    Measure Participants 1433 1383
    Serotype 8
    77.8
    5.2%
    86.8
    5.8%
    Serotype 10A
    75.5
    5%
    65.6
    4.4%
    Serotype 11A
    59.2
    3.9%
    51.9
    3.5%
    Serotype 12F
    87.4
    5.8%
    80.6
    5.4%
    Serotype 15B
    77.8
    5.2%
    63.8
    4.3%
    Serotype 22F
    82.7
    5.5%
    76.8
    5.2%
    Serotype 33F
    60.1
    4%
    55.5
    3.7%
    15. Secondary Outcome
    Title Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
    Description Percentage of participants with a >=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
    Time Frame Before vaccination to 1 month after vaccination

    Outcome Measure Data

    Analysis Population Description
    Evaluable-20 immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received the vaccination as randomized, had at least 1 valid OPA titer from the blood collection 27 to 49 days after 20vPnC, had no other major protocol deviations. Number analyzed =participants evaluable at specified rows.
    Arm/Group Title Cohort 2: 20vPnC Cohort 3: 20vPnC
    Arm/Group Description Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
    Measure Participants 321 317
    Serotype 1
    74.9
    5%
    86.0
    5.8%
    Serotype 3
    59.0
    3.9%
    56.7
    3.8%
    Serotype 4
    84.2
    5.6%
    91.4
    6.1%
    Serotype 5
    54.8
    3.6%
    64.8
    4.3%
    Serotype 6A
    85.9
    5.7%
    96.7
    6.5%
    Serotype 6B
    78.9
    5.2%
    89.2
    6%
    Serotype 7F
    73.0
    4.8%
    76.1
    5.1%
    Serotype 9V
    73.6
    4.9%
    84.0
    5.6%
    Serotype 14
    62.3
    4.1%
    62.2
    4.2%
    Serotype 18C
    82.5
    5.5%
    87.3
    5.9%
    Serotype 19A
    80.0
    5.3%
    82.6
    5.5%
    Serotype 19F
    64.2
    4.3%
    78.4
    5.3%
    Serotype 23F
    81.2
    5.4%
    87.7
    5.9%
    Serotype 8
    79.4
    5.3%
    83.0
    5.6%
    Serotype 10A
    78.8
    5.2%
    78.8
    5.3%
    Serotype 11A
    61.0
    4%
    47.3
    3.2%
    Serotype 12F
    93.2
    6.2%
    93.7
    6.3%
    Serotype 15B
    82.5
    5.5%
    73.4
    4.9%
    Serotype 22 F
    80.5
    5.3%
    83.8
    5.6%
    Serotype 33F
    63.9
    4.2%
    60.6
    4.1%
    16. Secondary Outcome
    Title Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
    Description The percentage of participants with OPA titers >=LLOQ along with corresponding 2-sided 95% CIs were calculated 1 month after vaccination for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
    Time Frame 1 month after Vaccination 1

    Outcome Measure Data

    Analysis Population Description
    Evaluable 13-matched immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received Vaccination 1 as randomized, had at least 1 valid OPA titer for any of the 13 matched serotypes from the blood collection 27 to 49 days after Vaccination 1, had no other major protocol deviations. Number analyzed =participants evaluable for this outcome measure at specified rows.
    Arm/Group Title Cohort 1: 20vPnC/Saline Cohort 1: 13vPnC/PPSV23
    Arm/Group Description Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1). Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
    Measure Participants 1435 1420
    Serotype 1
    85.0
    5.6%
    87.9
    5.9%
    Serotype 3
    84.2
    5.6%
    87.0
    5.8%
    Serotype 4
    91.1
    6%
    92.1
    6.2%
    Serotype 5
    71.9
    4.8%
    76.0
    5.1%
    Serotype 6A
    88.9
    5.9%
    90.9
    6.1%
    Serotype 6B
    90.5
    6%
    91.6
    6.1%
    Serotype 7F
    89.1
    5.9%
    91.3
    6.1%
    Serotype 9V
    89.1
    5.9%
    90.3
    6.1%
    Serotype 14
    91.6
    6.1%
    93.5
    6.3%
    Serotype 18C
    93.8
    6.2%
    94.7
    6.4%
    Serotype 19A
    96.3
    6.4%
    96.6
    6.5%
    Serotype 19F
    80.3
    5.3%
    81.5
    5.5%
    Serotype 23F
    82.1
    5.4%
    83.7
    5.6%
    17. Secondary Outcome
    Title Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population
    Description The percentage of participants with OPA titers >=LLOQ along with corresponding 2-sided 95% CIs were calculated 1 month after vaccination for pneumococcal serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F.
    Time Frame 1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline" or 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23"

    Outcome Measure Data

    Analysis Population Description
    E7-AIP included participants who were enrolled in appropriate cohort based on age, received 20vPnC if randomized to 20vPnC/saline group or received both vaccinations if randomized to 13vPnC/PPSV23 group, had at least 1 valid OPA titers for any of 7 additional serotypes from blood collection 27 to 49 days after Vaccination 1 or Vaccination 2 respectively, had no other major protocol deviations. Number analyzed= participants evaluable at specified rows.
    Arm/Group Title Cohort 1: 20vPnC/Saline Cohort 1: 13vPnC/PPSV23
    Arm/Group Description Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1). Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
    Measure Participants 1433 1383
    Serotype 8
    92.9
    6.2%
    96.6
    6.5%
    Serotype 10A
    95.6
    6.3%
    88.9
    6%
    Serotype 11A
    97.7
    6.5%
    95.4
    6.4%
    Serotype 12F
    95.7
    6.4%
    89.3
    6%
    Serotype 15B
    94.1
    6.2%
    83.3
    5.6%
    Serotype 22F
    98.6
    6.5%
    94.5
    6.3%
    Serotype 33F
    96.4
    6.4%
    92.8
    6.2%
    18. Secondary Outcome
    Title Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
    Description The percentage of participants with OPA titers >=LLOQ along with corresponding 2-sided 95% CIs were calculated 1 month after vaccination for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure were planned to be analyzed for the 20vPnC groups of Cohorts 2 and 3 only.
    Time Frame 1 month after vaccination

    Outcome Measure Data

    Analysis Population Description
    Evaluable-20 immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received the vaccination as randomized, had at least 1 valid OPA titer from the blood collection 27 to 49 days after 20vPnC, had no other major protocol deviations. Number analyzed =participants evaluable at specified rows.
    Arm/Group Title Cohort 2: 20vPnC Cohort 3: 20vPnC
    Arm/Group Description Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
    Measure Participants 321 317
    Serotype 1
    87.2
    5.8%
    92.1
    6.2%
    Serotype 3
    87.4
    5.8%
    89.9
    6%
    Serotype 4
    94.0
    6.2%
    98.1
    6.6%
    Serotype 5
    72.8
    4.8%
    81.1
    5.4%
    Serotype 6A
    91.8
    6.1%
    99.7
    6.7%
    Serotype 6B
    95.3
    6.3%
    99.0
    6.6%
    Serotype 7F
    92.7
    6.2%
    93.9
    6.3%
    Serotype 9V
    92.6
    6.1%
    99.0
    6.6%
    Serotype 14
    94.9
    6.3%
    99.1
    6.7%
    Serotype 18C
    97.5
    6.5%
    98.1
    6.6%
    Serotype 19A
    98.7
    6.5%
    99.7
    6.7%
    Serotype 19F
    81.9
    5.4%
    95.2
    6.4%
    Serotype 23F
    89.3
    5.9%
    96.5
    6.5%
    Serotype 8
    92.4
    6.1%
    95.8
    6.4%
    Serotype 10A
    98.3
    6.5%
    100.0
    6.7%
    Serotype 11A
    97.0
    6.4%
    99.6
    6.7%
    Serotype 12F
    97.9
    6.5%
    98.5
    6.6%
    Serotype 15B
    95.8
    6.4%
    96.8
    6.5%
    Serotype 22F
    98.2
    6.5%
    99.6
    6.7%
    Serotype 33F
    95.9
    6.4%
    99.6
    6.7%

    Adverse Events

    Time Frame Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
    Adverse Event Reporting Description Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was used for the analysis.
    Arm/Group Title Cohort 1: 20vPnC/Saline Cohort 1: 13vPnC/PPSV23 Cohort 2: 20vPnC Cohort 2: 13vPnC Cohort 3: 20vPnC Cohort 3: 13vPnC
    Arm/Group Description Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after vaccination 1). Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1). Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1). Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1). Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
    All Cause Mortality
    Cohort 1: 20vPnC/Saline Cohort 1: 13vPnC/PPSV23 Cohort 2: 20vPnC Cohort 2: 13vPnC Cohort 3: 20vPnC Cohort 3: 13vPnC
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Serious Adverse Events
    Cohort 1: 20vPnC/Saline Cohort 1: 13vPnC/PPSV23 Cohort 2: 20vPnC Cohort 2: 13vPnC Cohort 3: 20vPnC Cohort 3: 13vPnC
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 36/1507 (2.4%) 29/1490 (1.9%) 1/334 (0.3%) 1/111 (0.9%) 2/335 (0.6%) 1/112 (0.9%)
    Blood and lymphatic system disorders
    Blood loss anaemia 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Cardiac disorders
    Acute myocardial infarction 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 1/335 (0.3%) 0/112 (0%)
    Atrial fibrillation 1/1507 (0.1%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Cardiac failure congestive 0/1507 (0%) 2/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Coronary artery disease 3/1507 (0.2%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Myocardial infarction 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Silent myocardial infarction 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Gastrointestinal disorders
    Colitis 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Gastrointestinal haemorrhage 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Upper gastrointestinal haemorrhage 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    General disorders
    Chest pain 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Hernia 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Non-cardiac chest pain 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Systemic inflammatory response syndrome 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Hepatobiliary disorders
    Biloma 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Infections and infestations
    Appendicitis 2/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Arthritis infective 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Cellulitis 2/1507 (0.1%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Clostridium difficile colitis 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Erysipelas 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Diverticulitis 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Kidney infection 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Skin bacterial infection 0/1507 (0%) 0/1490 (0%) 0/334 (0%) 1/111 (0.9%) 0/335 (0%) 0/112 (0%)
    Herpes simplex meningitis 0/1507 (0%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 1/112 (0.9%)
    Injury, poisoning and procedural complications
    Femur fracture 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Gun shot wound 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Head injury 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Heat exhaustion 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Humerus fracture 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Meniscus injury 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Muscle rupture 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Post procedural haematuria 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Stress fracture 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Investigations
    Blood pressure increased 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Metabolism and nutrition disorders
    Dehydration 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Hyperglycaemia 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Hyponatraemia 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Type 2 diabetes mellitus 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Neck mass 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Osteoarthritis 2/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Rhabdomyolysis 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Glioblastoma multiforme 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Malignant melanoma 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Metastases to peritoneum 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Pancreatic carcinoma 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Prostate cancer 2/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Transitional cell carcinoma 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Nervous system disorders
    Cerebrovascular accident 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Hepatic encephalopathy 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Ischaemic stroke 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Syncope 1/1507 (0.1%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Transient ischaemic attack 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Product Issues
    Device malfunction 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Psychiatric disorders
    Completed suicide 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Renal and urinary disorders
    Acute kidney injury 2/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    End stage renal disease 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Haematuria 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Renal failure 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Nephrolithiasis 0/1507 (0%) 0/1490 (0%) 1/334 (0.3%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Ureteric obstruction 0/1507 (0%) 0/1490 (0%) 1/334 (0.3%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Chronic obstructive pulmonary disease 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Dyspnoea 2/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Hypoxia 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Pulmonary embolism 1/1507 (0.1%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 1/335 (0.3%) 0/112 (0%)
    Pulmonary oedema 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Respiratory failure 0/1507 (0%) 1/1490 (0.1%) 0/334 (0%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Other (Not Including Serious) Adverse Events
    Cohort 1: 20vPnC/Saline Cohort 1: 13vPnC/PPSV23 Cohort 2: 20vPnC Cohort 2: 13vPnC Cohort 3: 20vPnC Cohort 3: 13vPnC
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1074/1507 (71.3%) 1063/1490 (71.3%) 281/334 (84.1%) 91/111 (82%) 302/335 (90.1%) 107/112 (95.5%)
    General disorders
    Fatigue (FATIGUE) 454/1507 (30.1%) 455/1490 (30.5%) 130/334 (38.9%) 40/111 (36%) 143/335 (42.7%) 49/112 (43.8%)
    Injection site erythema (REDNESS) 110/1507 (7.3%) 92/1490 (6.2%) 27/334 (8.1%) 6/111 (5.4%) 30/335 (9%) 11/112 (9.8%)
    Injection site pain (PAIN) 834/1507 (55.3%) 803/1490 (53.9%) 240/334 (71.9%) 77/111 (69.4%) 272/335 (81.2%) 92/112 (82.1%)
    Injection site swelling (SWELLING) 113/1507 (7.5%) 118/1490 (7.9%) 29/334 (8.7%) 12/111 (10.8%) 39/335 (11.6%) 14/112 (12.5%)
    Pyrexia (FEVER) 0/1507 (0%) 0/1490 (0%) 5/334 (1.5%) 1/111 (0.9%) 4/335 (1.2%) 2/112 (1.8%)
    Infections and infestations
    Upper respiratory tract infection 0/1507 (0%) 0/1490 (0%) 4/334 (1.2%) 3/111 (2.7%) 7/335 (2.1%) 1/112 (0.9%)
    Influenza 0/1507 (0%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 7/335 (2.1%) 1/112 (0.9%)
    Nasopharyngitis 0/1507 (0%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 6/335 (1.8%) 2/112 (1.8%)
    Urinary tract infection 0/1507 (0%) 0/1490 (0%) 0/334 (0%) 0/111 (0%) 1/335 (0.3%) 2/112 (1.8%)
    Injury, poisoning and procedural complications
    Fall 0/1507 (0%) 0/1490 (0%) 4/334 (1.2%) 0/111 (0%) 0/335 (0%) 0/112 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia (JOINT PAIN) 190/1507 (12.6%) 203/1490 (13.6%) 51/334 (15.3%) 23/111 (20.7%) 45/335 (13.4%) 20/112 (17.9%)
    Myalgia (MUSCLE PAIN) 588/1507 (39%) 553/1490 (37.1%) 165/334 (49.4%) 55/111 (49.5%) 223/335 (66.6%) 83/112 (74.1%)
    Nervous system disorders
    Headache (HEADACHE) 324/1507 (21.5%) 345/1490 (23.2%) 107/334 (32%) 40/111 (36%) 130/335 (38.8%) 38/112 (33.9%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

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

    Results Point of Contact

    Name/Title Pfizer ClinicalTrials.gov Call Center
    Organization Pfizer Inc.
    Phone 1-800-718-1021
    Email ClinicalTrials.gov_Inquiries@pfizer.com
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT03760146
    Other Study ID Numbers:
    • B7471007
    • 2018-004279-11
    First Posted:
    Nov 30, 2018
    Last Update Posted:
    Dec 2, 2021
    Last Verified:
    Nov 1, 2021