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Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT03828617
Collaborator
(none)
1,710
Enrollment
21
Locations
4
Arms
7.8
Actual Duration (Months)
81.4
Patients Per Site
10.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18 through 49 years of age with no history of pneumococcal vaccination will be randomized in a 2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or 13vPnC.

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

Study Design

Study Type:
Interventional
Actual Enrollment :
1710 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 3 LOTS OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS 18 THROUGH 49 YEARS OF AGE
Actual Study Start Date :
Feb 14, 2019
Actual Primary Completion Date :
Oct 9, 2019
Actual Study Completion Date :
Oct 9, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 20vPnC Lot 1

20vPnC Lot 1

Biological: 20vPnC
20vPnC
Experimental: 20vPnC Lot 2

20vPnC Lot 2

Biological: 20vPnC
20vPnC
Experimental: 20vPnC Lot 3

20vPnC Lot 3

Biological: 20vPnC
20vPnC
Active Comparator: 13vPnC

13vPnC

Biological: 13vPnC
Pneumococcal conjugate vaccine

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants With Local Reactions Within 10 Days After Vaccination [Within 10 days after vaccination]

    Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm) and severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.

  2. Percentage of Participants With Systemic Events Within 7 Days After Vaccination [Within 7 days after vaccination]

    Systemic events fever, fatigue, headache, muscle pain, joint pain were recorded by using an electronic diary. Fever was defined as greater than or equal to (>=) 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.

  3. Percentage of Participants With Any Adverse Events (AEs) Within 1 Month After Vaccination [Within 1 month after vaccination]

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

  4. Percentage of Participants With Any Serious Adverse Events (SAEs) Within 6 Months After Vaccination [Within 6 month after vaccination]

    An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.

  5. Percentage of Participants With Any Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination [Within 6 months after vaccination]

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

  6. Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination [1 month after vaccination]

    OPA titers were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA GMTs and 2-sided 95% CIs were calculated. Data for this outcome measure were planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.

Secondary Outcome Measures

  1. Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination [Before vaccination to 1 month after vaccination]

    Fold rises are the ratios of the 1 month after vaccination to before vaccination OPA titers. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.

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

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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 49 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Male or female adults ≥18 and <50 years of age.

  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. Female subject of childbearing potential or male subject who is able to father children, and willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the dose of investigational product; or female subject not of childbearing potential or male subject not able to father children.

Exclusion Criteria:

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

  2. 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.

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

  4. Pregnant female subjects or breastfeeding female subjects (known or suspected).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anaheim Clinical Trials, LLC Anaheim California United States 92801
2 Kaiser Permanente Sacramento Sacramento California United States 95815
3 Kaiser Permanente South Sacramento Sacramento California United States 95823
4 Kaiser Permanente San Jose San Jose California United States 95119
5 Kaiser Permanente Santa Clara Santa Clara California United States 95051
6 Accel Research Sites - Clinical Research Unit DeLand Florida United States 32720
7 Research Centers of America, LLC Hollywood Florida United States 33024
8 Clinical Research Atlanta Stockbridge Georgia United States 30281
9 East West Medical Research Institute Honolulu Hawaii United States 96814
10 Heartland Research Associates, LLC Wichita Kansas United States 67207
11 Kentucky Pediatric/Adult Research Bardstown Kentucky United States 40004
12 Meridian Clinical Research, LLC Norfolk Nebraska United States 68701
13 Meridian Clinical Research, LLC Omaha Nebraska United States 68134
14 Rochester Clinical Research, Inc. Rochester New York United States 14609
15 M3 Wake Research, Inc. Raleigh North Carolina United States 27612
16 PMG Research of Wilmington, LLC Wilmington North Carolina United States 28401
17 Omega Medical Research Warwick Rhode Island United States 02886
18 Meridian Clinical Research, LLC Dakota Dunes South Dakota United States 57049
19 Benchmark Research Austin Texas United States 78705
20 J. Lewis Research, Inc. /Foothill Family Clinic Salt Lake City Utah United States 84109
21 J. Lewis Research, Inc. /Foothill Family Clinic South Salt Lake City Utah United States 84121

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:
NCT03828617
Other Study ID Numbers:
  • B7471008
First Posted:
Feb 4, 2019
Last Update Posted:
Nov 23, 2020
Last Verified:
Nov 1, 2020
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

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail A total of 1718 participants were enrolled, out of which only 1710 were randomized. There were 8 participants who were enrolled (signed informed consent document) but were not randomized into the study as the randomization system had reached the pre-specified capacity.
Arm/Group Title 20vPnC Lot 1 20vPnC Lot 2 20vPnC Lot 3 13vPnC
Arm/Group Description Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination. Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination. Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination. Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
Period Title: Overall Study
STARTED 489 490 486 245
Vaccinated 488 489 486 245
Safety Population 488 489 486 245
Evaluable Immunogenicity Population(EIP) 463 473 456 232
COMPLETED 465 475 460 235
NOT COMPLETED 24 15 26 10

Baseline Characteristics

Arm/Group Title 20vPnC Lot 1 20vPnC Lot 2 20vPnC Lot 3 13vPnC Total
Arm/Group Description Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination. Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination. Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination. Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination. Total of all reporting groups
Overall Participants 488 489 486 245 1708
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
35.6
(9.17)
35.7
(9.03)
34.9
(9.05)
35.0
(8.70)
35.3
(9.03)
Sex: Female, Male (Count of Participants)
Female
331
67.8%
316
64.6%
324
66.7%
144
58.8%
1115
65.3%
Male
157
32.2%
173
35.4%
162
33.3%
101
41.2%
593
34.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
48
9.8%
58
11.9%
56
11.5%
29
11.8%
191
11.2%
Not Hispanic or Latino
434
88.9%
427
87.3%
427
87.9%
215
87.8%
1503
88%
Unknown or Not Reported
6
1.2%
4
0.8%
3
0.6%
1
0.4%
14
0.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
5
1%
9
1.8%
5
1%
4
1.6%
23
1.3%
Asian
13
2.7%
17
3.5%
17
3.5%
12
4.9%
59
3.5%
Native Hawaiian or Other Pacific Islander
2
0.4%
1
0.2%
1
0.2%
2
0.8%
6
0.4%
Black or African American
87
17.8%
88
18%
97
20%
44
18%
316
18.5%
White
367
75.2%
351
71.8%
350
72%
173
70.6%
1241
72.7%
More than one race
6
1.2%
13
2.7%
13
2.7%
5
2%
37
2.2%
Unknown or Not Reported
8
1.6%
10
2%
3
0.6%
5
2%
26
1.5%

Outcome Measures

1. Primary Outcome
Title Percentage of Participants With Local Reactions Within 10 Days After Vaccination
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). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Time Frame Within 10 days after vaccination

Outcome Measure Data

Analysis Population Description
Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Arm/Group Title Pooled 20vPnC 13vPnC
Arm/Group Description Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination. Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
Measure Participants 1456 243
Redness: Any
7.0
1.4%
6.2
1.3%
Redness: Mild
3.9
0.8%
3.3
0.7%
Redness: Moderate
2.6
0.5%
2.9
0.6%
Redness: Severe
0.5
0.1%
0
0%
Swelling: Any
8.5
1.7%
8.6
1.8%
Swelling: Mild
5.4
1.1%
5.3
1.1%
Swelling: Moderate
2.9
0.6%
3.3
0.7%
Swelling: Severe
0.2
0%
0
0%
Pain at the injection site: Any
78.7
16.1%
75.7
15.5%
Pain at the injection site: Mild
50.0
10.2%
46.5
9.5%
Pain at the injection site: Moderate
27.5
5.6%
27.6
5.6%
Pain at the injection site: Severe
1.2
0.2%
1.6
0.3%
2. Primary Outcome
Title Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Description Systemic events fever, fatigue, headache, muscle pain, joint pain were recorded by using an electronic diary. Fever was defined as greater than or equal to (>=) 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Time Frame Within 7 days after vaccination

Outcome Measure Data

Analysis Population Description
Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Arm/Group Title Pooled 20vPnC 13vPnC
Arm/Group Description Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination. Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
Measure Participants 1456 243
Fever: >=38.0 degree C (Any)
1.2
0.2%
0.8
0.2%
Fever: >=38.0 degree C to 38.4 degree C
0.8
0.2%
0.4
0.1%
Fever: >38.4 degree C to 38.9 degree C
0.3
0.1%
0.4
0.1%
Fever: >38.9 degree C to 40.0 degree C
0.2
0%
0
0%
Fever: >40.0 degree C
0
0%
0
0%
Fatigue: Any
47.6
9.8%
43.6
8.9%
Fatigue: Mild
24.7
5.1%
24.3
5%
Fatigue: Moderate
21.2
4.3%
17.7
3.6%
Fatigue: Severe
1.7
0.3%
1.6
0.3%
Headache: Any
36.2
7.4%
37.9
7.8%
Headache: Mild
22.6
4.6%
27.2
5.6%
Headache: Moderate
12.0
2.5%
9.9
2%
Headache: Severe
1.6
0.3%
0.8
0.2%
Muscle pain: Any
62.1
12.7%
60.5
12.4%
Muscle pain: Mild
38.5
7.9%
38.7
7.9%
Muscle pain: Moderate
22.5
4.6%
19.8
4%
Muscle pain: Severe
1.1
0.2%
2.1
0.4%
Joint pain: Any
16.8
3.4%
14.0
2.9%
Joint pain: Mild
10.0
2%
7.8
1.6%
Joint pain: Moderate
6.5
1.3%
5.3
1.1%
Joint pain: Severe
0.4
0.1%
0.8
0.2%
3. Primary Outcome
Title Percentage of Participants With Any Adverse Events (AEs) Within 1 Month After Vaccination
Description An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Time Frame Within 1 month after vaccination

Outcome Measure Data

Analysis Population Description
Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination.
Arm/Group Title Pooled 20vPnC 13vPnC
Arm/Group Description Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination. Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
Measure Participants 1463 245
Number (95% Confidence Interval) [percentage of participants]
6.8
1.4%
5.3
1.1%
4. Primary Outcome
Title Percentage of Participants With Any Serious Adverse Events (SAEs) Within 6 Months After Vaccination
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. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Time Frame Within 6 month after vaccination

Outcome Measure Data

Analysis Population Description
Safety population includes all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination.
Arm/Group Title Pooled 20vPnC 13vPnC
Arm/Group Description Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination. Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
Measure Participants 1463 245
Number (95% Confidence Interval) [percentage of participants]
0.7
0.1%
0
0%
5. Primary Outcome
Title Percentage of Participants With Any Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
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. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Time Frame Within 6 months after vaccination

Outcome Measure Data

Analysis Population Description
Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination.
Arm/Group Title Pooled 20vPnC 13vPnC
Arm/Group Description Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination. Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
Measure Participants 1463 245
Number (95% Confidence Interval) [percentage of participants]
1.0
0.2%
2.0
0.4%
6. Primary Outcome
Title Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Description OPA titers were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA GMTs and 2-sided 95% CIs were calculated. Data for this outcome measure were planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.
Time Frame 1 month after vaccination

Outcome Measure Data

Analysis Population Description
EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, "Number analyzed" = participants evaluable for this outcome measure at specified rows.
Arm/Group Title 20vPnC Lot 1 20vPnC Lot 2 20vPnC Lot 3
Arm/Group Description Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination. Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination. Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.
Measure Participants 463 473 456
Serotype 1
199.5
175.1
164.6
Serotype 3
47.3
46.8
43.1
Serotype 4
1499.7
1568.2
1505.6
Serotype 5
125.8
135.6
116.8
Serotype 6A
4654.1
3748.3
3330.4
Serotype 6B
4403.3
4349.9
3907.3
Serotype 7F
1820.6
1865.6
1875.7
Serotype 9V
5120.4
4604.1
4921.7
Serotype 14
2240.2
2091.2
2001.9
Serotype 18C
3903.7
4450.7
4221.7
Serotype 19A
1457.8
1528.1
1434.4
Serotype 19F
524.5
529.2
549.0
Serotype 23F
1416.1
1547.5
1434.6
Serotype 8
1595.0
1345.9
1624.3
Serotype 10A
6328.1
5692.6
5962.2
Serotype 11A
8656.2
6728.5
8720.3
Serotype 12F
8563.0
7907.5
7412.4
Serotype 15B
7342.8
6356.9
7018.9
Serotype 22F
12507.5
11213.4
12728.6
Serotype 33F
10745.7
10328.2
10418.2
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 13vPnC
Comments Serotype 1: Geometric mean ratios (GMRs) (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% confidence intervals (CIs).
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio (GMR)
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.95 to 1.37
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 13vPnC
Comments Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio (GMR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.88 to 1.16
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 13vPnC
Comments Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.78 to 1.17
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 13vPnC
Comments Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.77 to 1.12
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 13vPnC
Comments Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.24
Confidence Interval (2-Sided) 95%
1.03 to 1.50
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 13vPnC
Comments Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.85 to 1.21
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 13vPnC
Comments Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.82 to 1.17
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 13vPnC
Comments Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.93 to 1.33
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 13vPnC
Comments Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.90 to 1.27
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 13vPnC
Comments Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.72 to 1.07
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 13vPnC
Comments Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.81 to 1.12
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 13vPnC
Comments Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.81 to 1.21
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 13vPnC
Comments Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.72 to 1.16
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 13vPnC
Comments Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
1.00 to 1.40
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 13vPnC
Comments Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.91 to 1.36
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 13vPnC
Comments Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.29
Confidence Interval (2-Sided) 95%
1.03 to 1.60
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 13vPnC
Comments Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.88 to 1.33
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 13vPnC
Comments Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
0.91 to 1.46
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 13vPnC
Comments Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.87 to 1.43
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 13vPnC
Comments Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.83 to 1.30
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 20vPnC Lot 3
Comments Serotype 1: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
1.01 to 1.46
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 20vPnC Lot 3
Comments Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.96 to 1.26
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 20vPnC Lot 3
Comments Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.82 to 1.22
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 20vPnC Lot 3
Comments Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.89 to 1.31
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 20vPnC Lot 3
Comments Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.40
Confidence Interval (2-Sided) 95%
1.16 to 1.69
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 20vPnC Lot 3
Comments Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.94 to 1.35
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 20vPnC Lot 3
Comments Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.81 to 1.16
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 20vPnC Lot 3
Comments Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.87 to 1.25
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 20vPnC Lot 3
Comments Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.94 to 1.33
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 20vPnC Lot 3
Comments Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.75 to 1.13
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 20vPnC Lot 3
Comments Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.86 to 1.20
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 20vPnC Lot 3
Comments Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.78 to 1.17
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 20vPnC Lot 3
Comments Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.78 to 1.25
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 20vPnC Lot 3
Comments Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.83 to 1.16
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 20vPnC Lot 3
Comments Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.87 to 1.30
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 20vPnC Lot 3
Comments Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.80 to 1.24
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 20vPnC Lot 3
Comments Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
0.94 to 1.42
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 20vPnC Lot 3
Comments Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.82 to 1.33
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 20vPnC Lot 3
Comments Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.77 to 1.26
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Pooled 20vPnC, 20vPnC Lot 3
Comments Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.82 to 1.29
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection 13vPnC, 20vPnC Lot 3
Comments Serotype 1: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.89 to 1.28
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection 13vPnC, 20vPnC Lot 3
Comments Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.95 to 1.24
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection 13vPnC, 20vPnC Lot 3
Comments Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.85 to 1.27
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection 13vPnC, 20vPnC Lot 3
Comments Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
0.96 to 1.41
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection 13vPnC, 20vPnC Lot 3
Comments Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.93 to 1.36
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection 13vPnC, 20vPnC Lot 3
Comments Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.93 to 1.33
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection 13vPnC, 20vPnC Lot 3
Comments Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.83 to 1.19
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection 13vPnC, 20vPnC Lot 3
Comments Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.78 to 1.12
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection 13vPnC, 20vPnC Lot 3
Comments Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.88 to 1.24
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection 13vPnC, 20vPnC Lot 3
Comments Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.86 to 1.29
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection 13vPnC, 20vPnC Lot 3
Comments Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.91 to 1.25
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection 13vPnC, 20vPnC Lot 3
Comments Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.79 to 1.17
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection 13vPnC, 20vPnC Lot 3
Comments Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.85 to 1.37
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 54
Statistical Analysis Overview Comparison Group Selection 13vPnC, 20vPnC Lot 3
Comments Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.70 to 0.98
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 55
Statistical Analysis Overview Comparison Group Selection 13vPnC, 20vPnC Lot 3
Comments Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.78 to 1.17
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 56
Statistical Analysis Overview Comparison Group Selection 13vPnC, 20vPnC Lot 3
Comments Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.62 to 0.96
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 57
Statistical Analysis Overview Comparison Group Selection 13vPnC, 20vPnC Lot 3
Comments Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.87 to 1.31
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 58
Statistical Analysis Overview Comparison Group Selection 13vPnC, 20vPnC Lot 3
Comments Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.71 to 1.15
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 59
Statistical Analysis Overview Comparison Group Selection 13vPnC, 20vPnC Lot 3
Comments Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.69 to 1.12
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 60
Statistical Analysis Overview Comparison Group Selection 13vPnC, 20vPnC Lot 3
Comments Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.
Type of Statistical Test Equivalence
Comments Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.79 to 1.24
Parameter Dispersion Type:
Value:
Estimation Comments
7. Secondary Outcome
Title Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Description Fold rises are the ratios of the 1 month after vaccination to before vaccination OPA titers. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.
Time Frame Before vaccination to 1 month after vaccination

Outcome Measure Data

Analysis Population Description
EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, "Number analyzed" = participants evaluable for this outcome measure at specified rows.
Arm/Group Title 20vPnC Lot 1 20vPnC Lot 2 20vPnC Lot 3
Arm/Group Description Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination. Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination. Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.
Measure Participants 463 473 456
Serotype 1
20.2
17.8
17.3
Serotype 3
5.0
5.0
4.6
Serotype 4
77.6
94.7
81.0
Serotype 5
8.7
9.4
8.0
Serotype 6A
157.2
119.6
128.4
Serotype 6B
72.5
75.4
70.5
Serotype 7F
18.3
19.5
19.0
Serotype 9V
25.4
23.3
21.6
Serotype 14
18.2
16.3
18.1
Serotype 18C
80.4
95.0
79.9
Serotype 19A
35.9
39.1
41.8
Serotype 19F
14.0
14.7
15.4
Serotype 23F
99.5
125.1
120.9
Serotype 8
38.3
38.8
46.1
Serotype 10A
20.8
19.0
20.2
Serotype 11A
6.9
5.0
5.3
Serotype 12F
175.5
174.6
175.7
Serotype 15B
112.5
84.2
91.7
Serotype 22F
83.8
63.3
77.8
Serotype 33F
8.3
8.6
7.4
8. Secondary Outcome
Title Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
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. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.
Time Frame Before vaccination to 1 month after vaccination

Outcome Measure Data

Analysis Population Description
EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, "Number analyzed" = participants evaluable for this outcome measure at specified rows.
Arm/Group Title 20vPnC Lot 1 20vPnC Lot 2 20vPnC Lot 3
Arm/Group Description Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination. Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination. Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.
Measure Participants 463 473 456
Serotype 1
83.7
17.2%
82.9
17%
82.4
17%
Serotype 3
56.1
11.5%
57.8
11.8%
53.0
10.9%
Serotype 4
85.0
17.4%
87.6
17.9%
86.2
17.7%
Serotype 5
65.7
13.5%
67.2
13.7%
65.3
13.4%
Serotype 6A
94.5
19.4%
93.1
19%
93.0
19.1%
Serotype 6B
90.3
18.5%
91.4
18.7%
89.2
18.4%
Serotype 7F
76.8
15.7%
76.7
15.7%
80.0
16.5%
Serotype 9V
79.1
16.2%
79.5
16.3%
75.7
15.6%
Serotype 14
70.0
14.3%
67.7
13.8%
67.7
13.9%
Serotype 18C
83.0
17%
88.2
18%
84.5
17.4%
Serotype 19A
81.7
16.7%
81.8
16.7%
85.5
17.6%
Serotype 19F
74.0
15.2%
76.2
15.6%
75.2
15.5%
Serotype 23F
85.6
17.5%
88.2
18%
88.8
18.3%
Serotype 8
82.0
16.8%
82.3
16.8%
82.5
17%
Serotype 10A
74.9
15.3%
74.5
15.2%
70.8
14.6%
Serotype 11A
52.4
10.7%
48.0
9.8%
42.2
8.7%
Serotype 12F
91.8
18.8%
93.1
19%
91.5
18.8%
Serotype 15B
81.6
16.7%
82.0
16.8%
81.0
16.7%
Serotype 22F
79.8
16.4%
82.1
16.8%
81.4
16.7%
Serotype 33F
62.7
12.8%
62.7
12.8%
62.7
12.9%
9. Secondary Outcome
Title Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
Description The percentage of participants with OPA titers >=LLOQ were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.
Time Frame 1 month after vaccination

Outcome Measure Data

Analysis Population Description
EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, "Number analyzed" = participants evaluable for this outcome measure at specified rows.
Arm/Group Title 20vPnC Lot 1 20vPnC Lot 2 20vPnC Lot 3
Arm/Group Description Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination. Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination. Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.
Measure Participants 463 473 456
Serotype 1
91.8
18.8%
92.8
19%
91.0
18.7%
Serotype 3
89.7
18.4%
89.6
18.3%
88.9
18.3%
Serotype 4
97.6
20%
97.0
19.8%
97.1
20%
Serotype 5
80.3
16.5%
84.3
17.2%
81.3
16.7%
Serotype 6A
99.1
20.3%
98.1
20.1%
98.2
20.2%
Serotype 6B
97.6
20%
99.6
20.4%
98.9
20.3%
Serotype 7F
94.7
19.4%
94.0
19.2%
96.6
19.9%
Serotype 9V
98.5
20.2%
98.9
20.2%
98.2
20.2%
Serotype 14
98.9
20.3%
99.4
20.3%
97.8
20.1%
Serotype 18C
96.9
19.9%
98.1
20.1%
98.7
20.3%
Serotype 19A
99.3
20.3%
100.0
20.4%
99.3
20.4%
Serotype 19F
91.2
18.7%
91.0
18.6%
90.7
18.7%
Serotype 23F
94.3
19.3%
95.8
19.6%
94.9
19.5%
Serotype 8
98.6
20.2%
99.1
20.3%
99.1
20.4%
Serotype 10A
99.7
20.4%
99.0
20.2%
99.3
20.4%
Serotype 11A
99.2
20.3%
99.5
20.3%
99.5
20.5%
Serotype 12F
99.0
20.3%
99.3
20.3%
99.0
20.4%
Serotype 15B
99.0
20.3%
98.6
20.2%
99.3
20.4%
Serotype 22F
99.7
20.4%
99.2
20.3%
99.5
20.5%
Serotype 33F
99.0
20.3%
98.8
20.2%
98.5
20.3%

Adverse Events

Time Frame Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination
Adverse Event Reporting Description Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.
Arm/Group Title Pooled 20vPnC 13vPnC
Arm/Group Description Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination. Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.
All Cause Mortality
Pooled 20vPnC 13vPnC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/1463 (0%) 0/245 (0%)
Serious Adverse Events
Pooled 20vPnC 13vPnC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 10/1463 (0.7%) 0/245 (0%)
Blood and lymphatic system disorders
Splenic cyst 1/1463 (0.1%) 0/245 (0%)
Gastrointestinal disorders
Gastritis 1/1463 (0.1%) 0/245 (0%)
Gastrooesophageal reflux disease 1/1463 (0.1%) 0/245 (0%)
Hiatus hernia 1/1463 (0.1%) 0/245 (0%)
Infections and infestations
Abdominal abscess 1/1463 (0.1%) 0/245 (0%)
Osteomyelitis 1/1463 (0.1%) 0/245 (0%)
Pneumonia mycoplasmal 1/1463 (0.1%) 0/245 (0%)
Staphylococcal bacteraemia 1/1463 (0.1%) 0/245 (0%)
Injury, poisoning and procedural complications
Procedural pneumothorax 1/1463 (0.1%) 0/245 (0%)
Subcutaneous haematoma 1/1463 (0.1%) 0/245 (0%)
Metabolism and nutrition disorders
Diabetic ketoacidosis 1/1463 (0.1%) 0/245 (0%)
Psychiatric disorders
Suicidal ideation 1/1463 (0.1%) 0/245 (0%)
Respiratory, thoracic and mediastinal disorders
Pleural effusion 1/1463 (0.1%) 0/245 (0%)
Skin and subcutaneous tissue disorders
Skin necrosis 1/1463 (0.1%) 0/245 (0%)
Other (Not Including Serious) Adverse Events
Pooled 20vPnC 13vPnC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1275/1463 (87.1%) 206/245 (84.1%)
General disorders
Fatigue 693/1463 (47.4%) 106/245 (43.3%)
Injection site erythema (REDNESS) 102/1463 (7%) 15/245 (6.1%)
Injection site pain (PAIN) 1146/1463 (78.3%) 184/245 (75.1%)
Injection site swelling (SWELLING) 124/1463 (8.5%) 21/245 (8.6%)
Pyrexia (FEVER) 18/1463 (1.2%) 2/245 (0.8%)
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN) 245/1463 (16.7%) 34/245 (13.9%)
Myalgia (MUSCLE PAIN) 904/1463 (61.8%) 147/245 (60%)
Nervous system disorders
Headache 527/1463 (36%) 92/245 (37.6%)

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:
NCT03828617
Other Study ID Numbers:
  • B7471008
First Posted:
Feb 4, 2019
Last Update Posted:
Nov 23, 2020
Last Verified:
Nov 1, 2020