Safety and Immunogenicity of Pneumococcal Conjugate Formu... | NCT05489328 | Trialant
NCT05489328
Sponsor
Pfizer
Status
Completed
Last Update Posted
Apr 18, 2024Actual
Enrollment
394Actual
Phase
Phase 1
Conditions
Pneumococcal Disease
Interventions
Candidate-1
Candidate-2
Candidate-3
Candidate-4
Candidate-5
Candidate-6
Candidate Control
13vPnC
PCV15
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT05489328
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C4801001
Secondary IDs
Not provided
Brief Title
Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age
Official Title
A PHASE 1, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF PNEUMOCOCCAL CONJUGATE FORMULATIONS IN HEALTHY ADULTS 18 THROUGH 49 YEARS OF AGE
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Apr 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 15, 2022Actual
Primary Completion Date
Oct 7, 2022Actual
Completion Date
Oct 7, 2022Actual
First Submitted Date
Aug 3, 2022
First Submission Date that Met QC Criteria
Aug 3, 2022
First Posted Date
Aug 5, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Oct 3, 2023
Results First Submitted that Met QC Criteria
Apr 16, 2024
Results First Posted Date
Apr 18, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 16, 2024
Last Update Posted Date
Apr 18, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of the study is to describe the safety and immunogenicity of Pneumococcal Conjugate Formulations in healthy adults 18 through 49 years of age.
Detailed Description
Not provided
Conditions Module
Conditions
Pneumococcal Disease
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
394Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Candidate-1
Experimental
Participants to receive a single injection of Candidate-1.
Other: Candidate-1
Candidate-2
Experimental
Participants to receive a single injection of Candidate-2.
Other: Candidate-2
Candidate-3
Experimental
Participants to receive a single injection of Candidate-3.
Other: Candidate-3
Candidate-4
Experimental
Participants to receive a single injection of Candidate-4.
Other: Candidate-4
Candidate-5
Experimental
Participants to receive a single injection of Candidate-5.
Other: Candidate-5
Candidate-6
Experimental
Participants to receive a single injection of Candidate-6.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Candidate-1
Other
Biological
Candidate-1
Candidate-2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention
Local reactions included redness, swelling and pain at the injection site collected in an electronic diary (e-diary) or case report form(CRF). Redness and swelling were measured and recorded in measuring device units. One measuring device unit=0.5 centimeter (cm). Redness and swelling reported in e-diary were graded as mild: greater than (>) 2.0 cm to 5.0 cm, moderate: >5.0 cm to 10.0 cm and severe > 10 cm. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; and severe: prevented daily activity. Severity definition from CRF: mild (does not interfere)/moderate (interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% confidence interval (CI) was based on the Clopper and Pearson method.
Within 7 days after study intervention
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were collected in an e-diary or CRF. Fever was defined as temperature greater than or equal to (>=) 38.0 degrees Celsius (C) and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees 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 activities. Severity definition from the CRF: mild (does not interfere)/moderate(interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Within 7 days after study intervention
Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Secondary Outcomes
Measure
Description
Time Frame
Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group
GMTs and the corresponding 2-sided CIs (from each candidate and candidate control group per the protocol objective) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student's t distribution).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female participants ≥18 and ≤49 years of age at the time of consent
Adults determined by clinical assessment to be eligible for the study, including adults with preexisting stable disease within 12 weeks before receipt of study intervention
Participants willing to use acceptable contraception for at least 28 days after study intervention; female participants not of childbearing potential; male participants unable to father children
Exclusion Criteria:
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component in pneumococcal conjugate vaccines and any other diphtheria toxoid-containing vaccine
Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study
Medical or psychiatric condition (recent or active suicidal ideation/behavior or laboratory abnormality) that may increase risk of study participation or make participant inappropriate for the study
Known or suspected immunodeficiency or other conditions associated with immunosuppression
Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation
Receipt of any inactivated or otherwise nonlive vaccine within 14 days or any live vaccine within 28 days before administration of study intervention
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
49 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Orange County Research Center
Tustin
California
92780
United States
Diablo Clinical Research, Inc.
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
A total of 394 participants were enrolled and randomized in the study of which 3 participants were not vaccinated and, 391 were administered study intervention. One participant randomized to Candidate-Control received Candidate-4.
Recruitment Details
The study was conducted at 17 sites in the United States.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Candidate-1
Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
FG001
Candidate-2
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Participants who were randomized
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
May 26, 2022
Sep 28, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Parallel Assignment
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Other: Candidate-6
Candidate Control
Active Comparator
Participants to receive a single injection of Candidate Control.
Other: Candidate Control
13-valent pneumococcal conjugate vaccine (13vPnC)
Other
Participants to receive a single injection of 13vPnC.
Biological: 13vPnC
15-valent pneumococcal conjugate vaccine (PCV15)
Other
Participants to receive a single injection of PCV15.
Biological: PCV15
Other
Biological
Candidate-2
Candidate-3
Other
Biological
Candidate-3
Candidate-4
Other
Biological
Candidate-4
Candidate-5
Other
Biological
Candidate-5
Candidate-6
Other
Biological
Candidate-6
Candidate Control
Other
Biological
Candidate Control
13vPnC
Biological
13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine (13vPnC)
PCV15
Biological
15-valent pneumococcal conjugate vaccine
15-valent pneumococcal conjugate vaccine (PCV15)
Within 1 month after study intervention
Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Within 1 month after study intervention
1 month after study intervention
Walnut Creek
California
94598
United States
Clinical Research Consulting
Milford
Connecticut
06460
United States
Proactive Clinical Research,LLC
Fort Lauderdale
Florida
33308
United States
Indago Research & Health Center, Inc
Hialeah
Florida
33012
United States
Qps-Mra, Llc
South Miami
Florida
33143
United States
Centennial Medical Group
Elkridge
Maryland
21075
United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy
Michigan
48098
United States
Prism Research LLC dba Nucleus Network
Saint Paul
Minnesota
55114
United States
South Jersey Infectious Disease
Somers Point
New Jersey
08244
United States
Accellacare - Wilmington
Wilmington
North Carolina
28401
United States
Clinical Trials of Texas, LLC
San Antonio
Texas
78229
United States
Diagnostics Research Group
San Antonio
Texas
78229
United States
IMA Clinical Research San Antonio
San Antonio
Texas
78229
United States
DM Clinical Research
Tomball
Texas
77375
United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City
Utah
84109
United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City
Utah
84121
United States
Alliance for Multispecialty Research, LLC
Norfolk
Virginia
23502
United States
Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
FG002
Candidate-3
Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
FG003
Candidate-4
Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
FG004
Candidate-5
Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
FG005
Candidate-6
Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
FG006
Candidate - Control
Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
FG007
PCV15
Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
FG008
13vPnC
Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
FG00041 subjects
FG00142 subjects
FG00239 subjects
FG00343 subjects
FG00445 subjects
FG00546 subjects
FG00647 subjects
FG00744 subjects
FG00847 subjects
Vaccinated
Participants who were administered the study intervention
FG00041 subjects
FG00142 subjects
FG00239 subjects
FG00343 subjects
FG00445 subjects
FG00546 subjects
FG00646 subjectsOne participant received Candidate-4.
FG00743 subjects
FG00846 subjects
COMPLETED
FG00041 subjects
FG00142 subjects
FG00238 subjects
FG00343 subjects
FG00443 subjects
FG00546 subjects
FG00646 subjects
FG00741 subjects
FG00846 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0042 subjects
FG0050 subjects
FG0061 subjects
FG0073 subjects
FG0081 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0042 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Analysis was performed on safety population which included all participants who received the study intervention. Participants were summarized according to the study intervention they received.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Candidate-1
Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
BG001
Candidate-2
Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
BG002
Candidate-3
Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
BG003
Candidate-4
Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
BG004
Candidate-5
Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
BG005
Candidate-6
Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
BG006
Candidate - Control
Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
BG007
PCV15
Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
BG008
13vPnC
Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00041
BG00142
BG00239
BG00344
BG00445
BG00546
BG00645
BG00743
BG00846
BG009391
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00035.9± 9.15
BG00135.2± 9.11
BG00235.3± 9.44
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00030
BG00126
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00013
BG00115
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention
Local reactions included redness, swelling and pain at the injection site collected in an electronic diary (e-diary) or case report form(CRF). Redness and swelling were measured and recorded in measuring device units. One measuring device unit=0.5 centimeter (cm). Redness and swelling reported in e-diary were graded as mild: greater than (>) 2.0 cm to 5.0 cm, moderate: >5.0 cm to 10.0 cm and severe > 10 cm. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; and severe: prevented daily activity. Severity definition from CRF: mild (does not interfere)/moderate (interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% confidence interval (CI) was based on the Clopper and Pearson method.
Safety population included all participants who received the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 7 days after study intervention
ID
Title
Description
OG000
Candidate-1
Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG001
Candidate-2
Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG002
Candidate-3
Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG003
Candidate-4
Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG004
Candidate-5
Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG005
Candidate-6
Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG006
Candidate - Control
Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
Units
Counts
Participants
OG00041
OG00142
OG00239
OG003
Title
Denominators
Categories
Redness: Mild
Title
Measurements
OG0000.0(0.0 to 8.6)
OG0010.0(0.0 to 8.4)
OG0020.0(0.0 to 9.0)
OG003
Primary
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were collected in an e-diary or CRF. Fever was defined as temperature greater than or equal to (>=) 38.0 degrees Celsius (C) and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees 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 activities. Severity definition from the CRF: mild (does not interfere)/moderate(interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Safety population included all participants who received the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 7 days after study intervention
ID
Title
Description
OG000
Candidate-1
Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG001
Candidate-2
Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
Primary
Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Safety population included all participants who received the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 1 month after study intervention
ID
Title
Description
OG000
Candidate-1
Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG001
Candidate-2
Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG002
Candidate-3
Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
Primary
Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Safety population included all participants who received the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 1 month after study intervention
ID
Title
Description
OG000
Candidate-1
Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG001
Candidate-2
Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG002
Candidate-3
Secondary
Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group
GMTs and the corresponding 2-sided CIs (from each candidate and candidate control group per the protocol objective) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student's t distribution).
Evaluable immunogenicity population included eligible participants who received study intervention as randomized, had at least 1 valid assay result within 27 to 49 days after administration, and had no major protocol deviations. Participants from each candidate and candidate control group were included as per the protocol specified objective. Number of Participants Analyzed= participants in evaluable immunogenicity population & had valid result 1 month after study intervention.
Posted
Geometric Mean
95% Confidence Interval
Titer
1 month after study intervention
ID
Title
Description
OG000
Candidate-1
Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG001
Candidate-2
Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
Time Frame
Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.
Description
The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Candidate-1
Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
0
41
0
41
25
41
EG001
Candidate-2
Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
0
42
0
42
27
42
EG002
Candidate-3
Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
0
39
0
39
21
39
EG003
Candidate-4
Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
0
44
0
44
28
44
EG004
Candidate-5
Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
0
45
1
45
30
45
EG005
Candidate-6
Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
0
46
0
46
30
46
EG006
Candidate - Control
Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
0
45
0
45
22
45
EG007
PCV15
Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
0
43
0
43
32
43
EG008
13vPnC
Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
0
46
0
46
37
46
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cellulitis
Infections and infestations
MedDRA 25.1
Non-systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected44 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected46 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected43 at risk
EG0080 events0 affected46 at risk
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Fatigue (FATIGUE)
General disorders
MedDRA 25.1
Systematic Assessment
EG00013 affected41 at risk
EG00120 affected42 at risk
EG00213 affected39 at risk
EG00319 affected44 at risk
EG00421 affected45 at risk
EG00521 affected46 at risk
EG00616 affected45 at risk
EG00723 affected43 at risk
EG00821 affected46 at risk
Injection site erythema (REDNESS)
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected42 at risk
EG0020 affected39 at risk
EG003
Injection site pain (PAIN)
General disorders
MedDRA 25.1
Systematic Assessment
EG0005 affected41 at risk
EG00113 affected42 at risk
EG0028 affected39 at risk
EG003
Injection site swelling (SWELLING)
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected42 at risk
EG0021 affected39 at risk
EG003
Pyrexia (FEVER)
General disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected41 at risk
EG0011 affected42 at risk
EG0021 affected39 at risk
EG003
Arthralgia (JOINT PAIN)
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected41 at risk
EG0016 affected42 at risk
EG0022 affected39 at risk
EG003
Myalgia (MUSCLE PAIN)
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0005 affected41 at risk
EG00110 affected42 at risk
EG0025 affected39 at risk
EG003
Headache (HEADACHE)
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG00018 affected41 at risk
EG00115 affected42 at risk
EG00215 affected39 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG008
13vPnC
Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
44
OG00445
OG00546
OG00645
OG00743
OG00846
2.3
(0.1 to 12.0)
OG0042.2(0.1 to 11.8)
OG0054.3(0.5 to 14.8)
OG0060.0(0.0 to 7.9)
OG0074.7(0.6 to 15.8)
OG0080.0(0.0 to 7.7)
Redness: Moderate
Title
Measurements
OG0000.0(0.0 to 8.6)
OG0012.4(0.1 to 12.6)
OG0020.0(0.0 to 9.0)
OG0030.0(0.0 to 8.0)
OG0042.2(0.1 to 11.8)
OG0052.2(0.1 to 11.5)
OG0060.0(0.0 to 7.9)
OG0074.7(0.6 to 15.8)
OG0082.2(0.1 to 11.5)
Redness: Severe
Title
Measurements
OG0000.0(0.0 to 8.6)
OG0010.0(0.0 to 8.4)
OG0020.0(0.0 to 9.0)
OG0030.0(0.0 to 8.0)
OG0040.0(0.0 to 7.9)
OG0050.0(0.0 to 7.7)
OG0060.0(0.0 to 7.9)
OG0070.0(0.0 to 8.2)
OG0080.0(0.0 to 7.7)
Swelling: Mild
Title
Measurements
OG0000.0(0.0 to 8.6)
OG0010.0(0.0 to 8.4)
OG0020.0(0.0 to 9.0)
OG0030.0(0.0 to 8.0)
OG0042.2(0.1 to 11.8)
OG0056.5(1.4 to 17.9)
OG0060.0(0.0 to 7.9)
OG0074.7(0.6 to 15.8)
OG0088.7(2.4 to 20.8)
Swelling: Moderate
Title
Measurements
OG0000.0(0.0 to 8.6)
OG0012.4(0.1 to 12.6)
OG0020.0(0.0 to 9.0)
OG0032.3(0.1 to 12.0)
OG0042.2(0.1 to 11.8)
OG0050.0(0.0 to 7.7)
OG0060.0(0.0 to 7.9)
OG0074.7(0.6 to 15.8)
OG0080.0(0.0 to 7.7)
Swelling: Severe
Title
Measurements
OG0000.0(0.0 to 8.6)
OG0010.0(0.0 to 8.4)
OG0022.6(0.1 to 13.5)
OG0030.0(0.0 to 8.0)
OG0040.0(0.0 to 7.9)
OG0052.2(0.1 to 11.5)
OG0060.0(0.0 to 7.9)
OG0070.0(0.0 to 8.2)
OG0080.0(0.0 to 7.7)
Pain At Injection Site: Mild
Title
Measurements
OG00012.2(4.1 to 26.2)
OG00126.2(13.9 to 42.0)
OG00220.5(9.3 to 36.5)
OG00325.0(13.2 to 40.3)
OG00437.8(23.8 to 53.5)
OG00523.9(12.6 to 38.8)
OG00611.1(3.7 to 24.1)
OG00737.2(23.0 to 53.3)
OG00854.3(39.0 to 69.1)
Pain At Injection Site: Moderate
Title
Measurements
OG0000.0(0.0 to 8.6)
OG0014.8(0.6 to 16.2)
OG0020.0(0.0 to 9.0)
OG0032.3(0.1 to 12.0)
OG0046.7(1.4 to 18.3)
OG00517.4(7.8 to 31.4)
OG0062.2(0.1 to 11.8)
OG00730.2(17.2 to 46.1)
OG0086.5(1.4 to 17.9)
Pain At Injection Site: Severe
Title
Measurements
OG0000.0(0.0 to 8.6)
OG0010.0(0.0 to 8.4)
OG0020.0(0.0 to 9.0)
OG0030.0(0.0 to 8.0)
OG0040.0(0.0 to 7.9)
OG0050.0(0.0 to 7.7)
OG0060.0(0.0 to 7.9)
OG0070.0(0.0 to 8.2)
OG0082.2(0.1 to 11.5)
OG002
Candidate-3
Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG003
Candidate-4
Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG004
Candidate-5
Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG005
Candidate-6
Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG006
Candidate - Control
Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG007
PCV15
Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG008
13vPnC
Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
Units
Counts
Participants
OG00041
OG00142
OG00239
OG00344
OG00445
OG00546
OG00645
OG00743
OG00846
Title
Denominators
Categories
Fever: >/=38.0 degrees C to 38.4 degrees C
Title
Measurements
OG0000.0(0.0 to 8.6)
OG0010.0(0.0 to 8.4)
OG0020.0(0.0 to 9.0)
OG0030.0(0.0 to 8.0)
OG0042.2(0.1 to 11.8)
OG0054.3(0.5 to 14.8)
OG0060.0(0.0 to 7.9)
OG0072.3(0.1 to 12.3)
OG0082.2(0.1 to 11.5)
Fever: >38.4 degrees C to 38.9 degrees C
Title
Measurements
OG0002.4(0.1 to 12.9)
OG0010.0(0.0 to 8.4)
OG0022.6(0.1 to 13.5)
OG003
Fever: >38.9 degrees C to 40.0 degrees C
Title
Measurements
OG0000.0(0.0 to 8.6)
OG0012.4(0.1 to 12.6)
OG0020.0(0.0 to 9.0)
OG003
Fever: >40.0 degrees C
Title
Measurements
OG0000.0(0.0 to 8.6)
OG0010.0(0.0 to 8.4)
OG0020.0(0.0 to 9.0)
OG003
Fatigue: Mild
Title
Measurements
OG00017.1(7.2 to 32.1)
OG00119.0(8.6 to 34.1)
OG00220.5(9.3 to 36.5)
OG003
Fatigue: Moderate
Title
Measurements
OG00014.6(5.6 to 29.2)
OG00126.2(13.9 to 42.0)
OG00212.8(4.3 to 27.4)
OG003
Fatigue: Severe
Title
Measurements
OG0000.0(0.0 to 8.6)
OG0012.4(0.1 to 12.6)
OG0020.0(0.0 to 9.0)
OG003
Headache: Mild
Title
Measurements
OG00034.1(20.1 to 50.6)
OG00123.8(12.1 to 39.5)
OG00225.6(13.0 to 42.1)
OG003
Headache: Moderate
Title
Measurements
OG0007.3(1.5 to 19.9)
OG00111.9(4.0 to 25.6)
OG00212.8(4.3 to 27.4)
OG003
Headache: Severe
Title
Measurements
OG0002.4(0.1 to 12.9)
OG0010.0(0.0 to 8.4)
OG0020.0(0.0 to 9.0)
OG003
Muscle Pain: Mild
Title
Measurements
OG00012.2(4.1 to 26.2)
OG0017.1(1.5 to 19.5)
OG00212.8(4.3 to 27.4)
OG003
Muscle Pain: Moderate
Title
Measurements
OG0000.0(0.0 to 8.6)
OG00114.3(5.4 to 28.5)
OG0020.0(0.0 to 9.0)
OG003
Muscle Pain: Severe
Title
Measurements
OG0000.0(0.0 to 8.6)
OG0012.4(0.1 to 12.6)
OG0020.0(0.0 to 9.0)
OG003
Joint Pain: Mild
Title
Measurements
OG0002.4(0.1 to 12.9)
OG0019.5(2.7 to 22.6)
OG0025.1(0.6 to 17.3)
OG003
Joint Pain: Moderate
Title
Measurements
OG0000.0(0.0 to 8.6)
OG0014.8(0.6 to 16.2)
OG0020.0(0.0 to 9.0)
OG003
Joint Pain: Severe
Title
Measurements
OG0000.0(0.0 to 8.6)
OG0010.0(0.0 to 8.4)
OG0020.0(0.0 to 9.0)
OG003
OG003
Candidate-4
Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG004
Candidate-5
Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG005
Candidate-6
Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG006
Candidate - Control
Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG007
PCV15
Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG008
13vPnC
Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
Units
Counts
Participants
OG00041
OG00142
OG00239
OG00344
OG00445
OG00546
OG00645
OG00743
OG00846
Title
Denominators
Categories
Title
Measurements
OG0002.4(0.1 to 12.9)
OG0014.8(0.6 to 16.2)
OG0025.1(0.6 to 17.3)
OG0030.0(0.0 to 8.0)
OG0048.9(2.5 to 21.2)
OG0054.3(0.5 to 14.8)
OG0060.0(0.0 to 7.9)
OG0072.3(0.1 to 12.3)
OG0082.2(0.1 to 11.5)
Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG003
Candidate-4
Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG004
Candidate-5
Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG005
Candidate-6
Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG006
Candidate - Control
Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG007
PCV15
Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG008
13vPnC
Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
Units
Counts
Participants
OG00041
OG00142
OG00239
OG00344
OG00445
OG00546
OG00645
OG00743
OG00846
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 8.6)
OG0010.0(0.0 to 8.4)
OG0020.0(0.0 to 9.0)
OG0030.0(0.0 to 8.0)
OG0042.2(0.1 to 11.8)
OG0050.0(0.0 to 7.7)
OG0060.0(0.0 to 7.9)
OG0070.0(0.0 to 8.2)
OG0080.0(0.0 to 7.7)
OG002
Candidate-3
Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG003
Candidate-4
Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG004
Candidate-5
Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG005
Candidate-6
Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.
OG006
Candidate - Control
Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.