Back to resultsTrial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age
Primary Purpose
Pneumococcal Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Multivalent
Prevnar 13
PPSV23
Saline
Sponsored by
About this trial
This is an interventional prevention trial for Pneumococcal Infections
Eligibility Criteria
Inclusion Criteria:
- Male or female adults >/= 60 to </=64 years of age (from the 60th birthday up to, but not including, the 65th birthday) at enrollment.
- Healthy adults, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy or requiring hospitalization within 3 months before receipt of investigational product, as determined by medical history, physical examination, laboratory screening, and clinical judgment of the investigator.
- Female subjects who are not of childbearing potential.
Exclusion Criteria:
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
- History of microbiologically proven invasive disease caused by S pneumoniae.
- 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.
Sites / Locations
- Anaheim Clinical Trials, LLC
- Clinical Research of South Florida
- Avail Clinical Research, LLC
- Qps-Mra, Llc
- Clinical Research Atlanta
- East-West Medical Research Institute
- Heartland Research Associates, LLC
- Lynn Health Science Institute
- Medical Research South, LLC
- Benchmark Research
- Clinical Trials of Texas, Inc.
- Martin Diagnostic Clinic
- J. Lewis Research Inc. / Foothill Family Clinic Draper
- J. Lewis Research, Inc. - Jordan River Family Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multivalent
Control
Arm Description
Pneumococcal conjugate vaccine
Prevnar 13 and PPSV23
Outcomes
Primary Outcome Measures
Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1
Local reactions included pain at injection site, swelling and redness recorded by participants in an electronic diary (e-diary). 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 centimeter (cm), moderate: 5.5 to 10.0 cm and severe: greater than or equal to (>=) 10.5 cm. Pain was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Systemic events included fever, fatigue, headache, muscle pain and joint pain, recorded by participants in an e-diary. Fever was categorized as: >=38.0 degrees Celsius (C), >=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: no interference with activity, moderate: some interference with activity and severe: prevents daily routine activity.
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination 1
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with either SAE or NDCMCs during the specified duration are reported.
Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination 1
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with either SAE or NDCMCs during the specified duration are reported.
Secondary Outcome Measures
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC
Antibody-mediated serum OPA against the 13 common pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ in the analysis.
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC
Antibody-mediated serum OPA against the 7 additional pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before Vaccination 1 to one month after Vaccination 1 were calculated as the mean of the difference of logarithmically transformed OPA results (after vaccination - before vaccination) and transform back to the original scale. GMFRs were calculated using data from participants with non-missing OPA results at both time points. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC
GMFR for 7 additional pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F) from before Vaccination 1 to one month after either Vaccination 1 (20vPnC) or Vaccination 2 (PPSV23) were calculated as the mean of the difference of logarithmically transformed OPA results (after vaccination - before vaccination) and transform back to the original scale. GMFRs were calculated using data from participants with non-missing OPA results at both time points. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03313037
Brief Title
Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age
Official Title
A PHASE 2, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS 60 THROUGH 64 YEARS OF AGE
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 10, 2017 (Actual)
Primary Completion Date
December 10, 2018 (Actual)
Study Completion Date
December 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Phase 2, randomized, double-blinded study with a 2-arm parallel design. Healthy adults aged 60 through 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine followed 1 month later with a dose of saline or Prevnar 13 followed 1 month later with a dose of PPSV23 (control group).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
444 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multivalent
Arm Type
Experimental
Arm Description
Pneumococcal conjugate vaccine
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Prevnar 13 and PPSV23
Intervention Type
Biological
Intervention Name(s)
Multivalent
Intervention Description
Pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
Prevnar 13
Intervention Description
Pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
PPSV23
Other Intervention Name(s)
Pneumovax 23
Intervention Description
Pneumococcal polysaccharide vaccine
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1
Description
Local reactions included pain at injection site, swelling and redness recorded by participants in an electronic diary (e-diary). 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 centimeter (cm), moderate: 5.5 to 10.0 cm and severe: greater than or equal to (>=) 10.5 cm. Pain was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.
Time Frame
within 10 days after Vaccination 1
Title
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Description
Systemic events included fever, fatigue, headache, muscle pain and joint pain, recorded by participants in an e-diary. Fever was categorized as: >=38.0 degrees Celsius (C), >=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: no interference with activity, moderate: some interference with activity and severe: prevents daily routine activity.
Time Frame
within 7 days after Vaccination 1
Title
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1
Description
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame
within 1 month after Vaccination 1 (up to 35 days)
Title
Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination 1
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with either SAE or NDCMCs during the specified duration are reported.
Time Frame
within 6 months after Vaccination 1 (up to 196 days)
Title
Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination 1
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with either SAE or NDCMCs during the specified duration are reported.
Time Frame
within 12 months after Vaccination 1 (up to 378 days)
Secondary Outcome Measure Information:
Title
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC
Description
Antibody-mediated serum OPA against the 13 common pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ in the analysis.
Time Frame
1 month after Vaccination 1
Title
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC
Description
Antibody-mediated serum OPA against the 7 additional pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.
Time Frame
1 month after Vaccination 1 for 20vPnC followed by saline reporting group; 1 month after Vaccination 2 for 13vPnC followed by PPSV23 reporting group
Title
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC
Description
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before Vaccination 1 to one month after Vaccination 1 were calculated as the mean of the difference of logarithmically transformed OPA results (after vaccination - before vaccination) and transform back to the original scale. GMFRs were calculated using data from participants with non-missing OPA results at both time points. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.
Time Frame
before Vaccination 1 to one month after Vaccination 1
Title
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC
Description
GMFR for 7 additional pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F) from before Vaccination 1 to one month after either Vaccination 1 (20vPnC) or Vaccination 2 (PPSV23) were calculated as the mean of the difference of logarithmically transformed OPA results (after vaccination - before vaccination) and transform back to the original scale. GMFRs were calculated using data from participants with non-missing OPA results at both time points. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.
Time Frame
before Vaccination 1 to 1 month after Vaccination 1 for 20vPnC followed by saline reporting group; before Vaccination 1 to 1 month after Vaccination 2 for 13vPnC followed by PPSV23 reporting group
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female adults >/= 60 to </=64 years of age (from the 60th birthday up to, but not including, the 65th birthday) at enrollment.
Healthy adults, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy or requiring hospitalization within 3 months before receipt of investigational product, as determined by medical history, physical examination, laboratory screening, and clinical judgment of the investigator.
Female subjects who are not of childbearing potential.
Exclusion Criteria:
Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
History of microbiologically proven invasive disease caused by S pneumoniae.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Clinical Research of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Qps-Mra, Llc
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Medical Research South, LLC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Benchmark Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Martin Diagnostic Clinic
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
J. Lewis Research Inc. / Foothill Family Clinic Draper
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
J. Lewis Research, Inc. - Jordan River Family Medicine
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
32716500
Citation
Hurley D, Griffin C, Young M, Scott DA, Pride MW, Scully IL, Ginis J, Severs J, Jansen KU, Gruber WC, Watson W. Safety, Tolerability, and Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine (PCV20) in Adults 60 to 64 Years of Age. Clin Infect Dis. 2021 Oct 5;73(7):e1489-e1497. doi: 10.1093/cid/ciaa1045.
Results Reference
derived
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7471002
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age
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