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Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age

Primary Purpose

Pneumococcal Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
Saline
Influenza vaccine
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Disease

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or female participants ≥65 years of age at the time of consent
  • Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease
  • Adults who have no history of ever receiving a pneumococcal vaccine, or have a history of receiving a licensed pneumococcal vaccination ≥6 months prior to first study vaccination.

Exclusion Criteria:

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
  • Previous vaccination with any investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation.

  • Vaccination with any influenza or pneumococcal vaccine <6 months before investigational product administration, or planned receipt of any licensed or investigational non-study influenza vaccine during study participation.

    -- Serious chronic disorder, that in the investigator's opinion would make the participant inappropriate for entry into the study

  • Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results

Sites / Locations

  • Alliance for Multispecialty Research, LLC
  • East Valley Gastroenterology and Hepatology Associates
  • Hope Research Institute
  • Paradigm Clinical Research Center
  • Artemis Institute for Clinical Research
  • California Research Foundation
  • Diablo Clinical Research, Inc.
  • Alliance for Multispecialty Research, LLC - Miami
  • Nature Coast Clinical Research
  • Indago Research and Health Center, Inc.
  • Jacksonville Center for Clinical Research
  • Lakes Research
  • Suncoast Research Group, LLC
  • Alpha Science Research, LLC
  • Clinical Neuroscience Solutions, Inc
  • Meridian Clinical Research, LLC
  • Clinical Research Atlanta
  • Advanced Clinical Research
  • Alliance for Multispecialty Research, LLC
  • Alliance for Multispecialty Research, LLC
  • Alliance for Multispecialty Research, LLC
  • Alliance for Multispecialty Research, LLC
  • Centennial Medical Group
  • Meridian Clinical Research, LLC
  • Sundance Clinical Research, LLC
  • Meridian Clinical Research
  • Meridian Clinical Research, LLC
  • Meridian Clinical Research, LLC
  • Meridian Clinical Research, LLC
  • PMG Research of Charlotte, LLC
  • PharmQuest
  • PMG Research of Hickory, LLC
  • Accellacare - Raleigh
  • M3 Wake Research, Inc.
  • PMG Research of Rocky Mount, LLC
  • PMG Research of Wilmington, LLC
  • Lillestol Research LLC
  • CTI Clinical Research Center
  • Meridian Clinical Research
  • Velocity Clinical Research, Inc.
  • Prestige Clinical Research
  • Lynn Health Science Institute
  • Omega Medical Research
  • Main Street Physician's Care
  • Coastal Carolina Research Center
  • Internal Medicine and Pediatric Associates of Bristol, PC
  • Clinical Research Associates, Inc.
  • Benchmark Research
  • Velocity Clinical Research, Austin
  • Benchmark Research
  • Texas Health Resource
  • Texas Center for Drug Development, Inc.
  • Wellness Clinical Research
  • LinQ Research, LLC
  • Diagnostics Research Group
  • Martin Diagnostic Clinic
  • J. Lewis Research Inc. / Foothill Family Clinic Draper
  • J. Lewis Research, Inc. / Foothill Family Clinic
  • J. Lewis Research, Inc. / Foothill Family Clinic South
  • J. Lewis Research, Inc / Jordan River Family Medicine
  • Alliance for Multispecialty Research - Norfolk
  • National Clinical Research, Inc
  • Allegiance Research Specialists, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Coadministration Group

Separate Administration Group

Arm Description

Participants receive injections of pneumococcal vaccine (20vPnC) and influenza vaccine at the same visit, and then receive an injection of saline 1 month later.

Participants receive injections of saline and influenza vaccine at the same visit, and then receive an injection of 20vPnC 1 month later.

Outcomes

Primary Outcome Measures

Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC
Local reactions were collected at the 20vPnC injection sites after Vaccination 1 and Vaccination 2 and were recorded by the participants using an electronic diary (e-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). Percentage of participants with local reactions at the 20vPnC injection site in the Coadministration group and the Separate administration group and the associated 2-sided 95% confidence interval (CI) based on the Clopper and Pearson method was presented.
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine
Systemic events including fever, fatigue, headache, muscle pain and joint pain were recorded by participants using an e-diary. Fever was defined as temperature >=38.0 degree Celsius (C) and categorized as >=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). Percentage of participants with systemic events within 7 days after each vaccination and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Each Vaccination by Each Vaccine
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Percentage of Participants With Serious Adverse Events (SAEs) From the First Vaccination up to 6 Months After Last Vaccination
An SAE was defined as any untoward medical occurrence that, 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 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. Percentage of participants with SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) up to 6 Months After Last Vaccination
An NDCMC was defined as a significant 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 NDCMC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC
OPA titers were measured from serum samples for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F. GMTs and 2-sided CIs were calculated by exponentiating the LS means and the corresponding CIs based on analysis of log-transformed OPA titers using a regression model
Model-Based Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Titers (GMT) at 1 Month After Vaccination With SIIV
HAI titers to the influenza strains (A/H1N1, A/H3N2, B/Victoria, and B/Phuket) in the SIIV administered sera samples was collected and reported in this outcome measure at 1 month after Vaccination 1. GMTs and 2-sided CIs were calculated by exponentiating the LS means and the corresponding CIs based on analysis of log-transformed HAI titers using a regression model.

Secondary Outcome Measures

Percentage of Participants With Greater Than or Equal to (≥4) Fold Rise in Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination With 20vPnC
OPA titers were measured from serum samples for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F. Percentage of participants with >=4 fold rise in serotype-specific OPA titers from before vaccination to 1 month after vaccination with 20vPnC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC
OPA titers were measured from serum samples for serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the OPA titers or fold rises and the corresponding CIs.
Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Fold Rise (GMFR) Before Vaccination to 1 Month After Vaccination With SIIV
HAI titers were measured from serum samples for serotypes A/H1N1, A/H3N2, B/Victoria, B/Phuket. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with SIIV. GMFRs were calculated for participants with non-missing values both before and after vaccination.

Full Information

First Posted
August 21, 2020
Last Updated
June 15, 2022
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04526574
Brief Title
Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age
Official Title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE (20VPNC) WHEN COADMINISTERED WITH SEASONAL INACTIVATED INFLUENZA VACCINE (SIIV) IN ADULTS ≥65 YEARS OF AGE
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
June 29, 2021 (Actual)
Study Completion Date
June 29, 2021 (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
Study of the safety and immunogenicity of 20vPnC and influenza vaccine administered at the same visit or separately

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1796 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coadministration Group
Arm Type
Active Comparator
Arm Description
Participants receive injections of pneumococcal vaccine (20vPnC) and influenza vaccine at the same visit, and then receive an injection of saline 1 month later.
Arm Title
Separate Administration Group
Arm Type
Active Comparator
Arm Description
Participants receive injections of saline and influenza vaccine at the same visit, and then receive an injection of 20vPnC 1 month later.
Intervention Type
Biological
Intervention Name(s)
Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
Intervention Description
Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Normal saline for injection
Intervention Type
Biological
Intervention Name(s)
Influenza vaccine
Intervention Description
Seasonal inactivated influenza vaccine (SIIV)
Primary Outcome Measure Information:
Title
Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC
Description
Local reactions were collected at the 20vPnC injection sites after Vaccination 1 and Vaccination 2 and were recorded by the participants using an electronic diary (e-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). Percentage of participants with local reactions at the 20vPnC injection site in the Coadministration group and the Separate administration group and the associated 2-sided 95% confidence interval (CI) based on the Clopper and Pearson method was presented.
Time Frame
Within 10 days after Vaccination 1 for Coadministration group and within 10 days after Vaccination 2 for Separate Administration group
Title
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine
Description
Systemic events including fever, fatigue, headache, muscle pain and joint pain were recorded by participants using an e-diary. Fever was defined as temperature >=38.0 degree Celsius (C) and categorized as >=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). Percentage of participants with systemic events within 7 days after each vaccination and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Time Frame
Within 7 days after each vaccination
Title
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Each Vaccination by Each Vaccine
Description
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time Frame
Within 1 month after each vaccination
Title
Percentage of Participants With Serious Adverse Events (SAEs) From the First Vaccination up to 6 Months After Last Vaccination
Description
An SAE was defined as any untoward medical occurrence that, 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 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. Percentage of participants with SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Time Frame
From Day 1 up to 6 months after last Vaccination (i.e. up to 7 months)
Title
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) up to 6 Months After Last Vaccination
Description
An NDCMC was defined as a significant 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 NDCMC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Time Frame
Up to 6 months after last Vaccination (i.e. up to 7 months)
Title
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC
Description
OPA titers were measured from serum samples for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F. GMTs and 2-sided CIs were calculated by exponentiating the LS means and the corresponding CIs based on analysis of log-transformed OPA titers using a regression model
Time Frame
1 month after the 20vPnC administration in each group (1 month after Vaccination 1 in the Coadministration group and 1 month after Vaccination 2 in the Separate Administration group).
Title
Model-Based Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Titers (GMT) at 1 Month After Vaccination With SIIV
Description
HAI titers to the influenza strains (A/H1N1, A/H3N2, B/Victoria, and B/Phuket) in the SIIV administered sera samples was collected and reported in this outcome measure at 1 month after Vaccination 1. GMTs and 2-sided CIs were calculated by exponentiating the LS means and the corresponding CIs based on analysis of log-transformed HAI titers using a regression model.
Time Frame
At 1 month after Vaccination 1 with SIIV
Secondary Outcome Measure Information:
Title
Percentage of Participants With Greater Than or Equal to (≥4) Fold Rise in Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination With 20vPnC
Description
OPA titers were measured from serum samples for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F. Percentage of participants with >=4 fold rise in serotype-specific OPA titers from before vaccination to 1 month after vaccination with 20vPnC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Time Frame
Before Vaccination 1 to 1 month after 20vPnC vaccination in both groups (i.e., 1 month after Vaccination 1 in Coadministration group and 1 month after Vaccination 2 in Separate Administration group)
Title
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC
Description
OPA titers were measured from serum samples for serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the OPA titers or fold rises and the corresponding CIs.
Time Frame
Before Vaccination 1 to 1 month after 20vPnC vaccination in both groups (i.e., 1 month after Vaccination 1 in Coadministration group and 1 month after Vaccination 2 in Separate Administration group)
Title
Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Fold Rise (GMFR) Before Vaccination to 1 Month After Vaccination With SIIV
Description
HAI titers were measured from serum samples for serotypes A/H1N1, A/H3N2, B/Victoria, B/Phuket. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with SIIV. GMFRs were calculated for participants with non-missing values both before and after vaccination.
Time Frame
Before Vaccination 1 to 1 month after Vaccination 1 with SIIV

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female participants ≥65 years of age at the time of consent Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease Adults who have no history of ever receiving a pneumococcal vaccine, or have a history of receiving a licensed pneumococcal vaccination ≥6 months prior to first study vaccination. Exclusion Criteria: History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) Previous vaccination with any investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation. Vaccination with any influenza or pneumococcal vaccine <6 months before investigational product administration, or planned receipt of any licensed or investigational non-study influenza vaccine during study participation. -- Serious chronic disorder, that in the investigator's opinion would make the participant inappropriate for entry into the study Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results
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
Alliance for Multispecialty Research, LLC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
East Valley Gastroenterology and Hepatology Associates
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Hope Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Paradigm Clinical Research Center
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
California Research Foundation
City
San Diego
State/Province
California
ZIP/Postal Code
92123-1881
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC - Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Nature Coast Clinical Research
City
Crystal River
State/Province
Florida
ZIP/Postal Code
34429
Country
United States
Facility Name
Indago Research and Health Center, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Lakes Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Suncoast Research Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Alpha Science Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Advanced Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Centennial Medical Group
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20854
Country
United States
Facility Name
Sundance Clinical Research, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Meridian Clinical Research
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Binghamton
State/Province
New York
ZIP/Postal Code
13901
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
PMG Research of Charlotte, LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
PharmQuest
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
PMG Research of Hickory, LLC
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Accellacare - Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
M3 Wake Research, Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
PMG Research of Rocky Mount, LLC
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Lillestol Research LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
CTI Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Meridian Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Velocity Clinical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Prestige Clinical Research
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Main Street Physician's Care
City
Little River
State/Province
South Carolina
ZIP/Postal Code
29566
Country
United States
Facility Name
Coastal Carolina Research Center
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Internal Medicine and Pediatric Associates of Bristol, PC
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Clinical Research Associates, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Benchmark Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Velocity Clinical Research, Austin
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Benchmark Research
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
Texas Health Resource
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
Texas Center for Drug Development, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Wellness Clinical Research
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Facility Name
LinQ Research, LLC
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
Diagnostics Research Group
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. / Foothill Family Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research, Inc. / Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
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
Facility Name
Alliance for Multispecialty Research - Norfolk
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
National Clinical Research, Inc
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Allegiance Research Specialists, LLC
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
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
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7471004
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age

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