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

June 15, 2022 updated by: Pfizer

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 of the safety and immunogenicity of 20vPnC and influenza vaccine administered at the same visit or separately

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1796

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Alliance for Multispecialty Research, LLC
    • Arizona
      • Chandler, Arizona, United States, 85224
        • East Valley Gastroenterology and Hepatology Associates
      • Phoenix, Arizona, United States, 85018
        • Hope Research Institute
    • California
      • Redding, California, United States, 96001
        • Paradigm Clinical Research Center
      • San Diego, California, United States, 92123-1881
        • California Research Foundation
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Alliance for MultiSpecialty Research, LLC - Miami
      • Crystal River, Florida, United States, 34429
        • Nature Coast Clinical Research
      • Hialeah, Florida, United States, 33012
        • Indago Research and Health Center, Inc.
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Miami, Florida, United States, 33135
        • Suncoast Research Group, LLC
      • Miami, Florida, United States, 33186
        • Alpha Science Research, LLC
      • Miami Lakes, Florida, United States, 33014
        • Lakes Research
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Meridian Clinical Research, LLC
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Atlanta
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research
    • Kansas
      • El Dorado, Kansas, United States, 67042
        • Alliance for Multispecialty Research, LLC
      • Wichita, Kansas, United States, 67207
        • Alliance for Multispecialty Research, LLC
      • Wichita, Kansas, United States, 67205
        • Alliance for Multispecialty Research, LLC
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • Alliance for Multispecialty Research, LLC
    • Maryland
      • Elkridge, Maryland, United States, 21075
        • Centennial Medical Group
      • Rockville, Maryland, United States, 20854
        • Meridian Clinical Research, LLC
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Sundance Clinical Research, LLC
    • Nebraska
      • Norfolk, Nebraska, United States, 68701
        • Meridian Clinical Research
      • Omaha, Nebraska, United States, 68134
        • Meridian Clinical Research, LLC
    • New York
      • Binghamton, New York, United States, 13901
        • Meridian Clinical Research, LLC
      • Endwell, New York, United States, 13760
        • Meridian Clinical Research, LLC
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • PMG Research of Charlotte, LLC
      • Greensboro, North Carolina, United States, 27408
        • PharmQuest
      • Hickory, North Carolina, United States, 28601
        • PMG Research of Hickory, LLC
      • Raleigh, North Carolina, United States, 27612
        • M3 Wake Research, Inc.
      • Raleigh, North Carolina, United States, 27609
        • Accellacare - Raleigh
      • Rocky Mount, North Carolina, United States, 27804
        • PMG Research of Rocky Mount, LLC
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington, LLC
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Lillestol Research LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • CTI Clinical Research Center
      • Cincinnati, Ohio, United States, 45219
        • Meridian Clinical Research
      • Cleveland, Ohio, United States, 44122
        • Velocity Clinical Research, Inc.
      • Franklin, Ohio, United States, 45005
        • Prestige Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Little River, South Carolina, United States, 29566
        • Main Street Physician's Care
      • North Charleston, South Carolina, United States, 29405
        • Coastal Carolina Research Center
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Internal Medicine and Pediatric Associates of Bristol, PC
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Associates, Inc.
    • Texas
      • Austin, Texas, United States, 78705
        • Benchmark Research
      • Cedar Park, Texas, United States, 78613
        • Velocity Clinical Research, Austin
      • Fort Worth, Texas, United States, 76135
        • Benchmark Research
      • Fort Worth, Texas, United States, 76135
        • Texas Health Resource
      • Houston, Texas, United States, 77081
        • Texas Center for Drug Development, Inc.
      • McKinney, Texas, United States, 75071
        • Wellness Clinical Research
      • Pearland, Texas, United States, 77584
        • LinQ Research, LLC
      • San Antonio, Texas, United States, 78229
        • Diagnostics Research Group
      • Tomball, Texas, United States, 77375
        • Martin Diagnostic Clinic
    • Utah
      • Draper, Utah, United States, 84020
        • J. Lewis Research Inc. / Foothill Family Clinic Draper
      • Salt Lake City, Utah, United States, 84109
        • J. Lewis Research, Inc. / Foothill Family Clinic
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis Research, Inc. / Foothill Family Clinic South
      • South Jordan, Utah, United States, 84095
        • J. Lewis Research, Inc / Jordan River Family Medicine
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Alliance for Multispecialty Research - Norfolk
      • Richmond, Virginia, United States, 23294
        • National Clinical Research, Inc
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Allegiance Research Specialists, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Coadministration Group
Participants receive injections of pneumococcal vaccine (20vPnC) and influenza vaccine at the same visit, and then receive an injection of saline 1 month later.
Other: Saline
Normal saline for injection
Biological: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
Biological: Influenza vaccine
Seasonal inactivated influenza vaccine (SIIV)
Active Comparator: Separate Administration Group
Participants receive injections of saline and influenza vaccine at the same visit, and then receive an injection of 20vPnC 1 month later.
Other: Saline
Normal saline for injection
Biological: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
Biological: Influenza vaccine
Seasonal inactivated influenza vaccine (SIIV)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC
Time Frame: Within 10 days after Vaccination 1 for Coadministration group and within 10 days after Vaccination 2 for Separate Administration group
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.
Within 10 days after Vaccination 1 for Coadministration group and within 10 days after Vaccination 2 for Separate Administration group
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine
Time Frame: Within 7 days after each vaccination
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.
Within 7 days after each vaccination
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Each Vaccination by Each Vaccine
Time Frame: Within 1 month after each vaccination
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.
Within 1 month after each vaccination
Percentage of Participants With Serious Adverse Events (SAEs) From the First Vaccination up to 6 Months After Last Vaccination
Time Frame: From Day 1 up to 6 months after last Vaccination (i.e. up to 7 months)
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.
From Day 1 up to 6 months after last Vaccination (i.e. up to 7 months)
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) up to 6 Months After Last Vaccination
Time Frame: Up to 6 months after last Vaccination (i.e. up to 7 months)
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.
Up to 6 months after last Vaccination (i.e. up to 7 months)
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC
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).
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
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).
Model-Based Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Titers (GMT) at 1 Month After Vaccination With SIIV
Time Frame: At 1 month after Vaccination 1 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.
At 1 month after Vaccination 1 with SIIV

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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)
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.
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)
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC
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)
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.
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)
Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Fold Rise (GMFR) Before Vaccination to 1 Month After Vaccination With SIIV
Time Frame: Before Vaccination 1 to 1 month after Vaccination 1 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.
Before Vaccination 1 to 1 month after Vaccination 1 with SIIV

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 29, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B7471004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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