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

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: Completed
• Conditions: Pneumococcal Disease
• Intervention / Treatment: Other: Saline; Biological: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC); Biological: Influenza vaccine

• Study Type: Interventional
• Enrollment (Actual): 1796
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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	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	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	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	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	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	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

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	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	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	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

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): June 29, 2021
• Study Completion (Actual): June 29, 2021

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Actual): July 8, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID 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