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
1 other identifier
interventional
1,796
1 country
63
Brief Summary
Study of the safety and immunogenicity of 20vPnC and influenza vaccine administered at the same visit or separately
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2020
Shorter than P25 for phase_3
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2020
CompletedFirst Posted
Study publicly available on registry
August 26, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2021
CompletedResults Posted
Study results publicly available
July 8, 2022
CompletedJuly 8, 2022
June 1, 2022
10 months
August 21, 2020
June 15, 2022
June 15, 2022
Conditions
Outcome Measures
Primary Outcomes (7)
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 Outcomes (3)
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
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
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
Before Vaccination 1 to 1 month after Vaccination 1 with SIIV
Study Arms (2)
Coadministration Group
ACTIVE COMPARATORParticipants receive injections of pneumococcal vaccine (20vPnC) and influenza vaccine at the same visit, and then receive an injection of saline 1 month later.
Separate Administration Group
ACTIVE COMPARATORParticipants receive injections of saline and influenza vaccine at the same visit, and then receive an injection of 20vPnC 1 month later.
Interventions
Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
Seasonal inactivated influenza vaccine (SIIV)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (63)
Alliance for Multispecialty Research, LLC
Mobile, Alabama, 36608, United States
East Valley Gastroenterology and Hepatology Associates
Chandler, Arizona, 85224, United States
Hope Research Institute
Phoenix, Arizona, 85018, United States
Paradigm Clinical Research Center
Redding, California, 96001, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
California Research Foundation
San Diego, California, 92123-1881, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Alliance for Multispecialty Research, LLC - Miami
Coral Gables, Florida, 33134, United States
Nature Coast Clinical Research
Crystal River, Florida, 34429, United States
Indago Research and Health Center, Inc.
Hialeah, Florida, 33012, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Suncoast Research Group, LLC
Miami, Florida, 33135, United States
Alpha Science Research, LLC
Miami, Florida, 33186, United States
Lakes Research
Miami Lakes, Florida, 33014, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32801, United States
Meridian Clinical Research, LLC
Savannah, Georgia, 31406, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Advanced Clinical Research
Meridian, Idaho, 83642, United States
Alliance for Multispecialty Research, LLC
El Dorado, Kansas, 67042, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, 67205, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, 67207, United States
Alliance for Multispecialty Research, LLC
New Orleans, Louisiana, 70119, United States
Centennial Medical Group
Elkridge, Maryland, 21075, United States
Meridian Clinical Research, LLC
Rockville, Maryland, 20854, United States
Sundance Clinical Research, LLC
St Louis, Missouri, 63141, United States
Meridian Clinical Research
Norfolk, Nebraska, 68701, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134, United States
Meridian Clinical Research, LLC
Binghamton, New York, 13901, United States
Meridian Clinical Research, LLC
Endwell, New York, 13760, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, 28209, United States
PharmQuest
Greensboro, North Carolina, 27408, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, 28601, United States
Accellacare - Raleigh
Raleigh, North Carolina, 27609, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612, United States
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina, 27804, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Lillestol Research LLC
Fargo, North Dakota, 58104, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Meridian Clinical Research
Cincinnati, Ohio, 45219, United States
Velocity Clinical Research, Inc.
Cleveland, Ohio, 44122, United States
Prestige Clinical Research
Franklin, Ohio, 45005, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Main Street Physician's Care
Little River, South Carolina, 29566, United States
Coastal Carolina Research Center
North Charleston, South Carolina, 29405, United States
Internal Medicine and Pediatric Associates of Bristol, PC
Bristol, Tennessee, 37620, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203, United States
Benchmark Research
Austin, Texas, 78705, United States
Velocity Clinical Research, Austin
Cedar Park, Texas, 78613, United States
Benchmark Research
Fort Worth, Texas, 76135, United States
Texas Health Resource
Fort Worth, Texas, 76135, United States
Texas Center for Drug Development, Inc.
Houston, Texas, 77081, United States
Wellness Clinical Research
McKinney, Texas, 75071, United States
LinQ Research, LLC
Pearland, Texas, 77584, United States
Diagnostics Research Group
San Antonio, Texas, 78229, United States
Martin Diagnostic Clinic
Tomball, Texas, 77375, United States
J. Lewis Research Inc. / Foothill Family Clinic Draper
Draper, Utah, 84020, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
J. Lewis Research, Inc / Jordan River Family Medicine
South Jordan, Utah, 84095, United States
Alliance for Multispecialty Research - Norfolk
Norfolk, Virginia, 23502, United States
National Clinical Research, Inc
Richmond, Virginia, 23294, United States
Allegiance Research Specialists, LLC
Wauwatosa, Wisconsin, 53226, United States
Related Publications (1)
Cannon K, Cardona JF, Yacisin K, Thompson A, Belanger TJ, Lee DY, Peng Y, Moyer L, Ginis J, Gruber WC, Scott DA, Watson W. Safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine coadministered with quadrivalent influenza vaccine: A phase 3 randomized trial. Vaccine. 2023 Mar 24;41(13):2137-2146. doi: 10.1016/j.vaccine.2022.11.046. Epub 2023 Feb 23.
PMID: 36828719DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2020
First Posted
August 26, 2020
Study Start
September 1, 2020
Primary Completion
June 29, 2021
Study Completion
June 29, 2021
Last Updated
July 8, 2022
Results First Posted
July 8, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
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.