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

Pneumococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04526574
• Other study ID #: B7471004
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2020
• Est. completion date: June 29, 2021

Study information

• Verified date: June 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1796
• Est. completion date: June 29, 2021
• Est. primary completion date: June 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumococcal Disease
• Pneumococcal Infections

Intervention

Biological:
• Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)

Other:
• Saline
Normal saline for injection

Biological:
• Influenza vaccine
Seasonal inactivated influenza vaccine (SIIV)

Locations

Country	Name	City	State
United States	Benchmark Research	Austin	Texas
United States	Meridian Clinical Research, LLC	Binghamton	New York
United States	Internal Medicine and Pediatric Associates of Bristol, PC	Bristol	Tennessee
United States	Velocity Clinical Research, Austin	Cedar Park	Texas
United States	East Valley Gastroenterology and Hepatology Associates	Chandler	Arizona
United States	PMG Research of Charlotte, LLC	Charlotte	North Carolina
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Meridian Clinical Research	Cincinnati	Ohio
United States	Velocity Clinical Research, Inc.	Cleveland	Ohio
United States	Alliance for Multispecialty Research, LLC - Miami	Coral Gables	Florida
United States	Nature Coast Clinical Research	Crystal River	Florida
United States	J. Lewis Research Inc. / Foothill Family Clinic Draper	Draper	Utah
United States	Alliance for Multispecialty Research, LLC	El Dorado	Kansas
United States	Centennial Medical Group	Elkridge	Maryland
United States	Meridian Clinical Research, LLC	Endwell	New York
United States	Lillestol Research LLC	Fargo	North Dakota
United States	Benchmark Research	Fort Worth	Texas
United States	Texas Health Resource	Fort Worth	Texas
United States	Prestige Clinical Research	Franklin	Ohio
United States	PharmQuest	Greensboro	North Carolina
United States	Indago Research and Health Center, Inc.	Hialeah	Florida
United States	PMG Research of Hickory, LLC	Hickory	North Carolina
United States	Texas Center for Drug Development, Inc.	Houston	Texas
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Main Street Physician's Care	Little River	South Carolina
United States	Wellness Clinical Research	McKinney	Texas
United States	Advanced Clinical Research	Meridian	Idaho
United States	Alpha Science Research, LLC	Miami	Florida
United States	Suncoast Research Group, LLC	Miami	Florida
United States	Lakes Research	Miami Lakes	Florida
United States	Alliance for Multispecialty Research, LLC	Mobile	Alabama
United States	Clinical Research Associates, Inc.	Nashville	Tennessee
United States	Alliance for Multispecialty Research, LLC	New Orleans	Louisiana
United States	Alliance for Multispecialty Research - Norfolk	Norfolk	Virginia
United States	Meridian Clinical Research	Norfolk	Nebraska
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Meridian Clinical Research, LLC	Omaha	Nebraska
United States	Clinical Neuroscience Solutions, Inc	Orlando	Florida
United States	LinQ Research, LLC	Pearland	Texas
United States	Hope Research Institute	Phoenix	Arizona
United States	Accellacare - Raleigh	Raleigh	North Carolina
United States	M3 Wake Research, Inc.	Raleigh	North Carolina
United States	Paradigm Clinical Research Center	Redding	California
United States	National Clinical Research, Inc	Richmond	Virginia
United States	Meridian Clinical Research, LLC	Rockville	Maryland
United States	PMG Research of Rocky Mount, LLC	Rocky Mount	North Carolina
United States	Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	J. Lewis Research, Inc. / Foothill Family Clinic	Salt Lake City	Utah
United States	J. Lewis Research, Inc. / Foothill Family Clinic South	Salt Lake City	Utah
United States	Diagnostics Research Group	San Antonio	Texas
United States	Artemis Institute for Clinical Research	San Diego	California
United States	California Research Foundation	San Diego	California
United States	Meridian Clinical Research, LLC	Savannah	Georgia
United States	J. Lewis Research, Inc / Jordan River Family Medicine	South Jordan	Utah
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Martin Diagnostic Clinic	Tomball	Texas
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Omega Medical Research	Warwick	Rhode Island
United States	Allegiance Research Specialists, LLC	Wauwatosa	Wisconsin
United States	Alliance for Multispecialty Research, LLC	Wichita	Kansas
United States	Alliance for Multispecialty Research, LLC	Wichita	Kansas
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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).
Primary	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	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)
Secondary	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)
Secondary	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

External Links

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