Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Vaccine in Adults 65 Years of Age or Older With Prior Pneumococcal Vaccination

Pneumococcal Disease Clinical Trial

Official title:

A PHASE 3, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS ≥65 YEARS OF AGE WITH PRIOR PNEUMOCOCCAL VACCINATION

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03835975
• Other study ID #: B7471006
• Secondary ID: 2018-004278-91
• Status: Completed
• Phase: Phase 3
• Start date: February 12, 2019
• Est. completion date: February 12, 2020

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Phase 3 will describe the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine formulation in adults 65 years of age or older with prior pneumococcal vaccination

Recruitment information / eligibility

• Status: Completed
• Enrollment: 875
• Est. completion date: February 12, 2020
• Est. primary completion date: February 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria

1. Male or female adults 65 years of age or greater.

2. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product.

3. Female subject of nonchildbearing potential; male subject not able to father children or who is able to father children and willing to use a highly effective method of contraception.

4. Male or female adults who meet 1 of the following:

1. Vaccination with PPSV23 greater than or equal to 1 year and less than or equal to 5 years prior to vaccination in the study, and no prior 13vPnC vaccination (Cohort A).

2. Vaccination with 13vPnC greater than or equal to 6 months prior to vaccination in the study, and no prior PPSV23 vaccination (Cohort B).

3. Vaccination with 13vPnC followed by PPSV23 (PPSV23 vaccination greater than or equal to 1 year prior to vaccination in the study) (Cohort C).

Exclusion Criteria

1. Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study.

2. History of microbiologically proven invasive disease caused by S pneumoniae.

Related Conditions & MeSH terms

• Pneumococcal Disease
• Pneumococcal Infections

Intervention

Biological:
• 13vPnC
Pneumococcal conjugate vaccine
• PPSV23
Pneumococcal polysaccharide vaccine
• 20vPnC
Pneumococcal conjugate vaccine

Locations

Country	Name	City	State
Sweden	Ladulaas Kliniska Studier	Boras
Sweden	Infektionskliniken	Eskilstuna
Sweden	CTC Gothia Forum	Goteborg
Sweden	ProbarE i Lund	Lund
Sweden	PharmaSite	Malmo	Skane
Sweden	Avdelningen for Kliniska Provningar	Orebro
Sweden	Akardo Med Site	Stockholm
Sweden	Karolinska Trial Alliance, KTA Prim	Stockholm
United States	MedPharmics, LLC	Albuquerque	New Mexico
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	East Valley Gastroenterology and Hepatology Associates	Chandler	Arizona
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Sterling Research Group, Ltd.	Cincinnati	Ohio
United States	J. Lewis Research Inc. / Foothill Family Clinic Draper	Draper	Utah
United States	Carolina Institute for Clinical Research	Fayetteville	North Carolina
United States	Prestige Clinical Research	Franklin	Ohio
United States	Medical Research South, LLC	Goose Creek	South Carolina
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Ventavia Research Group	Keller	Texas
United States	Optimal Research, LLC	Melbourne	Florida
United States	MedPharmics, LLC	Metairie	Louisiana
United States	Clinical Research Consulting, LLC	Milford	Connecticut
United States	Coastal Clinical Research, Inc.	Mobile	Alabama
United States	Meridian Clinical Research, LLC	Norfolk	Nebraska
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	The Pain Center of Arizona	Peoria	Arizona
United States	HOPE Research Institute	Phoenix	Arizona
United States	The Pain Center of Arizona	Phoenix	Arizona
United States	Columbia Research Group, Inc.	Portland	Oregon
United States	Kaiser Permanente Center For Health Research	Portland	Oregon
United States	Meridian Clinical Research, LLC	Rockville	Maryland
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	Meridian Clinical Research, LLC	Savannah	Georgia
United States	Kaiser Permanente Washington Health Research Institute	Seattle	Washington
United States	J. Lewis Research, Inc. / Jordan River Family Medicine	South Jordan	Utah
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Synexus Clinical Research US, Inc	The Villages	Florida
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Local Reactions Within 10 Days After Vaccination	Local reactions were recorded 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).	Within 10 days after vaccination
Primary	Percentage of Participants With Systemic Events Within 7 Days After Vaccination	Systemic events fever, fatigue, headache, muscle pain and joint pain were recorded by using an e-diary. Fever was defined as temperature >=38.0 degree Celsius (C) and categorized to >=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).	Within 7 days after vaccination
Primary	Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination	An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.	Within 1 month after vaccination
Primary	Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination	An SAE was any untoward medical occurrence 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 or significant 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.	Within 6 months after vaccination
Primary	Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination	An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects.	Within 6 months after vaccination
Primary	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination	OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution.	1 month after vaccination
Secondary	Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination	OPA GMFR is the ratio of OPA GMTs, 1 month after vaccination to before vaccination. OPA GMFRs from before to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.	From before vaccination to 1 month after vaccination
Secondary	Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination	Percentage of participants with a >=4-fold rise in pneumococcal OPA titers from before vaccination to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.	From before vaccination to 1 month after vaccination
Secondary	Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination	The percentage of participants with OPA titers >=LLOQ at 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.	1 month after vaccination

External Links

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