20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naïve Adults 60 Years of Age and Older in Japan, Korea, and Taiwan

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY-UNBLINDED TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS 60 YEARS OF AGE AND OLDER IN JAPAN, KOREA, AND TAIWAN

A phase 3, randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults 60 years of age and older in Japan, Korea, and Taiwan

Study Overview

• Status: Completed
• Conditions: Pneumococcal Disease
• Intervention / Treatment: Other: Saline; Biological: 20vPnC; Biological: 13vPnC; Biological: PPSV23

• Study Type: Interventional
• Enrollment (Actual): 1425
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-0025
    • SOUSEIKAI PS Clinic
  • Fukuoka
    • Itoshima, Fukuoka, Japan, 819-1104
      • Seishinkai Inoue Hospital
  • Kanagawa
    • Naka-ku, Yokohama-Shi, Kanagawa, Japan, 231-0861
      • Women's Clinic LUNA NEXT STAGE
  • Osaka
    • Osaka-shi, Osaka, Japan, 532-0003
      • Medical Corporation Heishinkai OPHAC Hospital
    • Suita-shi, Osaka, Japan, 565-0853
      • Medical Corporation Heishinkai OCROM Clinic
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 103-0025
      • Nihonbashi Sakura Clinic
    • Chuo-ku, Tokyo, Japan, 104-0031
      • Fukuwa Clinic
    • Hachioji-shi, Tokyo, Japan, 1920071
      • P-one clinic, Keikokai medical corporation
    • Shibuya-ku, Tokyo, Japan, 1500001
      • Hillside Clinic Jingumae
    • Shinjuku-ku, Tokyo, Japan, 160-0008
      • Medical Corporation Heishinkai ToCROM Clinic
• Korea, Republic of
  • Daegu, Korea, Republic of, 41944
    • Kyungpook National University Hospital
  • Incheon, Korea, Republic of, 22332
    • Inha University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of, 07441
    • Hallym University Kangnam Sacred Heart Hospital
  • Seoul, Korea, Republic of, 07985
    • Ewha Womans University Mokdong Hospital
  • Seoul, Korea, Republic of, 05355
    • Kangdong Sacred Heart Hospital
  • Gyeonggi-do
    • Ansan-si, Gyeonggi-do, Korea, Republic of, 15355
      • Korea University Ansan Hospital
    • Suwon, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou University Hospital
    • Suwon-si, Gyeonggi-do, Korea, Republic of, 16247
      • The Catholic university of Korea, St. Vincent's Hospital
  • Seoul-teukbyeolsi [seoul]
    • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 08308
      • Korea University Guro Hospital
• Taiwan
  • New Taipei City, Taiwan, 23561
    • Taipei Medical University Shuang Ho Hospital
  • New Taipei City,, Taiwan, 220
    • Far Eastern Memorial Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taoyuan City, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

• Male or female participants 60 years of age and older 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, 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 study intervention. (For adults 60 through 64 years of age to be enrolled at Japan sites: Participants must have a preexisting chronic stable disease with an elevated risk for pneumococcal disease.)

Exclusion criteria:

• History of microbiologically proven invasive disease caused by S pneumoniae.
• Serious chronic disorder, including metastatic malignancy, severe COPD requiring supplemental oxygen, end-stage renal disease with or without dialysis, cirrhosis of the liver, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
• Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 20vPnC/Saline; 20vPnC and saline	Other: Saline; Saline; Biological: 20vPnC; 20vPnC
Active Comparator: 13vPnC/PPSV23; 13vPnC and PPSV23	Biological: 13vPnC; Pneumococcal conjugate vaccine; Biological: PPSV23; Pneumococcal polysaccharide vaccine; Other Names: Pneumovax 23

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 1 (20vPnC or 13vPnC)	Reactions were collected in the e-diary including redness, swelling, and pain at the injection site. Exact 2-sided CI was calculated based on the Clopper and Pearson method. Redness and swelling were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), and severe (>10.0 cm). Pain at the injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), and severe (prevents daily activity).	Within 10 days after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC)	Events were collected in the e-diary including fever, headache, fatigue, muscle pain, and joint pain. Exact 2-sided CI was calculated based on the Clopper and Pearson method. Fever was categorized as ≥38.0 degree Celsius (°C), ≥38.0°C to 38.4°C, >38.4°C to 38.9°C, >38.9°C to 40.0°C, and >40.0°C. Fatigue, headache, muscle pain, and joint pain were graded as mild (does not interfere with activity), moderate (some interference with activity), and severe (prevents daily activity).	Within 7 days after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 (20vPnC or 13vPnC)	An AE is 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 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group
Percentage of Participants With Serious Adverse Events (SAEs) Within 1 Month After Vaccination 1 (20vPnC or 13vPnC)	An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; resulted in congenital anomaly/birth defect or that was considered to be an important medical event.	Within 1 month after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13-matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC)	OPA titers were determined for the 13 matching pneumococcal serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F. GMTs and 2-sided CIs were calculated by exponentiating the Least Square (LS) means and the corresponding CIs based on analysis of log-transformed OPA titers using a regression model with vaccine group, sex, smoking status, age at vaccination in years (continuous), baseline log-transformed OPA titers, and country.	1 month after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group
Pneumococcal OPA GMTs for 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23)	OPA titers were determined for serotypes: 8, 10A, 11A, 12F, 15B, 22F, and 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 with vaccine group, sex, smoking status, age at vaccination in years (continuous), baseline log-transformed OPA titers, and country.	1 month after 20vPnC in the 20vPnC/Saline group or 1 month after PPSV23 in the 13vPnC/PPSV23 group.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OPA Geometric Mean Fold Rise (GMFRs) For 13-matched Serotypes From Before To 1 Month After Vaccination 1 (20vPnC or 13vPnC)	GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student's t distribution), for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.	Before Vaccination 1 to 1 month after 20vPnC in the 20vPnC/saline group or 13vPnC in the 13vPnC/PPSV23 group.
OPA GMFRs for 7 Additional Serotypes From Before to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23)	GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student's t distribution), for serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F.	From before Vaccination 1 (20vPnC) to 1 month after Vaccination 1 (20vPnC) in the 20vPnC/Saline group or from before Vaccination 1 (13vPnC) to 1 month after Vaccination 2 (PPSV23) in the 13vPnC/PPSV23 group
Percentage of Participants With ≥4 Fold Rise for 13-matched Serotypes of OPA Titers From Before to 1 Month After Vaccination 1 (20vPnC or 13vPnC)	The percentage of participants with a ≥4-fold rise in OPA titers and associated 95% CI before vaccination to 1 month after vaccination with 20vPnC or 13vPnC for the 13 matching serotypes, including 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F were summarized.	From before Vaccination 1 to 1 month after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group
Percentage of Participants With ≥4 Fold Rise in 7 Additional Serotypes of OPA Titers From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23)	The percentage of participants with a ≥4-fold rise in OPA titers and associated 95% CI before vaccination to 1 month after vaccination with 20vPnC or PPSV23 for the 7 additional serotypes, including 8, 10A, 11A, 12F, 15B, 22F, and 33F were summarized.	From before Vaccination 1 (20vPnC) to 1 month after Vaccination 1 (20vPnC) in the 20vPnC/Saline group or from before Vaccination 1 (13vPnC) to 1 month after Vaccination 2 (PPSV23) in the 13vPnC/PPSV23 group
Percentage of Participants With 13-matched Serotypes of OPA Titers ≥The Lower Limit of Quantitation (LLOQ) 1 Month After Vaccination 1 (20vPnC or 13vPnC)	The percentage of participants with OPA titers ≥LLOQ and associated 95% CIs were calculated for the time point 1 month after vaccination with 20vPnC or 13vPnC for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.	1 month after 20vPnC in the 20vPnC/saline group or 13vPnC in the 13vPnC/PPSV23 group
Percentage of Participants With Pneumococcal OPA Titers ≥LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23)	The percentage of participants with OPA titers ≥LLOQ and associated 95% CIs were calculated for the time point 1 month after vaccination with 20vPnC in the 20vPnC/saline groups or PPSV23 in the 13vPnC/PPSV23 group for serotypes: 8, 10A, 11A, 12F, 15B, 22F, and 33F.	1 month after Vaccination 1 (20vPnC) in the 20vPnC/saline group or a month after Vaccination 2 (PPSV23) in the 13vPnC/PPSV23 group
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites	Reactions within 10 days after Vaccination 2 (PPSV23 or saline) in participants enrolled at Japan sites were collected in the e-diary including redness, swelling, and pain at the injection site. Exact 2-sided CI was calculated based on the Clopper and Pearson method. Redness and swelling were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), and severe (>10.0 cm). Pain at the injection site was grades as mild (does not interfere with activity), moderate (interferes with activity), and severe (prevents daily activity). This endpoint was requested by local Japan regulator.	Within 10 days after saline in 20vPnC/Saline group or PPSV23 in 13vPnC/PPSV23 group
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites	Events within 7 days after Vaccination 2 (PPSV23 or saline) in participants enrolled at Japan sites were collected in the e-diary including fever, headache, fatigue, muscle pain, and joint pain. Exact 2-sided CI was calculated based on the Clopper and Pearson method. Fever was categorized as ≥38.0 °C, ≥38.0°C to 38.4°C, >38.4°C to 38.9°C, >38.9°C to 40.0°C, and >40.0°C. Fatigue, headache, muscle pain, and joint pain were grades as mild (does not interfere with activity), moderate (some interference with activity), and severe (prevents daily activity). This endpoint was requested by local Japan regulator.	Within 7 days after saline in 20vPnC/Saline group or PPSV23 in 13vPnC/PPSV23 group

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, 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): June 14, 2021
• Primary Completion (Actual): May 13, 2022
• Study Completion (Actual): May 13, 2022

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 5, 2023
• Last Verified: November 1, 2023

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; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: B7471009

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
• product manufactured in and exported from the U.S.: Yes