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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

Primary Purpose

Pneumococcal Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
20vPnC
Saline
13vPnC
PPSV23
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Disease

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Seishinkai Inoue Hospital
  • Women's Clinic LUNA NEXT STAGE
  • Medical Corporation Heishinkai OPHAC Hospital
  • Medical Corporation Heishinkai OCROM Clinic
  • Nihonbashi Sakura Clinic
  • Fukuwa Clinic
  • P-one Clinic, Keikokai Medical Corporation
  • Hillside Clinic Jingumae
  • Medical Corporation Heishinkai ToCROM Clinic
  • SOUSEIKAI PS Clinic
  • Korea University Ansan Hospital
  • The Catholic University of Korea, St. Vincent's Hospital
  • Ajou university hospital
  • Korea University Guro Hospital
  • Kyungpook National University Hospital
  • Inha University Hospital
  • Severance Hospital, Yonsei University Health System
  • Kangdong Sacred Heart Hospital
  • Asan medical Center
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Hallym University Kangnam Sacred Heart Hospital
  • Ewha Womans University Mokdong Hospital
  • Far Eastern Memorial Hospital
  • Taipei Medical University Shuang Ho Hospital
  • China Medical University Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Linkou Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

20vPnC/Saline

13vPnC/PPSV23

Arm Description

20vPnC and saline

13vPnC and PPSV23

Outcomes

Primary Outcome Measures

Percentage of subjects reporting prompted local reactions within 10 days after vaccination (redness,swelling, and pain at the injection site)
Prompted local reactions after Vaccination 1.
Percentage of subjects reporting prompted systemic events within 7 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain)
Prompted systemic events after Vaccination 1.
Percentage of subjects reporting adverse events (AEs) within 1 month after vaccination
AEs occurring within 1 month after Vaccination 1.
Percentage of subjects reporting serious adverse events (SAEs) within 1 months after Vaccination 1
SAEs occurring within 1 month after Vaccination 1.
Serotype-specific OPA geometric mean titer (GMT) ratios 1 month after vaccination
OPA GMT ratios 1 month after vaccination between the 20vPnC and 13vPnC for the 13 matched serotypes and 1 month after vaccination between 20vPnC and PPSV23 for the 7 additional serotypes.

Secondary Outcome Measures

Serotype-specific OPA GMTs 1 month after vaccination
OPA GMTs 1 month after vaccination.
Geometric mean fold rise (GMFR) in serotype-specific OPA titers from before to 1 month after vaccination
GMFR in OPA titers 1 month after vaccination.
≥4-Fold rise in serotype-specific OPA titers from before to 1 month after vaccination
Participants with ≥4-fold rise in OPA titers 1 month after vaccination.
Serotype-specific OPA titers greater than or equal to the lower limit of quantitation (LLOQ) 1 month after vaccination
Participants with OPA titers greater than or equal to LLOQ 1 month after vaccination.
Percentage of subjects reporting prompted local reactions within 10 days after vaccination (redness,swelling, and pain at the injection site) in participants enrolled from Japan sites
Prompted local reactions after Vaccination 2.
Percentage of subjects reporting prompted systemic events within 7 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain) in participants enrolled from Japan sites
Prompted systemic events after Vaccination 2.

Full Information

First Posted
May 3, 2021
Last Updated
December 5, 2022
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04875533
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
May 13, 2022 (Actual)
Study Completion Date
May 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1424 (Actual)

8. Arms, Groups, and Interventions

Arm Title
20vPnC/Saline
Arm Type
Experimental
Arm Description
20vPnC and saline
Arm Title
13vPnC/PPSV23
Arm Type
Active Comparator
Arm Description
13vPnC and PPSV23
Intervention Type
Biological
Intervention Name(s)
20vPnC
Intervention Description
20vPnC
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Saline
Intervention Type
Biological
Intervention Name(s)
13vPnC
Intervention Description
Pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
PPSV23
Other Intervention Name(s)
Pneumovax 23
Intervention Description
Pneumococcal polysaccharide vaccine
Primary Outcome Measure Information:
Title
Percentage of subjects reporting prompted local reactions within 10 days after vaccination (redness,swelling, and pain at the injection site)
Description
Prompted local reactions after Vaccination 1.
Time Frame
10 days after Vaccination 1
Title
Percentage of subjects reporting prompted systemic events within 7 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain)
Description
Prompted systemic events after Vaccination 1.
Time Frame
7 days after Vaccination 1
Title
Percentage of subjects reporting adverse events (AEs) within 1 month after vaccination
Description
AEs occurring within 1 month after Vaccination 1.
Time Frame
1 month after Vaccination 1
Title
Percentage of subjects reporting serious adverse events (SAEs) within 1 months after Vaccination 1
Description
SAEs occurring within 1 month after Vaccination 1.
Time Frame
1 month after Vaccination 1
Title
Serotype-specific OPA geometric mean titer (GMT) ratios 1 month after vaccination
Description
OPA GMT ratios 1 month after vaccination between the 20vPnC and 13vPnC for the 13 matched serotypes and 1 month after vaccination between 20vPnC and PPSV23 for the 7 additional serotypes.
Time Frame
1 month after vaccination
Secondary Outcome Measure Information:
Title
Serotype-specific OPA GMTs 1 month after vaccination
Description
OPA GMTs 1 month after vaccination.
Time Frame
1 month after vaccination
Title
Geometric mean fold rise (GMFR) in serotype-specific OPA titers from before to 1 month after vaccination
Description
GMFR in OPA titers 1 month after vaccination.
Time Frame
From before to 1 month after vaccination
Title
≥4-Fold rise in serotype-specific OPA titers from before to 1 month after vaccination
Description
Participants with ≥4-fold rise in OPA titers 1 month after vaccination.
Time Frame
From before to 1 month after vaccination
Title
Serotype-specific OPA titers greater than or equal to the lower limit of quantitation (LLOQ) 1 month after vaccination
Description
Participants with OPA titers greater than or equal to LLOQ 1 month after vaccination.
Time Frame
1 month after vaccination
Title
Percentage of subjects reporting prompted local reactions within 10 days after vaccination (redness,swelling, and pain at the injection site) in participants enrolled from Japan sites
Description
Prompted local reactions after Vaccination 2.
Time Frame
10 days after Vaccination 2
Title
Percentage of subjects reporting prompted systemic events within 7 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain) in participants enrolled from Japan sites
Description
Prompted systemic events after Vaccination 2.
Time Frame
7 days after Vaccination 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Seishinkai Inoue Hospital
City
Itoshima
State/Province
Fukuoka
ZIP/Postal Code
819-1104
Country
Japan
Facility Name
Women's Clinic LUNA NEXT STAGE
City
Naka-ku, Yokohama-Shi
State/Province
Kanagawa
ZIP/Postal Code
231-0861
Country
Japan
Facility Name
Medical Corporation Heishinkai OPHAC Hospital
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
532-0003
Country
Japan
Facility Name
Medical Corporation Heishinkai OCROM Clinic
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0853
Country
Japan
Facility Name
Nihonbashi Sakura Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0025
Country
Japan
Facility Name
Fukuwa Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
P-one Clinic, Keikokai Medical Corporation
City
Hachioji-shi
State/Province
Tokyo
ZIP/Postal Code
1920071
Country
Japan
Facility Name
Hillside Clinic Jingumae
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
1500001
Country
Japan
Facility Name
Medical Corporation Heishinkai ToCROM Clinic
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0008
Country
Japan
Facility Name
SOUSEIKAI PS Clinic
City
Fukuoka
ZIP/Postal Code
812-0025
Country
Japan
Facility Name
Korea University Ansan Hospital
City
Ansan-si
State/Province
Gyeonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, St. Vincent's Hospital
City
Suwon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Ajou university hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Kangdong Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
05355
Country
Korea, Republic of
Facility Name
Asan medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Hallym University Kangnam Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
07441
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
ZIP/Postal Code
07985
Country
Korea, Republic of
Facility Name
Far Eastern Memorial Hospital
City
New Taipei City,
ZIP/Postal Code
220
Country
Taiwan
Facility Name
Taipei Medical University Shuang Ho Hospital
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7471009
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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