Clinical trial NCT04875533: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-05-06
Enrollment: 1425
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 1 (20vPnC or 13vPnC)
timeFrame: Within 10 days after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group
measure: Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC)
timeFrame: Within 7 days after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group
measure: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 (20vPnC or 13vPnC)
timeFrame: Within 1 month after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group
measure: Percentage of Participants With Serious Adverse Events (SAEs) Within 1 Month After Vaccination 1 (20vPnC or 13vPnC)
timeFrame: Within 1 Month After Vaccination 1 (20vPnC or 13vPnC)
measure: Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13-matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC)
timeFrame: 1 month after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group
measure: Pneumococcal OPA GMTs for 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23)
timeFrame: 1 month after 20vPnC in the 20vPnC/Saline group or 1 month after PPSV23 in the 13vPnC/PPSV23 group.
Secondary outcomes:
measure: OPA Geometric Mean Fold Rise (GMFRs) For 13-matched Serotypes From Before To 1 Month After Vaccination 1 (20vPnC or 13vPnC)
timeFrame: Before Vaccination 1 to 1 month after 20vPnC in the 20vPnC/saline group or 13vPnC in the 13vPnC/PPSV23 group.
measure: 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)
timeFrame: 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
measure: 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)
timeFrame: From before Vaccination 1 to 1 month after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group
measure: 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)
timeFrame: 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
measure: Percentage of Participants With 13-matched Serotypes of OPA Titers ≥The Lower Limit of Quantitation (LLOQ) 1 Month After Vaccination 1 (20vPnC or 13vPnC)
timeFrame: 1 month after 20vPnC in the 20vPnC/saline group or 13vPnC in the 13vPnC/PPSV23 group
measure: 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)
timeFrame: 1 month after Vaccination 1 (20vPnC) in the 20vPnC/saline group or a month after Vaccination 2 (PPSV23) in the 13vPnC/PPSV23 group
measure: Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites
timeFrame: Within 10 days after saline in 20vPnC/Saline group or PPSV23 in 13vPnC/PPSV23 group
measure: Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites
timeFrame: Within 7 days after saline in 20vPnC/Saline group or PPSV23 in 13vPnC/PPSV23 group
Other outcomes:
Locations:
city: Itoshima
country: Japan
facility: Seishinkai Inoue Hospital
state: Fukuoka
city: Naka-ku, Yokohama-Shi
country: Japan
facility: Women's Clinic LUNA NEXT STAGE
state: Kanagawa
city: Osaka-shi
country: Japan
facility: Medical Corporation Heishinkai OPHAC Hospital
state: Osaka
city: Suita-shi
country: Japan
facility: Medical Corporation Heishinkai OCROM Clinic
state: Osaka
city: Chuo-ku
country: Japan
facility: Nihonbashi Sakura Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
city: Hachioji-shi
country: Japan
facility: P-one Clinic, Keikokai Medical Corporation
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Hillside Clinic Jingumae
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Medical Corporation Heishinkai ToCROM Clinic
state: Tokyo
city: Fukuoka
country: Japan
facility: SOUSEIKAI PS Clinic
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Seoul-teukbyeolsi [seoul]
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Asan medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: New Taipei City,
country: Taiwan
facility: Far Eastern Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: