Clincosm LogoSign in Get a demo

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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT04875533
Collaborator
(none)
1,424
Enrollment
28
Locations
2
Arms
10.9
Actual Duration (Months)
50.9
Patients Per Site
4.6
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Biological: 20vPnC
  • Other: Saline
  • Biological: 13vPnC
  • Biological: PPSV23
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1424 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jun 14, 2021
Actual Primary Completion Date :
May 13, 2022
Actual Study Completion Date :
May 13, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 20vPnC/Saline

20vPnC and saline

Biological: 20vPnC
20vPnC

Other: Saline
Saline
Active Comparator: 13vPnC/PPSV23

13vPnC and PPSV23

Biological: 13vPnC
Pneumococcal conjugate vaccine

Biological: PPSV23
Pneumococcal polysaccharide vaccine
Other Names:
  • Pneumovax 23

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of subjects reporting prompted local reactions within 10 days after vaccination (redness,swelling, and pain at the injection site) [10 days after Vaccination 1]

      Prompted local reactions after Vaccination 1.

    2. Percentage of subjects reporting prompted systemic events within 7 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain) [7 days after Vaccination 1]

      Prompted systemic events after Vaccination 1.

    3. Percentage of subjects reporting adverse events (AEs) within 1 month after vaccination [1 month after Vaccination 1]

      AEs occurring within 1 month after Vaccination 1.

    4. Percentage of subjects reporting serious adverse events (SAEs) within 1 months after Vaccination 1 [1 month after Vaccination 1]

      SAEs occurring within 1 month after Vaccination 1.

    5. Serotype-specific OPA geometric mean titer (GMT) ratios 1 month after vaccination [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

    1. Serotype-specific OPA GMTs 1 month after vaccination [1 month after vaccination]

      OPA GMTs 1 month after vaccination.

    2. Geometric mean fold rise (GMFR) in serotype-specific OPA titers from before to 1 month after vaccination [From before to 1 month after vaccination]

      GMFR in OPA titers 1 month after vaccination.

    3. ≥4-Fold rise in serotype-specific OPA titers from before to 1 month after vaccination [From before to 1 month after vaccination]

      Participants with ≥4-fold rise in OPA titers 1 month after vaccination.

    4. Serotype-specific OPA titers greater than or equal to the lower limit of quantitation (LLOQ) 1 month after vaccination [1 month after vaccination]

      Participants with OPA titers greater than or equal to LLOQ 1 month after vaccination.

    5. 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 [10 days after Vaccination 2]

      Prompted local reactions after Vaccination 2.

    6. 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 [7 days after Vaccination 2]

      Prompted systemic events after Vaccination 2.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seishinkai Inoue Hospital Itoshima Fukuoka Japan 819-1104
    2 Women's Clinic LUNA NEXT STAGE Naka-ku, Yokohama-Shi Kanagawa Japan 231-0861
    3 Medical Corporation Heishinkai OPHAC Hospital Osaka-shi Osaka Japan 532-0003
    4 Medical Corporation Heishinkai OCROM Clinic Suita-shi Osaka Japan 565-0853
    5 Nihonbashi Sakura Clinic Chuo-ku Tokyo Japan 103-0025
    6 Fukuwa Clinic Chuo-ku Tokyo Japan 104-0031
    7 P-one Clinic, Keikokai Medical Corporation Hachioji-shi Tokyo Japan 1920071
    8 Hillside Clinic Jingumae Shibuya-ku Tokyo Japan 1500001
    9 Medical Corporation Heishinkai ToCROM Clinic Shinjuku-ku Tokyo Japan 160-0008
    10 PS Clinic Fukuoka Japan 812-0025
    11 Korea University Ansan Hospital Ansan-si Gyeonggi-do Korea, Republic of 15355
    12 The Catholic University of Korea, St. Vincent's Hospital Suwon-si Gyeonggi-do Korea, Republic of 16247
    13 Ajou university hospital Suwon Gyeonggi-do Korea, Republic of 16499
    14 Korea University Guro Hospital Seoul Seoul-teukbyeolsi [seoul] Korea, Republic of 08308
    15 Kyungpook National University Hospital Daegu Korea, Republic of 41944
    16 Inha University Hospital Incheon Korea, Republic of 22332
    17 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    18 Kangdong Sacred Heart Hospital Seoul Korea, Republic of 05355
    19 Asan medical Center Seoul Korea, Republic of 05505
    20 The Catholic University of Korea, Seoul St. Mary's Hospital Seoul Korea, Republic of 06591
    21 Hallym University Kangnam Sacred Heart Hospital Seoul Korea, Republic of 07441
    22 Ewha Womans University Mokdong Hospital Seoul Korea, Republic of 07985
    23 Far Eastern Memorial Hospital New Taipei City, Taiwan 220
    24 Taipei Medical University Shuang Ho Hospital New Taipei City Taiwan 23561
    25 China Medical University Hospital Taichung Taiwan 40447
    26 National Cheng Kung University Hospital Tainan Taiwan 704
    27 National Taiwan University Hospital Taipei Taiwan 10002
    28 Linkou Chang Gung Memorial Hospital Taoyuan City Taiwan 333

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT04875533
    Other Study ID Numbers:
    • B7471009
    First Posted:
    May 6, 2021
    Last Update Posted:
    Aug 5, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:
    Pneumococcal Infections
    Heptavalent Pneumococcal Conjugate Vaccine

    Study Results

    No Results Posted as of Aug 5, 2022