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

NCT04875533 | Completed Phase 3 Results FDA Drug

• 1 other identifier: B7471009
• Study Type: interventional
• Target: 1,425
• Locations: 3 countries
• Sites: 28

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

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (6)

• 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 Vaccination 1 (20vPnC or 13vPnC)

• 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 Outcomes (8)

• OPA Geometric Mean Fold Rise (GMFRs) For 13-matched Serotypes From Before To 1 Month After Vaccination 1 (20vPnC or 13vPnC)

  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)

  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)

  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)

  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)

  1 month after 20vPnC in the 20vPnC/saline group or 13vPnC in the 13vPnC/PPSV23 group

Study Arms (2)

20vPnC/Saline

EXPERIMENTAL

20vPnC and saline

Biological: 20vPnC; Other: Saline

13vPnC/PPSV23

ACTIVE COMPARATOR

13vPnC and PPSV23

Biological: 13vPnC; Biological: PPSV23

Interventions

20vPnC BIOLOGICAL

20vPnC

20vPnC/Saline

Saline OTHER

Saline

20vPnC/Saline

13vPnC BIOLOGICAL

Pneumococcal conjugate vaccine

13vPnC/PPSV23

PPSV23 BIOLOGICAL

Pneumococcal polysaccharide vaccine

Also known as: Pneumovax 23

13vPnC/PPSV23

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (28)

Seishinkai Inoue Hospital

Itoshima, Fukuoka, 819-1104, Japan

Location

Women's Clinic LUNA NEXT STAGE

Naka-ku, Yokohama-Shi, Kanagawa, 231-0861, Japan

Location

Medical Corporation Heishinkai OPHAC Hospital

Osaka, Osaka, 532-0003, Japan

Location

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, Osaka, 565-0853, Japan

Location

Nihonbashi Sakura Clinic

Chuo-ku, Tokyo, 103-0025, Japan

Location

Fukuwa Clinic

Chuo-ku, Tokyo, 104-0031, Japan

Location

P-one Clinic, Keikokai Medical Corporation

Hachioji-shi, Tokyo, 1920071, Japan

Location

Hillside Clinic Jingumae

Shibuya-ku, Tokyo, 1500001, Japan

Location

Medical Corporation Heishinkai ToCROM Clinic

Shinjuku-ku, Tokyo, 160-0008, Japan

Location

SOUSEIKAI PS Clinic

Fukuoka, 812-0025, Japan

Location

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, 15355, South Korea

Location

The Catholic University of Korea, St. Vincent's Hospital

Suwon, Gyeonggi-do, 16247, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Korea University Guro Hospital

Seoul, Seoul-teukbyeolsi [seoul], 08308, South Korea

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Kangdong Sacred Heart Hospital

Seoul, 05355, South Korea

Location

Asan medical Center

Seoul, 05505, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, 07441, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, 07985, South Korea

Location

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

Taipei Medical University Shuang Ho Hospital

New Taipei City, 23561, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Location

Related Publications (1)

• Haranaka M, Young Song J, Huang KC, de Solom R, Yamaji M, McElwee K, Kline M, Aizawa M, Peng Y, Scully I, Kogawara O, Gruber WC, Scott DA, Watson W. A phase 3 randomized trial of the safety and immunogenicity of 20-valent pneumococcal conjugate vaccine in adults >/= 60 years of age in Japan, South Korea, and Taiwan. Vaccine. 2024 Feb 15;42(5):1071-1077. doi: 10.1016/j.vaccine.2024.01.004. Epub 2024 Jan 23.

  PMID: 38267330 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

Sodium Chloride; 23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_lnquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 6, 2021
• Study Start: June 14, 2021
• Primary Completion: May 13, 2022
• Study Completion: May 13, 2022
• Last Updated: November 5, 2024
• Results First Posted: November 28, 2023

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

KR (12); JP (10); TW (6)