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

Phase 3

Completed

• Conditions: Pneumococcal Disease
• Interventions: Biological: 13vPnC; Biological: 20vPnC; Other: Saline; Biological: PPSV23

• Registration Number: NCT04875533
• Lead Sponsor: Pfizer

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-03
• Study First Posted: 2021-05-06
• Study Start: 2021-06-14
• Primary Completion: 2022-05-13
• Study Completion: 2022-05-13
• Results First Submitted: 2023-05-10
• Results First Submitted QC: 2023-11-05
• Results First Posted: 2023-11-28
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1425

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
13vPnC/PPSV23	13vPnC	13vPnC and PPSV23
20vPnC/Saline	Saline	20vPnC and saline
13vPnC/PPSV23	PPSV23	13vPnC and PPSV23
20vPnC/Saline	20vPnC	20vPnC and saline

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 1 (20vPnC or 13vPnC)	Within 10 days after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group	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).
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC)	Within 7 days after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group	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).
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 (20vPnC or 13vPnC)	Within 1 month after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group	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.
Percentage of Participants With Serious Adverse Events (SAEs) Within 1 Month After Vaccination 1 (20vPnC or 13vPnC)	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.
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13-matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC)	1 month after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group	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.
Pneumococcal OPA GMTs for 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23)	1 month after 20vPnC in the 20vPnC/Saline group or 1 month after PPSV23 in the 13vPnC/PPSV23 group.	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.

Secondary Outcome Measures

Name	Time	Method
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.	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.
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	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.
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)	1 month after Vaccination 1 (20vPnC) in the 20vPnC/saline group or a month after Vaccination 2 (PPSV23) in the 13vPnC/PPSV23 group	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.
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	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.
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	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.
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites	Within 7 days after saline in 20vPnC/Saline group or PPSV23 in 13vPnC/PPSV23 group	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.
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	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.
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites	Within 10 days after saline in 20vPnC/Saline group or PPSV23 in 13vPnC/PPSV23 group	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.

Trial Locations

Locations (28)

Seishinkai Inoue Hospital; 🇯🇵 Itoshima, Fukuoka, Japan

Medical Corporation Heishinkai OPHAC Hospital; 🇯🇵 Osaka-shi, Osaka, Japan

Fukuwa Clinic; 🇯🇵 Chuo-ku, Tokyo, Japan

SOUSEIKAI PS Clinic; 🇯🇵 Fukuoka, Japan

The Catholic University of Korea, St. Vincent's Hospital; 🇰🇷 Suwon-si, Gyeonggi-do, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of

Hallym University Kangnam Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan medical Center; 🇰🇷 Seoul, Korea, Republic of

Kangdong Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea, Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of

Far Eastern Memorial Hospital; 🇨🇳 New Taipei City,, Taiwan

Taipei Medical University Shuang Ho Hospital; 🇨🇳 New Taipei City, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Korea University Ansan Hospital; 🇰🇷 Ansan-si, Gyeonggi-do, Korea, Republic of

P-one Clinic, Keikokai Medical Corporation; 🇯🇵 Hachioji-shi, Tokyo, Japan

Women's Clinic LUNA NEXT STAGE; 🇯🇵 Naka-ku, Yokohama-Shi, Kanagawa, Japan

Medical Corporation Heishinkai OCROM Clinic; 🇯🇵 Suita-shi, Osaka, Japan

Hillside Clinic Jingumae; 🇯🇵 Shibuya-ku, Tokyo, Japan

Linkou Chang Gung Memorial Hospital; 🇨🇳 Taoyuan City, Taiwan

Medical Corporation Heishinkai ToCROM Clinic; 🇯🇵 Shinjuku-ku, Tokyo, Japan

Nihonbashi Sakura Clinic; 🇯🇵 Chuo-ku, Tokyo, Japan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan