Pneumococcal DiseasePhase 3NCT04875533

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

A Phase 3 study testing 20vPnC, Saline and 13vPnC in people with Pneumococcal Disease, run by Pfizer at 28 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Pneumococcal Disease
What is being tested?: 20vPnC, Saline and 13vPnC
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,425 participants
Where: 28 sitesin 3 countries
Study dates: 14 Jun 2021to 13 May 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.)

Who cannot join

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.

Trial locations and contacts

28 sites in 3 countries.

Country

City, postcode or hospital

28 sites in 3 countries

South Korea12 sites

Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 15355
Kyungpook National University Hospital
Daegu, 41944
Inha University Hospital
Incheon, 22332
Korea University Guro Hospital
Seoul, Seoul-teukbyeolsi [seoul], 08308
Severance Hospital, Yonsei University Health System
Seoul, 03722
Kangdong Sacred Heart Hospital
Seoul, 05355
Asan medical Center
Seoul, 05505
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441
Ewha Womans University Mokdong Hospital
Seoul, 07985
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
Ajou University Hospital
Suwon, Gyeonggi-do, 16499

Other trials in South Korea

Japan10 sites

Nihonbashi Sakura Clinic
Chuo-ku, Tokyo, 103-0025
Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031
SOUSEIKAI PS Clinic
Fukuoka, 812-0025
P-one Clinic, Keikokai Medical Corporation
Hachioji-shi, Tokyo, 1920071
Seishinkai Inoue Hospital
Itoshima, Fukuoka, 819-1104
Women's Clinic LUNA NEXT STAGE
Naka-ku, Yokohama-Shi, Kanagawa, 231-0861
Medical Corporation Heishinkai OPHAC Hospital
Osaka, Osaka, 532-0003
Hillside Clinic Jingumae
Shibuya-ku, Tokyo, 1500001
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, Tokyo, 160-0008
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, 565-0853

Other trials in Japan

Taiwan6 sites

Far Eastern Memorial Hospital
New Taipei City, 220
Taipei Medical University Shuang Ho Hospital
New Taipei City, 23561
China Medical University Hospital
Taichung, 40447
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 10002
Linkou Chang Gung Memorial Hospital
Taoyuan City, 333

Other trials in Taiwan

About this study

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

Conditions: Pneumococcal Disease
Being tested: 20vPnC, Saline, 13vPnC, PPSV23
Medical subject headings: Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

20vPnCBiological
20vPnC
SalineOther
Saline
13vPnCBiological
Pneumococcal conjugate vaccine
PPSV23Biological
Also called Pneumovax 23
Pneumococcal polysaccharide vaccine

Study groups in NCT04875533
Study group	Role	What they receive
20vPnC/Saline	Experimental	20vPnC and saline Receives: Biological: 20vPnC; Other: Saline
13vPnC/PPSV23	Active comparator	13vPnC and PPSV23 Receives: Biological: 13vPnC; Biological: PPSV23

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jun 202113 May 2022

First posted6 May 2021
Study start14 Jun 2021
Primary completion13 May 2022
Study completion13 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pneumococcal DiseaseStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,425 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04875533
Sponsor's protocol ID: B7471009
Status last verified: Oct 2024
First submitted: 3 May 2021
Last updated: 5 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 38267330

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04875533
Acronym / sponsor ID: B7471009
Conditions: Pneumococcal Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,425 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 14 Jun 2021 (actual)
Primary completion: 13 May 2022 (actual)
Study completion: 13 May 2022 (actual)
First posted: 6 May 2021 (actual)
Results: Posted 28 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
20vPnC/Saline	Experimental	Biological: 20vPnC, Other: Saline20vPnC and saline
13vPnC/PPSV23	Active comparator	Biological: 13vPnC, Biological: PPSV2313vPnC and PPSV23

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.)

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
20vPnC20vPnC	Biological	20vPnC/Saline
SalineSaline	Other	20vPnC/Saline
13vPnCPneumococcal conjugate vaccine	Biological	13vPnC/PPSV23
PPSV23Also: Pneumovax 23Pneumococcal polysaccharide vaccine	Biological	13vPnC/PPSV23

Primary outcome

Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 1 (20vPnC or 13vPnC)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.

8 secondary outcomes

OPA Geometric Mean Fold Rise (GMFRs) For 13-matched Serotypes From Before To 1 Month After Vaccination 1 (20vPnC or 13vPnC)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 1 month after 20vPnC in the 20vPnC/saline group or 13vPnC in the 13vPnC/PPSV23 group
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)
Time frame: 1 month after Vaccination 1 (20vPnC) in the 20vPnC/saline group or a month after Vaccination 2 (PPSV23) in the 13vPnC/PPSV23 group
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites
Time frame: Within 10 days after saline in 20vPnC/Saline group or PPSV23 in 13vPnC/PPSV23 group
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites
Time frame: Within 7 days after saline in 20vPnC/Saline group or PPSV23 in 13vPnC/PPSV23 group

Results and safety

Results posted to the registry on 28 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
20vPnC/Saline	711	692
13vPnC/PPSV23	710	699

Primary outcome: Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 1 (20vPnC or 13vPnC)

Time frame: Within 10 days after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group. Number (95% Confidence Interval). Unit: percentage of participants

Measure	20vPnC/Saline n = 710	13vPnC/PPSV23 n = 710
Redness-Any	12.4 (10.1 to 15.0)	9.7 (7.6 to 12.1)
Redness-Mild	6.2 (4.5 to 8.2)	4.5 (3.1 to 6.3)
Redness-Moderate	4.8 (3.3 to 6.6)	3.9 (2.6 to 5.6)
Redness-Severe	1.4 (0.7 to 2.6)	1.3 (0.6 to 2.4)
Swelling-Any	10.4 (8.3 to 12.9)	7.5 (5.6 to 9.7)
Swelling-Mild	5.4 (3.8 to 7.3)	3.5 (2.3 to 5.2)
Swelling-Moderate	4.5 (3.1 to 6.3)	3.1 (2.0 to 4.7)
Swelling-Severe	0.6 (0.2 to 1.4)	0.8 (0.3 to 1.8)

Population analysed: Safety population included all participants who received at least 1 dose of the study intervention (20vPnC, 13vPnC, PPSV23 or saline) and had safety follow-up after any vaccination. Here, "Number of Participants Analyzed"=number of participants with any e-diary data reported after 20vPnC or 13vPnC.

Primary outcome: Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC)

Time frame: Within 7 days after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group. Number (95% Confidence Interval). Unit: percentage of participants

Measure	20vPnC/Saline n = 710	13vPnC/PPSV23 n = 710
Fever ≥38.0°C	0.1 (0.0 to 0.8)	0.6 (0.2 to 1.4)
Fever ≥38.0°C to 38.4°C	0.1 (0.0 to 0.8)	0.3 (0.0 to 1.0)
Fever >38.4°C to 38.9°C	0 (0.0 to 0.5)	0.1 (0.0 to 0.8)
Fever >38.9°C to 40.0°C	0 (0.0 to 0.5)	0.1 (0.0 to 0.8)
Fever >40.0°C	0 (0.0 to 0.5)	0 (0.0 to 0.5)
Fatigue-Any	20.7 (17.8 to 23.9)	23.0 (19.9 to 26.2)
Fatigue-Mild	18.0 (15.3 to 21.1)	18.9 (16.1 to 21.9)
Fatigue-Moderate	2.7 (1.6 to 4.1)	3.8 (2.5 to 5.5)

Population analysed: Safety population included all participants who received at least 1 dose of the study intervention (20vPnC, 13vPnC, PPSV23 or saline) and had safety follow-up after any vaccination. Here, "Number of Participants Analyzed" is number of participants with any e-diary data reported after 20vPnC or 13vPnC.

Primary outcome: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 (20vPnC or 13vPnC)

Time frame: Within 1 month after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group. Number (95% Confidence Interval). Unit: percentage of participants

Measure	20vPnC/Saline n = 711	13vPnC/PPSV23 n = 710
Value	5.6 (4.0 to 7.6)	5.9 (4.3 to 7.9)

Primary outcome: Percentage of Participants With Serious Adverse Events (SAEs) Within 1 Month After Vaccination 1 (20vPnC or 13vPnC)

Time frame: Within 1 Month After Vaccination 1 (20vPnC or 13vPnC). Number (95% Confidence Interval). Unit: percentage of participants

Measure	20vPnC/Saline n = 711	13vPnC/PPSV23 n = 710
Value	0.4 (0.1 to 1.2)	0.6 (0.2 to 1.4)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
20vPnC/Saline (Vaccination 1)	3 of 711 (0.4%)	448 of 711 (63%)	0 of 711
13vPnC/PPSV23 (Vaccination 1)	4 of 710 (0.6%)	439 of 710 (61.8%)	0 of 710
20vPnC/Saline (Vaccination 2)	4 of 695 (0.6%)	78 of 695 (11.2%)	0 of 695
13vPnC/PPSV23 (Vaccination 2)	3 of 699 (0.4%)	333 of 699 (47.6%)	0 of 699

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38267330Haranaka 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

28 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 20vPnC, Saline and 13vPnC in people with Pneumococcal Disease, run by Pfizer at 28 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in South Korea, Japan, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 1 (20vPnC or 13vPnC) (time frame: Within 10 days after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04875533, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.