臨床研究等提出・公開システム

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-NAiVE ADULTS 60 YEARS OF AGE AND OLDER IN JAPAN, KOREA, AND TAIWAN

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naive Adults 60 Years of Age and Older in Japan, Korea, and Taiwan

1425

There were 832, 349, and 240 participants in Japan, Korea, and Taiwan, respectively. There were more male than female participants. The majority of the participants (59%) never smoked.

A total of 1425 participants were randomized in the study to receive either 20-valent pneumococcal conjugate vaccine (20vPnC)/saline or 13-valent pneumococcal conjugate vaccine (13vPnC)/23-valent pneumococcal polysaccharide vaccine (PPSV23), 1421 (99.7%) received Vaccination 1, 1394 (97.8%) received Vaccination 2, and 1391 (97.6%) completed all visits in the study.

* The proportions of participants who reported prompted local reactions and systemic events were similar in the 2 groups. Most local reactions and systemic events were mild or moderate in severity. * Rates of adverse events within 1 month after 20vPnC or 13vPnC were similar in the 2 groups. No safety concerns were identified. * The proportions of participants reporting any serious adverse events (SAEs) were low and similar in the 2 groups. No SAEs were considered related to 20vPnC in this study.

* The immune responses to all 13-matched vaccine serotypes induced by 20vPnC were noninferior to those induced by 13vPnC. * The immune responses to 6 of the 7 additional vaccine serotypes induced by 20vPnC were noninferior to those induced by PPSV23. * Serotype 8 narrowly missed the statistical noninferiority (NI) criterion 1 month after 20vPnC. However, the serotype 8 immune response is expected to be similarly protective as the 19 vaccine serotypes in 20vPnC that met NI, based on opsonophagocytic activity (OPA) geometric mean titer (GMT), geometric mean fold rise (GMFR), proportion of participants with a >=4-fold rise in OPA titers, and proportion of participants with OPA titers >= lower limit of quantitation (LLOQ). * Robust immune responses to all 20 vaccine serotypes 1 month after 20vPnC were observed in adults >=60 years of age, based on OPA GMTs, GMFRs, proportions of participants with a >=4-foldrise in OPA titers, and proportions of participants with OPA titers >= LLOQ. * Immune responses to all 20 vaccine serotypes were increased after 20vPnC for each of the 3 countries.

20vPnC was observed to have a tolerability and safety profile similar to 13vPnC. Based on the robust immune responses and comparability to licensed pneumococcal vaccines (13vPnC and PPSV23) for applicable serotypes, these data support that 20vPnC will be protective against pneumococcal disease due to the 20 serotypes in adults 60 years of age and older in Japan, Korea, and Taiwan.

Nov. 30, 2023

Dec. 07, 2022

https://www.clinicaltrials.gov/study/NCT04875533

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.

https://jrct.mhlw.go.jp/latest-detail/jRCT2051210030

Kawai Norisuke

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

clinical-trials@pfizer.com

Clinical Trials Information Desk

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

+81-3-5309-7000

clinical-trials@pfizer.com

Complete

June. 14, 2021

Interventional

randomized controlled trial

double blind

active control

parallel assignment

prevention purpose

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.

Both

Prevention of pneumococcal disease

Biological: 20vPnC
20vPnC

Other: Saline
Saline

Biological: 13vPnC
Pneumococcal conjugate vaccine

Biological: PPSV23
Pneumococcal polysaccharide vaccine
Other Name: Pneumovax 23

Primary Outcome Measures :
1.Percentage of subjects reporting prompted local reactions within 10 days after vaccination (redness,swelling, and pain at the injection site) [ Time Frame: 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) [ Time Frame: 7 days after Vaccination 1 ]
Prompted systemic events after Vaccination 1.

3.Percentage of subjects reporting adverse events (AEs) within 1 month after vaccination [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 7 days after Vaccination 2 ]
Prompted systemic events after Vaccination 2.

+81-6-6395-9000

May. 06, 2021

Korea/Taiwan