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

JRCT ID: jRCT2051210030

Registered date:25/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prevention of pneumococcal disease
• Date of first enrollment: 14/06/2021
• Target sample size: 1400
• Countries of recruitment: Korea,Japan,Taiwan,Japan
• Study type: Interventional

Intervention(s)

Biological: 20vPnC
20vPnC

Other: Saline
Saline

Biological: 13vPnC
Pneumococcal conjugate vaccine

Biological: PPSV23
Pneumococcal polysaccharide vaccine
Other Name: Pneumovax 23

Outcome(s)

Primary Outcome

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

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.

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.)

Exclude criteria

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.

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT04875533