A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.

Pfizer

Status and phase

Completed

Phase 3

Conditions

Pneumococcal Infections

Treatments

Biological: 13-valent pneumococcal conjugate vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT03571607

2018-003054-24 (EudraCT Number)

B1851172

Details and patient eligibility

About

This study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine in Japanese subjects aged 6 to 64 years who are considered to be at increased risk of pneumococcal disease and who are naive to pneumococcal vaccines.

Enrollment

206 patients

Sex

All

Ages

6 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Japanese males and females aged 6 to <65 years at enrollment.
Subjects with an increased risk of pneumococcal disease determined by documented medical history, physical examination, and clinical judgment of the investigator.

Exclusion criteria

Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt during study participation.
End-stage disease including but not limited to metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, or end-stage renal disease with or without dialysis.
Graft-versus-host disease (GVHD), history of solid organ transplant within 6 months before investigational product administration or history of HSCT, or potential for solid organ transplant or HSCT during study participation.
Receipt of cytotoxic chemotherapy or blood products within 3 months before investigational product administration or anti-B-cell antibodies within 6 months before investigational product administration through completion of study participation.
Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
Documented S pneumoniae infection within the past 5 years before investigational product administration.