Clinical trial NCT03571607: A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.
Official title: A PHASE 3, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO ASSESS 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-06-27
Enrollment: 206
Sex: ALL
Minimum age (years): 6
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
timeFrame: Day 1 up to Day 7
measure: Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
timeFrame: Day 1 up to Day 14
measure: Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
timeFrame: Day 1 up to Day 7
measure: Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
timeFrame: Day 1 up to Day 14
measure: Percentage of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: signing of informed consent form (Day 1) up to Day 43
Secondary outcomes:
measure: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
timeFrame: Pre-vaccination and 1 month after vaccination
measure: Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination
timeFrame: Pre-vaccination to 1 month after vaccination
measure: Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
timeFrame: Pre-vaccination and 1 month after vaccination
measure: GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination
timeFrame: Pre- vaccination to 1 month after vaccination
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Daido Clinic
state: Aichi
city: Fukuyama
country: Japan
facility: Nippon Kokan Fukuyama Hospital
state: Hiroshima
city: Fukuyama
country: Japan
facility: Fukuyama City Hospital
state: Hiroshima
city: Kawasaki
country: Japan
facility: Kawasaki Municipal Hospital
state: Kanagawa
city: Suzaka
country: Japan
facility: Nagano Prefectural Shinshu Medical Center
state: Nagano
city: Fukuoka
country: Japan
facility: Medical Co.LTA PS Clinic
city: Fukuoka
country: Japan
facility: Fukuoka Children's Hospital
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Yamazaki Y, Ikeda M, Imada T, Furuno K, Mizukami T, de Solom R, Shoji Y, Oe M, Aizawa M, Giardina PC, Schmoele-Thoma B, Scott DA. A phase 3, multicenter, single-arm, open-label study to assess the safety, tolerability, and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine in Japanese participants aged 6-64 years who are considered to be at increased risk of pneumococcal disease and who are naive to pneumococcal vaccines. Vaccine. 2021 Oct 15;39(43):6414-6421. doi: 10.1016/j.vaccine.2021.08.106. Epub 2021 Sep 23.