Phase 3
Completed N=206
A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.
Pneumococcal Infections
Source: ClinicalTrials.gov NCT03571607 ↗
Enrolled (actual)
206
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years — 21.3; 10.6; 10.6; 0.0 percentage of participants
◆ Published Evidence
Emerging
3citations · ~1 / year
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.
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.
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years |
21.3; 10.6; 10.6; 0.0; 34.0; 14.9 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years |
7.4; 5.2; 2.2; 0.0; 12.5; 5.1 | — |
| PRIMARY 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 |
12.5; 2.1; 0.0; 0.0; 37.5; 25.0 | — |
| PRIMARY 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 |
6.0; 0.0; 0.0; 0.0; 33.1; 25.4 | — |
| PRIMARY Percentage of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) |
16; 0 | — |
| SECONDARY Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination |
10; 152; 11; 63; 18; 1257 | — |
| SECONDARY Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination |
15.6; 5.5; 61.7; 11.2; 34.7; 21.9 | — |
| SECONDARY Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination |
0.132; 4.427; 0.115; 0.531; 0.055; 1.826 | — |
| SECONDARY GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination |
33.445; 4.605; 32.960; 47.565; 23.587; 22.421 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03571607) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.