Phase 3
N=206
A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.
Pneumococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT03571607 ↗Enrolled (actual)
206
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: 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 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13-valent pneumococcal conjugate vaccine (Biological)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Nov 2018
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 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03571607). 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.