E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Not possible to specify |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the safety and tolerability of a single dose of 13vPnC as measured by the incidence of local reactions, systemic events, adverse events, and serious adverse events. |
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E.2.2 | Secondary objectives of the trial |
To describe the immune responses elicited by a single dose of 13vPnC. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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 metastaticmalignancy, 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.
Documented S pneumoniae infection within the past 5 years before investigational product administration. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of subjects reporting local reactions (redness, swelling, pain at injection site) and severity of the local reactions occurring within the 7 day period following study vaccination in the 6- to <18-year age group.
Percentage of subjects reporting local reactions (redness, swelling, pain at injection site) and severity of the local reactions occurring within the 14 day period following study vaccination in the 18 to <65-year age group.
Percentage of subjects reporting adverse events (AEs) within 1 month after vaccination.
Percentage of subjects reporting serious adverse events (SAEs) within 1 month after vaccination. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
7 day period following study vaccination in the 6- to <18-year age group.
14 day period following study vaccination in the 18 to <65-year age group.
1 month after vaccination.
1 month after vaccination. |
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E.5.2 | Secondary end point(s) |
Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) 1 month after vaccination.
Geometric mean fold rises (GMFRs) in serotype specific OPA titers from before vaccination to 1 month after vaccination.
Serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) 1 month after vaccination.
GMFRs in serotype-specific IgG from before vaccination to 1 month after vaccination. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 month after vaccination |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 6 |