E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prophylaxis for prevention of Post-operative S. aureus infection |
Profilaxis para la prevención de la infección postoperatoria S. aureus |
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E.1.1.1 | Medical condition in easily understood language |
Bacterial infection |
Infección bacteriana |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060945 |
E.1.2 | Term | Bacterial infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004035 |
E.1.2 | Term | Bacterial infection due to staphylococcus aureus |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 |
Primary Efficacy Objective To assess the efficacy of SA4Ag in the prevention of postoperative S. aureus BSI and/or deep incisional or organ/space SSI occurring within 90 days of elective posterior instrumented lumbar spinal fusion procedures, in adults aged 18 to <86 years.
Primary Safety Objective To describe the safety and tolerability of a single vaccination of SA4Ag in adults aged 18 to <86 years undergoing elective posterior instrumented lumbar spinal fusion procedures, by measuring local reactions, systemic events, and AEs. |
Objetivo de eficacia principal Evaluar la eficacia de SA4Ag en la prevención de BSI por S. aureus postoperatoria y/o infección quirúrgica de órgano/espacio (SSI) o incisión profunda que se produce dentro de los 90 días siguientes a intervenciones quirúrgicas programadas de artrodesis vertebral posterior (lumbar) instrumentada, en adultos con edades comprendidas entre los 18 y <86 años
Objetivo de seguridad principal Describir la seguridad y la tolerancia de una vacuna individual de SA4Ag en adultos con edades comprendidas entre los 18 y <86 de edad que se someten a intervenciones quirúrgicas programadas de artrodesis vertebral posterior (lumbar) instrumentada midiendo las reacciones locales, los acontecimientos sistémicos y los acontecimientos adversos (AA). |
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E.2.2 | Secondary objectives of the trial |
Secondary Efficacy Objectives - To assess the efficacy of SA4Ag in the prevention of postoperative S. aureus BSI and/or deep incisional or organ/space SSI occurring within 180 days of elective posterior instrumented lumbar spinal fusion procedures, in adults 18 to <86 years of age. - To assess the efficacy of SA4Ag in the prevention of postoperative S. aureus SSI occurring within 90 days of elective posterior instrumented lumbar spinal fusion procedures, in adults 18 to <86 years of age. - To assess the efficacy of SA4Ag in the prevention of postoperative S. aureus SSI occurring within 180 days of elective posterior instrumented lumbar spinal fusion procedures, in adults 18 to <86 years of age. |
Objetivos de eficacia secundarios - Evaluar la eficacia de SA4Ag en la prevención de BSI por S. aureus postoperatoria y/o infección quirúrgica de órgano/espacio o incisión profunda (SSI) que se produce dentro de los 180 días siguientes a intervenciones quirúrgicas programadas de artrodesis vertebral posterior (lumbar) instrumentada en adultos con edades comprendidas entre los 18 y <86 años. - Evaluar la eficacia de SA4Ag en la prevención de SSI por S. aureus postoperatoria que se produce dentro de los 90 días siguientes a intervenciones quirúrgicas programadas de artrodesis vertebral posterior (lumbar) instrumentada, en adultos con edades comprendidas entre los 18 y <86 años. - Evaluar la eficacia de SA4Ag en la prevención de SSI por S. aureus postoperatoria que se produce dentro de los 180 días siguientes a intervenciones quirúrgicas programadas de artrodesis vertebral posterior (lumbar) instrumentada, en adultos con edades comprendidas entre los 18 y <86 años. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subject must personally sign and date the informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study. 2. Subject must be aged 18 to <86 years at the time of enrollment. 3. Subject must be scheduled to undergo an elective posterior instrumented lumbar spinal fusion procedure 10 to 60 days after study vaccination. 4. Subject must be available for the entire duration of the study, and willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures, including completion of the electronic diary (e-diary) for 10 days after study vaccination. 5. Subject must be able to be contacted by telephone during study participation. 6. Male subjects and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study. |
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E.4 | Principal exclusion criteria |
1. Planned spinal fusion procedure requiring separate operations performed on separate days (ie, staged procedure). 2. Surgical indication of malignancy, infection, or acute or emergency trauma. 3. History of major surgery (specifically, an open procedure that enters a body cavity, organ, or joint space) within 3 months prior to enrollment, or anticipated major surgery other than the index surgical procedure between study enrollment and completion of study participation. 4. History of any spinal surgery performed within 6 months prior to study enrollment. 5. History of any previous spinal surgery resulting in postoperative BSI or SSI. 6. Congenital or acquired immunodeficiency disorder, rheumatologic disorder, or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies, within the year prior to enrollment or the use of systemic corticosteroids (equivalent of ?10 mg/day of prednisone) for >14 days within 30 days prior to study enrollment. 7. History of leukemia, lymphoma, or underlying bone marrow disorder (eg, myelodysplasia, myeloma, myeloproliferative disorder) or history of bone marrow transplant. 8. Malignancy that required treatment with chemotherapy, immunotherapy, radiation therapy, or other antineoplastic target therapies within 24 months prior to study enrollment. 9. Any known or suspected malignancy to the spine. 10. Congenital, functional, or surgical asplenia. 11. End-stage renal disease (defined as requiring or anticipating requirement for hemodialysis, peritoneal dialysis, or renal transplant) or nephrotic syndrome. 12. Any contraindication to vaccination or vaccine components, including history of anaphylactic reaction to any vaccine or vaccine-related component. 13. Receipt of blood products or immunoglobulins (including monoclonal antibodies) within 6 months prior to study enrollment OR anticipated receipt of blood products or immunoglobulins (including monoclonal antibodies) prior to the index hospital admission. 14. Previous administration of S. aureus vaccine or S. aureus/Candida vaccine. 15. Antibiotic therapy for microbiologically confirmed ISA disease within 12 months prior to enrollment. 16. Participation in other studies involving investigational drug(s) (Phases 1-4) within 30 days before the current study begins and/or anticipated participation during the study. 17. Pregnant females, breastfeeding females, and males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception, for the duration of the study. 18. Presence of a colostomy, urostomy, tracheostomy, percutaneous gastrostomy tube, indwelling vascular, or urinary catheter; OR anticipated presence of a colostomy, urostomy, tracheostomy, percutaneous gastrostomy tube, indwelling vascular, or urinary catheter prior to the index hospital admission. 19. Other severe acute or chronic medical or psychiatric condition (including drug and alcohol dependencies) or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 20. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the conduct of the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Efficacy Endpoint The number of subjects in each vaccine group with postoperative S. aureus BSI and/or deep incisional or organ/space SSI occurring within 90 days of elective posterior instrumented lumbar spinal fusion procedures, as confirmed by the event adjudication committee (EAC).
Primary Safety Endpoints - Number and proportion of subjects in each vaccine group with local reactions (redness, swelling, and pain) occurring within the 10-day period following study vaccination. - Number and proportion of subjects in each vaccine group with systemic events (fever, fatigue, headache, vomiting, diarrhea, muscle or joint pain) occurring within the 10-day period following study vaccination. - Number and proportion of subjects in each vaccine group with AEs reported during the following time periods: - From vaccination until the day of surgery - From vaccination until the Day 42 postoperative evaluation - From the day of surgery until the Day 42 postoperative evaluation - From the Day 42 postoperative evaluation until the day 180 postoperative evaluation (newly diagnosed chronic medical disorders) - Number and proportion of subjects in each vaccine group with serious adverse events (SAEs) reported during the following time periods: - From vaccination until the Day 180 postoperative evaluation - From vaccination until the day of surgery - From the day of surgery until the Day 180 postoperative evaluation |
Criterio de valoración de eficacia principal - El número de sujetos en cada grupo de vacunas con BSI por S. aureus postoperatoria y/o infección quirúrgica de órgano/espacio o incisión profunda que se produce dentro de los 90 días siguientes a intervenciones quirúrgicas programadas de artrodesis vertebral posterior (lumbar) instrumentada, confirmado por el comité de adjudicación de acontecimientos (EAC, del inglés Event Adjudication Committee).
Criterios de valoración de seguridad principales - Número y proporción de sujetos en cada grupo de vacunas con reacciones locales (enrojecimiento, hinchazón y dolor) que se producen dentro del periodo de los 10 días siguientes a la vacunación del estudio. - Número y proporción de sujetos en cada grupo de vacunas con acontecimientos sistémicos (fiebre, cansancio, dolor de cabeza, vómitos, diarrea, dolor muscular o articular) que se producen dentro del periodo de los 10 días siguientes a la vacunación del estudio. - Número y proporción de sujetos en cada grupo de vacunas con AA informados durante los siguientes periodos de tiempo: - Desde la vacunación hasta el día de la intervención - Desde la vacunación hasta la evaluación postoperatoria del día 42 - Desde el día de la intervención hasta el día 42 de la evaluación postoperatoria - Desde la evaluación postoperatoria del día 42 hasta la evaluación postoperatoria del día 180 (afecciones crónicas de diagnóstico reciente) - Número y proporción de sujetos en cada grupo de vacunas con acontecimientos adversos graves (AAG) informados durante los siguientes periodos de tiempo - Desde la vacunación hasta la evaluación postoperatoria del día 180 - Desde la vacunación hasta el día de la intervención - Desde el día de la intervención hasta el día 180 de la evaluación postoperatoria |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Various - see protocol |
Varios - ver protocolo |
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E.5.2 | Secondary end point(s) |
Secondary Efficacy Endpoints: - The number of subjects in each vaccine group with postoperative S. aureus BSI and/or deep incisional or organ/space SSI occurring within 180 days of elective posterior instrumented lumbar spinal fusion procedures. - The number of subjects in each vaccine group with postoperative S. aureus SSI occurring within 90 days of elective posterior instrumented lumbar spinal fusion procedures. - The number of subjects in each vaccine group with postoperative S. aureus SSI occurring within 180 days of elective posterior instrumented lumbar spinal fusion procedures. |
Objetivos de eficacia secundarios - Evaluar la eficacia de SA4Ag en la prevención de BSI por S. aureus postoperatoria y/o infección quirúrgica de órgano/espacio o incisión profunda (SSI) que se produce dentro de los 180 días siguientes a intervenciones quirúrgicas programadas de artrodesis vertebral posterior (lumbar) instrumentada en adultos con edades comprendidas entre los 18 y <86 años. - Evaluar la eficacia de SA4Ag en la prevención de SSI por S. aureus postoperatoria que se produce dentro de los 90 días siguientes a intervenciones quirúrgicas programadas de artrodesis vertebral posterior (lumbar) instrumentada, en adultos con edades comprendidas entre los 18 y <86 años. - Evaluar la eficacia de SA4Ag en la prevención de SSI por S. aureus postoperatoria que se produce dentro de los 180 días siguientes a intervenciones quirúrgicas programadas de artrodesis vertebral posterior (lumbar) instrumentada, en adultos con edades comprendidas entre los 18 y <86 años. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Various - see protocol |
Varios - ver protocolo |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 |
Tolerability and immunogenicity |
Tolerabilidad y inmunogenicidad |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
France |
Germany |
Spain |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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LSLV |
Última Visita Último Paciente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |