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| ID | Type | Description | Link |
|---|---|---|---|
| 15/LO/2039 | Other Identifier | London 'Äì Surrey Borders Research Ethics Committee | |
| 191407 | Other Identifier | IRAS project ID |
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| Name | Class |
|---|---|
| Imperial College Healthcare NHS Trust | OTHER |
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This study forms part of an integrated, multi-study effort to identify potential biomarkers of reactogenicity to vaccines. We have selected PET-CT as it is in routine clinical use and has been serendipitously shown to image lymph nodes and injection site inflammation after immunisation.The study's objectives are exploratory:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fendrix | Experimental | Fendrix (Hepatitis B surface antigen adjuvanted by AS04C containing 3­O­desacyl­4'­monophosphoryl lipid A adsorbed on aluminium phosphate, GlaxoSmithKline; 0.5 mL. intramuscular. stat. |
|
| Bexsero | Experimental | Bexsero (Meningococcal group B subunit / Outer Membrane Vesicles, GlaxoSmithKline); 0.5 mL. intramuscular. stat. |
|
| Fluad | Experimental | Fluad (split virion inactivated seasonal trivalent influenza vaccine adjuvanted with MF59C, Northern Hemisphere 2016-17, Seqirus Vaccines and Diagnostics) 0.5 mL. intramuscular. stat. |
|
| Seasonal Trivalent Influenza Vaccine | Experimental | Seasonal Trivalent Influenza Vaccine ('ÄòSTIV'Äô, split virion inactivated, Northern Hemisphere 2016-17, Sanofi Pasteur); 0.5 mL. intramuscular. stat. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunization | Biological | Immunisation with one of four licensed vaccines |
|
| Measure | Description | Time Frame |
|---|---|---|
| 18FDG-PET/CT imaging | Quantification of PET activity at injection site and draining lymph nodes | 4 hours |
| 18FDG- or 11C-PBR28-PET/CT imaging | Quantification of PET activity at injection site and draining lymph nodes | 1 day |
| 18FDG- or 11C-PBR28-PET/CT imaging | Quantification of PET activity at injection site and draining lymph nodes | 3 days |
| 18FDG- or 11C-PBR28-PET/CT imaging | Quantification of PET activity at injection site and draining lymph nodes | 5 days |
| 18FDG- or 11C-PBR28-PET/CT imaging | Quantification of PET activity at injection site and draining lymph nodes | 7 days |
| 18FDG-PET/CT imaging | Quantification of PET activity at injection site and draining lymph nodes | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Diary card of reactogenicity | Recording of solicited and unsolicited adverse events after immunisation | 0 to 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David JM Lewis, MD | Imperial College Healthcare NHS Trust | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 10, 2022 | |
| Reset | Jun 6, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 10, 2022 | Jun 6, 2023 |
| ID | Term |
|---|---|
| D007114 | Immunization |
| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| D007158 |
| Immunologic Techniques |
| D008919 | Investigative Techniques |
| D011322 | Primary Prevention |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003140 | Communicable Disease Control |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |