Created at Source Raw Value Validated value
June 23, 2022, 2 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Groups 1 and 2 (ages 12-17) will be recruited first; then Groups 3 and 4 (ages 6-11) a few weeks afterwards. Group 1 75 participants between 12-17 years of age will receive either ChAdOx1 nCoV-19 5.0 x1010vp (N=60) OR Meningococcal Group B vaccine (Bexsero\u00ae) (N=15) with homologous boost at D28; then followed up at days 56; 182 and 364. Group 2 75 participants between 12-17 years of age will receive either ChAdOx1 nCoV-19 5.0 x1010vp (N=60) OR Meningococcal Group B vaccine (Bexsero\u00ae) (N=15) with homologous boost at D84; then followed up at days 112; 182 and 364. Group 3 75 participants between 6-11 years of age will receive either ChAdOx1 nCoV-19 5.0 x1010vp (N=60) OR Meningococcal Group B vaccine (Bexsero\u00ae) (N=15) with homologous boost at D28; then followed up at days 56; 182 and 364. Group 4 75 participants between 6-11 years of age will receive either ChAdOx1 nCoV-19 5.0 x1010vp (N=60) OR Meningococcal Group B vaccine (Bexsero\u00ae) (N=15) with homologous boost at D84; then followed up at days 112; 182 and 364. Volunteers will stay in the trial site for observation for a minimum of 15 minutes (+15 minutes); in case of immediate adverse events. All participants will be given the emergency 24-hour telephone number to contact the on-call study physician if needed. Safety will be assessed in real time. The DSMB will periodically assess safety and efficacy data every 4-8 weeks and/or as required. Additional safety assessments will be carried out by the DSMB 7 days after the first dose in Groups 3 & 4 (and made available to the MHRA where needed) to facilitate boosting as well as monitor for differ", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "12-17 years; D28, then followed up at days 56, 182 and 364", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "12-17 years; D84, then followed up at days 112, 182 and 364", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "6-11 years; D28, then followed up at days 56, 182 and 364", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "6-11 years; D84, then followed up at days 112, 182 and 364", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]

June 17, 2022, 12:30 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Groups 1 and 2 (ages 12-17) will be recruited first; then Groups 3 and 4 (ages 6-11) a few weeks afterwards.Group 175 participants between 12-17 years of age will receive either ChAdOx1 nCoV-19 5.0 x1010vp (N=60) OR Meningococcal Group B vaccine (Bexsero\u00ae) (N=15) with homologous boost at D28; then followed up at days 56; 182 and 364.Group 275 participants between 12-17 years of age will receive either ChAdOx1 nCoV-19 5.0 x1010vp (N=60) OR Meningococcal Group B vaccine (Bexsero\u00ae) (N=15) with homologous boost at D84; then followed up at days 112; 182 and 364.Group 375 participants between 6-11 years of age will receive either ChAdOx1 nCoV-19 5.0 x1010vp (N=60) OR Meningococcal Group B vaccine (Bexsero\u00ae) (N=15) with homologous boost at D28; then followed up at days 56; 182 and 364.Group 475 participants between 6-11 years of age will receive either ChAdOx1 nCoV-19 5.0 x1010vp (N=60) OR Meningococcal Group B vaccine (Bexsero\u00ae) (N=15) with homologous boost at D84; then followed up at days 112; 182 and 364.Volunteers will stay in the trial site for observation for a minimum of 15 minutes (+15 minutes); in case of immediate adverse events. All participants will be given the emergency 24-hour telephone number to contact the on-call study physician if needed.Safety will be assessed in real time. The DSMB will periodically assess safety and efficacy data every 4-8 weeks and/or as required. Additional safety assessments will be carried out by the DSMB 7 days after the first dose in Groups 3 & 4 (and made available to the MHRA where needed) to facilitate boosting as well as monitor for difference in reactogenicity and tolerability associated with age de-escalation.Participants will be followed over the duration of the study to record adverse events and episodes of", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 781, "treatment_name": "Meningococcal vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]

Feb. 19, 2021, 12:45 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Groups 1 and 2 (ages 12-17) will be recruited first; then Groups 3 and 4 (ages 6-11) a few weeks afterwards. Group 1 75 participants between 12-17 years of age will receive either ChAdOx1 nCoV-19 5.0 x1010vp (N=60) OR Meningococcal Group B vaccine (Bexsero\u00ae) (N=15) with homologous boost at D28; then followed up at days 56; 182 and 364. Group 2 75 participants between 12-17 years of age will receive either ChAdOx1 nCoV-19 5.0 x1010vp (N=60) OR Meningococcal Group B vaccine (Bexsero\u00ae) (N=15) with homologous boost at D84; then followed up at days 112; 182 and 364. Group 3 75 participants between 6-11 years of age will receive either ChAdOx1 nCoV-19 5.0 x1010vp (N=60) OR Meningococcal Group B vaccine (Bexsero\u00ae) (N=15) with homologous boost at D28; then followed up at days 56; 182 and 364. Group 4 75 participants between 6-11 years of age will receive either ChAdOx1 nCoV-19 5.0 x1010vp (N=60) OR Meningococcal Group B vaccine (Bexsero\u00ae) (N=15) with homologous boost at D84; then followed up at days 112; 182 and 364. Volunteers will stay in the trial site for observation for a minimum of 15 minutes (+15 minutes); in case of immediate adverse events. All participants will be given the emergency 24-hour telephone number to contact the on-call study physician if needed. Safety will be assessed in real time. The DSMB will periodically assess safety and efficacy data every 4-8 weeks and/or as required. Additional safety assessments will be carried out by the DSMB 7 days after the first dose in Groups 3 & 4 (and made available to the MHRA where needed) to facilitate boosting as well as monitor for differ", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "Boost at D28, two age sub groups", "treatment_id": 781, "treatment_name": "Meningococcal vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "Boost at D84, two age sub groups", "treatment_id": 781, "treatment_name": "Meningococcal vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "Boost at D28, two age sub groups", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Boost at D84, two age sub groups", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]