Prevention of COVID-19 infection in adolescents between 12-16 years of age Infections and Infestations COVID-19 (SARS-CoV-2 infection)
Conditions
Interventions
Current interventions as of 24/10/2023:
COHORT A:
All participants will receive their first immunisation with a standard dose of Pfizer-BioNTech (BNT162b2) vaccine, a dose of 30 µg (0.3 ml). This may
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
12 Years to 16 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 25/05/2022: For Cohort A: 1. Aged 12 to 16 years (inclusive) at enrolment For Cohort B: 1. Aged 12 to 15.5 years (inclusive) at enrolment 2. Already received two doses of 30 µg BNT162b2, the second dose received at least 91 days prior to randomisation For Cohorts A and B: 1. In good health as determined by a trial clinician. Participants may have well-controlled or mild to moderate comorbidity, as long as this would not render them considered as belonging to a 'high-risk' cohort at particular need of additional doses of COVID-19 2. Able and willing (in the Investigator's opinion) to comply with all study requirements 3. Registered with a GP, and willing to allow the investigators to discuss the participant’s medical history with their General Practitioner and access all medical records when relevant to study procedures 4. Parent/legal guardian/participant is willing and able to give written informed consent for participation in the trial. Parent/legal guardian to provide informed consent for participants under the age of 16. Participants aged 16 years will be assumed to be able to provide consent for themselves, however parental support will be encouraged and investigators will reserve the right to refuse enrolment if concerns arise. _____ Previous participant inclusion criteria as of 19/11/2021: 1. Parent/legal guardian/participant is willing and able to give written informed consent for participation in the trial 2. Aged 12 to 16 years inclusive at enrolment 3. In good health as determined by a trial clinician. Participants may have well controlled or mild-moderate comorbidity, as long as this would not render them considered as belonging to a ‘high -risk’ cohort at particular need of 2 doses of COVID-19 vaccine (see exclusion criteria below) as part of the national roll out 4. Able and willing (in the Investigator’s opinion) to comply with all study requirements 5. Registered with a GP, and willing to allow the investigators to discuss the participant’s medical history with their General Practitioner and access all medical records when relevant to study procedures _____ Previous participant inclusion criteria: 1. Parent/legal guardian/participant is willing and able to give written informed consent for participation in the trial 2. Aged 12 to 16 years inclusive at enrolment 3. In good health as determined by a trial clinician. Participants may have well controlled or mild-moderate comorbidity, as long as this would not render them eligible for 2 doses of COVID-19 vaccine (see exclusion criteria below) as part of the national roll out 4. Able and willing (in the Investigator’s opinion) to comply with all study requirements 5. Registered with a GP, and willing to allow the investigators to discuss the participant’s medical history with their General Practitioner and access all medical records when relevant to study procedures
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 24/11/2022: For Cohort A: 1. Previous receipt of more than one dose of a COVID-19 vaccine, or a COVID-19 vaccine other than BNT162b2 For Cohort B: 1. Previous receipt of more than two doses of a COVID-19 vaccine, or a COVID-19 vaccine other than BNT162b2 30 µg 2. Previous receipt of the 4CMenB vaccine 3. Participants in Cohort A are not eligible to be enrolled into Cohort B unless they received two full doses of BNT162b2 in Cohort A, and they have completed the Cohort A day 236 study visit. At this point they are eligible to enrol in Cohort B, in which case they will be treated as a new participant and receive a new, unrelated, participant number. For Cohorts A and B: 1. Belonging to a 'high- risk' cohort advised to receive additional doses of a COVID-19 vaccine (participants at increased risk of COVID-19, or household contacts of immunocompromised, based on JCVI and 'Green Book' guidelines current on 28/02/2022). 2. First-degree relative of study team member 3. Any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting =14 days) 4. History of anaphylaxis, allergic disease or reactions likely to be exacerbated by any component of study vaccines (e.g. hypersensitivity to the active substance or any of the SmPC/IB-listed ingredients of any study vaccine). This includes latex and polyethylene glycol/macrogol (PEG). 5. Pregnancy, lactation or unwillingness to practice effective contraception from enrolment to 3 months post-study vaccination (for post-menarcheal females only) 6. Malignancy requiring receipt of immunosuppressive chemotherapy or radiotherapy for treatment of solid organ cancer/haematological malignancy within the 6 months prior to consent 7. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture 8. Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban) 9. Any serious chronic illness requiring hospital specialist supervision 10. Congenital cardiovascular conditions 11. Severe and/or uncontrolled respiratory disease, gastrointestinal disease, liver disease, renal disease, rheumatological disease, and neurological illness (mild/moderate well-controlled comorbidities are allowed) 12. History of active or previous auto-immune neurological disorders (e.g. multiple sclerosis, Guillain-Barre syndrome, transverse myelitis) 13. Significant renal or hepatic impairment 14. Scheduled elective surgery requiring overnight admission and/or general anaesthetic during the trial 15. Insufficient level of English language to undertake all study requirements in the opinion of the Investigators 16. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines 17. Participants who have participated in another research trial involving an investigational product in the past 12 weeks (see exclusion criteria above for enrolment into Cohort B after participation in Cohort A of this study) 18. Note that a prior history of confirmed or suspected COVID-19 is NOT an exclusion criterion for this study, provided the particip
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 25/05/2022: Solicited systemic reactions measured by self-report 7 days after booster immunisation in Cohort A or 7 days after third dose in Cohort B _____ Previous primary outcome measure: Solicited systemic reactions measured by self-report 7 days after booster immunisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 25/05/2022: 1. Serious adverse events and adverse events of special interest will be collected throughout the study 2. Cellular immune responses by ELISpot on days 0 and 56 post-prime and days 14, 132 and 236 post-boost for Cohort A and days 0, 28, 84, 182, 210 in Cohort B 3. Anti-spike immunoglobulins measured by blood test at days 0 and 56 post-prime and days 132 and 236 post-boost for Cohort A and days 0, 84 and 182 in Cohort B 4. Anti-nucleocapsid immunoglobulins measured by blood test at days 0, 56, 140 and 238 5. Cellular immune responses measured by ELISpot at days 0, 56, 70, 140 and 238 6. Solicited local reactions collected by self-report at 7 days after prime and boost immunisation in Cohort A and 7 days post third dose in Cohort B 7. Unsolicited reactions collected by self-report at 28 days after prime and boost immunisation in Cohort A and 28 days post third dose in Cohort B _____ Previous secondary outcome measures as of 19/11/2021: 1. Serious adverse events and adverse events of special interest will be collected throughout the study 2. Anti-spike immunoglobulins measured by blood test at D0*, 56, 70, 84, 140, 238 3. Anti-nucleocapsid immunoglobulins measured by blood test at D0*, 56**, 140, 238 4. Cellular immune responses measured by ELISpot at D0*, 56, 70, 140, 238 5. Solicited local reactions and unsolicited reactions collected by self-report at 7 days and 28 days, respectively, after prime* and boost immunisation *Only for participants receiving their first dose of COVID-19 vaccine in the study **Only for participants receiving their first dose of COVID-19 vaccine in the community _____ Previous secondary outcome measures: 1. Serious adverse events and adverse events of special interest will be collected throughout the study 2. Anti-spike immunoglobulins measured by blood test at D0*, 56, 70, 84, 182, 364 3. Anti-nucleocapsid immunoglobulins measured by blood test at D0*, 56** 182, 364 4. Cellular immu | — |
Countries
England, United Kingdom
Contacts
Public ContactEmma Plested
Outcome results
None listed