E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Protection against COVID-19 |
|
E.1.1.1 | Medical condition in easily understood language |
Prevention of Infection with the Corona Virus |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051905 |
E.1.2 | Term | Coronavirus infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
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 describe the immune response to prophylactic BNT162b2 in participants ≥18 years of age without serological or virological evidence of past SARS-CoV-2 infection and with: • Asymptomatic CLL without treatment and undergoing observation, or CLL on BTK inhibitor or anti-CD20 monoclonal antibodies • Diagnosed with NSCLC and on chemotherapy, checkpoint inhibitors, or targeted agents for oncogene-driven tumors • Maintenance hemodialysis treatment due to end-stage renal disease • Immunomodulator therapy for an autoimmune inflammatory disorder To describe the immune response to prophylactic BNT162b2 in participants ≥2 to <18 years of age without serological or virological evidence of past SARS-CoV-2 infection and either: • Are on immunomodulator therapy for an autoimmune inflammatory disorder • Are on immunosuppression therapy after solid organ transplant • Underwent bone marrow or stem cell transplant at least 6 months before enrollment Full information in Section 3 of Protocol |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Participants are eligible to be included in the study only if all of the following criteria apply: Age and Sex: 1.Male or female participants who are ≥2 years of age at the time of enrollment (Visit 1). 2.Participants or participants’ parent(s)/legal guardians, as age appropriate, who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 3.Life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment (Visit 1). 4.Participants or participant’s parent(s)/legal guardians, as age appropriate, who are able to be contacted by telephone throughout the study period. 5.Female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children. Refer to Appendix 3 for reproductive criteria for male (Section 10.3.1) and female (Section 10.3.2) participants. Type of Participant and Disease Characteristics: 6.Participants who are immunocompromised by virtue of the following: • Having known NSCLC and is ≥18 years of age with at least 1 of the following: • Who received chemotherapy at least 2 weeks (14 days) before enrollment (or is treatment naïve), and is not expected to receive chemotherapy within at least 2 weeks (14 days) after dose administration; and/or • Receiving checkpoint inhibitor treatment (PD-1/PD-L1 inhibitor, CTLA-4 inhibitor) and has undergone at least 1 treatment cycle prior to enrollment (at Visit 1); or • Receiving targeted drug therapy treatment (EGFR, ALK, ROS1, BRAF, RET, MET, NTRK inhibitors) and has undergone at least 1 treatment cycle prior to enrollment (at Visit 1); or • Having known CLL and is ≥18 years of age with at least 1 of the following: • Has asymptomatic disease (eg, Rai stage <3, Binet stage A or B) and is undergoing observation and does not receive any treatment for CLL; or • Receiving B-cell inhibitory monoclonal antibody treatment (anti-CD20) and has received at least 3 cycles prior to enrollment; and/or • Receives a BTK inhibitor, PI3K inhibitor, or BCL-2 inhibitor OR • Is currently undergoing maintenance hemodialysis treatment secondary to end-stage renal disease and is ≥18 years of age OR • Is on active immunomodulator therapy (eg, TNFα inhibitor, tofacitinib or MTX) for an autoimmune inflammatory disorder (eg, inflammatory arthritis, such as rheumatoid arthritis, psoriatic arthritis, and juvenile idiopathic arthritis, and inflammatory bowel disease, such as ulcerative colitis and Crohn’s disease) at a stable* dose * Stable dose is defined as receiving the same dose for at least 3 months (84 days) with no changes in the 28 days prior to Visit 1. OR • Receiving a solid organ transplant at least 3 months (84 days) prior to enrollment (Visit 1) and with no acute rejection episodes within 2 months (60 days) prior to enrollment (Visit 1), and is ≥2 to <18 years of age OR • Has had an autologous or allogenic bone marrow or stem cell transplant at least 6 months (182 days) prior to enrollment (Visit 1), with adequate immune reconstitution for immunization, in the investigator’s opinion, and is ≥2 to <18 years of age
Informed Consent and Assent (as Appropriate): 7.The participant or participant’s parent(s)/legal guardian is capable of giving signed informed consent, and assent (as appropriate), as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. The investigator, or a person designated by the investigator, will obtain written informed consent (and assent, as appropriate) from each study participant or participant’s parent(s)/legal guardian (as defined in Appendix 1) before any study-specific activity is performed. All parent(s)/legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand. The investigator will retain the original copy of each participant's signed consent (and assent, as appropriate) document(s).
|
|
E.4 | Principal exclusion criteria |
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions: 1.Past clinical (based on COVID-19 symptoms/signs alone, if a SARS CoV 2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19, or a past clinical diagnosis of MIS-C. 2.Participants with active GVHD, transplant rejection, or PTLD, or participants who have had treatment for these conditions within 3 months (84 days) prior to study enrollment (Visit 1). 3.Participants <18 years of age whose weight is less than the 5th percentile of age-adjusted ideal body weight. 4.Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study. 5.History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). 6.Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 7.Participant who is pregnant or breastfeeding. 8.Participants who may be ineligible because of the number of phlebotomy assessments during this study, in the opinion of the investigator. 9. Participants who do not have adequate deltoid muscle mass to allow intramuscular vaccination, in the opinion of the investigator.
Prior/Concomitant Therapy: 10.Previous vaccination with any coronavirus vaccine. 11.Ongoing, or history of, treatment with blood/plasma products or immunoglobulins within 3 months (84 days) prior to Dose 1 or planned receipt of these medications prior to Dose 4.
Prior/Concurrent Clinical Study Experience: 12.Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation. 13.Previous participation in other studies involving study intervention containing LNPs.
Diagnostic Assessments: Not applicable.
Other Exclusions: 14.Participants who are direct descendants (child or grandchild) of investigational site staff members or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members. 15.Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
In participants complying with the key protocol criteria (evaluable participants) and no serological or virological evidence of past SARS CoV-2 infection in each disease subset: • GMTs at 1 month after Dose 3 and Dose 4 In participants complying with the key protocol criteria (evaluable participants) and no serological or virological evidence of past SARS CoV-2 infection in each age group (≥2 to <5, ≥5 to <12, and ≥12 to <18 years) and disease subset: • GMTs at 1 month after Dose 3 and 4 In participants receiving at least 1 dose of study intervention in each disease subset, the percentage of participants reporting: • Local reactions for up to 7 days following each dose • Systemic events for up to 7 days following each dose • AEs from Dose 1 through 1 month after Dose 2 • AEs from Dose 3 through 1 month after Dose 3 • AEs from Dose 4 through 1 month after Dose 4 • SAEs from Dose 1 through the duration of the study In participants receiving at least 1 dose of study intervention in each age group (≥2 to <5, ≥5 to <12, and ≥12 to <18 years) and disease subset, the percentage of participants reporting: • Local reactions for up to 7 days following each dose • Systemic events for up to 7 days following each dose • AEs from Dose 1 through 1 month after Dose 2 • AEs from Dose 3 through 1 month after Dose 3 • AEs from Dose 4 through 1 month after Dose 4 • SAEs from Dose 1 through the duration of the study
• Incidence rate of confirmed COVID 19 per 1000 person-years of follow-up • The number and percentage of each SARS-CoV-2 lineage among BNT162b2 recipients • Incidence rate of confirmed MIS-C cases |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Please see Section 3 of full clinical Protocol |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | No |
E.8.1.1 | Randomised | Yes |
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 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | No |
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 |
Brazil |
Mexico |
United States |
Germany |
|
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
|
A participant is considered to have completed the study if he/she has completed all phases of the study, including the last visit. The end of the study is defined as the date of the last visit of the last participant in the study. |
|
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 | |
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 | 10 |