E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Protection against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of infection with the coronavirus |
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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 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10084510 |
E.1.2 | Term | Coronavirus infections |
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 | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084529 |
E.1.2 | Term | 2019 novel coronavirus infection |
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 |
The overall purpose of this clinical trial is to learn about the safety, extent of the side effects, and immune responses of the study vaccine (called variant-adapted BNT162b2 RNA-based vaccine) in healthy children. For substudy-specific primary objectives, please refer to each respective substudy sections in the protocol: Substudy A: Please refer to Section 10.7.3 of the protocol Substudy B: Please refer to Section 10.8.3 of the protocol Substudy C: Please refer to Section 10.9.3 of the protocol Substudy D: Please refer to Section 10.10.3 of the protocol Substudy E: Please refer to Section 10.11.3 of the protocol |
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E.2.2 | Secondary objectives of the trial |
For substudy-specific secondary objectives, please refer to each respective substudy sections in the protocol: Substudy A: Please refer to Section 10.7.3 of the protocol Substudy B: Please refer to Section 10.8.3 of the protocol Substudy C: Please refer to Section 10.9.3 of the protocol Substudy D: Please refer to Section 10.10.3 of the protocol Substudy E: Please refer to Section 10.11.3 of the protocol |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
SUBSTUDY A, B, C, D, E - Protocol Amendment 04, 01 Sep 2023
Substudy A: This is a randomized study that is single-blinded (sponsor-unblinded) in Phase 1 and open-label in Phase 2/3. Phase 1 will evaluate the safety, tolerability, and immunogenicity of a 3-dose series of bivalent BNT162b2, followed by a fourth dose with BNT162b2 (Omi XBB.1.5) ~6 months after Dose 3. Phase 2/3 will evaluate the safety, tolerability, and immunogenicity of 2 doses of BNT162b2 (Omi XBB.1.5) at the dose level selected in the dose-finding portion of Substudy A Phase 1, compared with 3 doses of BNT162b2 (Omi XBB.1.5) at the 3-μg dose level in participants ≥6 months to <2 years of age. Substudy A Phase 2/3 will also evaluate the safety, tolerability, and immunogenicity of a single dose of BNT162b2 (Omi XBB.1.5) at the dose level selected in the dose-finding portion of Substudy A Phase 1 in COVID-19 vaccine–naïve participants ≥2 to <5 years of age, compared with 3 doses of BNT162b2 (Omi XBB.1.5) at the currently authorized 3-μg dose level in participants ≥6 months to <2 years of age, who will be enrolled contemporaneously into Substudy A Phase 2/3. (Number or treatment arms:11) Substudy B: This is an open-label study to evaluate the safety, tolerability, and immunogenicity of a third or fourth dose of bivalent BNT162b2 3 μg. (Number or treatment arms:3) Substudy C: This is a Phase 1, randomized study that is single-blinded (sponsor-unblinded) to evaluate the safety, tolerability, and immunogenicity of a fourth dose of bivalent BNT162b2. An originally planned Phase 2/3 open-label selected-dose portion of the study will no longer be pursued. (Number or treatment arms:4) Substudy D: This is an open-label study to evaluate the safety, tolerability, and immunogenicity of a third or fourth dose of bivalent BNT162b2.(Number or treatment arms:3) Substudy E: This is an open-label study to evaluate the safety, tolerability, and immunogenicity of a single dose of BNT162b2 (Omi XBB.1.5) in COVID-19 vaccine–naïve participants ≥2 to <12 years of age. (Number or treatment arms:2)
For substudy-specific objectives and endpoints, please refer to each respective substudy appendix of the protocol and E.2.1, E.2.2 and E.5 of the Form. |
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E.3 | Principal inclusion criteria |
Participants are eligible to be included in the study only if all of the substudy-specific inclusion criteria are met. For Substudy A, see Section 10.7.5.1. of the Study Protocol. For Substudy B, see Section 10.8.5.1. of the Study Protocol. For Substudy C, see Section 10.9.5.1. of the Study Protocol. For Substudy D, see Section 10.10.5.1. of the Study Protocol. For Substudy E, see Section 10.11.5.1. of the Study Protocol.
Some inclusion criteria are common to all substudies: participants (and their parent(s)/legal guardian(s) willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures; participants should be healthy; and participants (or their parent[s]/legal guardian[s]) must be capable of giving personal signed informed consent. |
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E.4 | Principal exclusion criteria |
Participants are excluded from the study if any of the substudy-specific exclusion criteria apply. For Substudy A, see Section 10.7.5.2. of the Study Protocol. For Substudy B, see Section 10.8.5.2. of the Study Protocol. For Substudy C, see Section 10.9.5.2. of the Study Protocol. For Substudy D, see Section 10.10.5.2. of the Study Protocol. For Substudy E, see Section 10.11.5.2. of the Study Protocol.
Some exclusion criteria are common to all substudies: Previous or current diagnosis of MIS-C; history of severe adverse reactions associated with a vaccine and/or severe allergic reaction to any component of the study vaccination; immunocompromised individuals; or participants with bleeding diathesis; Other medical or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Substudy A Primary Safety - Local reactions (participants ≥6 months to <2 years of age: tenderness at the injection site, redness, and swelling; participants ≥2 to <5 years of age: pain at the injection site, redness, and swelling) - Systemic events (participants ≥6 months to <2 years of age: fever, decreased appetite, drowsiness, and irritability; participants ≥2 to <5 years of age: fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) - AEs - SAEs Primary Immunogenicity (Phase 2/3 only) - SARS-CoV-2 Omicron XBB.1.5-neutralizing titers
Substudy B Primary Safety - Local reactions (participants ≥6 months to <2 years of age: tenderness at the injection site, redness, and swelling; participants ≥2 to <5 years of age: pain at the injection site, redness, and swelling) - Systemic events (participants ≥6 months to <2 years of age: fever, decreased appetite, drowsiness, and irritability; participants ≥2 to <5 years of age: fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) - AEs - SAEs Primary Immunogenicity - SARS-CoV-2 Omicron BA.4/BA.5–neutralizing titers
Substudy C Primary Safety - Local reactions (participants ≥6 months to <2 years of age: tenderness at the injection site, redness, and swelling; participants ≥2 to <5 years of age: pain at the injection site, redness, and swelling) - Systemic events (participants ≥6 months to <2 years of age: fever, decreased appetite, drowsiness, and irritability; participants ≥2 to <5 years of age: fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) - AEs - SAEs Primary Immunogenicity - SARS-CoV-2 reference-strain– neutralizing titers - SARS-CoV-2 Omicron BA.4/BA.5–neutralizing titers
Substudy D Primary Safety - Local reactions (pain at the injection site, redness, and swelling) - Systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) - AEs - SAEs Primary Immunogenicity - SARS-CoV-2 Omicron BA.4/BA.5–neutralizing titers
Substudy E Primary Safety - Local reactions (pain at the injection site, redness, and swelling) - Systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) - AEs - SAEs Primary Immunogenicity - SARS-CoV-2 reference-strain-neutralizing titers |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Please, see Protocol Section 3, Section 10.7.3; Section 10.8.3; Section 10.9.3; Section 10.10.3; Section 10.11.3 and Section 10.12.3. |
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E.5.2 | Secondary end point(s) |
Substudy A: Immunogenicity - SARS-CoV-2 reference-strain neutralizing titers - SARS-CoV-2 Omicron BA.4/BA.5–neutralizing titers
Substudy B: Secondary Immunogenicity - SARS-CoV-2 reference-strain-neutralizing titers - SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers
Substudy C: Not applicable.
Substudy D: Secondary Immunogenicity - SARS-CoV-2 reference-strain-neutralizing titers - SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers
Substudy E: Secondary Immunogenicity - SARS-CoV-2 Omicron XBB.1.5-neutralizing titers. - SARS-CoV-2 reference-strain-neutralizing titers |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Please, see Protocol Section 3, Section 10.7.3; Section 10.8.3; Section 10.9.3; Section 10.10.3; Section 10.11.3 and Section 10.12.3. |
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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 | Yes |
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 |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Open-label: SSA Phase 2/3, SSB, SSD, and SSE; Single-blinded (sponsor-unblinded): SSA Phase 1, SSC. |
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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 | 23 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
Brazil |
Mexico |
South Africa |
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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The end of the (sub)study is defined as the date of the last visit of the last participant in the (sub)study.
A participant is considered to have completed the (sub)study if he/she has completed all phases of the (sub)study, including the last visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 0 |