E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
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 |
1) To demonstrate that the immune responses induced by BNT162b2 are similar across the 3 US lots (Arms 1, 2, and 3) in subjects without evidence of SARS CoV-2 infection during the study. 2) To demonstrate that the immune response induced by the EU lot (Arm 4) of BNT162b2 is similar to the pooled US lots (Arms 1, 2, and 3) in subjects without evidence of SARS-CoV-2 infection during the study. 3) To demonstrate the noninferiority of the immune response to BNT162b2 in subjects receiving 20 mcg compared to subjects receiving the standard 30 mcg dose (prepared from the same manufacturing lot) without evidence of SARS-CoV-2 infection during the study. 4) To evaluate the safety of BNT162b2 when administered on a 2-dose schedule in healthy subjects 12 through 50 years of age. |
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E.2.2 | Secondary objectives of the trial |
To describe the immune responses induced by different 30-μg dose manufacturing lots of BNT162b2. To describe the immune responses induced by different doses of BNT162b2. |
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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 |
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E.3 | Principal inclusion criteria |
Inclusion Criteria:
Primary study: Male or female participants between the ages of 12 and 50 years, inclusive, at randomization. Booster study: Male or female participants between the ages of 18 and 50 years, inclusive, at rerandomization. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Capable of giving personal signed informed consent/have parent(s)/legal guardian capable of giving signed informed consent. |
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E.4 | Principal exclusion criteria |
Exclusion Criteria:
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. Known infection with HIV, HCV, or HBV. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention. Previous 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.
. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. Women who are pregnant or breastfeeding. Primary study: Previous vaccination with any coronavirus vaccine. Booster study: Previous vaccination with any coronavirus vaccine outside of this study. Receipt of medications intended to prevent COVID-19. Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation. Previous participation in other studies involving study intervention containing lipid nanoparticles. Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members. Additional Exclusion Criteria for the Booster study:
Current febrile illness (body temperature ≥100.4°F [≥38.0°C]) or other acute illness within 48 hours before study intervention administration. Receipt of any seasonal or pandemic influenza vaccine within 14 days, or any other nonstudy vaccine within 28 days, before or after study intervention administration. Receipt of short-term (<14 days) systemic corticosteroids. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Geometric Mean Ratio (GMR) of SARS-CoV-2 full-length S-binding antibody levels between US lots (Arms 1, 2 and 3) in participants without evidence of infection during the study [ Time Frame: At 1 month after Dose 2 ] As measured at the central laboratory
GMR of SARS-CoV-2 full-length S-binding antibody levels between the EU lot (Arm 4) and pooled US lots (Arms 1, 2, and 3) in participants without evidence of infection during the study [ Time Frame: At 1 month after Dose 2 ] As measured at the central laboratory
GMR of SARS-CoV-2 neutralizing antibody levels between the 20-microgram dose group (Arm 5) and the corresponding 30-microgram dose group (Arm 1, 2, or 3) in participants without evidence of SARS-C0V-2 infection during the study. [ Time Frame: At 1 month after Dose 2 ] As measured at the central laboratory
Percentage of participants reporting local reactions [ Time Frame: For 7 days after Dose 1 and Dose 2. For 7 days after Dose 3 (booster). ] Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
Percentage of participants reporting systemic events [ Time Frame: For 7 days after Dose 1 and Dose 2. For 7 days after Dose 3 (booster). ] Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries.
Percentage of participants reporting adverse events [ Time Frame: From Dose 1 through 1 month after Dose 2. From Dose 3 to 1 month after Dose 3. ] As elicited by investigational site staff
Percentage of participants reporting serious adverse events [ Time Frame: From Dose 1 through 1 month after Dose 2. From Dose 3 to 1 month after Dose 3. ] As elicited by investigational site staff
Geometric Mean Titers (GMT) of SARS-CoV-2 reference strain and B.1.351 strain neutralizing antibody levels for Booster Arm 1 (BNT162b2) and Booster Arm 2 (BNT162b2.B.1.351). [ Time Frame: Before Dose 1, 1 month after Dose 2, before Dose 3, and 1 week after and 1 month after Dose 3. ] As measured at the central laboratory
Geometric Mean IgG Concentrations (GMC) of SARS-CoV-2 full-length S-binding antibody levels for Booster Arm 1 (BNT162b2) and Booster Arm 2 (BNT162b2.B.1.351). [ Time Frame: Before Dose 1, 1 month after Dose 2, before Dose 3, and 1 week after and 1 month after Dose 3. ] As measured at the central laboratory
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 reference strain and B.1.351 strain neutralizing antibody levels for Booster Arm 1 (BNT162b2) and Booster Arm 2 (BNT162b2.B.1.351). [ Time Frame: From 1 month after Dose 2 to 1 week after and 1 month after Dose 3 and from before Dose 3 to 1 week after and 1 month after Dose 3. ] As measured at the central laboratory
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 full-length S-binding antibody levels for Booster Arm 1 (BNT162b2) and Booster Arm 2 (BNT162b2.B.1.351). [ Time Frame: From 1 month after Dose 2 to 1 week after and 1 month after Dose 3 and from before Dose 3 to 1 week after and 1 month after Dose 3. ] As measured at the central laboratory
Percentages of participants with seroresponse (based on neutralizing titers) to the reference strain. [ Time Frame: At 1 month after Sode 2, before Dose 3, and 1 week after and 1 month after Dose 3. ] As measured at the central laboratory
Percentages of participants with seroresponse (based on neutralizing titers) to the B.1.351 strain. [ Time Frame: At 1 month after Sode 2, before Dose 3, and 1 week after and 1 month after Dose 3. ] As measured at the central laboratory |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Geometric Mean Concentrations (GMCs) of SARS-CoV-2 full-length S-binding antibody levels in participants vaccinated with one of the 30-microgram lots (US or EU). [ Time Frame: At baseline (before Dose 1) and at 1 month after Dose 2 ] As measured at the central laboratory
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 full-length S-binding antibody levels in participants vaccinated with one of the 30-microgram lots (US or EU) [ Time Frame: From baseline (before Dose 1) to 1 month after Dose 2 ] As measured at the central laboratory
GMTs of SARS CoV-2 neutralizing antibody levels in participants vaccinated with the 20-microgram or 30-microgram dose (from same US lot) [ Time Frame: At baseline (before Dose 1) and 1 month after Dose 2 ] As measured at the central laboratory
GMFRs of SARS-CoV-2 neutralizing antibody levels in participants vaccinated with the 20-microgram or 30-microgram dose (from same US lot). [ Time Frame: From baseline (before Dose 1) to 1 month after Dose 2 ] As measured at the central laboratory |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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) | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 7 |
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 |
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E.8.7 | Trial has a data monitoring committee | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 5 |