Protection against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 23.0 Level: HLT Classification code 10084510 Term: Coronavirus infections System Organ Class: 10021881 - Infections and infestations MedDRA version: 23.1 Level: LLT Classification code 10084529 Term: 2019 novel coronavirus infection System Organ Class: 1
Conditions
Interventions
Trade Name: Comirnaty
Product Name: BNT162b2 (Omi XBB.1.5)
Pharmaceutical Form: Dispersion for injection
INN or Proposed INN: Raxtozinameran
Current Sponsor code: BNT162b2 XBB1.5
Concentration unit: µ
Sponsors
BioNTech SE
Eligibility
Sex/Gender
All
Inclusion criteria
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 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. Are the trial subjects under 18? yes Number of subjects for this age range: 39 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 517 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 165
Exclusion criteria
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 Some exclusion criteria are common to all substudies: history of severe adverse reactions associated with a vaccine and/or severe allergic reaction to any component of the study vaccination; immunocompromised individuals; participants with bleeding diathesis; women who are pregnant or breastfeeding; 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; history of myocarditis or pericarditis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall purpose of this clinical trial is to learn about the safety, tolerability, and immune response of new BNT162b2 RNA-based vaccine candidates targeting new variants (under monitoring, of interest, and/or of concern) of SARS-CoV-2 in healthy participants. 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;Secondary Objective: 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;Primary end point(s): Primary Safety Substudies A, B and C - 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 Substudy A - SARS-CoV-2 Omi XBB.1.5–neutralizing titers - SARS-CoV-2 Omi BA.4/BA.5–neutralizing titers Primary Immunogenicity Substudy B - SARS-CoV-2 Omi XBB.1.5–neutralizing titers Primary Immunogenicity Substudy C - SARS-CoV-2 Omi JN.1–neutralizing titers - SARS-CoV-2 Omi XBB.1.5–neutralizing titers (Cohorts 1 and 2 only) - SARS-CoV-2 Omi KP.2– neutralizing titers (Cohort 3 only);Timepoint(s) of evaluation of this end point: Please, see Protocol Section 3, Section 10.7.3; Section 10.8.3; and Section 10.9.3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
United States
Contacts
Public ContactClinical trials patient information
BioNTech
Outcome results
None listed