Alliance for Multispecialty Research, LLC | AMR Mobile, AL
Status and phase
Conditions
Treatments
About
The purpose of this clinical protocol is to learn about the safety, tolerability, and immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2 in healthy people.
Substudy A:
This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose,
The study is about 6 months long for each participant.
Participants will have at least 5 visits to the clinic.
At each clinic visit a blood sample will be taken.
At least 1 nasal swab will taken.
Substudy B:
This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose,
The study is about 6 months long for each participant.
Participants will have at least 5 visits to the clinic.
At each clinic visit a blood sample will be taken.
At least 1 nasal swab will taken.
Substudy C:
This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi JN.1) and BNT162b2 "(2024-2025 variant)" given as a single 30 µg dose to:
The study is about 6 months long for each participant.
Participants will have at least 6 visits (Cohort 1) or at least 5 visits (Cohort 2) to the clinic.
At each clinic visit a blood sample will be taken.
At least 1 nasal swab will taken.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
SSA
Inclusion Criteria:
Exclusion Criteria
SSB
Inclusion Criteria:
Exclusion Criteria:
SSC
Inclusion Criteria:
Exclusion Criteria
Primary purpose
Allocation
Interventional model
Masking
940 participants in 4 patient groups
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Central trial contact
Pfizer CT.gov Call Center
Data sourced from clinicaltrials.gov
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