Page 3 - pfizervax
P. 3
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001
5.3. Lifestyle Considerations ..........................................................................................44
5.3.1. Contraception ..............................................................................................44
5.4. Screen Failures ........................................................................................................44
5.5. Criteria for Temporarily Delaying Enrollment/Randomization/Study
Intervention Administration ......................................................................................44
6. STUDY INTERVENTION ..................................................................................................45
6.1. Study Intervention(s) Administered ........................................................................46
6.1.1. Manufacturing Process ...............................................................................46
6.1.2. Administration ............................................................................................46
6.2. Preparation/Handling/Storage/Accountability ........................................................47
6.2.1. Preparation and Dispensing ........................................................................48
6.3. Measures to Minimize Bias: Randomization and Blinding.....................................48
6.3.1. Allocation to Study Intervention ................................................................48
6.3.2. Blinding of Site Personnel ..........................................................................48
6.3.3. Blinding of the Sponsor ..............................................................................49
6.3.4. Breaking the Blind ......................................................................................50
6.4. Study Intervention Compliance ...............................................................................50
6.5. Concomitant Therapy ..............................................................................................50
6.5.1. Prohibited During the Study .......................................................................50
6.5.2. Permitted During the Study ........................................................................51
6.6. Dose Modification ...................................................................................................51
6.7. Intervention After the End of the Study ..................................................................52
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT
DISCONTINUATION/WITHDRAWAL ...........................................................................52
7.1. Discontinuation of Study Intervention ....................................................................52
7.2. Participant Discontinuation/Withdrawal From the Study .......................................53
7.2.1. Withdrawal of Consent ...............................................................................53
7.3. Lost to Follow-up ....................................................................................................54
8. STUDY ASSESSMENTS AND PROCEDURES ...............................................................54
8.1. Efficacy and/or Immunogenicity Assessments .......................................................55
8.1.1. Biological Samples .....................................................................................58
8.2. Safety Assessments .................................................................................................58
8.2.1. Clinical Safety Laboratory Assessments (Phase 1 Participants Only) .......59
Page 3
