@MYTH©bubu et les 12 comploteurs

 

pfizer lui-même le reconnait

MYTH©bubu : ah oui ou ca ? à mon avis tu n’es pas allé voir le protocole de l’étude

 

6.3.2. Blinding of Site Personnel

In this observer blinded study, the study staff receiving, storing, dispensing, preparing, and administering the study interventions will be unblinded. All other study and site personnel, including the investigator, investigator staff, and participants, will be blinded to study intervention assignments. In particular, the individuals who evaluate participant safety will be blinded. Because the BNT162 RNA-based COVID-19 vaccine candidates and placebo are different in physical appearance, the study intervention syringes will be administered in a manner that prevents the study participants from identifying the study intervention type based on its appearance.

The responsibility of the unblinded dispenser and administrator must be assigned to an individual or individuals who will not participate in the evaluation of any study participants. Contact between the unblinded dispenser and study participants and unblinded administrator and study participants should be kept to a minimum. The remaining site personnel must not know study intervention assignments.

6.3.3. Blinding of the Sponsor

To facilitate rapid review of data in real time, sponsor staff will be unblinded to study intervention allocation for the participants in Phase 1. The majority of sponsor staff will be blinded to study intervention allocation in Phase 2/3. All laboratory testing personnel performing serology assays will remain blinded to study intervention assigned/received throughout the study. The following sponsor staff, who will have no part in the blinded conduct of the study, will be unblinded in Phase 2/3 (further details will be provided in a data blinding plan)

 

 PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001, p. 48-49

 

Study Sponsor :

BioNTech

Study Conducted By :

Pfizer

Study Intervention Number :

PF-07302048

Study Intervention Name :

RNA-Based COVID-19 Vaccines

US IND Number :

19736

EudraCT Number :

2020-002641-42

Protocol Number :

C4591001

Phase :

1/2/3

Short Title : A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals

«  [C]ontrairement à vous seul la vérité et les faits m’intéresse  !  »

Auteur anonyme, première moitié du XXIe siècle

 

Heil Μπουρλά !