Published May 22, 2023
| Version v1
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Considerations for unblinding individual study participants during vaccine trials
Creators
- Neal, Halsey
- Evans, Stephen
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Santosham, Mathuram
- Hacker, Adam
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Edwards, Kathryn
- Chandler, Rebecca, E.
- Dudley, Matthew Z.
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Dekker, Cornelia E.
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Al-Abri, Seif
- Narendra, Arora
- Buttery, Jim
- Dodoo, Alex
- Eskola, Juhani
- Heininger, Ulrich
- Jee, Youngmee
- Khuri, Najwa
- Obaro, Stephen
- Orenstein, Walt
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Pitisuttithum, Punnee
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safadi, marco1
- Whitney, Cynthia G.
- Black, Steve
- 1. Irmandade da Santa Casa de Misericórdia de São Paulo
Description
Premature unblinding of individual participants is rarely reported in publications, but such unblinding can disrupt vaccine trials by causing worry and drop-out of other participants or ''pseudo unblinding," in which participants or investigators over-interpret certain symptoms as being related to receiving an investigational product. This review summarizes appropriate reasons for unblinding in vaccine trials. Regulatory guidance could be improved by distinguishing guidance for vaccine trials from drug trials, with the recognition that unblinding individual participants in vaccine studies is rarely needed for management of adverse events following immunization.
Notes (English)
The SPEAC Project is funded in whole by CEPI
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