Aug 25, 2020
Schedule of Study Visits and Evaluations (Appendix A of Phase 3 study of Vaccine Candidate for COVID-19)
- Chris Ockenhouse1,
- Chris Gast1,
- Renee Holt1,
- Jorge Flores1
- 1Center for Vaccine Innovation and Access, PATH (Washington D.C. and Seattle, Washington)
- Coronavirus Method Development Community
- PATH
Protocol Citation: Chris Ockenhouse, Chris Gast, Renee Holt, Jorge Flores 2020. Schedule of Study Visits and Evaluations (Appendix A of Phase 3 study of Vaccine Candidate for COVID-19). protocols.io https://dx.doi.org/10.17504/protocols.io.bj6bkran
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
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Created: August 21, 2020
Last Modified: August 25, 2020
Protocol Integer ID: 40867
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Abstract
This is Appendix A of "Phase 3 randomized, double-blinded, placebo-controlled trial to evaluate the safety, immunogenicity, and efficacy of Vaccine Candidate against COVID-19 in adults > 18 years of age"
This generic Phase 3 protocol was developed by the PATH team with support of the Bill and Melinda Gates Foundation. The aim of the collection is to share recommended best practices in designing and implementing a Phase 3 study of a COVID-19 vaccine candidate. As Phase 3 trials of different Vaccine Candidates proceed around the world, following the same protocols will ensure consistency and comparability of the Phase 3 trial results.
Please note that this is an evolving document, to be versioned and updated, based on community feedback and new data.
Attachments
Guidelines
APPENDIX A: SCHEDULE OF STUDY VISITS AND EVALUATIONS -EXAMPLE PROVIDED; VACCINE DEPENDENT
| Study Day | -7 to 1 | 1 | 15 (+7 days) | 29 (+5 days) | 57 (+5 days) | 57 to study end | 180 | 365/ 730 | |
| Visit # | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | |
| Clinic visits | X | X | X | X | X | X | X | ||
| Phone call, SMS text, email (approximately every two weeks) | X | ||||||||
| Informed consent form signed | X | ||||||||
| Initial screening | X | ||||||||
| Inclusion and exclusion criteria | X | X | X | ||||||
| Demographic data | X | ||||||||
| Medical history screening | X | ||||||||
| Height/weight measurements | X | ||||||||
| Vital signs/physical examination screening | X | ||||||||
| Blood collection for safety: hematology (CBC), ALT, AST, Bilirubin, creatinine | X | ||||||||
| Nasopharyngeal swab for SARS-CoV-2 RT-PCR | X | ||||||||
| Blood collection for serology (X mL) | X | X | X | X | X | ||||
| Randomization | X | ||||||||
| Concomitant medication | X | X | X | X | X | X | |||
| Pregnancy test (urine or blood) | X | X | X | ||||||
| Study vaccination | X | X | |||||||
| Interim medical history | X | X | X | X | X | ||||
| Review of diary/memory aid | X | X | X | ||||||
| Vital signs/targeted physical examination | X | X | |||||||
| COVID-19 case capture | X | X | X | X | X | X | X | ||
| Total blood volume (mL) | X | X | X | X | X | X | X | ||
| Study end | X |