Ten pivotal COVID-19 vaccine trial protocols (Pfizer/BioNTech, Moderna, AstraZeneca, Janssen / Johnson & Johnson) with their full amendment histories extracted verbatim from each protocol PDF’s ‘Summary of Changes’ section. Sources: the PHMPT FOIA release at phmpt.org, clinicaltrials.gov, the NEJM 2020 protocol supplement, and the Internet Archive Wayback Machine. Use the menu above or the table below to jump to any trial.
| Trial code | Sponsor | Purpose | Total entries in history | Direct PDFs available | Report |
|---|---|---|---|---|---|
| C4591001 | Pfizer / BioNTech | Pivotal Phase 1/2/3 efficacy trial (initially adults 16+, later expanded to 12+); Amendments 1–20 sourced from Pfizer's Final Protocol Amendment 20 on clinicaltrials.gov | 22 | 6 | Open report → |
| C4591007 | Pfizer / BioNTech | Pediatric efficacy/safety trial in children 6 months to <12 years | 4 | 3 | Open report → |
| C4591015 | Pfizer / BioNTech | Maternal immunization trial — safety/immunogenicity in pregnant participants | 3 | 1 | Open report → |
| C4591020 | Pfizer / BioNTech | Phase 4 effectiveness study in healthcare workers and household contacts | 1 | 1 | Open report → |
| C4591024 | Pfizer / BioNTech | Phase 2b open-label safety/tolerability/immunogenicity study in immunocompromised participants ≥2 years; recruitment stopped before Amendment 5 | 6 | 1 | Open report → |
| Moderna P201 | ModernaTX | Phase 2 dose-confirmation trial of mRNA-1273 | 4 | 1 | Open report → |
| Moderna P301 (COVE) | ModernaTX | COVE — pivotal Phase 3 randomized efficacy study of mRNA-1273 in adults 18+ | 5 | 1 | Open report → |
| AZ D8110C00001 | AstraZeneca | Pivotal Phase 3 randomized double-blind placebo-controlled efficacy trial of AZD1222 (ChAdOx1-S; Vaxzevria) in adults ≥18; ~32,400 participants across US, Chile, Peru | 7 | 1 | Open report → |
| J&J ENSEMBLE | Janssen / Johnson & Johnson | Pivotal Phase 3 randomized double-blind placebo-controlled efficacy trial of single-dose Ad26.COV2.S in adults ≥18 | 8 | 1 | Open report → |
| J&J ENSEMBLE 2 | Janssen / Johnson & Johnson | Pivotal Phase 3 randomized double-blind placebo-controlled efficacy trial of two-dose Ad26.COV2.S in adults ≥18 | 8 | 1 | Open report → |