COVID-19 CoVPN Protocol 3003/Janseen

Project: Research project

Project Details

Description

For purposes of this Amendment, the CRS has been approved to carry out protocol
VAC31518COV3001 [CoVPN 3003] (“Amendment 5 Protocol”) in emergency response to COVID-19
for CoVPN 3003/Janssen. This Amendment is subject to the applicable terms of Collaborative
Agreement Between National Institute of Allergy and Infectious Diseases (“NIAID”) and Janssen
Research & Development, LLC (“Company”) based on Protocol VAC31518COV3001 [CoVPN 3003]
dated August 18, 2020 ("Amendment 5 CTA"), including Addendum II’s Subaward Flow Down
Clauses, as shown in Appendix H. Amendment 5 CTA is confidential in accordance with this
Agreement’s Article 15. Upon CRS request, UCLA shall provide a copy of Janssen’s: Home
Healthcare Visit Program Site Guide, Talking Points for LTMs, and/or Governance and RACICOV3001
ph 3, each and all of which are confidential in accordance with this Agreement’s Article 15. Protocol is entitled “A Randomized,
Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of
Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18
Years and Older.
StatusFinished
Effective start/end date9/3/2011/30/20

Funding

  • University of California at Los Angeles (CoVPN3003-Janssen//3UM1AI068636-14S2 REVISED)
  • National Institute of Allergy and Infectious Diseases (CoVPN3003-Janssen//3UM1AI068636-14S2 REVISED)

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