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Result Summary for 580299/004

Result Summary
Protocol ID: 580299/004
Clinical Study ID: 580299/004
Official Title: Study to Evaluate the Safety and Immunogenicity of MEDI-517, a Virus-Like Particle Vaccine against Human Papillomavirus Types 16 and 18, when Formulated with Aluminum Hydroxide, AS04, or without Adjuvant, in Healthy Adult Female Volunteers
Phase: Phase 2
Study Indications or Diseases:
  • Papillomavirus Vaccines
Generic Name: Human Papillomavirus Types 16 and 18 Vaccine
Trade/Product Name: Cervarix
Approved Drug Label: http://www.gsk.com/products.html
Results Summary: Click here to download result summary. Click here to download result summary.
Citations:
  • Verstraeten T et al. (2008) Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 26(51):6630–6638.
  • Descamps D et al. (2009) Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: A pooled analysis of 11 clinical trials. Hum Vaccin. 5(5):51-59.
  • Giannini S et al. (2006) Enhanced humoral and memory B cellular immunity using HPV 16/18 L1 VLP vaccine formulated with the MPL/aluminium salt combination (AS04) compared to aluminium salt only. Vaccine. 24(33-34):5937-5949.

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