Clinical Trial and Post-Licensure Safety Profile of a Prophylactic Human Papillomavirus (Types 6, 11, 16, and 18) L1 Virus-Like Particle Vaccine
| Autor: | Michael A. Gold, Gretchen M. Tamms, Richard M. Haupt, Adrian Dana, Keith S. Reisinger, Heather L. Sings, Eliav Barr, Darron R. Brown, Archana Chatterjee, Haiping Zhou, Anne R. Meibohm, Stan L. Block |
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| Rok vydání: | 2010 |
| Předmět: |
Adult
Male Microbiology (medical) Sexually transmitted disease Pediatrics medicine.medical_specialty Adolescent Drug-Related Side Effects and Adverse Reactions Fever Pain Genital warts law.invention Placebos Young Adult Human Papillomavirus Recombinant Vaccine Quadrivalent Types 6 11 16 18 Randomized controlled trial law Product Surveillance Postmarketing medicine Humans Papillomavirus Vaccines Young adult Child Adverse effect Cervical cancer business.industry Incidence Papillomavirus Infections Headache medicine.disease United States Vaccines Virosome Clinical trial Vaccination Infectious Diseases Pediatrics Perinatology and Child Health Immunology Female business |
| Zdroj: | Pediatric Infectious Disease Journal. 29:95-101 |
| ISSN: | 0891-3668 |
| DOI: | 10.1097/inf.0b013e3181b77906 |
| Popis: | We describe the safety of the human papillomavirus (HPV)-6/11/16/18 vaccine using updated clinical trial data (median follow-up time of 3.6 years) and summarize up to 3 years of post-licensure surveillance.In 5 clinical trials, 21,480 girls/women aged 9 to 26 years and boys aged 9 to 16 years receivedor=1 dose of HPV-6/11/16/18 vaccine or placebo. All serious and non-serious adverse experiences (AEs) and new medical conditions were recorded for the entire study period(s). As of June 2009,25 million doses of HPV-6/11/16/18 vaccine had been distributed in the United States with50 million doses globally. Post-licensure safety as summarized by the Centers for Disease Control and Prevention using the United States Vaccine Adverse Event Reporting System database is also reported.Eight subjects experienced a treatment-related serious AE (0.05% vaccine; 0.02% placebo). Of 18 deaths (0.1% vaccine; 0.1% placebo), all were considered unrelated to study treatment. New medical conditions which were potentially consistent with autoimmune phenomena were reported in 2.4% of both vaccine and placebo recipients. Pain, the most common injection-site AE, occurred more frequently with vaccine (81% vaccine; 75% placeboaluminum; 45% placebo-saline). No differences were seen in the incidence of the most common non-serious AEs-headache and pyrexia. The Vaccine Adverse Event Reporting System has received 14,072 reports for the HPV-6/11/16/18 vaccine since licensure, with only 7% being serious AEs, about half the average reported for licensed vaccines in general.HPV-6/11/16/18 vaccination was associated with more injection-site pain than placebo but similar incidences of systemic and serious AEs and new medical conditions potentially consistent with autoimmune phenomena. Based on review of post-licensure safety information, the benefits of vaccination to prevent the majority of genital tract precancers and cancers continue to far outweigh its risks. |
| Databáze: | OpenAIRE |
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