Loading...
Please wait, while we are loading the content...
Similar Documents
A quadrivalent vaccine against human papillomavirus prevented anogenital diseases in young women.
| Content Provider | Semantic Scholar |
|---|---|
| Author | Andrews, Jeff |
| Copyright Year | 2007 |
| Abstract | M e t h o d s Design: Randomized, placebo-controlled trial (Females United to Unilaterally Reduce Endo/Ectocervical Disease [FUTURE] I study). Allocation: Concealed.* Blinding: Blinded (participants, clinicians, outcome assessors, adjudication committee, {data analysts, and data safety and monitoring committee}†).* Follow-up period: Mean 3 years (maximum 4 y). Follow-up started on day 1 in the intention-to-treat and susceptible populations and 1 month after the third dose of vaccine in the per-protocol population. Setting: 62 sites in 16 countries worldwide. Participants: 5455 healthy, nonpregnant women 16 to 24 years of age (mean 20 y) with no history of genital warts or abnormal results on cervical cytologic testing. Women with > 4 lifetime sex partners were excluded. Intervention: Quadrivalent HPV-6/11/16/18 L1 viruslike-particle vaccine (n = 2723) or placebo (n = 2732) in 3 doses injected on day 1, month 2, and month 6. Outcomes: 2 primary composite endpoints: external anogenital and vaginal lesions (anogenital warts or vulvar or vaginal intraepithelial neoplasia grades 1 to 3 or cancer associated with vaccine-type HPV) and cervical lesions (cervical intraepithelial neoplasia [CIN] grades 1 to 3, adenocarcinoma in situ, or cancer associated with vaccine-type HPV). Patient follow-up: 100% in the intention-totreat population (all randomized women); 98% in the susceptible population (women who were negative for HPV type 6, 11, 16, or 18 on day 1); and 83% in the per-protocol population (women who received all 3 doses of vaccine, had no major protocol violation, and were negative for HPV type 6, 11, 16, or 18 on day 1 and through 1 mo after the third dose). |
| Starting Page | 71 |
| Ending Page | 71 |
| Page Count | 1 |
| File Format | PDF HTM / HTML |
| PubMed reference number | 17975873 |
| Journal | Medline |
| Volume Number | 147 |
| Issue Number | 3 |
| Alternate Webpage(s) | http://acpjc.acponline.org/Content/pdf/ACPJC-2007-147-3-071.pdf |
| Journal | ACP journal club |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |
