Evidence for Immunogenicity, Safety in 26-55 year old females | ||||||
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STUDY DETAILS | SUMMARY | |||||
Study | Vaccine | Study Design | Participants | Summary of Key Findings | Level of Evidence | Quality |
HPV014 (120) | Cervarix™ | Non-randomized, open-label, age-stratified Study To assess immunogenicity and safety of vaccine in women aged 26–55 years compared with women aged 15–25 years |
Females 15 to 55 years =666 |
At Month 2, all initially seronegative women became seropositive for both HPV 16 and 18. At Month 7, HPV-16 GMTs (95% CI) were: in 15-25 year olds: 7908.4 (6874.0–9098.5); in 26-45 year olds: 4029.2 (3402.7–4771.0); in 46-55 year olds: 2566.8 (2181.2–3020.6) At Month 7, HPV-18, GMTs (95% CI) were: in 15-25 year olds: 3499.3 (3098.7–3951.6); in 26-45 year olds: 1837.3 (1602.1–2107.0); in 46-55 year olds: 1313.0 (1145.6–1504.9) Incidence of local symptoms (within 30 days) lower in the 46–55 year-old group (69.2% versus 81.6% [26–45] and 85.7% [15–25]) |
Level II-1 | Good |