Skip to main content
. 2012 Jan 2;38(ACS-1):1–62. doi: 10.14745/ccdr.v38i00a01
Evidence for Immunogenicity, Safety in 26-55 year old females
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