207644 - Meta analysis of HPV-associated CIN2, CIN2+ and CIN3+ cases in efficacy studies according to baseline cytology and DNA status.

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Safety Pooling
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Systematic review and meta-analysis

Study drug and medical condition

• Name of medicine:
  Cervarix
• Name of medicine, other:
  Havrix
• Medical condition to be studied:
  Human papilloma virus test

Population studied

• Short description of the study population:
  Female subjects with high grade cytology and who were DNA positive at baseline (before vaccination).
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)
• Estimated number of subjects:
  1

Study design details

• Main study objective:
  - Provide a summary table on incidence of cases of CIN2, CIN2+, CIN3+ in each group and study, according to baseline status. - Cumulative incidence of CIN2, CIN2+ and CIN3+ will be presented in the form of a graph. - Type distribution for CIN2, CIN2+ and CIN3+ cases will be provided overall and by cytology status at baseline (Normal/Low/High).
• Outcomes:
  - Demographic characteristics presented by pooled studies. - Baseline cytology and DNA status. - Baseline cytology and DNA status by HPV serostatus. - Summary on incidence of CIN2, CIN2+, CIN3+ cases, in each group and study. - Cumulative incidence of CIN2, CIN2+ and CIN3+. - Type distribution for CIN2, CIN2+ and CIN3+ cases: overall and by baseline cytology status.
• Data analysis plan:
  All analysis will be descriptive in nature with the intent to understand the difference in incidence of CIN cases. Interpretation from this analysis needs to be made carefully by considering that this is a post-hoc analysis and no formal sample size computations were done for evaluation of the study objectives. Subjects enrolled in the Clinical studies in this analysis were not randomised for DNA status and cytology status at baseline.

Documents

Study results

gsk-207644-sar-redact