Efficacy/Effectiveness of Cervarix against grade 3 cervical intraepithelial neoplasia or worse (CIN3, CIN3+) and cervical cancer. A systematic review and meta-regression analysis (EPI-HPV-101 VE DB 221785)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000026
• EU PAS number:
  EUPAS1000000026
• Study ID:
  1000000026
• Official title and acronym:
  Efficacy/Effectiveness of Cervarix against grade 3 cervical intraepithelial neoplasia or worse (CIN3, CIN3+) and cervical cancer. A systematic review and meta-regression analysis (EPI-HPV-101 VE DB 221785)
• DARWIN EU® study:
  No
• Study countries:
  Belgium
• Study description:
  A study to evaluate the efficacy/effectiveness of the vaccination with GSK’s bivalent HPV vaccine (Cervarix) of girls and women against HPV on cervical cancer and cervical intraepithelial neoplasia grade 3 or worse (CIN3, CIN3+).
• Study status:
  Finalised

Research institution and networks

Institutions

GlaxoSmithKline (GSK)

Study timelines

Date when funding contract was signed

Actual: 07/09/2023

Study start date

Actual: 07/09/2023

Date of final study report

Planned: 29/02/2024

Actual: 01/03/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline (GSK)

Study protocol

Initial protocol

Protocol_Anonymised.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable