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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/31689
• EU PAS number:
  EUPAS17902
• Study ID:
  31689
• Official title and acronym:
  207644 - Meta analysis of HPV-associated CIN2, CIN2+ and CIN3+ cases in efficacy studies according to baseline cytology and DNA status.
• DARWIN EU® study:
  No
• Study countries:
  Belgium
• Study description:
  This analysis is performed following the outcome of discussion in the HPV Safety Review Team about the potential imbalance observed in the incidence of Cervical Intraepithelial Neoplasms (CIN)2+ and CIN3+ in HPV-015 study: more CIN2+ cases were accrued in the vaccine group in subjects with high grade cytology and who were DNA positive at baseline (before vaccination). This was noticed while preparing a response to questions received by EMA on the submission for HPV-015 study and was decided to investigate further by looking to other efficacy studies including younger subjects (<25 years) and pooled.
• Study status:
  Finalised

Research institution and networks

Institutions

GlaxoSmithKline (GSK)

Study timelines

Date when funding contract was signed

Actual: 30/01/2017

Study start date

Actual: 31/01/2017

Date of final study report

Actual: 30/06/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GSK Vaccines

Study protocol

Initial protocol

gsk-207644-sap-redact

Regulatory

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