Last updated: 02/20/2024 08:50:58
Meta analysis of HPV-associated CIN2, CIN2+ and CIN3+ cases in efficacy studies according to baseline cytology and DNA status
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Meta analysis of HPV-associated CIN2, CIN2+ and CIN3+ cases in efficacy studies according to baseline cytology and DNA status
Trial 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Demographic characteristics presented by pooled studies
Timeframe: At time of analysis
Overview of DNA status for subjects with cytology at baseline
Timeframe: At time of analysis
Overview of DNA status for subjects (By HPV types) with cytology at baseline
Timeframe: At time of analysis
Summary table on incidence of cases of CIN2, CIN2+, CIN3
Timeframe: At time of analysis
Cumulative incidence of CIN2, CIN2+ and CIN3+
Timeframe: At time of analysis
Type distribution for CIN2, CIN2+ and CIN3+ cases
Timeframe: At time of analysis
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
0
Primary completion date:
2017-15-02
Observational study model:
Case-Control
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Cervical Intraepithelial Neoplasia
Product
SB580299
Collaborators
Not applicable
Study date(s)
January 2017 to February 2017
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
15+ years
Accepts healthy volunteers
Yes
- A subject who participated in any of the HPV-008 (NCT00122681); HPV-015 (NCT00294047); HPV-039 (NCT00779766) or HPV-032 (NCT00316693) studies and
- For whom results are available.
- A subject who did not participate in any of the HPV-008 (NCT00122681); HPV-015 (NCT00294047); HPV-039 (NCT00779766) or HPV-032 (NCT00316693) studies or
- A subject who participated in any of the HPV-008 (NCT00122681); HPV-015 (NCT00294047); HPV-039 (NCT00779766) or HPV-032 (NCT00316693) studies, but for whom results are not available.
Inclusion and exclusion criteria
Inclusion criteria:
- For whom results are available.
A subject who participated in any of the HPV-008 (NCT00122681); HPV-015 (NCT00294047); HPV-039 (NCT00779766) or HPV-032 (NCT00316693) studies and
Exclusion criteria:
- A subject who participated in any of the HPV-008 (NCT00122681); HPV-015 (NCT00294047); HPV-039 (NCT00779766) or HPV-032 (NCT00316693) studies, but for whom results are not available.
A subject who did not participate in any of the HPV-008 (NCT00122681); HPV-015 (NCT00294047); HPV-039 (NCT00779766) or HPV-032 (NCT00316693) studies or
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2017-15-02
Actual study completion date
2017-15-02
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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