Last updated: 03/21/2024 14:30:56

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

GSK study ID
221785
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Efficacy/Effectiveness of Cervarix against grade 3 cervical intraepithelial neoplasia or worse (CIN3, CIN3+) and cervical cancer. A systematic review and meta-regression analysis
Trial description: The purpose of this study is to evaluate the efficacy/effectiveness of the vaccination with GlaxoSmithKline’s (GSK’s) bivalent human papillomavirus (HPV) vaccine (Cervarix) of girls and women against HPV on cervical cancer and cervical intraepithelial neoplasia grade 3 or worse (CIN3, CIN3+) by conducting a systematic review and meta-regression analysis.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Combined efficacy/effectiveness of GSK’s bivalent HPV vaccine on CIN3+ caused by HPV 16/18 vaccine types (Combined randomized controlled trials/observational studies)

Timeframe: From 1 January 2000 up to 21 June 2022

Overall efficacy/effectiveness of GSK’s bivalent HPV vaccine on CIN3+ caused by any HPV type (Combined randomized controlled trials/observational studies)

Timeframe: From 1 January 2000 up to 21 June 2022

Efficacy of GSK’s bivalent HPV vaccine on CIN3+ caused by HPV 16/18 vaccine types (Randomized controlled trials)

Timeframe: From 1 January 2000 up to 21 June 2022

Effectiveness of GSK’s bivalent HPV vaccine on CIN3+ caused by HPV 16/18 vaccine types (Observational studies)

Timeframe: From 1 January 2000 up to 21 June 2022

Efficacy of GSK’s bivalent HPV vaccine on CIN3+ caused by any HPV type (Randomized controlled trials)

Timeframe: From 1 January 2000 up to 21 June 2022

Effectiveness of GSK’s bivalent HPV vaccine on CIN3+ caused by any HPV type (Observational studies)

Timeframe: From 1 January 2000 up to 21 June 2022

Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
296000
Primary completion date:
2023-29-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Infections, Papillomavirus
Product
Not applicable
Collaborators
Not applicable
Study date(s)
September 2023 to September 2023
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female
Age
12 - 25 Years
Accepts healthy volunteers
Yes
  • All studies that meet the following criteria were included:
  • Studies that report Cervarix efficacy (randomised controlled trials, RCTs) or effectiveness (observational studies) against cervical cancer and/or grade 3 cervical intraepithelial neoplasia or worse (CIN3, CIN3+).
  • Systematic reviews, reviews, modelling, economic studies (including cost-effectiveness and comparative effectiveness), letters to the editor, case reports, and case series were excluded. Conference abstracts and proceedings were excluded. Studies that have unreliable data for the extraction were excluded. Grey literature was not included.
Inclusion and exclusion criteria
Inclusion criteria:

    All studies that meet the following criteria were included:

    • Studies that report Cervarix efficacy (randomised controlled trials, RCTs) or effectiveness (observational studies) against cervical cancer and/or grade 3 cervical intraepithelial neoplasia or worse (CIN3, CIN3+).
    • Studies that have a comparator group receiving either placebo or another vaccine, or a control group of unvaccinated participants.
    • The intervention group was considered as vaccinated if participants received at least one dose of the vaccine.
    • Studies published in journal articles between 1 January 2000 to 21 June 2022. The following databases were screened: PubMed, Embase, SCOPUS, and Cochrane Central Register for Clinical Trials (CENTRAL).
    • Studies with the following design could be included: randomised controlled trials and observational studies (cohort, cross-sectional, case-control, longitudinal, population-based surveillance).
    • Journal articles with abstract in the following languages: English, French, Spanish, Portuguese, German, and Italian.
Exclusion criteria:
  • Systematic reviews, reviews, modelling, economic studies (including cost-effectiveness and comparative effectiveness), letters to the editor, case reports, and case series were excluded. Conference abstracts and proceedings were excluded. Studies that have unreliable data for the extraction were excluded. Grey literature was not included.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Clinical study report
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

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
2023-29-09
Actual study completion date
2023-29-09

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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