Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
VIVIANE: Cervarix in women >25 years
NCT00294047Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2006
- Primary completion
- Jan 2014
- Countries
- 12
- Sponsor
- GSK
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- human papillomavirus infection
01
Overview
Phase 3, randomised, double-blind trial of Human papillomavirus type 16 L1 capsid protein residues 2-471 antigen in human papillomavirus infection (2 arms), sponsored by GSK. Primary endpoints: Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 at 84 months and Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Detected Using the HPV Type Assignment… at 84 months. Started Feb 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Cervarix Group
Cervarix vaccine (0, 1, 6 months)
Aluminium Hydroxide Group
Placebo (0, 1, 6 months)
03
Who it enrols
Healthy women aged 26 years and older with an intact cervix, no history of HPV infection or treatment, and negative pregnancy test.
04
Endpoints
Primary
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Detected Using the HPV Type Assignment…
Secondary
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection
Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset
05
Results
Primary endpoints met
Beyond the preview
Go deeper on NCT00294047.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00294047.