At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 798 enrolled
Drug / intervention
Cervarix™biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Assess Lot-to-lot Consistency of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Following Manufacturing Adjustments Administered Intramuscularly According to a 0,1,6-mth Schedule in Healthy Female Subjects (18-25 y)
In Brief
A Phase 3 clinical trial evaluating Cervarix™ for Infections, Papillomavirus and Papillomavirus Vaccines. Completed, enrolled 798 participants across 8 sites in 3 countries.
Detailed Summary
Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will compare the immune response induced by different lots of the HPV-16/18 L1/AS04 vaccine, following adjustments to the manufacturing process.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark, Lithuania, Poland
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2005
First PostedNov 2005
Primary CompletionMar 2007
TodayJul 2026
First PostedNov 8, 2005
Enrollment StartOct 28, 2005
Primary CompletionMar 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.7 years ago
Interventions
Cervarix™biological
GSK Biologicals' vaccine against human papillomaviruses 16 and 18.