At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 37 target
Drug / intervention
HPV prophylactic vaccine Gardasilbiological
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.
Multicenter Clinical Trial Evaluating the Immunological Response of Vaccination Against Infection by Human Papillomavirus (HPV) 6, 11, 16, 18 in Girls Receiving Immunosuppressive Therapy.
In Brief
A Phase 2 clinical trial evaluating HPV prophylactic vaccine Gardasil for Transplantation and 2 related conditions. Completed, enrolled 37 participants across 9 sites.
Detailed Summary
PRIMAVERA is a Phase IIa clinical trial, with the objective to assess the immunologic response to HPV vaccine in a population of immunocompromised girls. The principal hypothesis is that the immunologic response to tetravalent vaccine in girls who received immunosuppressive treatment is comparable to the immunologic response in girls that are not immunosuppressed.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 2012
Enrollment StartOct 2012
Primary CompletionMay 2015
Study CompletionOct 2016
TodayJul 2026
First PostedSep 18, 2012
Enrollment StartOct 11, 2012
Primary CompletionMay 1, 2015
Study CompletionOct 20, 2016
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 13.8 years ago
Interventions
HPV prophylactic vaccine Gardasilbiological
3 injections: at Inclusion visit then 2 and 6 months after.