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Multicenter Trial Evaluating the Immunogenicity of HPV Vaccination in Girls on Immunosuppressive Therapy.
Sponsor: University Hospital, Bordeaux
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.
Official title: Multicenter Clinical Trial Evaluating the Immunological Response of Vaccination Against Infection by Human Papillomavirus (HPV) 6, 11, 16, 18 in Girls Receiving Immunosuppressive Therapy.
Key Details
Gender
FEMALE
Age Range
9 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
37
Start Date
2012-10-11
Completion Date
2016-10-20
Last Updated
2026-05-20
Healthy Volunteers
No
Interventions
HPV prophylactic vaccine Gardasil
3 injections: at Inclusion visit then 2 and 6 months after.
Locations (9)
CHU de Bordeaux, Hôpital Pellegrin-Enfants
Bordeaux, France
HCLyon, Hôpital Femme-mère-enfant
Bron, France
CHU de Lille, Hôpital Jeanne de Flandres
Lille, France
CHU de Montpellier, Hôpital Arnaud de Villeneuve
Montpellier, France
CHU de Nantes, Hôpital Mère-Enfants
Nantes, France
AP-HP, Hôpital Robert Debré
Paris, France
AP-HP, Hôpital Armand Trousseau
Paris, France
AP-HP, Hôpital Necker-Enfants
Paris, France
CHU de Toulouse, Hôpital des Enfants
Toulouse, France