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COMPLETED
NCT01687192
PHASE2

Multicenter Trial Evaluating the Immunogenicity of HPV Vaccination in Girls on Immunosuppressive Therapy.

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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

BIOLOGICAL

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