Immune memory to HPV induced by Gardasil in girls and boys

Phase 1

• Conditions: Healthy subjects undergoing voluntary vaccination; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2013-005581-19-IT
• Lead Sponsor: Bambino Gesù Children’s Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-09
• Last Update Posted: 22 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

a.Age 11 to 12 years old, at enrolment
Male and female
undergoing voluntary vaccination
Expected compliance form the subject and his/her parents to the study protocol
Signed Informed Consent Form (ICF) by parent(s) or legal representative(s) and by the subject

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects suffering from hypersensitivity to human papillomavirus vaccine, yeast, or any component
Subjects under immunosuppressive treatment, suffering from hematological and neoplastic diseases

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the frequency of B cells able to produce antibodies specific for HPV6/11/16/18 before and after vaccination with Gardasil® at any vaccination point from 2 dose vaccine schedule.;Secondary Objective: To evaluate the influence of each vaccine dose on the frequency of memory B cells and the level of specific antibodies in the serum <br>To correlate the level of serum antibodies to the frequency of specific memory B cells<br>;Primary end point(s): To determine the frequency of B cells able to produce antibodies specific for HPV6/11/16/18 before and after vaccination with Gardasil® at any vaccination point from 2 dose vaccine schedule.;Timepoint(s) of evaluation of this end point: 48 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To evaluate the influence of each vaccine dose on the frequency of memory B cells and the level of specific antibodies in the serum <br>To correlate the level of serum antibodies to the frequency of specific memory B cells<br>;Timepoint(s) of evaluation of this end point: 48 months