Immune memory to HPV induced by Gardasil in girls and boys

Immune memory to HPV induced by Gardasil in girls and boys - B-cell memory to Gardasil®

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005581-19-IT

Enrollment

Unknown

Registered

2014-07-09

Start date

2014-07-31

Completion date

Unknown

Last updated

2016-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy subjects undergoing voluntary vaccination

Interventions

Trade Name: Gardasil Product Name: Gardasil Pharmaceutical Form: Suspension for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 To correlate the level of serum antibodies to the frequency of specific memory B cells ;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	—

Measure

Time frame

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 To correlate the level of serum antibodies to the frequency of specific memory B cells ;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

Measure	Time frame
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 To correlate the level of serum antibodies to the frequency of specific memory B cells ;Timepoint(s) of evaluation of this end point: 48 months	—

Countries

Italy

Contacts

Public ContactRita Carsetti

Bambino Gesù Children’s Hospital

rita.carsetti@opbg.net00390668592647

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026