Clinical trial NCT00309166: Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine in Young Males.
Official title: An Observer-blind, Randomized, Controlled Study to Assess the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Male Subjects Aged 10-18 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infections, Papillomavirus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-03-31
Enrollment: 270
Sex: MALE
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main aim of this vaccine is to prevent cervical cancer in women. However, it could also be relevant to vaccinate selected groups of males. Therefore, this study is designed to evaluate the safety and immunogenicity of the HPV vaccine in pre-teen and adolescent male subjects aged 10-18 years.


Eligibility criteria: Inclusion criteria:

* A male between, and including, 10 and 18 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject prior to enrolment
* For subjects below the legal age of consent, a written informed consent must be obtained from the subject's parent/guardian. In addition, a written informed assent must be obtained from the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion criteria:

* Previous vaccination against Human Papillomavirus (HPV).
* Previous vaccination against Hepatitis B, known clinical history of Hepatitis B infection.
* Cancer or autoimmune disease under treatment.

Primary outcomes:
measure: Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18
timeFrame: At Month 7
measure: Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)
timeFrame: At Month 7
Secondary outcomes:
measure: Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18
timeFrame: At Month 2
measure: Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)
timeFrame: At Month 2
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: Within 30 days (Day 0-29) after any vaccination, up to 7 months
measure: Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions
timeFrame: Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
measure: Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
timeFrame: At Month 2 and Month 7, post-vaccination
measure: Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
timeFrame: At Month 2 and at Month 7, post-vaccination
Other outcomes:
Locations:
city: Kotka
country: Finland
facility: GSK Investigational Site
city: Kouvola
country: Finland
facility: GSK Investigational Site
city: Mikkeli
country: Finland
facility: GSK Investigational Site
city: Rauma
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Petaja T, Keranen H, Karppa T, Kawa A, Lantela S, Siitari-Mattila M, Levanen H, Tocklin T, Godeaux O, Lehtinen M, Dubin G. Immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in healthy boys aged 10-18 years. J Adolesc Health. 2009 Jan;44(1):33-40. doi: 10.1016/j.jadohealth.2008.10.002.
citation: Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.