Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine in Young Males.

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-05

Study Completion Date

2007-06-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Infections, Papillomavirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Cervarix Group

Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.

Group Type EXPERIMENTAL

Cervarix vaccine

Intervention Type BIOLOGICAL

All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule.

Engerix-B Group

Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.

Group Type ACTIVE_COMPARATOR

Engerix-B vaccine

Intervention Type BIOLOGICAL

All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule

Interventions

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Cervarix vaccine

All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule.

Intervention Type BIOLOGICAL

Engerix-B vaccine

All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule

Intervention Type BIOLOGICAL

Other Intervention Names

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HPV vaccine HBV vaccine

Eligibility Criteria

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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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Kotka, , Finland

Site Status

GSK Investigational Site

Kouvola, , Finland

Site Status

GSK Investigational Site

Mikkeli, , Finland

Site Status

GSK Investigational Site

Rauma, , Finland

Site Status

GSK Investigational Site

Tampere, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type BACKGROUND

PMID: 19101456 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 18845199 (View on PubMed)

Study Documents

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