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

NCT00309166 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2018-09-17

Study results available
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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.

Conditions

  • Infections, Papillomavirus

Interventions

BIOLOGICAL

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.

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-04-05
Primary Completion
2007-06-01
Completion
2007-06-19

Countries

  • Finland

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00309166 on ClinicalTrials.gov