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

Phase 2

Completed

• Conditions: Infections, Papillomavirus
• Interventions: Biological: Cervarix vaccine; Biological: Engerix-B vaccine

• Registration Number: NCT00309166
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-03-28
• Study First Submitted QC: 2006-03-28
• Study First Posted: 2006-03-31
• Study Start: 2006-04-05
• Primary Completion: 2007-06-01
• Study Completion: 2007-06-19
• Results First Submitted: 2016-12-19
• Status Verified: 2018-02
• Results First Submitted QC: 2018-02-05
• Last Update Submitted: 2018-02-05
• Results First Posted: 2018-09-17
• Last Update Posted: 2018-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 270

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervarix Group	Cervarix vaccine	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.
Engerix-B Group	Engerix-B vaccine	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.

Primary Outcome Measures

Name	Time	Method
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18	At Month 7	Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies \[anti-HPV-16 titers greater than or equal to (≥) 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 titres ≥7 EL.U/mL\] in the serum of subjects seronegative before vaccination.
Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)	At Month 7	Titers were presented as geometric mean titers (GMT).

Secondary Outcome Measures

Name	Time	Method
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18	At Month 2	Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titres ≥ 8 EL.U/mL and anti-HPV-18 titres ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination.
Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions	Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)	NOCDs include asthma, Chron's disease, dermatitis atopic. MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Within 7 days (Days 0-6) after each dose and across doses, up to 7 months	Solicited local symptoms assessed were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade; Grade 3 pain = pain that prevented normal activity; Grade 3 redness/swelling = redness/swelling spreading beyond (\>) 50 mm.
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters	At Month 2 and at Month 7, post-vaccination	The occurence of clinically relevant abnormalities was assessed in the following biochemical and haematological parameters: lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in terms of normal, below and above laboratory values were - normal, below, above and missing.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Within 7 days (Days 0-6) after each dose and across doses, up to 7 months	Solicited general symptoms assessed were arthralgia, fatigue, fever (defined as axillary temperature ≥37.5 °C), gastrointestinal, headache, myalgia, rash and urticaria. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination; Grade 3 = symptom that prevented normal activity; Grade 3 fever = temperature \> 39.0 °C; Related = symptoms considered by the investigator to have a causal relationship to vaccination.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	Within 30 days (Day 0-29) after any vaccination, up to 7 months	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)	At Month 2	Titers were presented as GMTs.
Number of Subjects With Serious Adverse Events (SAEs)	Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Trial Locations

Locations (1)

GSK Investigational Site; 🇫🇮 Tampere, Finland