Phase 2
Completed N=270
Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine in Young Males.
Infections, Papillomavirus
Source: ClinicalTrials.gov NCT00309166 ↗
Enrolled (actual)
270
Serious AEs
1.5%
Results posted
Sep 2018
Primary outcomePrimary: Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 — 163; 1; 150; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 |
165; 0; 152; 4 | — |
| PRIMARY Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18) |
5254.5; 4.1; 3696.9; 3.7 | — |
| SECONDARY Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 |
165; 0; 152; 4 | — |
| SECONDARY Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18) |
5254.5; 4.1; 3696.9; 3.7 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
149; 25; 1; 0; 24; 12 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
17; 7; 0; 0; 10; 3 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
68; 31; 5; 2; 5; 1 | — |
| SECONDARY Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions |
2; 1; 22; 10; 0; 0 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
2; 0; 1; 1 | — |
| SECONDARY Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters |
117; 56; 5; 1; 18; 6 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00309166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.