A Study to Evaluate the Efficacy of Quadrivalent HPV (Types 6, 11, 16, and 18) L1 Virus-Like Particle (VLP) in Reducing the Incidence of HPV 6-, 11-, 16-, and 18-Related Anogenital Warts, and the Incidence of HPV 6-, 11-, 16-, and 18-Related Genital Infection in 16- to 23-Year-Old Men - HPV Vaccine Efficacy Study in Young Me

Phase 1

• Conditions: Prevention of Human Papillomavirus Infections; MedDRA version: 7.0Level: LLTClassification code 10063001

• Registration Number: EUCTR2004-002945-10-FI
• Lead Sponsor: Suomen MSD OY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11-18
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 2700

Inclusion Criteria

Candidate subjects must meet ALL of the following:
a. Healthy, males between the ages 16 years and 0 days and 23 years and 364 days.
b. No clinical evidence of gross genital lesion suggesting sexually-transmitted disease, and no clinically present anogenital warts.
c. No temperature =100°F or =37.8°C (oral) within 24 hours prior to vaccinations (vaccinations can be scheduled at a later date when the temperature falls into normal range).
d. Must agree to refrain from sexual activity (including vaginal and anal penetration and any genital contact) for 2 calendar days prior to any scheduled visit that includes sample collection, to avoid detection of viral DNA which has been deposited in the male genital area during sexual intercourse and is not the result of ongoing infection.
e. Individuals who have experienced sexual debut but have had no more than 5 lifetime sexual partners. For protocol purposes, a female sexual partner is defined as a woman with whom the subject has engaged in vaginal intercourse. For protocol purposes, a male sexual partner is defined as a man with whom the subject engaged in insertive or receptive anal intercourse.
f. Must agree to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes.
g-1) Additional inclusion criteria for heterosexual male subjects
Subjects must be a heterosexual male, who has had exclusively female sexual partners.
g-2) Additional inclusion criteria for MSM subjects
Subjects must have engaged in either insertive or receptive anal intercourse with another male sexual partner within the past year.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Candidate subjects who manifest ANY of the following exclusion criteria at the time of randomization will NOT be eligible for the study:
a. Individuals concurrently enrolled in clinical studies of investigational agents or studies involving collection of genital specimens.
b. History of known prior vaccination with an HPV vaccine.
c. Receipt of inactivated vaccines within 14 days prior to enrollment or receipt of live virus vaccines within 21 days prior to enrollment.
d. Individuals who have history of anogenital warts, or who have clinically present anogenital warts at Day 1.
e. History of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension or shock) that required medical intervention.
f. Individuals allergic to any vaccine component, including aluminum, yeast, or BENZONASE™ (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]).
g. Individuals who have received any immune globulin or blood derived products within the 6 months prior to the first injection, or plan to receive any through Month 7 of the study.
h. Individuals with history of splenectomy, known immune disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis), or receiving immunosuppressives (e.g., substances or treatments known to diminish the immune response such as radiation therapy, administration of antimetabolites, antilymphocytic sera, systemic corticosteroids). Individuals who have received periodic treatments with immunosuppressives, defined as at least 3 courses of oral corticosteroids each lasting at least 1 week in duration for the year prior to enrollment, will be excluded. Subjects using topical steroids (i.e., inhaled or nasal) will be eligible for vaccination.
i. Individuals who are immunocompromised or have been diagnosed as having Human Immunodeficiency Virus (HIV) infection.
j. Individuals with known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
k. History of recent (within the last 12 months) or ongoing alcohol or drug abuse.
Alcohol and drug abusers are defined as those who drink or use drugs despite recurrent social, interpersonal, and legal problems as results of alcohol or drug use.
l. Any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives.
m. Any plan to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled.
n. Individuals with fewer than one or >5 lifetime sexual partners.
o.Inability to give informed consent/assent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified