A Study for V503 in 16- to 26-Year-Old Men and 16- to 26-Year-Old Wome

Conditions: Prevention of external genital lesions, anal cancers and related precancers, and persistent infection caused by Human Papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52 and 58.
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2012-002758-22-FI

Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2500

Inclusion Criteria

1.Subject is male or female, between the ages of 16 years and 0 days and 26 years and 364 days on the day of enrollment.
2.Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory results.
3.Subject (or, for minor subjects, parent/legal guardian and subject) fully understands study procedures, alternative treatments available, the risks involved with the study, and voluntarily agrees to participate by giving written informed consent. The subject may also provide consent/assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
4.Subject agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes.
5.Subject is able to read, understand, and complete the Vaccination Report Card.
6.a) (HM and female subjects only) Subject has a lifetime history of 0 to 4 male and/or female sexual partners at the time of enrollment.
b) (MSM subjects only) Subject has a lifetime history of up to 5 male and/or female sexual partners at the time of enrollment.
Male or female partner is defined as someone with whom the subject has penile penetrative sexual intercourse or someone who has contacted, either by penetrative (with fingers or other objects) or non-penetrative means, the subject's genitalia during sexual activity.
7.(HM subjects only) Subject must be sexually naïve or a heterosexual male who has exclusively female sexual partners.
8.(MSM subjects only) Subjects must identify themselves as a man who has sex with men and must have engaged in either insertive or receptive anal intercourse or oral sex with another male sexual partner within the past year.
9.(Female subjects only) Subject has never had Pap testing or has only had normal Pap test results.
*(Female subjects only) Since the first day of the subject’s last menstrual period through Day 1, the subject has not had sex with males or has had sex with males and used effective contraception with no failures (an example of a failure is a male condom that ruptures during sexual intercourse). Effective contraception is defined as a marketed, approved contraceptive product that the subject has used per the manufacturer’s instructions with every act of sexual intercourse. The subject understands and agrees that during the Day 1 through Month 7 period, she should not have sexual intercourse with males without effective contraception, and the uses of the rhythm method alone, withdrawal alone, and emergency contraception, are not acceptable methods per the protocol.

Are the trial subjects under 18? yes
Number of subjects for this age range: 500
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2000
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
;
1.Subject is male or female, between the ages of 16 years and 0 days and 26 years and 364 days on the day of enrollment.
2.Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory results.
3.Subject (or, for minor subjects, parent/legal guardian and subject) fully understands study procedures, alternative treatments available, the risks involved with the study, and voluntarily agrees to participate by giving written informed consent. The subject may also provide consent/assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
4.Subject agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes.
5.Subject is able to read, understand, and complete the Vaccination Report Card.
6.a) (HM and female subjects only) Subject has a lifetime history of 0 to 4 male and/or female sexual partners at the time of enrollment.
b) (MSM subjects only) Subject has a lifetime history of up to 5 male and/or female sexual partners at the time of enrollment.
Male or female partner is defined as someone with whom the subject has penile penetrative sexual intercourse or someone who has contacted, either by penetrative (with fingers or other objects) or non-penetrative means, the subject's genitalia during sexual activity.
7.(HM subjects only) Subject must be sexually naïve or a heterosexual male who has exclusively female sexual partners.
8.(MSM subjects only) Subjects must identify themselves as a man who has sex with men and must have engaged in either insertive or receptive anal intercourse or oral sex with another male sexual partner within the past year.
9.(Female subjects only) Subject has never had Pap testing or has only had normal Pap test results.
*(Female subjects only) Since the first day of the subject’s last menstrual period through Day 1, the subject has not had sex with males or has had sex with males and used effective contraception with no failures (an example of a failure is a male condom that ruptures during sexual intercourse). Effective contraception is defined as a marketed, approved contraceptive product that the subject has used per the manufacturer’s instructions with every act of sexual intercourse. The subject understands and agrees that during the Day 1 through Month 7 period, she should not have sexual intercourse with males without effective contraception, and the uses of the rhythm method alone, withdrawal alone, and emergency contraception, are not acceptable methods per the protocol.

Exclusion Criteria

1.Subject has a known allergy to any vaccine component, including aluminum, yeast, or BENZONASE™ (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]). For the purpose of this exclusion criterion, an allergy to vaccine components is defined as an allergic reaction that met the criteria for a serious adverse experience.
2.Subject has a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention.
3.Subject has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
4.Subject is concurrently enrolled in another clinical study of investigational agents.
5.(Female subjects only) - Subject is pregnant (as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL ß-hCG).
6.(Female subjects only) Subject is expecting to donate eggs during Day 1 through Month 7 of the study.
7.Subject is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition.
8.Subject has had a splenectomy.
9.Subject is receiving or has received in the year prior to enrollment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava™), TNF-a antagonists, monoclonal antibody therapies (including rituximab [Rituxan™]), intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a subject will be excluded if he/she is currently receiving steroid therapy, has recently (defined as within 2 weeks of enrollment) received such therapy, or has received 2 or more courses of high-dose corticosteroids (orally or parenterally) lasting at least 1 week in duration in the year prior to enrollment. Subjects using inhaled, nasal or topical steroids are considered eligible for the study.
10.Subject has received any immune globulin product (including RhoGAM™ [Ortho-Clinical Diagnostics]) or blood-derived product within the 3 months prior to the Day 1 vaccination, or plans to receive any such product during Day 1 through Month 7 of the study.
11.*Subject has received non-replicating (inactivated) vaccines within 14 days prior to the Day 1 vaccination or has received replicating (live) vaccines within 21 days prior to the Day 1 vaccination.
12.Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
13.*Subject has had a fever (defined as an oral temperature of =100.0°F or =37.8°C) within the 24-hour period prior to the Day 1 vaccination.
14.Subject has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
15.Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
16.Subject is, at the time of signing informed consent, a user of recreational or illi;
1.Subject has a known allergy to any vaccine component, including aluminum, yeast, or BENZONASE™ (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]). For the purpose of this exclusion criterion, an allergy to vaccine components is defined as an allergic reaction that met the criteria for a serious adverse experience.
2.Subject has a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention.
3.Subject has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
4.Subject is concurrently enrolled in another clinical study of investigational agents.
5.(Female subjects only) - Subject is pregnant (as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL ß-hCG).
6.(Female subjects only) Subject is expecting to donate eggs during Day 1 through Month 7 of the study.
7.Subject is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition.
8.Subject has had a splenectomy.
9.Subject is receiving or has received in the year prior to enrollment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava™), TNF-a antagonists, monoclonal antibody therapies (including rituximab [Rituxan™]), intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a subject will be excluded if he/she is currently receiving steroid therapy, has recently (defined as within 2 weeks of enrollment) received such therapy, or has received 2 or more courses of high-dose corticosteroids (orally or parenterally) lasting at least 1 week in duration in the year prior to enrollment. Subjects using inhaled, nasal or topical steroids are considered eligible for the study.
10.Subject has received any immune globulin product (including RhoGAM™ [Ortho-Clinical Diagnostics]) or blood-derived product within the 3 months prior to the Day 1 vaccination, or plans to receive any such product during Day 1 through Month 7 of the study.
11.*Subject has received non-replicating (inactivated) vaccines within 14 days prior to the Day 1 vaccination or has received replicating (live) vaccines within 21 days prior to the Day 1 vaccination.
12.Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
13.*Subject has had a fever (defined as an oral temperature of =100.0°F or =37.8°C) within the 24-hour period prior to the Day 1 vaccination.
14.Subject has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
15.Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
16.Subject is, at the time of signing informed consent, a user of recreational or illi