E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This study is to study the tolerability and immunogenicity of V503, specific conditions (effiecacy endpoints) are not being investigated in this study. |
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E.1.1.1 | Medical condition in easily understood language |
Specific conditions are not being investigated in this study. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
1)To demonstrate administration of a 2-dose 9-valent HPV L1 VLP vaccine at Day 1 & Month 6 induces non-inferior GMTs for serum anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18, anti-HPV 31, anti-HPV 33, anti-HPV 45, anti-HPV 52, & anti-HPV 58 in 9 to 14 year old girls compared to 16 to 26 year old young women receiving 3 doses. 2)To demonstrate administration of a 2-dose 9-valent HPV L1 VLP vaccine at Day 1 & Month 6 induces non-inferior GMTs for serum anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18, anti-HPV 31, anti-HPV 33, anti-HPV 45, anti-HPV 52, & anti-HPV 58 in 9 to 14 year old boys compared to 16 to 26 year old young women receiving 3 doses. 3)To demonstrate administration of a 2-dose 9-valent HPV L1 VLP vaccine at Day 1 and Month 12 induces non-inferior GMTs for serum anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18, anti-HPV 31, anti-HPV 33, anti-HPV 45, anti-HPV 52, & anti-HPV 58 in 9 to 14 year old boys & girls compared to 16 to 26 year old women receiving 3 doses. |
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E.2.2 | Secondary objectives of the trial |
1) Objective: To demonstrate that the administration of a 2-dose 9-valent HPV L1 VLP vaccine at Day 1 and Month 6 induces non-inferior immune responses with respect to seroconversion percentages to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in 9 to 14 year old girls compared to 16 to 26 year old young adult women. 2) Objective: To demonstrate that the administration of a 2-dose 9-valent HPV L1 VLP vaccine at Day 1 and Month 6 induces non-inferior immune responses with respect to seroconversion percentages to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in 9 to 14 year old boys compared to 16 to 26 year old young adult women. 3) Objective: To demonstrate that the administration of a 2-dose 9-valent HPV L1 VLP vaccine at Day 1 and Month 12 induces non-inferior immune responses with respect to seroconversion percentages to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in 9 to 14 year old boys and girls compared to 16 to 26 year old young adult women. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Boys and Girls Age 9 to 14 Years
1. Subject is male or female, between the ages of 9 years and 14 years 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.
4. Subject must not yet have had coitarche and does not plan on becoming sexually active during the vaccination period (Day 1 through Month 7 or Day 1 through Month 13).
5.1.2.2 Inclusion Criteria: Women Age 16 to 26 Years
For items with an asterisk (*), if the subject does not meet these inclusion criteria, the Day 1 visit may be rescheduled for a time when these criteria can be met.
5. Subject is female, between the ages of 16 and 26 years on the day of enrollment.
6. Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory results.
7. 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.
8. Subject has never had Pap testing or has only had normal Pap test results.
9. Subject has a lifetime history of 0 to 4 male and/or female sexual partners at the time
of enrollment.
10. *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). |
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E.4 | Principal 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 tovaccine components is defined as an allergic reaction that met the criteria for serious adverse experiences.
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 clinical studies of investigational agents.
5. (Females only) - Subject is pregnant (as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL β-hCG).
6. (Young Adult Women only - 16 to 26 years of age) - 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 certain immunosuppressive therapies.
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 or Day 1 through Month 13 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°F or ≥37.8°C) within the 24-hour period prior to the Day 1 vaccination.
14. Subject is unable to give consent/assent.
15. Subject has a history of a positive test for HPV. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Immunogenicity Endpoints
The primary immunogenicity endpoints are HPV-9 cLIA geometric mean titers (GMTs) to HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 4 weeks post last dose. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Immunogenicity Endpoints
The secondary immunogenicity endpoints are the HPV-9 cLIA seroconversion percentages to each of HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 by 4 weeks post last dose. Seroconversion is defined as changing serostatus from seronegative to seropositive, by 4 weeks post last dose. A subject with a HPV-9 cLIA titer at or above the serostatus cutoff for a given HPV type is considered seropositive for that type.
Safety Endpoints
Safety assessment will focus on the serious adverse experiences which will be collected for
the duration of the study.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Chile |
Colombia |
Thailand |
Israel |
Mexico |
South Africa |
Turkey |
Canada |
Korea, Democratic People's Republic of |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 10 |