E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
vaccination against HPV infection/related disease |
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E.1.1.1 | Medical condition in easily understood language |
vaccination against HPV infection/related disease |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071147 |
E.1.2 | Term | Human papilloma virus immunization |
E.1.2 | System Organ Class | 100000004865 |
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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 |
Part I
1) IMMUNOGENICITY
To evaluate the serum antibody titers to the vaccine HPV types at 1 month Postdose 3 in the subjects recieved the quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine compared with placebo.
2) SAFETY
To demonstrate that a 3-dose regimen of V501 is generally safe and well tolerated.
Part II
1) IMMUNOGENICITY
To describe the persistence of the serum antibody titers for the vaccine HPV types (Types 6, 11, 16, 18) during 2 years of study period after 3-dose regimen of V501.
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E.2.2 | Secondary objectives of the trial |
Part I
1) IMMUNOGENICITY
To compare the serum antibody titers to the vaccine HPV types (Types 6, 11, 16, 18) at 1 month Postdose 3 in the V501 group with the data of a Japanese phase II double-blind comparative study in females aged 18 to 26 years (PN027).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The subjects who satisfy all the criteria below at Visit 1 will be enrolled in the study.
1) Preadolescent and adolescent girls between the ages 9 years and 17 years.
2) Must not yet have had coitarche and does not plan on becoming sexually active through the course of the study.
3) Temperature (oral) measured at the test before the initial injection of the investigational product is <37.5C.
4) Subject from whom written informed consent form is obtained from the guardian (legal representative) before the start of study (assent should be obtained from the subject whenever possible)
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E.4 | Principal exclusion criteria |
The subject who violates any of the criteria below at Visit 1 will be excluded from the study.
1) Concurrent participation in any other trial within 1 month of the start of this study
2) Positive to the pregnancy test (by a urinary pregnancy test with HCG sensitivity adjusted to 25 IU) at the initial visit of this study. Also a person who wish to become pregnant during the period from the start of investigational vaccination to 7 months after vaccination or a breastfeeding subject.
3) History of known prior vaccination with a HPV vaccine
4) Receipt of inactivated vaccines within 14 days before the start of this study or receipt of live virus vaccines within 28 days before the start of this study.
5) History of serious allergic reaction (e.g., swelling of the mouth and throat, difficulty of breathing, hypotension, or shock) by drug administration.
6) Allergic to the ingredients of vaccine containing aluminum or to yeast
7) Treatment with immunoglobulin or any blood-derived products during the 6 months before the start of this study or scheduled treatment with any such product during the study period
8) Individuals with history of splenectomy, known immune disorder (e.g., systemic erythematosus, rheumatic disease), receiving immunosuppressives (e.g., substances or treatment known to diminish immune response such as radiation therapy, administration of antimetabolite, antilymphocytic sera, oral or parenteral systemic corticosteroid). Individuals who have received periodic treatments with immunosuppressives, defined as at least 3 courses of systemic corticosteroids each lasting at least 1 week in duration for the year prior to enrollment, will be excluded. Those who have received topical (e.g., inhaled or intranasal) corticosteroid therapy may be enrolled.
9) Thrombocytopenia or coagulopathy that contradicts intramuscular injection
10) Diagnosed immunodeficiency or HIV infection
11) Presence or history of alcohol or drug abuse. Alcohol abuse is defined as the failure to abstain from taking alcohol despite repetition of alcohol-related social, interpersonal, and legal troubles.
12) Any other condition that disqualifies the individual for the study in the opinion of the investigator/subinvestigator
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E.5 End points |
E.5.1 | Primary end point(s) |
Immunogenicity endpoints
Serum antibody titer of each HPV type (HPV 6, HPV 11, HPV 16, and HPV 18)contained in vaccines
Safety endpoints
Vital signs (temperature (oral), sitting blood pressure, and pulse rate), laboratory values, injection site reactions, and adverse events
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1.Immunogenicity: Serum will be collected at Visits 1, 2, 3, 5, 6, and 7. Analysis will occur after Period I and again after Period II
2. Safety: Analysis will occur after Period I
a. Vital signs will be measured at Visit 1, 2, 4 or at the time of discontinuation.
b. Injection site reactions will be observed at Visit 1 2, 4.
c. Laboratory values: The following examinations will be performed at visit 1, 2, 5 or at the time of discontinuation before visit 5. Hematology: WBC, RBC, hemoglobin, hematocrit, and platelet countBlood Chemistry: Total protein, total bilirubin, AST (GOT), ALT (GPT), BUN, and serum creatinineUrinalysis: Sugars, proteins, and urobilinogen
d. Adverse events: during the study treatment (including placebo) or during the follow-up period.
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E.5.2 | Secondary end point(s) |
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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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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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.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 7 |