Japan Adolescent Study of V501 in Females Aged 9 to 17 Years

Phase 1

• Conditions: vaccination against HPV infection/related disease; MedDRA version: 19.1Level: LLTClassification code 10071147Term: Human papilloma virus immunizationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-000112-42-Outside-EU/EEA
• Lead Sponsor: Banyu Pharmaceutical Co., Ltd. a subsidiary of Merck & Co., Inc, Kenilworth, New Jersey

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-11
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

• Status: A
• Sex: Female
• Target Recruitment: 107

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 <37.5?C.
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)

Are the trial subjects under 18? yes
Number of subjects for this age range: 107
F.1.2 Adults (18-64 years) no
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

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

Study & Design

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