A Study of the Safety, Tolerability, and Immunogenicity of a 9-valent Human Papillomavirus Vaccine ([9vHPV]; V503) Administered to 9- to 15-Year-Old Japanese Girls (V503-008).

Study Description

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Brief Summary:

This study will evaluate the safety, tolerability, and immunogenicity of V503 in Japanese girls between the ages of 9 and 15 and will determine whether V503 induces an acceptable immune response to all human papillomavirus (HPV) strains contained in the vaccine. The success criterion for the primary analysis requires that point estimates for seroconversion rate be greater than 90% for all 9 HPV types.

Condition or disease	Intervention/treatment	Phase
Papillomavirus Infections	Biological: V503	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	100 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	A Phase III Open-label, Safety, Tolerability and Immunogenicity Study of a 9-Valent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 9- to 15-Year-Old Japanese Preadolescent and Adolescent Girls
Study Start Date :	January 2011
Actual Primary Completion Date :	August 2013
Actual Study Completion Date :	August 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: All Enrolled; 9-valent human papillomavirus (9vHPV) L1 VLP vaccine (V503), 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.	Biological: V503; V503 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

Outcome Measures

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Primary Outcome Measures :

1. Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine [ Time Frame: 4 weeks post-vaccination 3 (Month 7) ]
   Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
2. Percentage of Participants With an Injection-site Adverse Event (AE) [ Time Frame: up to 5 days after any vaccination ]
   An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.
3. Percentage of Participants With a Non-Injection Site (Systemic) AE [ Time Frame: up to 15 days after any vaccination ]
   An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.
4. Percentage of Participants With a Vaccine-related AE [ Time Frame: up to 15 days after any vaccination ]
   An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Adverse experience that is judged by the Investigator to be "definitely related," "probably related," or "possibly related" to the study drug is defined as a vaccine-related AE.

Secondary Outcome Measures :

1. Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine [ Time Frame: 4 weeks post-vaccination 3 (Month 7) ]
   Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers are reported in milli Merck Units/mL.

Eligibility Criteria

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Ages Eligible for Study:	9 Years to 15 Years (Child)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Participant is in good physical health-
• Participant's parent/legal guardian is able to read, understand, and complete the vaccine report card
• Participant's parent/legal guardian agrees to provide a phone number for follow-up purposes
• Participant is not sexually active and does not plan to become sexually active during the time from Day 1 to Month 7 of the study

Exclusion Criteria:

• Participant has a history of severe allergic reaction that required medical intervention
• Participant has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
• Participant is pregnant
• Participant intends to donate blood during the time from Day 1 to Month 7 of the study
• Participant is immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
• Participant has had a splenectomy
• Participant has received any of the following immunosuppressive therapies in the year prior to enrollment: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava), tumor necrosis factor alpha (TNF-α) antagonists, monoclonal antibody therapies, antilymphocyte sera, or other therapy known to interfere with the immune response.
• Participant has received any immune globulin product or blood-derived product in the three months prior to the Day 1 vaccination, or plans to receive any such product through Month 7 of the study
• Participant has received any inactivated vaccines within 14 days of the Day 1 vaccination or any live vaccines within 28 days of the Day 1 vaccination
• Participant has received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
• Participant has had a fever (oral temperature ≥37.8°C) within 24 hours of the Day 1 vaccination
• Participant has a history of a positive test for HPV or history of genital warts

Contacts and Locations

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Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

Study Director:	Medical Director	Merck Sharp & Dohme Corp.

More Information

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Study Data/Documents: CSR Synopsis 

Publications of Results:

Iwata S, Murata S, Rong Han S, Wakana A, Sawata M, Tanaka Y. Safety and Immunogenicity of a 9-Valent Human Papillomavirus Vaccine Administered to 9- to 15-Year-Old Japanese Girls. Jpn J Infect Dis. 2017 Jul 24;70(4):368-373. doi: 10.7883/yoken.JJID.2016.299. Epub 2016 Dec 22.

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT01254643 History of Changes
Other Study ID Numbers:	V503-008
First Posted:	December 6, 2010
Results First Posted:	December 22, 2014
Last Update Posted:	March 22, 2017
Last Verified:	February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Keywords provided by Merck Sharp & Dohme Corp.:

Papillomavirus vaccines; Uterine cervical cancer; Human Papilloma Virus infections

Additional relevant MeSH terms:

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections	Vaccines; Immunologic Factors; Physiological Effects of Drugs