A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01047345

First Posted: January 12, 2010

Last Update Posted: April 21, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

Tracking Information

First Submitted Date ^ICMJE

January 11, 2010

First Posted Date ^ICMJE

January 12, 2010

Results First Submitted Date

December 12, 2014

Results First Posted Date

December 22, 2014

Last Update Posted Date

April 21, 2017

Actual Start Date ^ICMJE

February 24, 2010

Primary Completion Date

June 10, 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percentage of Participants Who Experience an Injection-site Adverse Event (AE) - Base Study [ Time Frame: up to 5 days after any vaccination - Base Study ]
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. The percentage of participants who reported an AE that was associated with the injection site such as redness, swelling, and pain/tenderness/soreness was summarized.
Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) - Base Study [ Time Frame: up to 5 days after any vaccination - Base Study ]
Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded.
Percentage of Participants Who Experience a Systemic AE - Base Study [ Time Frame: up to 14 days after any vaccination - Base Study ]
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.
Percentage of Participants Who Experience a Serious Adverse Event (SAE) Within 15 Days of Any Vaccination - Base Study [ Time Frame: up to 14 days after any vaccination - Base Study ]
An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.
Percentage of Participants Who Experience a Vaccine-related SAE Any Time During Study- Base Study [ Time Frame: Up to 7 months - Base Study ]
An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention. An SAE that is judged by the Investigator to be "definitely related," "probably related," or "possibly related" is defined as a vaccine-related SAE.
Percentage of Participants Who Experience a Severe Injection-site AE - Base Study [ Time Frame: up to 5 days after any vaccination - Base Study ]
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. Participants were instructed to estimate the severity of AEs such as pain at injection site as mild (awareness of symptom, but easily tolerated), moderate (discomfort enough to cause interference with usual activities), or severe (incapacitating with inability to work or do usual activity). Additionally, participants were instructed to measure any swelling and/or erythema at its greatest width. Swelling or erythema with diameter >2 inches (>5 cm) was recorded as severe. All AEs associated with the injection site and reported as severe were summarized.

Original Primary Outcome Measures ^ICMJE

Number of participants who experience serious or non-serious adverse events [ Time Frame: Day 1 to Month 7 ]

Change History

Complete list of historical versions of study NCT01047345 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study [ Time Frame: 4 weeks post-vaccination 3 (Month 7; End of Base Study) ]

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.

Original Secondary Outcome Measures ^ICMJE

Number of participants who are seropositive to each of the HPV types contained in V503 [ Time Frame: Month 7 ]

Current Other Outcome Measures ^ICMJE

Percentage of Participants Who Experience an SAE- Extension Study [ Time Frame: up to Month 7 - Extension Study ]

An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)

Official Title ^ICMJE

A Phase III, Randomized, International, Placebo-Controlled, Double-Blind Clinical Trial to Study the Tolerability and Immunogenicity of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Given to Females 12-26 Years of Age Who Have Previously Received GARDASIL™

Brief Summary

This study will evaluate whether V503 (9vHPV vaccine), is well tolerated in girls and women between 12 and 26 years old who have previously been vaccinated with GARDASIL™. Participants will receive vaccination with 9vHPV vaccine or placebo on Day 1, Month 2, and Month 6 of the Base Study. Participants who receive placebo in the Base Study will be eligible to receive vaccination with 9vHPV vaccine on Day 1, Month 2, and Month 6 of the Extension Study.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Cervical Cancers
Vulvar Cancers
Vaginal Cancers
Genital Warts

Intervention ^ICMJE

Biological: V503
V503 (9vHPV) vaccine given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study or the Study Extension
Biological: Placebo to V503
Placebo to V503 (saline) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study

Study Arms

Experimental: 9vHPV Vaccine
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.

Intervention: Biological: V503
Placebo Comparator: Placebo
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
Interventions:
- Biological: V503
- Biological: Placebo to V503

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

924

Completion Date

November 28, 2015

Primary Completion Date

June 10, 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Participants Age 12 to 15 Years:

Participant is in good health
Parent/legal guardian and participant agree to provide study personnel with a primary telephone number for follow-up
Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1
Participant has not received any other HPV vaccine
Participant is not yet sexually active

Participants Age 16 to 26 Years:

Participant is in good health
Participant agrees to provide a primary telephone number for follow-up
Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1
Participant has not received any other HPV vaccine
Participant has never had Papanicolaou (Pap) testing or has only had normal results
Participant has a history of 0 to 4 lifetime sexual partners at enrollment

Exclusion Criteria:

All participants:

Participant has a history of severe allergic reaction that required medical intervention
Participant has any disorder that would contraindicate intramuscular injections
Participant is pregnant
Participant is immunocompromised or has an autoimmune condition
Participant has had a splenectomy
Participant has received any immune globulin product or blood-derived product
Participant has participated in a HPV vaccine clinical trial

Participants Age 16 to 26 Only:

Participant expects to donate eggs during the study
Participant has a history of abnormal cervical biopsy result
Participant has a history of HPV-related external genital lesions, external genital cancer, HPV-related vaginal lesions, or vaginal cancer

Sex/Gender

Sexes Eligible for Study:

Female

Ages

12 Years to 26 Years (Child, Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Canada, Colombia, Denmark, Hong Kong, Mexico, Puerto Rico, Sweden, United States

Administrative Information

NCT Number ^ICMJE

NCT01047345

Other Study ID Numbers ^ICMJE

V503-006
2010_504 ( Other Identifier: Merck Registration Number )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

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

Responsible Party

Merck Sharp & Dohme Corp.

Study Sponsor ^ICMJE

Merck Sharp & Dohme Corp.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Director

Merck Sharp & Dohme Corp.

PRS Account

Merck Sharp & Dohme Corp.

Verification Date

March 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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