Overview

This trial is active, not recruiting.

Conditions cervical cancers, vulvar cancers, vaginal cancers, genital warts
Treatments v503, placebo to v503
Phase phase 3
Sponsor Merck Sharp & Dohme Corp.
Start date February 2010
End date June 2011
Trial size 924 participants
Trial identifier NCT01047345, 2010_504, V503-006

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
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.
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
(Placebo Comparator)
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 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
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
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

Primary Outcomes

Measure
Percentage of Participants Who Experience an Injection-site Adverse Event (AE) - Base Study
time frame: up to 5 days after any vaccination - Base Study
Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) - Base Study
time frame: up to 5 days after any vaccination - Base Study
Percentage of Participants Who Experience a Systemic AE - Base Study
time frame: up to 14 days after any vaccination - Base Study
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
Percentage of Participants Who Experience a Vaccine-related SAE Within 15 Days of Any Vaccination - Base Study
time frame: up to 14 days after any vaccination - Base Study
Percentage of Participants Who Experience a Severe Injection-site AE - Base Study
time frame: up to 5 days after any vaccination - Base Study

Secondary Outcomes

Measure
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)

Eligibility Criteria

Female participants from 12 years up to 26 years old.

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

Additional Information

Official title 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™
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..