Clinical trial NCT01047345: 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: 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™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Cancers
Vulvar Cancers
Vaginal Cancers
Genital Warts
Keywords: Cervical cancer
Genital warts
Human papillomavirus vaccine
GARDASIL™
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-01-12
Enrollment: 924
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Experience an Injection-site Adverse Event (AE) - Base Study
timeFrame: up to 5 days after any vaccination - Base Study
measure: Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) - Base Study
timeFrame: up to 5 days after any vaccination - Base Study
measure: Percentage of Participants Who Experience a Systemic AE - Base Study
timeFrame: up to 14 days after any vaccination - Base Study
measure: Percentage of Participants Who Experience a Serious Adverse Event (SAE) Within 15 Days of Any Vaccination - Base Study
timeFrame: up to 14 days after any vaccination - Base Study
measure: Percentage of Participants Who Experience a Vaccine-related SAE Any Time During Study- Base Study
timeFrame: Up to 7 months - Base Study
measure: Percentage of Participants Who Experience a Severe Injection-site AE - Base Study
timeFrame: 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
timeFrame: 4 weeks post-vaccination 3 (Month 7; End of Base Study)
Other outcomes:
measure: Percentage of Participants Who Experience an SAE- Extension Study
timeFrame: up to Month 7 - Extension Study
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Garland SM, Cheung TH, McNeill S, Petersen LK, Romaguera J, Vazquez-Narvaez J, Bautista O, Shields C, Vuocolo S, Luxembourg A. Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine. Vaccine. 2015 Nov 27;33(48):6855-64. doi: 10.1016/j.vaccine.2015.08.059. Epub 2015 Sep 26.
citation: Moreira ED Jr, Block SL, Ferris D, Giuliano AR, Iversen OE, Joura EA, Kosalaraksa P, Schilling A, Van Damme P, Bornstein J, Bosch FX, Pils S, Cuzick J, Garland SM, Huh W, Kjaer SK, Qi H, Hyatt D, Martin J, Moeller E, Ritter M, Baudin M, Luxembourg A. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics. 2016 Aug;138(2):e20154387. doi: 10.1542/peds.2015-4387. Epub 2016 Jul 15.
citation: Moreira ED, Giuliano AR, de Hoon J, Iversen OE, Joura EA, Restrepo J, Van Damme P, Vandermeulen C, Ellison MC, Krick A, Shields C, Heiles B, Luxembourg A. Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age. Hum Vaccin Immunother. 2018 Feb 1;14(2):396-403. doi: 10.1080/21645515.2017.1403700. Epub 2017 Dec 14.