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)

NCT01047345 | Completed Phase 3 Results DMC

• 2 other identifiers: V503-0062010_504
• Study Type: interventional
• Target: 924
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Cancers; Vulvar Cancers; Vaginal Cancers; Genital Warts

Keywords

Cervical cancer; Genital warts; Human papillomavirus vaccine; GARDASIL™

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants Who Experience an Injection-site Adverse Event (AE) - 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.

  up to 5 days after any vaccination - Base Study

• Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) - 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.

  up to 5 days after any vaccination - Base Study

• Percentage of Participants Who Experience a Systemic AE - 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.

  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

  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.

  up to 14 days after any vaccination - Base Study

• Percentage of Participants Who Experience a Vaccine-related SAE Any Time During Study- 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.

  Up to 7 months - Base Study

• Percentage of Participants Who Experience a Severe Injection-site AE - 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.

  up to 5 days after any vaccination - Base Study

Secondary Outcomes (1)

• Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study

  4 weeks post-vaccination 3 (Month 7; End of Base Study)

Other Outcomes (1)

• Percentage of Participants Who Experience an SAE- Extension Study

  up to Month 7 - Extension Study

Study Arms (2)

9vHPV Vaccine

EXPERIMENTAL

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.

Biological: V503

Placebo

PLACEBO COMPARATOR

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.

Biological: V503; Biological: Placebo to V503

Interventions

V503 BIOLOGICAL

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

9vHPV Vaccine; Placebo

Placebo to V503 BIOLOGICAL

Placebo to V503 (saline) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study

Placebo

Eligibility Criteria

• Age: 12 Years - 26 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (3)

• 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.

  PMID: 26411885 RESULT

• 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.

  PMID: 27422279 RESULT

• 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.

  PMID: 29211620 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Condylomata Acuminata

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vulvar Diseases; Vaginal Diseases; Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 12, 2010
• Study Start: February 24, 2010
• Primary Completion: June 10, 2011
• Study Completion: November 28, 2015
• Last Updated: November 27, 2018
• Results First Posted: December 22, 2014

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share