Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)

Cervical Cancer Clinical Trial

Official title:

A Study to Demonstrate Immunogenicity and Tolerability of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents, and To Determine End-Expiry Specifications for the Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00092495
• Other study ID #: V501-016
• Secondary ID: 2004_083
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2004
• Last updated: December 29, 2014
• Start date: December 2002
• Est. completion date: February 2009

Study information

• Verified date: December 2014
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary purpose of the study is to determine if an investigational vaccine Gardasil (V501) with 4 components will provide an immune response and will be well tolerated in pre-adolescents and adolescents.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3055
• Est. completion date: February 2009
• Est. primary completion date: September 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 23 Years

Eligibility

Inclusion Criteria:

• Healthy adolescents and pre-adolescents with no prior sexual history

• Healthy women who have an intact uterus with lifetime history of 0-4 sexual partners

Exclusion Criteria:

• Prior Human Papillomavirus (HPV) vaccination

• Prior abnormal Paps

• Prior history of genital warts

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cervical Cancer
• Genital Warts
• Uterine Cervical Neoplasms

Intervention

Biological:
• V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (4)

Barr E, Gause CK, Bautista OM, Railkar RA, Lupinacci LC, Insinga RP, Sings HL, Haupt RM. Impact of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine in a sexually active population of North American women. Am J Obstet Gynecol. 2008 Mar;198(3):261.e1-11. doi: 10.1016/j.ajog.2007.09.001. — View Citation

Block SL, Nolan T, Sattler C, Barr E, Giacoletti KE, Marchant CD, Castellsagué X, Rusche SA, Lukac S, Bryan JT, Cavanaugh PF Jr, Reisinger KS; Protocol 016 Study Group. Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women. Pediatrics. 2006 Nov;118(5):2135-45. — View Citation

Giuliano AR, Lazcano-Ponce E, Villa L, Nolan T, Marchant C, Radley D, Golm G, McCarroll K, Yu J, Esser MT, Vuocolo SC, Barr E. Impact of baseline covariates on the immunogenicity of a quadrivalent (types 6, 11, 16, and 18) human papillomavirus virus-like-particle vaccine. J Infect Dis. 2007 Oct 15;196(8):1153-62. Epub 2007 Sep 17. — View Citation

Perez G, Lazcano-Ponce E, Hernandez-Avila M, García PJ, Muñoz N, Villa LL, Bryan J, Taddeo FJ, Lu S, Esser MT, Vuocolo S, Sattler C, Barr E. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like-particle vaccine in Latin American women. Int J Cancer. 2008 Mar 15;122(6):1311-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3	Seroconversion is defined as going from seronegative to seropositive.; Seropositivity is defined as an anti-HPV 6 titer = 20 milliMerck units per milliliter (mMU/mL).	Week 4 Postdose 3 (Month 7)	No
Primary	Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3		Week 4 Postdose 3 (Month 7)	No
Primary	Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3	Seroconversion is defined as going from seronegative to seropositive.; Seropositivity is defined as an anti-HPV 11 titer = 16 milliMerck units per milliliter (mMU/mL).	Week 4 Postdose 3 (Month 7)	No
Primary	Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3		Week 4 Postdose 3 (Month 7)	No
Primary	Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3	Seropositivity is defined as an anti-HPV 16 titer = 20 milliMerck units per milliliter (mMU/mL). Seroconversion is defined as going from seronegative to seropositive.	Week 4 Postdose 3 (Month 7)	No
Primary	Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3		Week 4 Postdose 3 (Month 7)	No
Primary	Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3	Seroconversion is defined as going from seronegative to seropositive.; Seropositivity is defined as an anti-HPV 16 titer = 20 milliMerck units per milliliter (mMU/mL).	Week 4 Postdose 3 (Month 7)	No
Primary	Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3	Seroconversion is defined as going from seronegative to seropositive.; Seropositivity is defined as an anti-HPV 18 titer = 24 milliMerck units per milliliter (mMU/mL).	Week 4 Postdose 3 (Month 7)	No
Primary	Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3		Week 4 Postdose 3 (Month 7)	No