Clinical trial · Interventional

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

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

NCT00092495CI-TRIAL-00016602completedPhase 3Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Cervical Cancer	Malignant Cervical Neoplasm	CURATED_EXACT	0.92
Genital Warts	Condyloma Acuminatum	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine	Biological	—	UNRESOLVED

Design

Arms and outcomes

Arms (4)

type
EXPERIMENTAL
label
1
description
100% Formulation qHPV Vaccine
interventionNames
1. Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
type
EXPERIMENTAL
label
2
description
60% Formulation qHPV Vaccine
interventionNames
1. Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
type
EXPERIMENTAL
label
3
description
40% Formulation qHPV Vaccine

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 10 Years
Maximum age: 23 Years

Show eligibility criteria text

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

References

Publications (6)

BACKGROUNDBlock SL, Nolan T, Sattler C, Barr E, Giacoletti KE, Marchant CD, Castellsague 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. doi: 10.1542/peds.2006-0461. PMID 17079588
BACKGROUNDBarr 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. PMID 18313445
BACKGROUNDPerez G, Lazcano-Ponce E, Hernandez-Avila M, Garcia PJ, Munoz 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. doi: 10.1002/ijc.23260. PMID 18000825
BACKGROUNDGiuliano 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. doi: 10.1086/521679. Epub 2007 Sep 17. PMID 17955433
DERIVEDGarland SM, Ault KA, Gall SA, Paavonen J, Sings HL, Ciprero KL, Saah A, Marino D, Ryan D, Radley D, Zhou H, Haupt RM, Garner EIO; Quadrivalent Human Papillomavirus Vaccine Phase III Investigators. Pregnancy and infant outcomes in the clinical trials of a human papillomavirus type 6/11/16/18 vaccine: a combined analysis of five randomized controlled trials. Obstet Gynecol. 2009 Dec;114(6):1179-1188. doi: 10.1097/AOG.0b013e3181c2ca21. PMID 19935017