Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)

A Phase IIa Randomized, Double-Blind Controlled With Gardasil, Clinical Trial to Study theTolerability and Immunogenicity of V505 (a Multivalent Human Papilloma Virus [HPV] L1 Virus Like Particle [VLP] Vaccine) in Healthy 16 to 26 Year Old Women

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00520598

Enrollment

511

Registered

2007-08-24

Start date

2007-10-31

Completion date

2011-05-31

Last updated

2015-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Genital Warts, Human Papillomavirus Infection, Vaginal Cancer, Vulvar Cancer

Brief summary

The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)

Interventions

BIOLOGICALComparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant

0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen at Day 1, Month 2 and Month 6.

BIOLOGICALComparator: Placebo (unspecified)

0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.

BIOLOGICALComparator: V505 formulation 1

0.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6.

DRUGComparator: V505 formulation 2

0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6.

BIOLOGICALComparator: V505 formulation 3

0.5 ml injection of V505 formulation 3 as 2 dose regimen at Day 1 and Month 6.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 26 Years

Healthy volunteers

Yes

Inclusion criteria

* Female between 16 to 26 years old * Has never had Pap testing or have only had normal Pap test results * Lifetime history of 0 to 4 sexual partners

Exclusion criteria

* History of an abnormal cervical biopsy result; History of a positive test for HPV; History of external genital/vaginal warts; Currently a user of any illegal drugs or an alcohol abuser * History of severe allergic reaction that required medical attention * Are pregnant * Received a marketed HPV vaccine * Currently enrolled in a clinical trial * Currently has (or has a history of) certain medical conditions or is currently taking or has taken certain medications (details will be discussed at time of consent)

Design outcomes

Primary

Measure	Time frame
Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen	4 weeks post dose 3

Secondary

Measure	Time frame
Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 2-dose regimen	4 weeks post dose 2

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026