Study to Test the Safety of HPV Vaccine in Women (V501-011)(COMPLETED)

Immunogenicity and Safety of Quadrivalent HPV L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women When Administered Alone or Concomitantly With Hepatitis B Vaccine (Recombinant)--the F.U.T.U.R.E. Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00517309

Acronym

FUTURE

Enrollment

1877

Registered

2007-08-16

Start date

2001-12-28

Completion date

2004-06-11

Last updated

2017-03-22

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

Conditions

Cervical Cancer, Genital Warts

Brief summary

The primary purpose of the study is to test the safety of HPV Vaccine in Women

Interventions

BIOLOGICALV501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years

BIOLOGICALComparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 Years

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 23 Years

Healthy volunteers

Yes

Inclusion criteria

* Females age 16 to 23 years old * Must agree to refrain from sexual activity (vaginal or anal) for 48 hours prior to any scheduled visit

Exclusion criteria

* History of vaccination with an HPV vaccine * History of hepatitis B infection * History of vaccination with hepatitis B vaccine * History of genital warts or treatment for genital warts

Design outcomes

Primary

Measure	Time frame
Quadrivalent HPV vaccine is generally well tolerated when administered alone or concomitantly with hepatitis B vaccine.	—

Secondary

Measure	Time frame
HPV vaccine is well tolerated in 16-23 year old females.	—

Outcome results

None listed

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