NCT00365378

Brief Summary

Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy, immunogenicity, and safety.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,409

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 1999

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
9 months until next milestone

Results Posted

Study results publicly available

April 9, 2010

Completed
Last Updated

October 23, 2015

Status Verified

October 1, 2015

Enrollment Period

4.5 years

First QC Date

August 16, 2006

Results QC Date

March 22, 2010

Last Update Submit

October 22, 2015

Conditions

HPV 16 Infection

Outcome Measures

Primary Outcomes (3)

  • Incidence of Persistent HPV 16 Infection

    Cases of persistent infection were those with detection of HPV 16 by PCR (Polymerase chain reaction) on at least 2 consecutive visits at least 4 months apart; or detection of HPV 16 in a cervical biopsy specimen showing pathologic evidence of CIN1 (Cervical intraepithelial neoplasia), CIN2 or CIN3 together with HPV 16 detected at the visit immediately before or after the biopsy; or detection of HPV 16 on a subject's last visit.

    Through Month 48

  • Incidence of HPV 16-related CIN1, CIN2 or C1N3

    Cases of HPV 16-related CIN1, CIN2 or CIN3 are those with detection of HPV 16 in a cervical biopsy specimen showing pathologic evidence of CIN1, CIN2 or CIN3 together with HPV 16 detected at the visit immediately before or after the biopsy.

    Through Month 48

  • Serum Anti-HPV 16 Geometric Mean Titers

    The limit of detection of the assay was 6 mMU/ml. Samples with titer below the limit of detection were assigned a value of 3 for calculation of GMT and confidence interval. GMTs and confidence limits below the limit of detection are shown as "6.0".

    Month 7

Study Arms (2)

1

EXPERIMENTAL

HPV 16 L1 VLP vaccine

Biological: Comparator: HPV 16 L1 Vaccine

2

PLACEBO COMPARATOR

Placebo

Biological: Comparator: Placebo

Interventions

Comparator: HPV 16 L1 VaccineBIOLOGICAL

A 0.5 intramuscular injection given at Day 1, Month 2, and Month 6

Also known as: V501
1
Comparator: PlaceboBIOLOGICAL

A 0.5 intramuscular placebo injection given at Day 1, Month 2, and Month 6

2

Eligibility Criteria

Age16 Years - 23 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy, unmarried females age 16 to 23 years with intact uteri
  • Not pregnant at enrollment
  • Agreed to use effective contraception through Month 7 of the study
  • A lifetime history of 0 to 5 male partners with whom the subjects engaged in at least one episode of insertive intercourse

You may not qualify if:

  • No prior history of Human Papillomavirus (HPV) vaccination
  • No receipt of any other vaccination within 1 month prior to enrollment or plans to receive any other vaccination within 1 month prior to or after any dose of study vaccine
  • No prior history of an abnormal Papanicolaou (Pap) test showing Squamous intraepithelial lesion (SIL) or biopsy showing Cervical intraepithelial neoplasia (CIN)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Mao C, Koutsky LA, Ault KA, Wheeler CM, Brown DR, Wiley DJ, Alvarez FB, Bautista OM, Jansen KU, Barr E. Efficacy of human papillomavirus-16 vaccine to prevent cervical intraepithelial neoplasia: a randomized controlled trial. Obstet Gynecol. 2006 Jan;107(1):18-27. doi: 10.1097/01.AOG.0000192397.41191.fb.

    PMID: 16394035BACKGROUND

  • Koutsky LA, Ault KA, Wheeler CM, Brown DR, Barr E, Alvarez FB, Chiacchierini LM, Jansen KU; Proof of Principle Study Investigators. A controlled trial of a human papillomavirus type 16 vaccine. N Engl J Med. 2002 Nov 21;347(21):1645-51. doi: 10.1056/NEJMoa020586.

    PMID: 12444178BACKGROUND

  • Paavonen J; Future II Study Group. Baseline demographic characteristics of subjects enrolled in international quadrivalent HPV (types 6/11/16/18) vaccine clinical trials. Curr Med Res Opin. 2008 Jun;24(6):1623-34. doi: 10.1185/03007990802068151. Epub 2008 Apr 23.

    PMID: 18435868BACKGROUND

  • 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.

    PMID: 18313445BACKGROUND

  • Ault KA; Future II Study Group. Effect of prophylactic human papillomavirus L1 virus-like-particle vaccine on risk of cervical intraepithelial neoplasia grade 2, grade 3, and adenocarcinoma in situ: a combined analysis of four randomised clinical trials. Lancet. 2007 Jun 2;369(9576):1861-1868. doi: 10.1016/S0140-6736(07)60852-6.

    PMID: 17544766BACKGROUND

  • Fraser C, Tomassini JE, Xi L, Golm G, Watson M, Giuliano AR, Barr E, Ault KA. Modeling the long-term antibody response of a human papillomavirus (HPV) virus-like particle (VLP) type 16 prophylactic vaccine. Vaccine. 2007 May 22;25(21):4324-33. doi: 10.1016/j.vaccine.2007.02.069. Epub 2007 Mar 12.

    PMID: 17445955BACKGROUND

  • Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.

    PMID: 41276263DERIVED

  • Wiley DJ, Masongsong EV, Lu S, Heather L S, Salem B, Giuliano AR, Ault KA, Haupt RM, Brown DR. Behavioral and sociodemographic risk factors for serological and DNA evidence of HPV6, 11, 16, 18 infections. Cancer Epidemiol. 2012 Jun;36(3):e183-9. doi: 10.1016/j.canep.2011.12.007. Epub 2012 Jan 25.

    PMID: 22277329DERIVED

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Intervention Hierarchy (Ancestors)

Vaccines, CombinedVaccinesBiological ProductsComplex MixturesPapillomavirus VaccinesViral Vaccines

Limitations and Caveats

Of note, the number of subjects reported in the results posting is slightly different than that specified in the publication by Koutsky, et al (2002). The data provided here is based on final data.

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 Monitor

    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 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2006

First Posted

August 17, 2006

Study Start

September 1, 1999

Primary Completion

March 1, 2004

Study Completion

July 1, 2009

Last Updated

October 23, 2015

Results First Posted

April 9, 2010

Record last verified: 2015-10