Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)

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Brief Title

Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)

Official Title

A Randomized, Double-Blind, Multicenter, Biphasic, Controlled With GARDASIL™ Dose-Escalation Study of Octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and ISCOMATRIX™ (IMX)

Brief Summary

      This study will examine the safety and tolerability of octavalent Human Papillomavirus (HPV)
      L1 Virus-Like Particle (VLP) vaccine formulated with amorphous aluminum hydroxysulfate (AAHS)
      and ISCOMATRIX™ (IMX). Reviews of safety and tolerability will be used to select the dose(s)
      of IMX for further studies of the octavalent HPV L1 VLP vaccine.
    

Detailed Description

      The study was performed in 2 staggered phases, Phase A and Phase B. In Phase A, participants
      were randomized to qHPV, Octavalent HPV with 15 mcg IMX/AAHS, or Octavalent HPV with 30 mcg
      IMX/AAHS. After the safety for Phase A was reviewed, Phase B was initiated. In Phase B,
      participants were randomized to qHPV, Octavalent HPV with 60 mcg IMX/AAHS or Octavalent HPV
      with 120 mcg IMX/AAHS.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A


Condition

Human Papilloma Virus

Intervention

Octavalent HPV with 15 mcg IMX / AAHS

Study Arms / Comparison Groups

 qHPV (GARDASIL™) - Phase A Control
Description:  Quadrivalent Human Papillomavirus (qHPV) (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™). This is the control for the Octavalent HPV with 15 mcg ISCOMATRIX™ (IMX) / Aluminum Hydroxyphosphate Sulfate (AAHS) and Octavalent HPV with 30 mcg IMX / AAHS during Phase A.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

158

Start Date

April 2006

Completion Date

November 2009

Primary Completion Date

December 2007

Eligibility Criteria

        Inclusion Criteria:

          -  Participant is in good physical health

          -  Participant has had a lifetime history of 0 to 4 sexual partners

          -  Females between 18-to-24 years

        Exclusion Criteria:

          -  Participant has a history of abnormal Pap test

          -  Participant has a history of positive test for HPV

          -  Participant has a history of recent or ongoing alcohol or drug abuse

          -  Participant is immunocompromised or has an autoimmune condition

          -  Participant has received immunosuppressive therapy within a year of screening

          -  Participant has previously received an HPV vaccine

          -  Participant is pregnant

          -  Participant has a history of external genital/vaginal warts

          -  Participant is currently enrolled in a clinical trial

          -  Participant has a history of a severe allergic reaction that required medical
             attention
      

Gender

Female

Ages

18 Years - 24 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Medical Monitor, , 



Administrative Informations


NCT ID

NCT00851643

Organization ID

V502-002

Secondary IDs

2009_552

Responsible Party

Sponsor

Study Sponsor

Merck Sharp & Dohme Corp.


Study Sponsor

Medical Monitor, Study Director, Merck Sharp & Dohme Corp.


Verification Date

February 2016