Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)

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Brief Title

Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)

Official Title

A Randomized, International, Double-Blinded (With In-House Blinding), Controlled With GARDASIL, Dose-Ranging, Tolerability, Immunogenicity, and Efficacy Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 16- to 26- Year-Old Women

Brief Summary

      The purpose of this study was to evaluate the safety, efficacy, and immunogenicity of V503 in
      comparison to GARDASIL. The primary hypotheses tested in the study were 1) V503 administered
      to 16- to 26-year-old adolescents and young women is generally well-tolerated, 2) V503
      reduces combined incidence of Human Papillomavirus (HPV) Type 31/33/45/52/58-related disease
      compared with GARDASIL, and 3) V503 induces non-inferior geometric mean titers for HPV Type
      6/11/16/18 antibodies compared with GARDASIL.
    

Detailed Description

      The study included a dose-finding evaluation of a 3-dose regimen of V503 and GARDASIL, a
      safety/efficacy evaluation of a 3-dose regimen of the selected V503 dose formulation and
      GARDASIL, and an extension consisting of 2 substudies: an evaluation of immune memory in
      participants receiving a fourth vaccination with V503 (Cohort 1), and an opportunity for
      participants who received GARDASIL in the Base Study to receive a 3-dose regimen of V503
      (Cohort 2).
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (Test of Hypothesis)

Secondary Outcome

 Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Persistent Infection

Condition

Cervical Cancer

Intervention

Comparator: GARDASIL

Study Arms / Comparison Groups

 Low-dose V503
Description:  V503 (9-Valent Human Papillomavirus [HPV] Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.

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

14840

Start Date

September 24, 2007

Completion Date

July 7, 2016

Primary Completion Date

April 10, 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Female between 16- to 26-years-old

          -  Has never had Pap testing or has only had normal Pap (Papanicolaou) test results

          -  For the immune memory substudy in the extension (Cohort 1): was randomized to V503 in
             the base study and was in the per-protocol immunogenicity population for ≥1 HPV type

          -  For the 3-dose V503 vaccination substudy in the extension (Cohort 2): was randomized
             to GARDASIL in the base study and received ≥1 dose of GARDASIL

        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 marketed HPV vaccine or participated in an HPV trial

          -  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 the time of consent.)
      

Gender

Female

Ages

16 Years - 26 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Medical Monitor, , 



Administrative Informations


NCT ID

NCT00543543

Organization ID

V503-001

Secondary IDs

2007_538

Responsible Party

Sponsor

Study Sponsor

Merck Sharp & Dohme Corp.


Study Sponsor

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


Verification Date

October 2018