Clinical Trial: Comparison of Purified Vero Rabies Vaccine, Serum Free With Human Diploid Cell Vaccine in Pre-exposure Use

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Immunogenicity of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Human Diploid Cell Vaccine, Imovax® Rabies in Pre-

Brief Summary:

The aim of this study is to generate data on immunogenicity and safety of Purified Vero Rabies Vaccine - Serum Free (VRVg) in comparison with Imovax® Rabies in order to support the registration of VRVg in the USA.

Primary Objectives:

  • To demonstrate that VRVg is non inferior to Imovax® Rabies in terms of proportion of subjects achieving an rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day 42.
  • To demonstrate that the observed proportion of subjects achieving an RVNA titer ≥ 0.5 IU/mL at Day 42 is at least 99%, with a 95% lower confidence limit of at least 97%.

Secondary Objectives:

  • To assess the clinical safety of VRVg each vaccine after each vaccine injection when administered in a pre-exposure schedule.
  • To describe the immune response induced by each vaccine 21 days after two vaccinations (Day 28) in a randomized subset of subjects and 14 days after the last vaccination of the primary vaccination series.
  • To describe antibody persistence at 6 and 12 months after the first vaccination in all subjects, and at 18 and 24 months in a subset of subjects.

Detailed Summary:

The vaccination will be given in three injections, at Day 0, Day 7, and Day 28, respectively, based on the Advisory Committee on Immunization Practice (ACIP) and the World Health Organization (WHO) recommendations for pre-exposure regimen. A booster dose will be administered 1 year after the first vaccine injection in a randomized subset of participants.

Safety will be assessed in all participants up to 28 days after vaccination, as applicable, in terms of occurrence of adverse events (AEs), and serious adverse events (SAEs) and adverse events of special interest (AESIs) up to Month 12.


Sponsor: Sanofi Pasteur, a Sanofi Company

Current Primary Outcome:

  • Number of participants with rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day 42 (14 days after the last vaccination of primary vaccination series). [ Time Frame: Day 42 post-vaccination ]
    Rabies virus neutralizing antibody titer will be determined by the rapid fluorescent focus inhibition test (RFFIT)
  • Antibody Persistence in terms of rabies virus neutralizing antibody titers at 6 months and 12 months after the first vaccination [ Time Frame: 6 and 12 months post-vaccination ]
    Rabies virus neutralizing antibody titer will be determined by the rapid fluorescent focus inhibition test (RFFIT)


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of Participants Reporting Solicited Injection Site Reactions, Solicited Systemic Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring Throughout the Trial [ Time Frame: Day 0 up to 12 months post-vaccination ]

Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: fever (temperature), headache, malaise, and myalgia.


Original Secondary Outcome: Same as current

Information By: Sanofi

Dates:
Date Received: February 4, 2013
Date Started: February 2013
Date Completion:
Last Updated: January 16, 2016
Last Verified: January 2016