Submitted by: Erah Jean Baria 2018-11-20 00:00:00 Last Updated by: Jeverly Ann S. Principe 2018-11-20 08:37:37 Export to PDF

Imovax® Rabies and VERORAB® Immunogenicity and Safety after One Week 2-sites Intradermal or 1-site Intramuscular Pre-Exposure Prophylaxis Regimens, Followed by a Simulated Intradermal or Intramuscular Post-Exposure Prophylaxis Regimen at One Year

PHRR181120-001988

VAJ00001

2017-CT0432

Phase III, open-label, randomized, controlled trial conducted in healthy subjects aged 2 years and older in the Philippines

This is a Phase III, open-label, randomized, controlled trial conducted in the Philippines. A total of 570 healthy subjects aged ≥ 2 years will be randomized into 5 groups for pre-exposure prophylaxis (PrEP):

Start Date Duration in Months Target Completion Date Actual Completion Date
2018-09-26 14 2019-11-26 0000-00-00

Ongoing

Institution Classification Region LTO #
Sanofi Pasteur Private Business NCR CDRR-NCR-S-8
Institution Amount Region
Sanofi Pasteur N/A NCR
Name E-Mail Phone Number Postal Address
Erah Jean Baria erahjean.baria@sanofi.com 09989626069 21st flr, One World Place, 32nd st. BGC Taguig City
Name E-Mail Phone Number Postal Address
Thelma Laot thelma.laot@sanofi.com 09989626313 21st flr, One World Place, 32nd st. BGC Taguig City
Name Expertise Affiliation
Beatriz P. Quiambao, MD Pedia Infectious Research Institute for Tropical Medicine
Jonathan Lim, MD Pedia Infectious Chong Hua Hospital
Project Location Institutional Ethics Review Board
Research Institute for Tropical Medicine Research Institute for Tropical Medicine Institutional Review Board
Chong Hua Hospital Chong Hua Hospital Ethics Review Committee

Rabies

To demonstrate that a short IM PrEP regimen is non-inferior to the reference IM PrEP regimen in terms of seroconversion rate 14 days after the last PrEP vaccination with HDCV (Group 1 versus Group 2).

Unspecified

Recruiting

  • Philippines

Clinical Trial

Unspecified

2018-01-19

None

Inclusion:

1) Aged ≥ 2 years* on the day of inclusion
2) Subject aged < 18 years: Assent form has been signed and dated by
the subject (as appropriate, according to country-specific institution
requirements), and informed consent form (ICF) signed and dated by
the parent or another legally acceptable representative
Subject aged ≥ 18 years: ICF signed and dated by the subject
3) The subject (and parent/legally acceptable representative, if applicable)
is able to attend all scheduled visits and to comply with all trial

Exclusion:
1) Subject is pregnant, or lactating, or of childbearing potential and not
using an effective method of contraception or abstinence from at least
4 weeks prior to the first vaccination until at least 4 weeks after the last
vaccination. To be considered of non-childbearing potential, a female
must be pre-menarche or post-menopausal for at least 1 year, or
surgically sterile.
2) Participation at the time of study enrollment (or in the 4 weeks
preceding the first trial vaccination) or planned participation during the
present trial period in another clinical trial investigating a vaccine, drug,
medical device, or medical procedure.
3) Receipt of any vaccine in the 4 weeks preceding the first trial
vaccination or planned receipt of any vaccine in the 4 weeks following
any trial vaccination except for influenza vaccination, which may be
received at least 2 weeks before study vaccines. This exception includes
monovalent pandemic influenza vaccines and multivalent influenza
vaccines.
4) Previous vaccination at any time against rabies with either the trial
vaccine or another vaccine
5) Receipt of immune globulins, blood, or blood-derived products in the
past 3 months
6) Known or suspected congenital or acquired immunodeficiency; or
receipt of immunosuppressive therapy, such as anti-cancer
chemotherapy or radiation therapy, within the preceding 6 months; or
long-term systemic corticosteroid therapy (prednisone or equivalent for
more than 2 consecutive weeks within the past 3 months)
7) Known systemic hypersensitivity to any of the vaccine components, or
history of a life-threatening reaction to the vaccines used in the trial or
to a vaccine containing any of the same substances
8) Self-reported thrombocytopenia, contraindicating IM vaccination
9) Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding
inclusion, contraindicating intramuscular vaccination
10) Deprived of freedom by an administrative or court order, or in an
emergency setting, or hospitalized involuntarily
11) Current alcohol abuse or drug addiction
12) Chronic illness that, in the opinion of the investigator, is at a stage
where it might interfere with trial conduct or completion
13) Moderate or severe acute illness/infection (according to investigator
judgment) on the day of vaccination or febrile illness (temperature
≥ 38.0°C). A prospective subject should not be included in the study
until the condition has resolved or the febrile event has subsided
14) Identified as an Investigator or employee of the Investigator or study
center with direct involvement in the proposed study, or identified as an
immediate family member (i.e., parent, spouse, natural or adopted child)
of the Investigator or employee with direct involvement in the proposed
study
15) History of Guillain-Barré syndrome
16) Receipt of chloroquine or other medications used for malaria
chemoprophylaxis, with or without other anti-malarial treatment, for
more than 4 weeks (duration of anti-malarial course) and part of the
treatment received within the 2 weeks before vaccination,
contraindicating intradermal vaccination

Interventional

Imovax® Rabies, Human Diploid Cell Vaccine (HDCV) and Verorab®, Purified Vero cell Rabies Vaccine (PVRV)

Imovax Rabies - Freeze-dried suspension of inactivated rabies virus reconstituted with 1 mL

diluent.
Verorab - Freeze-dried inactivated rabies virus rehydrated with diluent

Randomized

Open Label

Unspecified

Parallel

To demonstrate that a short IM PrEP regimen is non-inferior to the reference
IM PrEP regimen in terms of seroconversion rate 14 days after the last PrEP
vaccination with HDCV (Group 1 versus Group 2).

Phase III

570

Unspecified

Unspecified

26 Sep 2018

Utilization Utilization Info
No records found.

Copyright © One Window Project 2018. All rights reserved.